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FDA Paragraph IV list

Drybench Patent.

FDA Paragraph IV list: B

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose group's drug name, as listed, starts with B, 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

Baclofen

NDA 208193 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Solution · 5 mg/5 mL

    RLD/NDA as listed: Ozobax 208193
    First PIV submission
    26 Jul 2021
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    17 Feb 2025
    First applicant approval
    6 Dec 2024
    First marketing
    15 Jan 2025
    Last qualifying patent expiry (as listed by FDA)
    30 Aug 2039

Baclofen

NDA 215602 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Suspension · 25 mg/5 mL

    RLD/NDA as listed: Fleqsuvy 215602
    First PIV submission
    20 May 2022
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    12 Jun 2023
    First applicant approval
    8 Jun 2023
    First marketing
    19 Jun 2023
    Last qualifying patent expiry (as listed by FDA)
    29 Sep 2037

Baloxavir Marboxil

NDA 210854 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 40 mg and 80 mg

    RLD/NDA as listed: Xofluza 210854
    First PIV submission
    24 Oct 2022
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    15 Jul 2026
    First applicant approval
    17 Jun 2026
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    25 Sep 2038

Balsalazide Disodium

NDA 020610 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 750 mg

    RLD/NDA as listed: Colazal 20610
    First PIV submission
    26 May 2022
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    14 Apr 2025
    First applicant approval
    8 Jun 2023
    First marketing
    8 Jun 2023
    Last qualifying patent expiry (as listed by FDA)
    24 Aug 2026

Balsalazide Disodium

NDA 022205 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 1.1 g

    RLD/NDA as listed: Giazo 22205
    First PIV submission
    5 Nov 2013
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    11 Feb 2020
    First applicant approval
    8 Sep 2015
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    23 Jun 2031

Baricitinib

NDA 207924 · 2 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 1 mg and 2 mg

    RLD/NDA as listed: Olumiant 207924
    First PIV submission
    31 May 2022
    ANDAs
    2
    180-day status
    Eligible
    Decision posted
    17 Mar 2025
    First applicant approval
    22 Jul 2024
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    8 Jun 2030

  • Tablets · 4 mg

    RLD/NDA as listed: Olumiant 207924
    First PIV submission
    3 Oct 2023
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    18 Aug 2025
    First applicant approval
    8 Aug 2025
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    8 Jun 2030

Beclomethasone Dipropionate

NDA 020911 · 1 row · Listed patents and exclusivities · Open in the app

  • Inhalation Aerosol · 40 mcg/actuation and 80 mcg/actuation

    RLD/NDA as listed: Qvar 20911
    First PIV submission
    10 Jan 2020
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    5 Jan 2026
    First applicant approval
    16 Dec 2025
    First marketing
    17 Mar 2026
    Last qualifying patent expiry (as listed by FDA)
    18 May 2031

Beclomethasone Dipropionate

NDA 207921 · 2 rows · Listed patents and exclusivities · Open in the app

  • Inhalation Aerosol · 40 mcg/actuation

    RLD/NDA as listed: Qvar Redihaler 207921
    First PIV submission
    30 Oct 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)
    19 Aug 2041

  • Inhalation Aerosol · 80 mcg/actuation

    RLD/NDA as listed: Qvar Redihaler 207921
    First PIV submission
    31 Jul 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)
    19 Aug 2041

Belinostat

NDA 206256 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 500 mg/vial

    RLD/NDA as listed: Beleodaq 206256
    First PIV submission
    3 Jul 2018
    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 Oct 2027

Belumosudil Mesylate

NDA 214783 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 200 mg

    RLD/NDA as listed: Rezurock 214783
    First PIV submission
    16 Jul 2025
    ANDAs
    3
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    14 Jul 2042

Belzutifan

NDA 215383 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 40 mg

    RLD/NDA as listed: Welireg 215383
    First PIV submission
    13 Aug 2025
    ANDAs
    3
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    30 Jun 2042

Bempedoic Acid

NDA 211616 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 180 mg

    RLD/NDA as listed: Nexletol 211616
    First PIV submission
    21 Feb 2024
    ANDAs
    9
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    19 Jun 2040

Bempedoic Acid and Ezetimibe

NDA 211617 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 180 mg/10 mg

    RLD/NDA as listed: Nexlizet 211617
    First PIV submission
    21 Feb 2024
    ANDAs
    3
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    19 Jun 2040

Bendamustine Hydrochloride

NDA 022249 · 2 rows · Listed patents and exclusivities · Open in the app

  • Injection · 25 mg/vial and 100 mg/vial

    RLD/NDA as listed: Treanda 22249
    First PIV submission
    4 Jun 2013
    ANDAs
    10
    180-day status
    Eligible
    Decision posted
    10 Jan 2023
    First applicant approval
    7 Dec 2022
    First marketing
    7 Dec 2022
    Last qualifying patent expiry (as listed by FDA)
    26 Oct 2030

  • Injection · 90 mg/mL, 0.5 mL and 2 mL in single-dose vials

    RLD/NDA as listed: Treanda 22249
    First PIV submission
    19 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 Sep 2029

Bendamustine Hydrochloride

NDA 205580 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 100 mg/4 mL (25 mg/mL) multiple-dose vials

    RLD/NDA as listed: Belrapzo 205580
    First PIV submission
    17 Jul 2018
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    19 Aug 2024
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    28 Jan 2031

Bendamustine Hydrochloride

NDA 208194 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 100 mg/4 mL (25 mg/mL) multiple-dose vials

    RLD/NDA as listed: Bendeka 208194
    First PIV submission
    4 May 2017
    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 Mar 2033

Benzyl Alcohol

NDA 022129 · 1 row · Listed patents and exclusivities · Open in the app

  • Lotion · 0.05

    RLD/NDA as listed: Ulesfia 22129
    First PIV submission
    11 Apr 2016
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    15 Jun 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    19 May 2024

Bepotastine Besilate

NDA 022288 · 1 row · Listed patents and exclusivities · Open in the app

  • Ophthalmic Solution · 1.4999999999999999E-2

    RLD/NDA as listed: Bepreve 22288
    First PIV submission
    9 Sep 2013
    ANDAs
    3
    180-day status
    Extinguished Deferred
    Decision posted
    2/11/2020 2/11/2020
    First applicant approval
    5 Mar 2019
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    19 Sep 2019

Berotralstat Hydrochloride

NDA 214094 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 110 mg and 150 mg

    RLD/NDA as listed: Orladeyo 214094
    First PIV submission
    3 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)
    1 Nov 2039

Betamethasone Dipropionate

NDA 208079 · 1 row · Listed patents and exclusivities · Open in the app

  • Topical Spray · 5.0000000000000001E-4

    RLD/NDA as listed: Sernivo 208079
    First PIV submission
    15 Feb 2018
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    13 Jul 2020
    First applicant approval
    17 Jun 2020
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    31 Aug 2030

Betamethasone Valerate

NDA 020934 · 1 row · Listed patents and exclusivities · Open in the app

  • Foam · 0.12%

    RLD/NDA as listed: Luxiq 20934
    First PIV submission
    10 Aug 2007
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    11 Feb 2020
    First applicant approval
    26 Nov 2012
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    24 May 2017

Betaxolol

NDA 019270 · 1 row · Listed patents and exclusivities · Open in the app

  • Ophthalmic Solution · 0.5%(base)

    RLD/NDA as listed: Betoptic 19270
    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

Bexarotene

NDA 020155 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 75 mg

    RLD/NDA as listed: Targretin 20155
    First PIV submission
    6 Jun 2011
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    11 Feb 2020
    First applicant approval
    12 Aug 2014
    First marketing
    9 Jul 2015
    Last qualifying patent expiry (as listed by FDA)
    5 Oct 2016

Bictegravir Sodium, Emtricitabine and Tenofovir Alafenamide Fumarate

NDA 210251 · 2 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 30 mg/120 mg/ 15 mg

    RLD/NDA as listed: Biktarvy 210251
    First PIV submission
    28 Sep 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)
    19 Jun 2035

  • Tablets · 50 mg/200 mg/ 25 mg

    RLD/NDA as listed: Biktarvy 210251
    First PIV submission
    7 Feb 2022
    ANDAs
    3
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    8 Nov 2036

Bimatoprost

NDA 021275 · 1 row · Listed patents and exclusivities · Open in the app

  • Ophthalmic Solution · 0.03%

    RLD/NDA as listed: Lumigan 21275
    First PIV submission
    22 Dec 2008
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    11 Feb 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Bimatoprost

NDA 022184 · 1 row · Listed patents and exclusivities · Open in the app

  • Ophthalmic Solution · 1E-4

    RLD/NDA as listed: Lumigan 22184
    First PIV submission
    5 Apr 2011
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    17 Mar 2025
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    13 Jun 2027

Bimatoprost

NDA 022369 · 1 row · Listed patents and exclusivities · Open in the app

  • Topical Solution · 2.9999999999999997E-4

    RLD/NDA as listed: Latisse 22369
    First PIV submission
    3 May 2010
    ANDAs
    1
    180-day status
    Extinguished Deferred
    Decision posted
    6/18/2019 6/18/2019
    First applicant approval
    1 Dec 2014
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    25 May 2024

Binimetinib

NDA 210498 · 2 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 15 mg

    RLD/NDA as listed: Mektovi 210498
    First PIV submission
    27 Jun 2022
    ANDAs
    3
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    18 Oct 2033

  • Tablets · 45 mg

    RLD/NDA as listed: Mektovi 210498
    First PIV submission
    26 Jun 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)
    18 Oct 2033

Bismuth Subcitrate Potassium, Metronidazole, and Tetracycline Hydrochloride

NDA 050786 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 140 mg/125 mg/ 125 mg

    RLD/NDA as listed: Pylera 50786
    First PIV submission
    12 Aug 2014
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    11 Feb 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    14 Dec 2018

Bivalirudin

NDA 020873 · 1 row · Listed patents and exclusivities · Open in the app

  • For Injection · 250 mg/vial

    RLD/NDA as listed: Angiomax 20873
    First PIV submission
    1 Sep 2009
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    11 Feb 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    27 Jul 2028

Bortezomib

NDA 021602 · 1 row · Listed patents and exclusivities · Open in the app

  • For Injection · 3.5 mg/vial

    RLD/NDA as listed: Velcade 21602
    First PIV submission
    20 Nov 2008
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    27 Jan 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    25 Jan 2022

Bosentan

NDA 209279 · 1 row · Listed patents and exclusivities · Open in the app

  • for Oral Suspension · 32 mg

    RLD/NDA as listed: Tracleer 209279
    First PIV submission
    8 Feb 2019
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    17 Feb 2025
    First applicant approval
    5 Feb 2025
    First marketing
    18 Aug 2025
    Last qualifying patent expiry (as listed by FDA)
    28 Dec 2027

Bosutinib

NDA 203341 · 2 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 100 mg and 500 mg

    RLD/NDA as listed: Bosulif 203341
    First PIV submission
    6 Sep 2016
    ANDAs
    2
    180-day status
    Non-Forfeiture Deferred
    Decision posted
    6/22/2026 6/9/2025
    First applicant approval
    23 May 2025
    First marketing
    11 Jun 2026
    Last qualifying patent expiry (as listed by FDA)
    23 Nov 2026

  • Tablets · 400 mg

    RLD/NDA as listed: Bosulif 203341
    First PIV submission
    25 Oct 2018
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    15 Jul 2026
    First applicant approval
    12 Jun 2026
    First marketing
    12 Jun 2026
    Last qualifying patent expiry (as listed by FDA)
    23 Nov 2026

Brexpiprazole

NDA 205422 · 3 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 0.25 mg

    RLD/NDA as listed: Rexulti 205422
    First PIV submission
    10 Jul 2019
    ANDAs
    17
    180-day status
    Eligible
    Decision posted
    6 Sep 2022
    First applicant approval
    11 Aug 2022
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    12 Oct 2032

  • Tablets · 0.5 mg, 1 mg, 2 mg and 3 mg

    RLD/NDA as listed: Rexulti 205422
    First PIV submission
    10 Jul 2019
    ANDAs
    18
    180-day status
    Eligible
    Decision posted
    6 Sep 2022
    First applicant approval
    11 Aug 2022
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    12 Oct 2032

  • Tablets · 4 mg

    RLD/NDA as listed: Rexulti 205422
    First PIV submission
    10 Jul 2019
    ANDAs
    16
    180-day status
    Extinguished Eligible
    Decision posted
    4/13/2026 9/6/2022
    First applicant approval
    11 Aug 2022
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    12 Apr 2026

Brimonidine

NDA 204708 · 1 row · Listed patents and exclusivities · Open in the app

  • Topical Gel · 3.3E-3

    RLD/NDA as listed: Mirvaso 204708
    First PIV submission
    15 Dec 2014
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    8 Oct 2019
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    13 Jun 2031

Brimonidine Tartrate

NDA 020613 · 1 row · Listed patents and exclusivities · Open in the app

  • Ophthalmic Solution · 0.2%

    RLD/NDA as listed: Alphagan 20613
    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

Brimonidine Tartrate

NDA 021262 · 1 row · Listed patents and exclusivities · Open in the app

  • Ophthalmic Solution · 0.15%

    RLD/NDA as listed: Alphagan P 21262
    First PIV submission
    3 Nov 2006
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    11 Feb 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    28 Jan 2022

Brimonidine Tartrate

NDA 021764 · 1 row · Listed patents and exclusivities · Open in the app

  • Ophthalmic Solution · 1.5E-3

    RLD/NDA as listed: Qoliana 21764
    First PIV submission
    24 Oct 2023
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    29 Sep 2025
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    19 Aug 2025

Brimonidine Tartrate

NDA 021770 · 1 row · Listed patents and exclusivities · Open in the app

  • Ophthalmic Solution · 0.1%

    RLD/NDA as listed: Alphagan P 21770
    First PIV submission
    20 Dec 2006
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    13 Dec 2022
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    28 Jul 2021

Brimonidine Tartrate

NDA 208144 · 1 row · Listed patents and exclusivities · Open in the app

  • Ophthalmic Solution · 0.025%

    RLD/NDA as listed: Lumify (OTC) 208144
    First PIV submission
    12 Jul 2021
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    4 Mar 2024
    First applicant approval
    16 Feb 2024
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    14 Jul 2030

Brimonidine Tartrate

NDA 218424 · 1 row · Listed patents and exclusivities · Open in the app

  • Ophthalmic Solution · 2.5000000000000001E-4

    RLD/NDA as listed: Lumify PF (OTC) 218424
    First PIV submission
    2 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)
    14 Jul 2030

Brimonidine Tartrate and Timolol Maleate

NDA 021398 · 1 row · Listed patents and exclusivities · Open in the app

  • Ophthalmic Solution · 0.2%/0.5%

    RLD/NDA as listed: Combigan 21398
    First PIV submission
    21 Nov 2008
    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)
    19 Apr 2022

Brinzolamide and Brimonidine Tartrate

NDA 204251 · 1 row · Listed patents and exclusivities · Open in the app

  • Ophthalmic Suspension · 1%/0.2%

    RLD/NDA as listed: Simbrinza 204251
    First PIV submission
    1 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)
    30 Oct 2030

Brivaracetam

NDA 205836 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 10 mg, 25 mg, 50 mg, 75 mg and 100 mg

    RLD/NDA as listed: Briviact 205836
    First PIV submission
    12 May 2020
    ANDAs
    7
    180-day status
    Extinguished Eligible
    Decision posted
    3/2/2026 7/25/2022
    First applicant approval
    9 Jun 2022
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    21 Feb 2026

Brivaracetam

NDA 205837 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 50 mg/5 mL

    RLD/NDA as listed: Briviact 205837
    First PIV submission
    12 May 2020
    ANDAs
    2
    180-day status
    Extinguished
    Decision posted
    2 Mar 2026
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    21 Feb 2026

Brivaracetam

NDA 205838 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Solution · 10 mg/mL

    RLD/NDA as listed: Briviact 205838
    First PIV submission
    12 May 2020
    ANDAs
    1
    180-day status
    Extinguished Eligible
    Decision posted
    3/2/2026 3/2/2026
    First applicant approval
    19 Feb 2026
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    21 Feb 2026

Bromfenac Sodium

NDA 203168 · 1 row · Listed patents and exclusivities · Open in the app

  • Ophthalmic Solution · 6.9999999999999999E-4

    RLD/NDA as listed: Prolensa 203168
    First PIV submission
    26 Jul 2013
    ANDAs
    1
    180-day status
    Non-Forfeiture
    Decision posted
    19 Nov 2019
    First applicant approval
    22 Nov 2023
    First marketing
    8 Jan 2024
    Last qualifying patent expiry (as listed by FDA)
    11 Sep 2025

Bromfenac Sodium

NDA 206911 · 1 row · Listed patents and exclusivities · Open in the app

  • Ophthalmic Solution · 7.5000000000000002E-4

    RLD/NDA as listed: Bromsite 206911
    First PIV submission
    25 Oct 2017
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    19 Feb 2024
    First applicant approval
    2 Feb 2024
    First marketing
    12 Feb 2024
    Last qualifying patent expiry (as listed by FDA)
    7 Aug 2029

Budesonide

NDA 020746 · 1 row · Listed patents and exclusivities · Open in the app

  • Nasal Spray · 0.032 mg (32 mcg)/spray

    RLD/NDA as listed: Rhinocort 20746
    First PIV submission
    14 May 2007
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    11 Feb 2020
    First applicant approval
    12 May 2014
    First marketing
    13 May 2014
    Last qualifying patent expiry (as listed by FDA)
    29 Oct 2017

Budesonide

NDA 020929 · 2 rows · Listed patents and exclusivities · Open in the app

  • Inhalation Suspension · 0.25 mg/2 mL and 0.5 mg/2 mL

    RLD/NDA as listed: Pulmicort Respules 20929
    First PIV submission
    15 Sep 2005
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    18 Nov 2008
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    27 Feb 2006

  • Inhalation Suspension · 1 mg/2 mL

    RLD/NDA as listed: Pulmicort Respules 20929
    First PIV submission
    28 May 2010
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    11 Feb 2020
    First applicant approval
    27 Sep 2013
    First marketing
    27 Jul 2015
    Last qualifying patent expiry (as listed by FDA)
    23 Dec 2018

Budesonide

NDA 021324 · 1 row · Listed patents and exclusivities · Open in the app

  • Enteric Coated Capsules · 3 mg

    RLD/NDA as listed: Entocort EC 21324
    First PIV submission
    1 Feb 2008
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    11 Feb 2020
    First applicant approval
    2 Apr 2014
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    1 Jan 2015

Budesonide

NDA 203634 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 9 mg

    RLD/NDA as listed: Uceris 203634
    First PIV submission
    11 Mar 2013
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    18 Jun 2019
    First applicant approval
    3 Jul 2018
    First marketing
    5 Jul 2018
    Last qualifying patent expiry (as listed by FDA)
    9 Jun 2020

Budesonide

NDA 213976 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Suspension · 2 mg/10 mL

    RLD/NDA as listed: Eohilia 213976
    First PIV submission
    31 Mar 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)
    10 Jan 2039

Budesonide

NDA 215935 · 1 row · Listed patents and exclusivities · Open in the app

  • Delayed-release Capsules · 4 mg

    RLD/NDA as listed: Tarpeyo 215935
    First PIV submission
    26 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)
    23 Jan 2043

Budesonide and Formoterol Fumarate Dihydrate

NDA 021929 · 1 row · Listed patents and exclusivities · Open in the app

  • Metered Inhalation · 80 mcg/4.5 mcg per inhalation and 160 mcg/4.5 mcg per inhalation

    RLD/NDA as listed: Symbicort 21929
    First PIV submission
    26 Jun 2018
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    18 Mar 2022
    First applicant approval
    15 Mar 2022
    First marketing
    31 Jul 2023
    Last qualifying patent expiry (as listed by FDA)
    16 Oct 2028

Bupivacaine Liposome

NDA 022496 · 2 rows · Listed patents and exclusivities · Open in the app

  • Injectable Suspension · 133 mg/10 mL

    RLD/NDA as listed: Exparel 22496
    First PIV submission
    28 Dec 2021
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    8 Jul 2024
    First applicant approval
    1 Jul 2024
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    22 Jan 2041

  • Injectable Suspension · 266 mg/20 mL

    RLD/NDA as listed: Exparel 22496
    First PIV submission
    20 Aug 2021
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    8 Jul 2024
    First applicant approval
    1 Jul 2024
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    22 Jan 2041

Buprenorphine

NDA 021306 · 2 rows · Listed patents and exclusivities · Open in the app

  • Transdermal System · 15 mcg/hr

    RLD/NDA as listed: Butrans 21306
    First PIV submission
    16 Dec 2013
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    18 Jun 2019
    First applicant approval
    20 Nov 2018
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    29 Sep 2017

  • Transdermal System · 5 mcg/hr 10 mcg/hr 20 mcg/hr

    RLD/NDA as listed: Butrans 21306
    First PIV submission
    6 Jun 2013
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    18 Jun 2019
    First applicant approval
    20 Nov 2018
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    29 Sep 2017

Buprenorphine and Naloxone

NDA 205637 · 2 rows · Listed patents and exclusivities · Open in the app

  • Buccal Film · 2.1 mg/0.3 mg and 4.2 mg/0.7 mg

    RLD/NDA as listed: Bunavail 205637
    First PIV submission
    23 Nov 2016
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    20 Aug 2032

  • Buccal Film · 6.3 mg/1 mg

    RLD/NDA as listed: Bunavail 205637
    First PIV submission
    21 Dec 2015
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    20 Aug 2032

Buprenorphine Hydrochloride

NDA 207932 · 3 rows · Listed patents and exclusivities · Open in the app

  • Buccal Film · 300 mcg, 450 mcg, 600 mcg and 750 mcg

    RLD/NDA as listed: Belbuca 207932
    First PIV submission
    4 Oct 2016
    ANDAs
    1
    180-day status
    Extinguished Non-Forfeiture
    Decision posted
    6/29/2021 2/9/2021
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    23 Jul 2027

  • Buccal Film · 75 mcg and 150 mcg

    RLD/NDA as listed: Belbuca 207932
    First PIV submission
    24 Oct 2016
    ANDAs
    1
    180-day status
    Extinguished Non-Forfeiture
    Decision posted
    6/29/2021 2/9/2021
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    23 Jul 2027

  • Buccal Film · 900 mcg

    RLD/NDA as listed: Belbuca 207932
    First PIV submission
    12 Sep 2016
    ANDAs
    1
    180-day status
    Extinguished Non-Forfeiture
    Decision posted
    6/29/2021 2/9/2021
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    23 Jul 2027

Buprenorphine Hydrochloride and Naloxone Hydrochloride

NDA 022410 · 3 rows · Listed patents and exclusivities · Open in the app

  • Sublingual Film · 12 mg/3 mg

    RLD/NDA as listed: Suboxone 22410
    First PIV submission
    14 May 2013
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    25 Feb 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    13 Feb 2023

  • Sublingual Film · 2 mg/0.5 mg and 8 mg/2 mg

    RLD/NDA as listed: Suboxone 22410
    First PIV submission
    15 Oct 2012
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    25 Feb 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    13 Feb 2023

  • Sublingual Film · 4 mg/1 mg

    RLD/NDA as listed: Suboxone 22410
    First PIV submission
    14 May 2013
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    25 Feb 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    13 Feb 2023

Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate

NDA 204242 · 4 rows · Listed patents and exclusivities · Open in the app

  • Sublingual Tablets · 0.7 mg/0.18 mg

    RLD/NDA as listed: Zubsolv 204242
    First PIV submission
    4 May 2017
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    3 Oct 2024
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    18 Sep 2032

  • Sublingual Tablets · 1.4 mg/0.36 mg and 5.7 mg/1.4 mg

    RLD/NDA as listed: Zubsolv 204242
    First PIV submission
    22 Oct 2013
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    3 Oct 2024
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    22 May 2030

  • Sublingual Tablets · 2.9 mg/7.1 mg

    RLD/NDA as listed: Zubsolv 204242
    First PIV submission
    21 Dec 2015
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    3 Oct 2024
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    18 Sep 2032

  • Sublingual Tablets · 8.6 mg/2.1 mg and 11.4 mg/2.9 mg

    RLD/NDA as listed: Zubsolv 204242
    First PIV submission
    24 Jul 2015
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    3 Oct 2024
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    18 Sep 2032

Bupropion Hydrobromide

NDA 022108 · 3 rows · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 174 mg

    RLD/NDA as listed: Aplenzin 22108
    First PIV submission
    28 Sep 2009
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    25 Feb 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    27 Jun 2026

  • Extended-release Tablets · 348 mg

    RLD/NDA as listed: Aplenzin 22108
    First PIV submission
    24 Sep 2009
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    25 Feb 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    27 Jun 2026

  • Extended-release Tablets · 522 mg

    RLD/NDA as listed: Aplenzin 22108
    First PIV submission
    24 Dec 2009
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    25 Feb 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    27 Jun 2026

Bupropion Hydrochloride

NDA 018644 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 75 mg and 100 mg

    RLD/NDA as listed: Wellbutrin 18644
    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

Bupropion Hydrochloride

NDA 020358 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 100 mg, 150 mg and 200 mg

    RLD/NDA as listed: Wellbutrin SR 20358
    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

Bupropion Hydrochloride

NDA 020711 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 150 mg

    RLD/NDA as listed: Zyban 20711
    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

Bupropion Hydrochloride

NDA 021515 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 150 mg and 300 mg

    RLD/NDA as listed: Wellbutrin XL 21515
    First PIV submission
    21 Sep 2004
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    25 Feb 2020
    First applicant approval
    14 Dec 2006
    First marketing
    5/30/2008 - 150 mg 12/4/2006 - 300 mg
    Last qualifying patent expiry (as listed by FDA)
    30 Oct 2018

Bupropion Hydrochloride

NDA 022497 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 450 mg

    RLD/NDA as listed: Forfivo XL 22497
    First PIV submission
    28 Feb 2013
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    25 Feb 2020
    First applicant approval
    blank
    First marketing
    1 Oct 2018
    Last qualifying patent expiry (as listed by FDA)
    25 Jun 2027

Buspirone Hydrochloride

NDA 018731 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 5 mg, 7.5 mg, 10 mg, 15 mg and 30 mg

    RLD/NDA as listed: Buspar 18731
    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

Busulfan

NDA 020954 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 6 mg/mL

    RLD/NDA as listed: Busulfex 20954
    First PIV submission
    26 Dec 2012
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    25 Feb 2020
    First applicant approval
    21 Sep 2018
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    30 Sep 2013

Butoconazole Nitrate

NDA 019881 · 1 row · Listed patents and exclusivities · Open in the app

  • Vaginal Cream · 0.02

    RLD/NDA as listed: Gynazole-1 19881
    First PIV submission
    23 Dec 2009
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    25 Feb 2020
    First applicant approval
    18 May 2012
    First marketing
    15 Nov 2012
    Last qualifying patent expiry (as listed by FDA)
    17 Nov 2017

Butorphanol Tartrate

NDA 019890 · 1 row · Listed patents and exclusivities · Open in the app

  • Nasal Spray · 10 mg/mL

    RLD/NDA as listed: Stadol NS 19890
    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