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FDA Paragraph IV list

Drybench Patent.

FDA Paragraph IV list: D

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose group's drug name, as listed, starts with D, grouped by the NDA number the list gives.

FDA capture · review pending. Each row is shown as captured from FDA's list. Spreadsheet day numbers are shown as dates; a cell that cannot be read as one date is shown as written. A row is placed under an NDA only by the number in its RLD/NDA cell; nothing is joined by name. How this page reads the list has not been independently reviewed by a regulatory-affairs reviewer.

Paragraph IV list captured
17 October 2026
Last checked
30 October 2026

Rows as FDA lists them, not a forecast of market entry and not legal, regulatory or investment advice.

FDA's list is not complete and names no ANDA applicant, patent number or litigation. A product not shown here may still have had a Paragraph IV certification submitted; a product shown under an NDA may have more rows among those kept apart.

The list gives the last qualifying patent's expiry without pediatric exclusivity; in the app's Patents view, the Orange Book lists any *PED period as a separate row with its own date. The two dates describe different things. A blank cell is one FDA left blank in its list. Dates are FDA's own; the last qualifying patent expiry is not recomputed from the Orange Book.

Paragraph IV certificationWhat changed, by week

Dabigatran Etexilate Mesylate

NDA 022512 · 2 rows · Listed patents and exclusivities · Open in the app

  • Capsules · eq. to 110 mg base

    RLD/NDA as listed: Pradaxa 22512
    First PIV submission
    15 Dec 2015
    ANDAs
    2
    180-day status
    Eligible
    Decision posted
    8 Jan 2024
    First applicant approval
    15 Dec 2023
    First marketing
    13 Feb 2024
    Last qualifying patent expiry (as listed by FDA)
    20 Jan 2031

  • Capsules · eq. to 75 mg base and 150 mg base

    RLD/NDA as listed: Pradaxa 22512
    First PIV submission
    20 Oct 2014
    ANDAs
    17
    180-day status
    Eligible
    Decision posted
    15 Jun 2020
    First applicant approval
    11 Mar 2020
    First marketing
    75 mg - 7/1/2022 150 mg-3/11/2020
    Last qualifying patent expiry (as listed by FDA)
    31 Aug 2027

Dabrafenib Mesylate

NDA 202806 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 50 mg and 75 mg

    RLD/NDA as listed: Tafinlar 202806
    First PIV submission
    13 Nov 2025
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    15 Oct 2030

Dalbavancin Hydrochloride

NDA 021883 · 1 row · Listed patents and exclusivities · Open in the app

  • Powder For Injection · 500 mg/vial

    RLD/NDA as listed: Dalvance 21883
    First PIV submission
    23 May 2023
    ANDAs
    3
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    23 May 2028

Dalfampridine

NDA 022250 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 10 mg

    RLD/NDA as listed: Ampyra 22250
    First PIV submission
    22 Jan 2014
    ANDAs
    8
    180-day status
    Eligible
    Decision posted
    19 Nov 2019
    First applicant approval
    23 Jan 2017
    First marketing
    10 Sep 2018
    Last qualifying patent expiry (as listed by FDA)
    26 May 2027

Dapagliflozin

NDA 202293 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 5 mg and 10 mg

    RLD/NDA as listed: Farxiga 202293
    First PIV submission
    8 Jan 2018
    ANDAs
    20
    180-day status
    Eligible
    Decision posted
    13 Apr 2026
    First applicant approval
    6 Apr 2026
    First marketing
    6 Apr 2026
    Last qualifying patent expiry (as listed by FDA)
    26 May 2030

Dapagliflozin and Metformin Hydrochloride

NDA 205649 · 2 rows · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 2.5 mg/1000 mg

    RLD/NDA as listed: Xigduo XR 205649
    First PIV submission
    29 Oct 2018
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    13 Apr 2026
    First applicant approval
    6 Apr 2026
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    12 Nov 2030

  • Dapaglifozin and Metformin Hydrochloride · Extended-release Tablets · 5 mg/500 mg 5 mg/1000 mg 10 mg/500 mg 10 mg/1000 mg

    RLD/NDA as listed: Xigduo XR 205649
    First PIV submission
    8 Jan 2018
    ANDAs
    10
    180-day status
    Eligible
    Decision posted
    13 Apr 2026
    First applicant approval
    6 Apr 2026
    First marketing
    6 Apr 2026
    Last qualifying patent expiry (as listed by FDA)
    26 May 2030

Dapagliflozin and Saxagliptan

NDA 209091 · 2 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 10 mg/5 mg

    RLD/NDA as listed: Qtern 209091
    First PIV submission
    8 Jan 2018
    ANDAs
    5
    180-day status
    Eligible
    Decision posted
    13 Apr 2026
    First applicant approval
    6 Apr 2026
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    16 Dec 2029

  • Tablets · 5 mg/5 mg

    RLD/NDA as listed: Qtern 209091
    First PIV submission
    29 Jul 2020
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    16 Dec 2029

Dapsone

NDA 207154 · 1 row · Listed patents and exclusivities · Open in the app

  • Gel · 7.4999999999999997E-2

    RLD/NDA as listed: Aczone 207154
    First PIV submission
    13 Feb 2017
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    2 Jul 2019
    First applicant approval
    26 Jun 2019
    First marketing
    26 Jun 2019
    Last qualifying patent expiry (as listed by FDA)
    18 Nov 2033

Daptomycin

NDA 021572 · 1 row · Listed patents and exclusivities · Open in the app

  • For Injection · 500 mg/vial

    RLD/NDA as listed: Cubicin 21572
    First PIV submission
    19 Nov 2008
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    19 Nov 2019
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    24 Sep 2019

Darifenacin Hydrobromide

NDA 021513 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 7.5 mg and 15 mg

    RLD/NDA as listed: Enablex 21513
    First PIV submission
    22 Dec 2008
    ANDAs
    3
    180-day status
    Deferred
    Decision posted
    7 Apr 2020
    First applicant approval
    13 Mar 2015
    First marketing
    15 Mar 2016
    Last qualifying patent expiry (as listed by FDA)
    21 Aug 2016

Darolutamide

NDA 212099 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 300 mg

    RLD/NDA as listed: Nubeqa 212099
    First PIV submission
    31 Jul 2023
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    27 Feb 2038

Darunavir and Cobicistat

NDA 205395 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 800 mg/150 mg

    RLD/NDA as listed: Prezcobix 205395
    First PIV submission
    24 Jul 2020
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    6 Oct 2032

Darunavir Ethanolate

NDA 021976 · 4 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 400 mg

    RLD/NDA as listed: Prezista 21976
    First PIV submission
    23 Jun 2010
    ANDAs
    3
    180-day status
    Eligible
    Decision posted
    13 Nov 2023
    First applicant approval
    14 Sep 2023
    First marketing
    18 Oct 2024
    Last qualifying patent expiry (as listed by FDA)
    26 Dec 2026

  • Tablets · 600 mg

    RLD/NDA as listed: Prezista 21976
    First PIV submission
    23 Jun 2010
    ANDAs
    4
    180-day status
    Eligible
    Decision posted
    2 Jul 2019
    First applicant approval
    21 Nov 2017
    First marketing
    1 Jun 2023
    Last qualifying patent expiry (as listed by FDA)
    26 Dec 2026

  • Tablets · 75 mg, 150 mg and 300 mg

    RLD/NDA as listed: Prezista 21976
    First PIV submission
    23 Jun 2010
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    18 Aug 2025
    First applicant approval
    22 Jul 2025
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    26 Dec 2026

  • Tablets · 800 mg

    RLD/NDA as listed: Prezista 21976
    First PIV submission
    14 May 2013
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    4 Oct 2022
    First applicant approval
    29 Sep 2022
    First marketing
    1 Jun 2023
    Last qualifying patent expiry (as listed by FDA)
    26 Dec 2026

Darunavir, Cobicistat, Emtricitabine, Tenofovir Alafenamide

NDA 210455 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 800 mg/150 mg/ 200 mg/10 mg

    RLD/NDA as listed: Symtuza 210455
    First PIV submission
    16 Aug 2021
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    19 Jul 2038

Dasatinib

NDA 021986 · 2 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 20 mg, 50 mg, 70 mg and 100 mg

    RLD/NDA as listed: Sprycel 21986
    First PIV submission
    28 Jun 2010
    ANDAs
    1
    180-day status
    Non-Forfeiture Deferred
    Decision posted
    10/19/2021 4/7/2020
    First applicant approval
    10 Jun 2016
    First marketing
    3 Sep 2024
    Last qualifying patent expiry (as listed by FDA)
    28 Mar 2026

  • Tablets · 80 mg and 140 mg

    RLD/NDA as listed: Sprycel 21986
    First PIV submission
    17 Jun 2011
    ANDAs
    1
    180-day status
    Non-Forfeiture
    Decision posted
    2 Oct 2021
    First applicant approval
    23 Nov 2021
    First marketing
    3 Sep 2024
    Last qualifying patent expiry (as listed by FDA)
    28 Mar 2026

Deferasirox

NDA 021882 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets for Suspension · 125 mg, 250 mg, and 500 mg

    RLD/NDA as listed: Exjade 21882
    First PIV submission
    28 Oct 2011
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    2 Jul 2019
    First applicant approval
    26 Jan 2016
    First marketing
    22 Mar 2019
    Last qualifying patent expiry (as listed by FDA)
    5 Apr 2019

Deferasirox

NDA 206910 · 2 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 180 mg

    RLD/NDA as listed: Jadenu 206910
    First PIV submission
    21 Apr 2016
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    16 Jul 2019
    First applicant approval
    13 Dec 2019
    First marketing
    17 Dec 2019
    Last qualifying patent expiry (as listed by FDA)
    21 Nov 2034

  • Tablets · 90 mg and 360 mg

    RLD/NDA as listed: Jadenu 206910
    First PIV submission
    19 Oct 2015
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    16 Jul 2019
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    5 Apr 2019

Deferiprone

NDA 021825 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 500 mg

    RLD/NDA as listed: Ferriprox 21825
    First PIV submission
    29 Jan 2016
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    13 Aug 2019
    First applicant approval
    8 Feb 2019
    First marketing
    28 Sep 2020
    Last qualifying patent expiry (as listed by FDA)
    28 Jun 2021

Defibrotide Sodium

NDA 208114 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 200 mg/2.5 mL

    RLD/NDA as listed: Defitelio 208114
    First PIV submission
    27 Dec 2024
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    22 Jun 2032

Degarelix Acetate

NDA 022201 · 1 row · Listed patents and exclusivities · Open in the app

  • Powder for Injection · 80 mg/vial and 120 mg/vial

    RLD/NDA as listed: Firmagon 22201
    First PIV submission
    20 Dec 2019
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    27 Apr 2032

Deoxycholic Acid

NDA 206333 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 10 mg/mL (2 mL)

    RLD/NDA as listed: Kybella 206333
    First PIV submission
    13 Jul 2018
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    4 May 2021
    First applicant approval
    2 Apr 2021
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    2 Mar 2030

Desflurane

NDA 020118 · 1 row · Listed patents and exclusivities · Open in the app

  • Inhalation · 99.9%

    RLD/NDA as listed: Suprane 20118
    First PIV submission
    11 Sep 2008
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    8 Apr 2014

Desloratadine

NDA 021165 · 2 rows · Listed patents and exclusivities · Open in the app

  • Orally Disintegrating Tablets · 2.5 mg and 5 mg

    RLD/NDA as listed: Clarinex 21165
    First PIV submission
    21 Jun 2006
    ANDAs
    3
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    12 Jul 2010
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    7 Jul 2019

  • Tablets · 5 mg

    RLD/NDA as listed: Clarinex 21165
    First PIV submission
    21 Jun 2006
    ANDAs
    11
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    25 Oct 2010
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    7 Jul 2019

Desloratadine

NDA 021300 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Solution · 0.5 mg/mL

    RLD/NDA as listed: Clarinex Syrup 21300
    First PIV submission
    8 May 2008
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    1 Jun 2018

Desloratadine and Pseudoephedrine Sulfate

NDA 021313 · 2 rows · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 2.5 mg/120 mg

    RLD/NDA as listed: Clarinex-D 24 Hour 21313
    First PIV submission
    1 Jun 2007
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    18 Feb 2021

  • Extended-release Tablets · 5 mg/240 mg

    RLD/NDA as listed: Clarinex-D 24 Hour 21313
    First PIV submission
    21 Jun 2006
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    26 Apr 2011
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    28 Mar 2022

Desmopressin Acetate

NDA 017922 · 1 row · Listed patents and exclusivities · Open in the app

  • Nasal Spray · 1E-4

    RLD/NDA as listed: DDAVP 17922
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Desmopressin Acetate

NDA 018938 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 4 mcg/mL, 1 mL and 10 mL vials

    RLD/NDA as listed: DDAVP 18938
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Desmopressin Acetate

NDA 019955 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 0.1 mg and 0.2 mg

    RLD/NDA as listed: DDAVP 19955
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Desogestrel; Ethinyl Estradiol Tablets

NDA 020713 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 0.15mg/  0.02 mg and 0.01 mg

    RLD/NDA as listed: Mircette 20713
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Desonide

NDA 021844 · 1 row · Listed patents and exclusivities · Open in the app

  • Gel · 5.0000000000000001E-4

    RLD/NDA as listed: Desonate 21844
    First PIV submission
    1 Dec 2010
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    15 Jun 2020
    First applicant approval
    11 May 2020
    First marketing
    9 Jul 2020
    Last qualifying patent expiry (as listed by FDA)
    3 Aug 2020

Desoximetasone

NDA 204141 · 1 row · Listed patents and exclusivities · Open in the app

  • Topical Spray · 2.5000000000000001E-3

    RLD/NDA as listed: Topicort 204141
    First PIV submission
    18 Dec 2013
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    20 Jan 2017
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    23 Apr 2028

Desvenlafaxine Succinate

NDA 021992 · 2 rows · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 25 mg

    RLD/NDA as listed: Pristiq 21992
    First PIV submission
    8 May 2015
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    7 Apr 2020
    First applicant approval
    29 Jul 2016
    First marketing
    29 Jul 2016
    Last qualifying patent expiry (as listed by FDA)
    5 Jul 2027

  • Extended-release Tablets · 50 mg and 100 mg

    RLD/NDA as listed: Pristiq 21992
    First PIV submission
    29 Feb 2012
    ANDAs
    12
    180-day status
    Eligible
    Decision posted
    18 Jun 2019
    First applicant approval
    29 Jun 2015
    First marketing
    28 Feb 2017
    Last qualifying patent expiry (as listed by FDA)
    11 Feb 2022

Deutetrabenazine

NDA 208082 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 6 mg, 9 mg and 12 mg

    RLD/NDA as listed: Austedo 208082
    First PIV submission
    5 Apr 2021
    ANDAs
    2
    180-day status
    Eligible
    Decision posted
    17 Feb 2025
    First applicant approval
    26 Dec 2024
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    7 Mar 2036

Deutetrabenazine

NDA 216354 · 3 rows · Listed patents and exclusivities · Open in the app

  • Deutetrabenazine New · Extended-release Tablets · 18 mg

    RLD/NDA as listed: Austedo XR 216354
    First PIV submission
    11 Sep 2026
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    10 Jun 2041

  • Extended-release Tablets · 48 mg

    RLD/NDA as listed: Austedo XR 216354
    First PIV submission
    8 Jun 2026
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    10 Jun 2041

  • Extended-release Tablets · 6 mg, 12 mg and 24 mg

    RLD/NDA as listed: Austedo XR 216354
    First PIV submission
    2 Mar 2026
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    10 Jun 2041

Dexlansoprazole

NDA 022287 · 1 row · Listed patents and exclusivities · Open in the app

  • Delayed-release Capsules · 30 mg

    RLD/NDA as listed: Dexilant 22287
    First PIV submission
    30 Nov 2010
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    2 Aug 2026

Dexmedetomidine

NDA 021038 · 3 rows · Listed patents and exclusivities · Open in the app

  • Injection · 100 mcg/mL

    RLD/NDA as listed: Precedex 21038
    First PIV submission
    8 Apr 2009
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    7 Apr 2020
    First applicant approval
    14 Jun 2016
    First marketing
    22 Sep 2014
    Last qualifying patent expiry (as listed by FDA)
    31 Mar 2019

  • Injection · 4 mcg/mL, 20 mL vials

    RLD/NDA as listed: Precedex 21038
    First PIV submission
    30 Sep 2015
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    2 Jul 2019
    First applicant approval
    29 Nov 2018
    First marketing
    3 Jun 2019
    Last qualifying patent expiry (as listed by FDA)
    4 Jan 2032

  • Injection · 4 mcg/mL, 50 mL and 100 mL vials

    RLD/NDA as listed: Precedex 21038
    First PIV submission
    26 Dec 2013
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    13 Aug 2019
    First applicant approval
    30 Jan 2020
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    4 Jan 2032

Dexmethylphenidate

NDA 021802 · 6 rows · Listed patents and exclusivities · Open in the app

  • Dexmethylphenidate Hydrochloride · Extended-release Capsules · 15 mg

    RLD/NDA as listed: Focalin XR 21802
    First PIV submission
    14 May 2007
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    27 Jan 2020
    First applicant approval
    18 Nov 2013
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    1 Nov 2019

  • Extended-release Capsules · 25 mg

    RLD/NDA as listed: Focalin XR 21802
    First PIV submission
    30 Sep 2011
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    27 Jan 2020
    First applicant approval
    30 Nov 2016
    First marketing
    5 Jan 2017
    Last qualifying patent expiry (as listed by FDA)
    1 Nov 2019

  • Dexmethylphenidate Hydrochloride · Extended-release Capsules · 30 mg

    RLD/NDA as listed: Focalin XR 21802
    First PIV submission
    15 Dec 2010
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    27 Jan 2020
    First applicant approval
    28 Aug 2013
    First marketing
    18 Nov 2013
    Last qualifying patent expiry (as listed by FDA)
    1 Nov 2019

  • Extended-release Capsules · 35 mg

    RLD/NDA as listed: Focalin XR 21802
    First PIV submission
    29 Sep 2011
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    27 Jan 2020
    First applicant approval
    30 Nov 2016
    First marketing
    5 Jan 2017
    Last qualifying patent expiry (as listed by FDA)
    1 Nov 2019

  • Dexmethylphenidate Hydrochloride · Extended-release Capsules · 40 mg

    RLD/NDA as listed: Focalin XR 21802
    First PIV submission
    20 Dec 2010
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    27 Jan 2020
    First applicant approval
    19 Nov 2013
    First marketing
    22 Nov 2013
    Last qualifying patent expiry (as listed by FDA)
    1 Nov 2019

  • Dexmethylphenidate Hydrochloride · Extended-release Capsules · 5 mg, 10 mg and 20 mg

    RLD/NDA as listed: Focalin XR 21802
    First PIV submission
    30 Mar 2007
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    27 Jan 2020
    First applicant approval
    19 Nov 2013
    First marketing
    10 Nov 2014
    Last qualifying patent expiry (as listed by FDA)
    1 Nov 2019

Dexmethylphenidate Hydrochloride

NDA 021278 · 2 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 2.5 mg

    RLD/NDA as listed: Focalin 21278
    First PIV submission
    27 Jul 2004
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    7 Apr 2020
    First applicant approval
    29 Jan 2007
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    4 Dec 2015

  • Tablets · 5 mg and 10 mg

    RLD/NDA as listed: Focalin 21278
    First PIV submission
    27 May 2004
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    7 Apr 2020
    First applicant approval
    29 Jan 2007
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    4 Dec 2015

Dexrazoxane

NDA 020212 · 1 row · Listed patents and exclusivities · Open in the app

  • For Injection · 250 mg/vial

    RLD/NDA as listed: Zinecard 20212
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Dextroamphetamine saccharate; Amphetamine aspartate; Dextroamphetamine Sulfate; Amphetamine Sulfate

NDA 011522 · 2 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 5 mg, 10 mg, 20 mg, 30 mg

    RLD/NDA as listed: Adderall 11522
    First PIV submission
    18 Nov 2009
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    6 Jul 2020

  • Tablets · 7.5 mg, 12.5 mg and 15 mg

    RLD/NDA as listed: Adderall 11522
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Dextroamphetamine saccharate; Amphetamine aspartate; Dextroamphetamine Sulfate; Amphetamine Sulfate

NDA 021303 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Capsules · 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg

    RLD/NDA as listed: Adderall XR 21303
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Dextromethorphan Hydrobromide and Bupropion Hydrochloride

NDA 215430 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Tablet · 45 mg/105 mg

    RLD/NDA as listed: Auvelity 215430
    First PIV submission
    22 Dec 2022
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    7 Jan 2040

Dextromethorphan Hydrobromide and Quinidine Sulfate

NDA 021879 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 20 mg/10 mg

    RLD/NDA as listed: Nuedexta 21879
    First PIV submission
    7 Mar 2011
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    10 Mar 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    13 Aug 2026

Dextromethorphan Polistirex

NDA 018658 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Suspension · 30 mg/5 mL

    RLD/NDA as listed: Delsym 18658
    First PIV submission
    12 Jan 2009
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    7 Apr 2020
    First applicant approval
    25 May 2012
    First marketing
    27 Aug 2012
    Last qualifying patent expiry (as listed by FDA)
    16 Apr 2017

Diazepam

NDA 013263 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 2 mg, 5 mg and 10 mg

    RLD/NDA as listed: Valium 13263
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Diazepam

NDA 020648 · 3 rows · Listed patents and exclusivities · Open in the app

  • Rectal Gel · 2.5 mg/0.5 mL 5 mg/mL 10 mg/2 mL 15 mg/3 mL 20 mg/4 mL

    RLD/NDA as listed: Diastat 20648
    First PIV submission
    23 Mar 2004
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    31 Oct 2012

  • Rectal Gel · 5 mg/mL, 2mL pre-filled syringe

    RLD/NDA as listed: Diastat Acudial 20648
    First PIV submission
    23 Dec 2008
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    17 Sep 2013

  • Rectal Gel · 5 mg/mL, 4mL pre-filled syringe

    RLD/NDA as listed: Diastat Acudial 20648
    First PIV submission
    8 Dec 2008
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    17 Sep 2013

Diazepam

NDA 211635 · 2 rows · Listed patents and exclusivities · Open in the app

  • Nasal Spray · 10 mg/spray

    RLD/NDA as listed: Valtoco 211635
    First PIV submission
    14 Feb 2024
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    27 Mar 2029

  • Nasal Spray · 5 mg/spray and 7.5 mg/spray

    RLD/NDA as listed: Valtoco 211635
    First PIV submission
    3 Apr 2025
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    27 Mar 2029

Diazoxide Choline

NDA 216665 · 2 rows · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 150 mg

    RLD/NDA as listed: Vykat XR 216665
    First PIV submission
    22 Jul 2026
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    12 Nov 2035

  • Extended-release Tablets · 25 mg and 75 mg

    RLD/NDA as listed: Vykat XR 216665
    First PIV submission
    28 Jul 2026
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    12 Nov 2035

Diclofenac

NDA 204592 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 18 mg and 35 mg

    RLD/NDA as listed: Zorvolex 204592
    First PIV submission
    6 Jun 2014
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    23 Apr 2030

Diclofenac Epolamine

NDA 021234 · 1 row · Listed patents and exclusivities · Open in the app

  • Topical Patch · 1.2999999999999999E-2

    RLD/NDA as listed: Flector 21234
    First PIV submission
    26 Jun 2015
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    2 Jul 2019
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    13 Apr 2019

Diclofenac Potassium

NDA 022165 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Solution (Sachet) · 50 mg

    RLD/NDA as listed: Cambia 22165
    First PIV submission
    24 Jan 2011
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    16 Jun 2026

Diclofenac Potassium

NDA 022202 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 25 mg

    RLD/NDA as listed: Zipsor 22202
    First PIV submission
    14 Nov 2012
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    11 Feb 2020
    First applicant approval
    23 Feb 2016
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    24 Feb 2029

Diclofenac Sodium

NDA 020947 · 1 row · Listed patents and exclusivities · Open in the app

  • Topical Solution · 1.4999999999999999E-2

    RLD/NDA as listed: Pennsaid 20947
    First PIV submission
    11 Jul 2012
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    7 Apr 2020
    First applicant approval
    27 May 2014
    First marketing
    27 May 2014
    Last qualifying patent expiry (as listed by FDA)
    10 Jul 2029

Diclofenac Sodium

NDA 021005 · 1 row · Listed patents and exclusivities · Open in the app

  • Topical Gel · 0.03

    RLD/NDA as listed: Solaraze 21005
    First PIV submission
    16 Dec 2009
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    7 Apr 2020
    First applicant approval
    28 Oct 2013
    First marketing
    21 Nov 2013
    Last qualifying patent expiry (as listed by FDA)
    11 Aug 2015

Diclofenac Sodium

NDA 022396 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 37.5 mg/mL, 1 mL single-dose vials

    RLD/NDA as listed: Dyloject 22396
    First PIV submission
    15 Dec 2015
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    2 Jul 2019
    First applicant approval
    18 Jun 2019
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    22 Mar 2027

Diclofenac Sodium

NDA 204623 · 1 row · Listed patents and exclusivities · Open in the app

  • Topical Solution · 0.02

    RLD/NDA as listed: Pennsaid 204623
    First PIV submission
    3 Jun 2014
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    5 May 2022
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    9 Aug 2030

Diclofenac Sodium and Misoprostol

NDA 020607 · 2 rows · Listed patents and exclusivities · Open in the app

  • Delayed-release Tablets · 50 mg/0.2 mg

    RLD/NDA as listed: Arthrotec 20607
    First PIV submission
    29 Jun 2009
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    10 Mar 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    11 Feb 2014

  • Delayed-release Tablets · 75 mg/0.2 mg

    RLD/NDA as listed: Arthrotec 20607
    First PIV submission
    28 Nov 2008
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    10 Mar 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    11 Feb 2014

Didanosine

NDA 021183 · 1 row · Listed patents and exclusivities · Open in the app

  • Delayed-release Capsules · 200 mg, 250 mg and 400 mg

    RLD/NDA as listed: Videx EC 21183
    First PIV submission
    1 Jun 2004
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    7 Apr 2020
    First applicant approval
    3 Dec 2004
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    1 Mar 2007

Difelikefalin Acetate

NDA 214916 · 1 row · Listed patents and exclusivities · Open in the app

  • Intravenous Solution · 0.065 mg/1.3 mL

    RLD/NDA as listed: Korsuva 214916
    First PIV submission
    25 Aug 2025
    ANDAs
    5
    180-day status
    Eligible
    Decision posted
    14 Sep 2026
    First applicant approval
    31 Aug 2026
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    12 Nov 2027

Difluprednate

NDA 022212 · 1 row · Listed patents and exclusivities · Open in the app

  • Ophthalmic Emulsion · 5.0000000000000001E-4

    RLD/NDA as listed: Durezol 22212
    First PIV submission
    1 May 2014
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    2 Jul 2019
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    18 May 2019

Diltiazem Hydrochloride

NDA 019471 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Capsules · 60 mg, 90 mg and 120 mg

    RLD/NDA as listed: Cardizem SR 19471
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Diltiazem Hydrochloride

NDA 020062 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Capsules · 120 mg, 180 mg, 240 mg, 300 mg and 360 mg

    RLD/NDA as listed: Cardizem CD 20062
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Diltiazem Hydrochloride

NDA 020092 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Capsules · 120 mg, 180 mg and 240 mg

    RLD/NDA as listed: Dilacor XR 20092
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Diltiazem Hydrochloride

NDA 020401 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Capsules · 120 mg, 180 mg, 240 mg, 300 mg, 360 mg and 420 mg

    RLD/NDA as listed: Tiazac 20401
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Diltiazem Hydrochloride

NDA 021392 · 2 rows · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 120 mg, 180 mg, 240 mg, 300 mg and 360 mg

    RLD/NDA as listed: Cardizem LA 21392
    First PIV submission
    30 Aug 2005
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    19 Nov 2019
    First applicant approval
    15 Mar 2010
    First marketing
    15 Mar 2010
    Last qualifying patent expiry (as listed by FDA)
    25 Jun 2013

  • Extended-release Tablets · 420 mg

    RLD/NDA as listed: Cardizem LA 21392
    First PIV submission
    25 Apr 2005
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    19 Nov 2019
    First applicant approval
    15 Mar 2010
    First marketing
    15 Mar 2010
    Last qualifying patent expiry (as listed by FDA)
    25 Jun 2013

Dimethyl Fumarate

NDA 204063 · 1 row · Listed patents and exclusivities · Open in the app

  • Delayed-release Capsules · 120 mg and 240 mg

    RLD/NDA as listed: Tecfidera 204063
    First PIV submission
    27 Mar 2017
    ANDAs
    29
    180-day status
    Eligible
    Decision posted
    24 Aug 2020
    First applicant approval
    17 Aug 2020
    First marketing
    18 Aug 2020
    Last qualifying patent expiry (as listed by FDA)
    7 Feb 2028

Diroximel Fumarate

NDA 211855 · 1 row · Listed patents and exclusivities · Open in the app

  • Delayed-release Capsules · 231 mg

    RLD/NDA as listed: Vumerity 211855
    First PIV submission
    23 Dec 2020
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    11 Nov 2025
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    20 Sep 2033

Divalproex Sodium

NDA 018723 · 1 row · Listed patents and exclusivities · Open in the app

  • Delayed-release Tablets · 125 mg, 250 mg and 500 mg

    RLD/NDA as listed: Depakote 18723
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Divalproex Sodium

NDA 021168 · 2 rows · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 250 mg

    RLD/NDA as listed: Depakote ER 21168
    First PIV submission
    3 May 2004
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

  • Extended-release Tablets · 500 mg

    RLD/NDA as listed: Depakote ER 21168
    First PIV submission
    8 Feb 2005
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Docetaxel

NDA 020449 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 40 mg/mL, 0.5 mL and 2 mL vials

    RLD/NDA as listed: Taxotere 20449
    First PIV submission
    30 Jun 2009
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    22 Nov 2013

Dofetilide

NDA 020931 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 0.125 mg, 0.25 mg, and 0.5 mg

    RLD/NDA as listed: Tikosyn 20931
    First PIV submission
    1 May 2014
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    13 Aug 2019
    First applicant approval
    6 Jun 2016
    First marketing
    7 Jun 2016
    Last qualifying patent expiry (as listed by FDA)
    9 Oct 2018

Dolutegravir Sodium

NDA 204790 · 2 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 10 mg and 25 mg

    RLD/NDA as listed: Tivicay 204790
    First PIV submission
    14 Aug 2017
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    2 Feb 2026
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    8 Dec 2029

  • Tablets · 50 mg

    RLD/NDA as listed: Tivicay 204790
    First PIV submission
    14 Aug 2017
    ANDAs
    4
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Dolutegravir Sodium

NDA 213983 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets for Suspension · 5 mg

    RLD/NDA as listed: Tivicay PD 213983
    First PIV submission
    21 Jul 2021
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    8 Dec 2029

Dolutegravir Sodium and Lamivudine

NDA 211994 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 50 mg/300 mg

    RLD/NDA as listed: Dovato 211994
    First PIV submission
    30 Jul 2019
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    8 Dec 2029

Dolutegravir Sodium and Rilpivirine

NDA 210192 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 50 mg/25 mg

    RLD/NDA as listed: Juluca 210192
    First PIV submission
    19 Nov 2019
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    24 Jan 2031

Donepezil Hydrochloride

NDA 020690 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 5 mg and 10 mg

    RLD/NDA as listed: Aricept 20690
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Donepezil Hydrochloride

NDA 021720 · 1 row · Listed patents and exclusivities · Open in the app

  • Orally Disintegrating Tablets · 5 mg and 10 mg

    RLD/NDA as listed: Aricept ODT 21720
    First PIV submission
    30 Jun 2010
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    26 Nov 2010
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    23 Jun 2022

Donepezil Hydrochloride

NDA 022568 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 23 mg

    RLD/NDA as listed: Aricept 22568
    First PIV submission
    9 Jul 2013
    ANDAs
    blank
    180-day status
    Eligible
    Decision posted
    7 Apr 2020
    First applicant approval
    24 Jul 2013
    First marketing
    26 Jul 2013
    Last qualifying patent expiry (as listed by FDA)
    4 Oct 2026

Doravirine, Lamivudine and Tenofovir Disoproxil Fumarate

NDA 210807 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 100 mg/300 mg/ 300 mg

    RLD/NDA as listed: Delstrigo 210807
    First PIV submission
    30 Aug 2022
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    29 Nov 2036

Doripenem

NDA 022106 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 250 mg/vial and 500 mg/vial

    RLD/NDA as listed: Doribax 22106
    First PIV submission
    12 Oct 2011
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    5 Jun 2015

Dorzolamide Hydrochloride

NDA 020408 · 1 row · Listed patents and exclusivities · Open in the app

  • Ophthalmic Solution · 2%

    RLD/NDA as listed: Trusopt 20408
    First PIV submission
    11 Oct 2005
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    28 Oct 2008
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    28 Apr 2008

Dorzolamide Hydrochloride and Timolol Maleate

NDA 020869 · 1 row · Listed patents and exclusivities · Open in the app

  • Ophthalmic Solution · 2%/0.5%

    RLD/NDA as listed: Cosopt 20869
    First PIV submission
    11 Oct 2005
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    28 Oct 2008
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    28 Apr 2008

Doxazosin Mesylate

NDA 019668 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 1 mg, 2 mg, 4 mg and 8 mg

    RLD/NDA as listed: Cardura 19668
    First PIV submission
    Pre-MMA
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Doxepin Hydrochloride

NDA 022036 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 3 mg and 6 mg

    RLD/NDA as listed: Silenor 22036
    First PIV submission
    16 Sep 2010
    ANDAs
    2
    180-day status
    Extinguished Eligible
    Decision posted
    7/27/2020 6/18/2019
    First applicant approval
    26 Jul 2013
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    17 Feb 2020

Doxercalciferol

NDA 020862 · 2 rows · Listed patents and exclusivities · Open in the app

  • Capsules · 0.5 mcg and 2.5 mcg

    RLD/NDA as listed: Hectorol 20862
    First PIV submission
    25 Mar 2009
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    7 Apr 2020
    First applicant approval
    1/14/2014 9/23/2011
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    18 Jul 2021

  • Capsules · 1 mcg

    RLD/NDA as listed: Hectorol 20862
    First PIV submission
    12 Feb 2010
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    9 Sep 2016
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    11 Feb 2014

Doxercalciferol

NDA 021027 · 2 rows · Listed patents and exclusivities · Open in the app

  • Injection · 2 mcg/mL, 2 mL ampules

    RLD/NDA as listed: Hectorol 21027
    First PIV submission
    15 Oct 2007
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    19 Nov 2019
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

  • Injection · 2 mcg/mL, 1 mL in 2 mL vial

    RLD/NDA as listed: Hectorol 21027
    First PIV submission
    28 Dec 2011
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    19 Nov 2019
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Doxycycline

NDA 050805 · 1 row · Listed patents and exclusivities · Open in the app

  • Delayed-release Capsules · 40 mg

    RLD/NDA as listed: Oracea 50805
    First PIV submission
    12 Dec 2008
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    24 Aug 2022
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    5 Apr 2022

Doxycycline Hyclate

NDA 050795 · 6 rows · Listed patents and exclusivities · Open in the app

  • Delayed-release Tablets · 150 mg

    RLD/NDA as listed: Doryx 50795
    First PIV submission
    19 Dec 2008
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    15 Dec 2022

  • Delayed-release Tablets · 200 mg

    RLD/NDA as listed: Doryx 50795
    First PIV submission
    19 May 2014
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    7 Apr 2020
    First applicant approval
    19 May 2016
    First marketing
    19 May 2016
    Last qualifying patent expiry (as listed by FDA)
    15 Dec 2022

  • Delayed-release Tablets · 50 mg

    RLD/NDA as listed: Doryx 50795
    First PIV submission
    5 Nov 2015
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    7 Apr 2020
    First applicant approval
    23 May 2016
    First marketing
    23 May 2016
    Last qualifying patent expiry (as listed by FDA)
    3 Feb 2028

  • Delayed-release Tablets · 60 mg and 120 mg

    RLD/NDA as listed: Doryx MPC 50795
    First PIV submission
    28 Sep 2017
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Aug 2023
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    23 Dec 2034

  • Delayed-release Tablets · 75 mg and 100 mg

    RLD/NDA as listed: Doryx 50795
    First PIV submission
    PIV received prior to 2/5/2009
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    7 Apr 2020
    First applicant approval
    28 Dec 2010
    First marketing
    30 Dec 2010
    Last qualifying patent expiry (as listed by FDA)
    15 Dec 2022

  • Delayed-release Tablets · 80 mg

    RLD/NDA as listed: Doryx 50795
    First PIV submission
    1 Jul 2015
    ANDAs
    1
    180-day status
    Extinguished Eligible
    Decision posted
    4/18/2023 4/7/2020
    First applicant approval
    29 Apr 2016
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    15 Dec 2022

Doxylamine Succinate and Pyridoxine Hydrochloride

NDA 021876 · 1 row · Listed patents and exclusivities · Open in the app

  • Delayed-release Tablets · 10 mg/10 mg

    RLD/NDA as listed: Diclegis 21876
    First PIV submission
    1 Aug 2013
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    2 Jul 2019
    First applicant approval
    19 Aug 2016
    First marketing
    21 Jun 2019
    Last qualifying patent expiry (as listed by FDA)
    21 Jun 2021

Doxylamine Succinate and Pyridoxine Hydrochloride

NDA 209661 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 20 mg/20 mg

    RLD/NDA as listed: Bonjesta 209661
    First PIV submission
    28 Aug 2018
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    5 May 2022
    First applicant approval
    1 Mar 2022
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    18 Feb 2033

Dronabinol

NDA 205525 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Solution · 5 mg/mL

    RLD/NDA as listed: Syndros 205525
    First PIV submission
    17 Apr 2017
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    12 Jan 2021
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    6 Aug 2028

Dronedarone Hydrochloride

NDA 022425 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 400 mg

    RLD/NDA as listed: Multaq 22425
    First PIV submission
    1 Jul 2013
    ANDAs
    7
    180-day status
    Eligible
    Decision posted
    6 Feb 2024
    First applicant approval
    31 Jan 2024
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    16 Apr 2029

Drospirenone

NDA 211367 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 4 mg

    RLD/NDA as listed: Slynd 211367
    First PIV submission
    7 Jan 2022
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    28 Jun 2031

Drospirenone and Estradiol

NDA 021355 · 2 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 0.25 mg/0.5 mg

    RLD/NDA as listed: Angeliq 21355
    First PIV submission
    8 Jan 2015
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    22 Oct 2031

  • Tablets · 0.5 mg/1 mg

    RLD/NDA as listed: Angeliq 21355
    First PIV submission
    26 Dec 2007
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    11 Aug 2017

Drospirenone and Ethinyl Estradiol

NDA 021098 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 3 mg/0.03 mg

    RLD/NDA as listed: Yasmin 21098
    First PIV submission
    7 Jan 2005
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    9 May 2008
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    31 Aug 2020

Drospirenone and Ethinyl Estradiol

NDA 021676 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 3 mg/0.02 mg

    RLD/NDA as listed: Yaz 21676
    First PIV submission
    29 Sep 2006
    ANDAs
    1
    180-day status
    Extinguished Deferred
    Decision posted
    11/17/2022 11/17/2022
    First applicant approval
    30 Mar 2009
    First marketing
    1 Jun 2010
    Last qualifying patent expiry (as listed by FDA)
    20 Dec 2021

Drospirenone and Ethinyl Estradiol and Levomefolate Calcium and Levomefolate Calcium

NDA 022532 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 3 mg/0.02 mg/ 0.451 mg and 0.451 mg

    RLD/NDA as listed: Beyaz 22532
    First PIV submission
    13 Nov 2012
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    7 Apr 2020
    First applicant approval
    11 Oct 2016
    First marketing
    11 Oct 2016
    Last qualifying patent expiry (as listed by FDA)
    3 Mar 2022

Drospirenone and Ethinyl Estradiol and Levomefolate Calcium and Levomefolate Calcium

NDA 022574 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 3 mg/0.03 mg/ 0.451 mg and 0.451 mg

    RLD/NDA as listed: Safyral 22574
    First PIV submission
    28 Sep 2012
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    11 Oct 2016
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    3 Mar 2022

Duloxetine Hydrochloride

NDA 021427 · 2 rows · Listed patents and exclusivities · Open in the app

  • Delayed-release Capsules · 20 mg, 30 mg and 60 mg

    RLD/NDA as listed: Cymbalta 21427
    First PIV submission
    4 Aug 2008
    ANDAs
    16
    180-day status
    Eligible
    Decision posted
    7 Apr 2020
    First applicant approval
    11 Dec 2013
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    18 Jul 2014

  • Delayed-release Capsules · 40 mg

    RLD/NDA as listed: Cymbalta 21427
    First PIV submission
    10 May 2012
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    7 Apr 2020
    First applicant approval
    11 Dec 2013
    First marketing
    15 Jul 2015
    Last qualifying patent expiry (as listed by FDA)
    18 Jul 2014

Dutasteride

NDA 021319 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 0.5 mg

    RLD/NDA as listed: Avodart 21319
    First PIV submission
    29 Oct 2007
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    7 Apr 2020
    First applicant approval
    21 Dec 2010
    First marketing
    9 Oct 2015
    Last qualifying patent expiry (as listed by FDA)
    20 Nov 2015

Dutasteride and Tamsulosin Hydrochloride

NDA 022460 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 0.5 mg/0.4 mg

    RLD/NDA as listed: Jalyn 22460
    First PIV submission
    26 Oct 2010
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    7 Apr 2020
    First applicant approval
    26 Feb 2014
    First marketing
    18 Nov 2015
    Last qualifying patent expiry (as listed by FDA)
    20 Nov 2015