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FDA Paragraph IV list

Drybench Patent.

FDA Paragraph IV list: A

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

Abacavir

NDA 020978 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Solution · 20 mg/mL

    RLD/NDA as listed: Ziagen 20978
    First PIV submission
    27 Dec 2012
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    11 Feb 2020
    First applicant approval
    26 Sep 2016
    First marketing
    15 Sep 2017
    Last qualifying patent expiry (as listed by FDA)
    14 May 2018

Abacavir Sulfate

NDA 020977 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 300 mg

    RLD/NDA as listed: Ziagen 20977
    First PIV submission
    28 Jan 2009
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    11 Feb 2020
    First applicant approval
    18 Jun 2012
    First marketing
    19 Jun 2012
    Last qualifying patent expiry (as listed by FDA)
    14 May 2018

Abacavir Sulfate and Lamivudine

NDA 021652 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 600 mg/300 mg

    RLD/NDA as listed: Epzicom 21652
    First PIV submission
    27 Sep 2007
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    11 Feb 2020
    First applicant approval
    29 Sep 2016
    First marketing
    29 Sep 2016
    Last qualifying patent expiry (as listed by FDA)
    14 May 2018

Abacavir Sulfate, Dolutegravir and Lamivudine

NDA 205551 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 600 mg/50 mg/ 300 mg

    RLD/NDA as listed: Triumeq 205551
    First PIV submission
    14 Aug 2017
    ANDAs
    5
    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

Abacavir Sulfate, Dolutegravir and Lamivudine

NDA 215413 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets for Oral Suspension · 60 mg/5 mg/30 mg

    RLD/NDA as listed: Triumeq PD 215413
    First PIV submission
    31 Mar 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)
    8 Dec 2029

Abacavir Sulfate, Lamivudine and Zidovudine

NDA 021205 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 300 mg/150 mg/ 300 mg

    RLD/NDA as listed: Trizivir 21205
    First PIV submission
    22 Mar 2011
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    11 Feb 2020
    First applicant approval
    5 Dec 2013
    First marketing
    17 Dec 2013
    Last qualifying patent expiry (as listed by FDA)
    14 May 2018

Abaloparatide

NDA 208743 · 1 row · Listed patents and exclusivities · Open in the app

  • Subcutaneous Injection · 3.12 mg/1.56 mL

    RLD/NDA as listed: Tymlos 208743
    First PIV submission
    21 Jun 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)
    10 Jan 2040

Abemaciclib

NDA 208716 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 50 mg, 100 mg, 150 mg, 200 mg

    RLD/NDA as listed: Verzenio 208716
    First PIV submission
    23 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)
    28 Sep 2031

Abiraterone Acetate

NDA 202379 · 2 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 250 mg

    RLD/NDA as listed: Zytiga 202379
    First PIV submission
    28 Apr 2015
    ANDAs
    13
    180-day status
    Eligible
    Decision posted
    18 Jun 2019
    First applicant approval
    31 Oct 2018
    First marketing
    21 Nov 2018
    Last qualifying patent expiry (as listed by FDA)
    24 Aug 2027

  • Tablets · 500 mg

    RLD/NDA as listed: Zytiga 202379
    First PIV submission
    23 Aug 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)
    24 Aug 2027

Abiraterone Acetate

NDA 210308 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 125 mg

    RLD/NDA as listed: Yonsa 210308
    First PIV submission
    23 Jul 2018
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    25 Jul 2022
    First applicant approval
    24 Jun 2022
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    17 Mar 2034

Abrocitinib

NDA 213871 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 50 mg, 100 mg and 200 mg

    RLD/NDA as listed: Cibinqo 213871
    First PIV submission
    14 Jan 2026
    ANDAs
    3
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Acalabrutinib

NDA 210259 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 100 mg

    RLD/NDA as listed: Calquence 210259
    First PIV submission
    1 Nov 2021
    ANDAs
    5
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    1 Jul 2036

Acalabrutinib Maleate

NDA 216387 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 100 mg

    RLD/NDA as listed: Calquence 216387
    First PIV submission
    13 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)
    1 Jul 2036

Acarbose

NDA 020482 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 25 mg, 50 mg and 100 mg

    RLD/NDA as listed: Precose 20482
    First PIV submission
    22 Mar 2005
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    11 Feb 2020
    First applicant approval
    7 May 2008
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    6 Sep 2009

Acetaminophen

NDA 019872 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 650 mg

    RLD/NDA as listed: Tylenol 19872
    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

Acetaminophen

NDA 022450 · 2 rows · Listed patents and exclusivities · Open in the app

  • Injection · 1000 mg/100 mL (10 mg/mL)

    RLD/NDA as listed: Ofirmev 22450
    First PIV submission
    7 Apr 2011
    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)
    6 Jun 2021

  • Injection · 650 mg/65 mL (10 mg/mL)

    RLD/NDA as listed: Ofirmev 22450
    First PIV submission
    31 Jul 2024
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    9 Jun 2025
    First applicant approval
    21 May 2025
    First marketing
    11 Jul 2025
    Last qualifying patent expiry (as listed by FDA)
    11 Sep 2031

Acetaminophen and Tramadol Hydrochloride

NDA 021123 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 325 mg/ 37.5 mg

    RLD/NDA as listed: Ultracet 21123
    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

Acetaminophen/ Aspirin/ Caffeine

NDA 020802 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 250 mg/ 250 mg/ 65 mg

    RLD/NDA as listed: Excedrin (migraine) 20802
    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

Acetylcysteine

NDA 021539 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 200 mg/mL, 30 mL vials

    RLD/NDA as listed: Acetadote 21539
    First PIV submission
    4 Apr 2012
    ANDAs
    3
    180-day status
    Eligible
    Decision posted
    11 Feb 2020
    First applicant approval
    7 Nov 2012
    First marketing
    30 Nov 2012
    Last qualifying patent expiry (as listed by FDA)
    21 May 2026

Acyclovir Sodium

NDA 018603 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 50 mg/mL, 10 mL and 20 mL vials

    RLD/NDA as listed: Zovirax 18603
    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

Adapalene

NDA 021753 · 1 row · Listed patents and exclusivities · Open in the app

  • Topical Gel · 0.30%

    RLD/NDA as listed: Differin 21753
    First PIV submission
    15 Sep 2009
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    11 Feb 2020
    First applicant approval
    14 Jun 2012
    First marketing
    28 Apr 2014
    Last qualifying patent expiry (as listed by FDA)
    23 Feb 2025

Adapalene and Benzoyl Peroxide

NDA 022320 · 1 row · Listed patents and exclusivities · Open in the app

  • Gel · 0.1%/2.5%

    RLD/NDA as listed: Epiduo 22320
    First PIV submission
    30 Dec 2011
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    11 Feb 2020
    First applicant approval
    30 Sep 2015
    First marketing
    27 Jul 2017
    Last qualifying patent expiry (as listed by FDA)
    18 Jul 2027

Adapalene and Benzoyl Peroxide

NDA 207917 · 1 row · Listed patents and exclusivities · Open in the app

  • Gel · 0.3%/2.5%

    RLD/NDA as listed: Epiduo Forte 207917
    First PIV submission
    4 May 2016
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    18 Jun 2019
    First applicant approval
    17 Oct 2018
    First marketing
    1 Dec 2021
    Last qualifying patent expiry (as listed by FDA)
    12 Mar 2023

Adapalene, Benzoyl Peroxide and Clindamycin Phosphate

NDA 216632 · 1 row · Listed patents and exclusivities · Open in the app

  • Gel · 0.15%/3.1%/1.2%

    RLD/NDA as listed: Cabtreo 216632
    First PIV submission
    27 Nov 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)
    28 Dec 2040

Adefovir Dipivoxil

NDA 021449 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 10 mg

    RLD/NDA as listed: Hepsera 21449
    First PIV submission
    8 Jun 2010
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    11 Feb 2020
    First applicant approval
    29 Aug 2013
    First marketing
    3 Sep 2013
    Last qualifying patent expiry (as listed by FDA)
    23 Jul 2018

Adenosine

NDA 020059 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 3 mg/mL, 20 mL and 30 mL vials

    RLD/NDA as listed: Adenoscan 20059
    First PIV submission
    18 Apr 2005
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    11 Feb 2020
    First applicant approval
    29 Aug 2013
    First marketing
    23 Sep 2013
    Last qualifying patent expiry (as listed by FDA)
    24 Mar 2015

Afatinib Dimaleate

NDA 201292 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 20 mg, 30 mg and 40 mg

    RLD/NDA as listed: Gilotrif 201292
    First PIV submission
    12 Jul 2017
    ANDAs
    7
    180-day status
    Non-Forfeiture
    Decision posted
    11 Nov 2025
    First applicant approval
    14 Jul 2026
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    19 Dec 2029

Albuterol Sulfate

NDA 019604 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 4 mg and 8 mg

    RLD/NDA as listed: Volmax 19604
    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

Albuterol Sulfate

NDA 019621 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Syrup · 2 mg(base)/ 5 mL

    RLD/NDA as listed: Ventolin 19621
    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

Albuterol Sulfate

NDA 020503 · 1 row · Listed patents and exclusivities · Open in the app

  • Inhalation Aerosol · 0.09 mg base per actuation

    RLD/NDA as listed: Proventil HFA 20503
    First PIV submission
    20 May 2015
    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 Dec 2016

Albuterol Sulfate

NDA 020949 · 2 rows · Listed patents and exclusivities · Open in the app

  • Inhalation Solution · 0.021%

    RLD/NDA as listed: Accuneb 20949
    First PIV submission
    19 Oct 2005
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    11 Feb 2020
    First applicant approval
    25 Sep 2007
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    28 Dec 2021

  • Inhalation Solution · 4.2000000000000002E-4

    RLD/NDA as listed: Accuneb 20949
    First PIV submission
    6 Apr 2004
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    11 Feb 2020
    First applicant approval
    28 Jun 2004
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    28 Dec 2021

Albuterol Sulfate

NDA 021457 · 1 row · Listed patents and exclusivities · Open in the app

  • Inhalation Aerosol · 0.09 mg base per actuation

    RLD/NDA as listed: Pro-Air HFA 21457
    First PIV submission
    18 May 2012
    ANDAs
    1
    180-day status
    Non-Forfeiture Deferred
    Decision posted
    8/24/2020 3/10/2020
    First applicant approval
    24 Feb 2020
    First marketing
    26 Feb 2020
    Last qualifying patent expiry (as listed by FDA)
    12 Sep 2023

Albuterol Sulfate and Ipratropium Bromide

NDA 020950 · 1 row · Listed patents and exclusivities · Open in the app

  • Inhalation Solution · 0.083%/ 0.017%

    RLD/NDA as listed: Duoneb 20950
    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

Albuterol Sulfate and Ipratropium Bromide

NDA 021747 · 1 row · Listed patents and exclusivities · Open in the app

  • Inhalation Aerosol · 100 mcg/20 mcg per actuation

    RLD/NDA as listed: Combivent Respimat 21747
    First PIV submission
    30 Mar 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)
    16 Oct 2030

Alcaftadine

NDA 022134 · 1 row · Listed patents and exclusivities · Open in the app

  • Ophthalmic Solution · 2.5000000000000001E-3

    RLD/NDA as listed: Lastacaft 22134
    First PIV submission
    30 Jul 2014
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    27 Aug 2019
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    5 Oct 2029

Alectinib

NDA 208434 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 150 mg

    RLD/NDA as listed: Alecensa 208434
    First PIV submission
    11 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)
    4 Mar 2032

Alendronate Sodium

NDA 020560 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 5 mg, 10 mg, 35 mg, 40 mg and 70 mg

    RLD/NDA as listed: Fosamax 20560
    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

Alendronate Sodium

NDA 021575 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Solution · 70 mg/75 mL

    RLD/NDA as listed: Fosamax 21575
    First PIV submission
    7 Sep 2007
    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)
    17 Jul 2018

Alendronate Sodium and Cholecalciferol

NDA 021762 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 70 mg/2800 IU and 70 mg/5600 IU

    RLD/NDA as listed: Fosamax Plus D 21762
    First PIV submission
    20 Nov 2007
    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)
    17 Jul 2018

Alfuzosin Hydrochloride

NDA 021287 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 10 mg

    RLD/NDA as listed: Uroxatral 21287
    First PIV submission
    12 Jun 2007
    ANDAs
    9
    180-day status
    Eligible
    Decision posted
    11 Feb 2020
    First applicant approval
    18 Jul 2011
    First marketing
    18 Jul 2011
    Last qualifying patent expiry (as listed by FDA)
    22 Aug 2017

Aliskiren Hemifumarate

NDA 021985 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 150 mg and 300 mg

    RLD/NDA as listed: Tekturna 21985
    First PIV submission
    27 Jan 2014
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    13 Aug 2019
    First applicant approval
    22 Mar 2019
    First marketing
    25 Mar 2019
    Last qualifying patent expiry (as listed by FDA)
    19 Feb 2026

Aliskiren Hemifumarate and Hydrochlorothiazide

NDA 022107 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 150 mg/12.5 mg 150 mg/25 mg 300 mg/12.5 mg 300 mg/25 mg

    RLD/NDA as listed: Tekturna HCT 22107
    First PIV submission
    7 Mar 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)
    13 Jul 2028

Almotriptan Malate

NDA 021001 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 6.25 mg and 12.5 mg

    RLD/NDA as listed: Axert 21001
    First PIV submission
    8 Dec 2005
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    11 Feb 2020
    First applicant approval
    7 Jul 2015
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    7 May 2015

Alogliptin

NDA 022271 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 6.25 mg, 12.5 mg and 25 mg

    RLD/NDA as listed: Nesina 22271
    First PIV submission
    25 Jan 2017
    ANDAs
    5
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    16 Jun 2029

Alogliptin and Metformin Hydrochloride

NDA 203414 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 12.5 mg/500 mg and 12.5 mg/1000 mg

    RLD/NDA as listed: Kazano 203414
    First PIV submission
    25 Jan 2017
    ANDAs
    3
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    24 May 2029

Alosetron Hydrochloride

NDA 021107 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 0.5 mg and 1 mg

    RLD/NDA as listed: Lotronex 21107
    First PIV submission
    2 Dec 2010
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    11 Feb 2020
    First applicant approval
    4 May 2015
    First marketing
    21 May 2015
    Last qualifying patent expiry (as listed by FDA)
    5 Oct 2018

Alprazolam

NDA 018276 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 0.25 mg, 0.5 mg, 1 mg and 2 mg

    RLD/NDA as listed: Xanax 18276
    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

Alprazolam

NDA 021726 · 1 row · Listed patents and exclusivities · Open in the app

  • Orally Disintegrating Tablets · 0.25 mg, 0.5 mg, 1 mg and 2 mg

    RLD/NDA as listed: Niravam 21726
    First PIV submission
    27 Dec 2005
    ANDAs
    1
    180-day status
    Extinguished Eligible
    Decision posted
    7/2/2019 7/2/2019
    First applicant approval
    9 Jan 2009
    First marketing
    14 Jan 2009
    Last qualifying patent expiry (as listed by FDA)
    9 Apr 2018

Alvimopan

NDA 021775 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 12 mg

    RLD/NDA as listed: Entereg 21775
    First PIV submission
    16 Jun 2017
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    2 Jan 2020
    First applicant approval
    19 Dec 2019
    First marketing
    19 Dec 2019
    Last qualifying patent expiry (as listed by FDA)
    31 Jul 2030

Amantadine

NDA 208944 · 2 rows · Listed patents and exclusivities · Open in the app

  • Extended-release Capsules · 137 mg

    RLD/NDA as listed: Gocovri 208944
    First PIV submission
    16 Jan 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)
    2 Dec 2030

  • Extended-release Capsules · 68.5 mg

    RLD/NDA as listed: Gocovri 208944
    First PIV submission
    30 Apr 2020
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    2 Sep 2024
    First applicant approval
    26 Aug 2024
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    4 Dec 2034

Ambrisentan

NDA 022081 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 5 mg and 10 mg

    RLD/NDA as listed: Letairis 22081
    First PIV submission
    9 Feb 2015
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    27 Aug 2019
    First applicant approval
    28 Mar 2019
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    9 Jul 2018

Amifampridine Phosphate

NDA 208078 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 10 mg

    RLD/NDA as listed: Firdapse 208078
    First PIV submission
    28 Nov 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)
    25 Feb 2037

Amifostine

NDA 020221 · 1 row · Listed patents and exclusivities · Open in the app

  • For Injection · 500 mg/vial

    RLD/NDA as listed: Ethyol 20221
    First PIV submission
    16 Apr 2004
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    11 Feb 2020
    First applicant approval
    14 Mar 2008
    First marketing
    27 Mar 2008
    Last qualifying patent expiry (as listed by FDA)
    31 Jul 2012

Amiodarone Hydrochloride

NDA 022325 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 150 mg/100 mL

    RLD/NDA as listed: Nexterone 22325
    First PIV submission
    24 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)
    13 Mar 2029

Amlodipine Benzoate

NDA 211340 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Suspension · 1 mg/mL

    RLD/NDA as listed: Katerzia 211340
    First PIV submission
    29 Dec 2020
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    26 Jun 2023
    First applicant approval
    13 Jun 2023
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    11 Apr 2039

Amlodipine Besylate

NDA 019787 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 2.5 mg, 5 mg and 10 mg

    RLD/NDA as listed: Norvasc 19787
    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

Amlodipine Besylate and Atorvastatin Calcium

NDA 021540 · 4 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 2.5 mg/10 mg 2.5 mg/20 mg 10 mg/40 mg

    RLD/NDA as listed: Caduet 21540
    First PIV submission
    17 Sep 2009
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    11 Feb 2020
    First applicant approval
    29 Nov 2013
    First marketing
    1 Feb 2011
    Last qualifying patent expiry (as listed by FDA)
    11 Aug 2018

  • Tablets · 2.5 mg/40 mg

    RLD/NDA as listed: Caduet 21540
    First PIV submission
    17 Sep 2009
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    11 Feb 2020
    First applicant approval
    29 Nov 2013
    First marketing
    1 Feb 2011
    Last qualifying patent expiry (as listed by FDA)
    11 Aug 2018

  • Tablets · 5 mg/10 mg 5 mg/20 mg 5 mg/40 mg 10 mg/10 mg 10 mg/20 mg 10 mg/80 mg

    RLD/NDA as listed: Caduet 21540
    First PIV submission
    29 Dec 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)
    11 Aug 2018

  • Tablets · 5 mg/80 mg

    RLD/NDA as listed: Caduet 21540
    First PIV submission
    7 Apr 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)
    11 Aug 2018

Amlodipine Besylate and Benazepril Hydrochloride

NDA 020364 · 2 rows · Listed patents and exclusivities · Open in the app

  • Capsules · 2.5 mg/10 mg 5 mg/10 mg 5 mg/20 mg 10 mg/20 mg

    RLD/NDA as listed: Lotrel 20364
    First PIV submission
    9 Jun 2004
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    11 Feb 2020
    First applicant approval
    18 Mar 2007
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    19 Dec 2017

  • Capsules · 5 mg/40 mg and 10 mg/40 mg

    RLD/NDA as listed: Lotrel 20364
    First PIV submission
    17 Nov 2006
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    11 Feb 2020
    First applicant approval
    29 Jul 2010
    First marketing
    3 Jan 2011
    Last qualifying patent expiry (as listed by FDA)
    19 Dec 2017

Amlodipine Besylate and Celecoxib

NDA 210045 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 2.5 mg/200 mg, 5 mg/200 mg, 10 mg/200 mg

    RLD/NDA as listed: Consensi 210045
    First PIV submission
    29 Jun 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)
    14 Jun 2038

Amlodipine Besylate and Olmesartan Medoxomil

NDA 022100 · 2 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 10 mg/20 mg and 5 mg/40 mg

    RLD/NDA as listed: Azor 22100
    First PIV submission
    31 Mar 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)
    25 Apr 2016

  • Tablets · 5 mg/20 mg and 10 mg/40 mg

    RLD/NDA as listed: Azor 22100
    First PIV submission
    11 Feb 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)
    25 Apr 2016

Amlodipine Besylate and Valsartan

NDA 021990 · 4 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 10 mg/160 mg

    RLD/NDA as listed: Exforge 21990
    First PIV submission
    1 Oct 2007
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    11 Feb 2020
    First applicant approval
    28 Mar 2013
    First marketing
    30 Sep 2014
    Last qualifying patent expiry (as listed by FDA)
    8 Jul 2019

  • Tablets · 10 mg/320 mg

    RLD/NDA as listed: Exforge 21990
    First PIV submission
    9 Nov 2007
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    11 Feb 2020
    First applicant approval
    28 Mar 2013
    First marketing
    30 Sep 2014
    Last qualifying patent expiry (as listed by FDA)
    8 Jul 2019

  • Tablets · 5 mg/160 mg

    RLD/NDA as listed: Exforge 21990
    First PIV submission
    22 Oct 2007
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    11 Feb 2020
    First applicant approval
    28 Mar 2013
    First marketing
    30 Sep 2014
    Last qualifying patent expiry (as listed by FDA)
    8 Jul 2019

  • Tablets · 5 mg/320 mg

    RLD/NDA as listed: Exforge 21990
    First PIV submission
    26 Nov 2007
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    11 Feb 2020
    First applicant approval
    28 Mar 2013
    First marketing
    30 Sep 2014
    Last qualifying patent expiry (as listed by FDA)
    8 Jul 2019

Amlodipine, Hydrochlorothiazide and Valsartan

NDA 022314 · 2 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 10 mg/12.5 mg/ 160 mg

    RLD/NDA as listed: Exforge HCT 22314
    First PIV submission
    22 Oct 2009
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    11 Feb 2020
    First applicant approval
    25 Sep 2012
    First marketing
    1 Dec 2014
    Last qualifying patent expiry (as listed by FDA)
    18 Jul 2017

  • Tablets · 5 mg/12.5 mg/160 mg, 5 mg/25 mg/160 mg, 10 mg/25 mg/160 mg and 10 mg/25 mg/320 mg

    RLD/NDA as listed: Exforge HCT 22314
    First PIV submission
    14 Sep 2009
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    11 Feb 2020
    First applicant approval
    25 Sep 2012
    First marketing
    1 Dec 2014
    Last qualifying patent expiry (as listed by FDA)
    18 Jul 2017

Amoxicillin and Clavulanate Potassium

NDA 050785 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 1000 mg/62.5 mg

    RLD/NDA as listed: Augmentin XR 50785
    First PIV submission
    21 Jan 2009
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    11 Feb 2020
    First applicant approval
    21 Apr 2010
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    4 Apr 2020

Amphetamine

NDA 204326 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Orally Disintegrating Tablets · 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, 18.8 mg

    RLD/NDA as listed: Adzenys XR- ODT 204326
    First PIV submission
    10 May 2016
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    26 Jun 2023
    First applicant approval
    22 Jun 2023
    First marketing
    8 Dec 2025
    Last qualifying patent expiry (as listed by FDA)
    28 Jan 2032

Amphetamine

NDA 210526 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 5 mg, 10 mg, 15 mg and 20 mg

    RLD/NDA as listed: Dyanavel XR 210526
    First PIV submission
    22 Jan 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)
    24 Sep 2038

Amphetamine Aspartate;Amphetamine Sulfate;Dextroamphetamine Saccharate; Dextroamphetamine Sulfate

NDA 022063 · 2 rows · Listed patents and exclusivities · Open in the app

  • Extended-release Capsules · 12.5 mg and 25 mg

    RLD/NDA as listed: Mydayis 22063
    First PIV submission
    7 Aug 2017
    ANDAs
    1
    180-day status
    Extinguished Deferred
    Decision posted
    9/4/2023 2/8/2022
    First applicant approval
    31 Jan 2022
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    24 Aug 2029

  • Extended-release Capsules · 37.5 mg and 50 mg

    RLD/NDA as listed: Mydayis 22063
    First PIV submission
    3 Aug 2017
    ANDAs
    1
    180-day status
    Extinguished Deferred
    Decision posted
    9/4/2023 2/8/2022
    First applicant approval
    31 Jan 2022
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    24 Aug 2029

Angiotensin II Acetate

NDA 209360 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 2.5 mg/mL

    RLD/NDA as listed: Giapreza 209360
    First PIV submission
    21 Dec 2021
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    9 Jun 2025
    First applicant approval
    3 Jun 2025
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    18 Dec 2034

Apalutamide

NDA 210951 · 2 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 240 mg

    RLD/NDA as listed: Erleada 210951
    First PIV submission
    20 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)
    30 Jan 2040

  • Tablets · 60 mg

    RLD/NDA as listed: Erleada 210951
    First PIV submission
    14 Feb 2022
    ANDAs
    5
    180-day status
    Eligible
    Decision posted
    17 Mar 2025
    First applicant approval
    17 Mar 2025
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    30 Apr 2038

Apixaban

NDA 202155 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 2.5 mg and 5 mg

    RLD/NDA as listed: Eliquis 202155
    First PIV submission
    28 Dec 2016
    ANDAs
    25
    180-day status
    Eligible
    Decision posted
    14 Jan 2020
    First applicant approval
    23 Dec 2019
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    24 Feb 2031

Apremilast

NDA 205437 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 10 mg, 20 mg and 30 mg

    RLD/NDA as listed: Otezla 205437
    First PIV submission
    22 Mar 2018
    ANDAs
    11
    180-day status
    Eligible
    Decision posted
    22 Feb 2021
    First applicant approval
    17 Feb 2021
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    29 May 2034

Aprepitant

NDA 021549 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsule · 40 mg, 80 mg and 125 mg

    RLD/NDA as listed: Emend 21549
    First PIV submission
    3 Nov 2008
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    11 Feb 2020
    First applicant approval
    24 Sep 2012
    First marketing
    27 Dec 2016
    Last qualifying patent expiry (as listed by FDA)
    17 Apr 2015

Aprepitant

NDA 207865 · 1 row · Listed patents and exclusivities · Open in the app

  • for Oral Suspension · 125 mg/Kit

    RLD/NDA as listed: Emend 207865
    First PIV submission
    23 Nov 2016
    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)
    26 Sep 2027

Aprepitant

NDA 209296 · 1 row · Listed patents and exclusivities · Open in the app

  • Intravenous Emulsion · 130 mg/18 mL

    RLD/NDA as listed: Cinvanti 209296
    First PIV submission
    29 Apr 2022
    ANDAs
    1
    180-day status
    Non-Forfeiture
    Decision posted
    15 Dec 2025
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    18 Sep 2035

Aprepitant

NDA 216457 · 1 row · Listed patents and exclusivities · Open in the app

  • Intravenous Emulsion · 32 mg/4.4 mL

    RLD/NDA as listed: Aponvie 216457
    First PIV submission
    7 Nov 2023
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    19 Mar 2026
    First applicant approval
    5 Mar 2026
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    18 Sep 2035

Arformoterol Tartrate

NDA 021912 · 1 row · Listed patents and exclusivities · Open in the app

  • Inhalation Solution · Eq. 0.015 mg base/ 2 mL

    RLD/NDA as listed: Brovana 21912
    First PIV submission
    1 Oct 2009
    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)
    9 Nov 2021

Argatroban

NDA 020883 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 100 mg/mL, 2.5 mL vials

    RLD/NDA as listed: Argatroban 20883
    First PIV submission
    24 Sep 2007
    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)
    30 Jun 2014

Argatroban in Sodium Chloride

NDA 022434 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 1 mg/mL, 50 mL vials

    RLD/NDA as listed: Argatroban 22434
    First PIV submission
    16 Dec 2011
    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)
    26 Sep 2027

Aripiprazole

NDA 021436 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg

    RLD/NDA as listed: Abilify 21436
    First PIV submission
    15 Nov 2006
    ANDAs
    8
    180-day status
    Extinguished
    Decision posted
    11 Feb 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    20 Oct 2014

Aripiprazole

NDA 021713 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Solution · 1 mg/mL

    RLD/NDA as listed: Abilify 21713
    First PIV submission
    20 Dec 2007
    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)
    24 Apr 2022

Aripiprazole

NDA 021729 · 1 row · Listed patents and exclusivities · Open in the app

  • Orally Disintegrating Tablets · 10 mg, 15 mg, 20 mg and 30 mg

    RLD/NDA as listed: Abilify 21729
    First PIV submission
    15 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)
    20 Oct 2014

Aripiprazole

NDA 202971 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Injectable Suspension · 300 mg/vial and 400 mg/vial

    RLD/NDA as listed: Abilify Maintena Kit 202971
    First PIV submission
    20 Dec 2021
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    17 Feb 2025
    First applicant approval
    3 Dec 2024
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    8 Mar 2034

Armodafinil

NDA 021875 · 3 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 100 mg

    RLD/NDA as listed: Nuvigil 21875
    First PIV submission
    8 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)
    18 Dec 2023

  • Tablets · 200 mg

    RLD/NDA as listed: Nuvigil 21875
    First PIV submission
    3 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)
    18 Dec 2023

  • Tablets · 50 mg, 150 mg and 250 mg

    RLD/NDA as listed: Nuvigil 21875
    First PIV submission
    24 Jul 2009
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    11 Feb 2020
    First applicant approval
    1 Jun 2012
    First marketing
    1 Jun 2016
    Last qualifying patent expiry (as listed by FDA)
    18 Dec 2024

Arsenic Trioxide

NDA 021248 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 1 mg/mL

    RLD/NDA as listed: Trisenox 21248
    First PIV submission
    11 Aug 2015
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    11 Feb 2020
    First applicant approval
    31 Aug 2018
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    10 Nov 2018

Asciminib Hydrochloride

NDA 215358 · 2 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 100 mg

    RLD/NDA as listed: Scemblix 215358
    First PIV submission
    13 Nov 2025
    ANDAs
    5
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    14 May 2040

  • Tablets · 20 mg and 40 mg

    RLD/NDA as listed: Scemblix 215358
    First PIV submission
    13 Nov 2025
    ANDAs
    6
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    14 May 2040

Asenapine Maleate

NDA 022117 · 2 rows · Listed patents and exclusivities · Open in the app

  • Sublingual Tablets · 2.5 mg

    RLD/NDA as listed: Saphris 22117
    First PIV submission
    27 Jul 2017
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    12 Jan 2021
    First applicant approval
    10 Dec 2020
    First marketing
    10 Dec 2020
    Last qualifying patent expiry (as listed by FDA)
    6 Apr 2026

  • Sublingual Tablets · 5 mg and 10 mg

    RLD/NDA as listed: Saphris 22117
    First PIV submission
    13 Aug 2013
    ANDAs
    4
    180-day status
    Eligible
    Decision posted
    12 Jan 2021
    First applicant approval
    10 Dec 2020
    First marketing
    10 Dec 2020
    Last qualifying patent expiry (as listed by FDA)
    6 Apr 2026

Aspirin and Dipyridamole

NDA 020884 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Capsules · 25 mg and 200 mg

    RLD/NDA as listed: Aggrenox 20884
    First PIV submission
    1 Feb 2007
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    11 Feb 2020
    First applicant approval
    14 Aug 2009
    First marketing
    1 Jul 2015
    Last qualifying patent expiry (as listed by FDA)
    18 Jan 2017

Aspirin and Omeprazole

NDA 205103 · 1 row · Listed patents and exclusivities · Open in the app

  • Delayed-release Tablets · 81 mg/40 mg and 325 mg/40 mg

    RLD/NDA as listed: Yosprala 205103
    First PIV submission
    17 Oct 2016
    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 Feb 2023

Atazanavir Sulfate

NDA 021567 · 3 rows · Listed patents and exclusivities · Open in the app

  • Capsules · 100 mg and 150 mg

    RLD/NDA as listed: Reyataz 21567
    First PIV submission
    19 Mar 2010
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    11 Feb 2020
    First applicant approval
    22 Apr 2014
    First marketing
    27 Dec 2017
    Last qualifying patent expiry (as listed by FDA)
    21 Dec 2018

  • Capsules · 200 mg

    RLD/NDA as listed: Reyataz 21567
    First PIV submission
    16 Feb 2010
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    11 Feb 2020
    First applicant approval
    22 Apr 2014
    First marketing
    27 Dec 2017
    Last qualifying patent expiry (as listed by FDA)
    21 Dec 2018

  • Capsules · 300 mg

    RLD/NDA as listed: Reyataz 21567
    First PIV submission
    20 Jul 2009
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    11 Feb 2020
    First applicant approval
    22 Apr 2014
    First marketing
    27 Dec 2017
    Last qualifying patent expiry (as listed by FDA)
    21 Dec 2018

Atazanavir Sulfate and Cobicistat

NDA 206353 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 300 mg/150 mg

    RLD/NDA as listed: Evotaz 206353
    First PIV submission
    13 Sep 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)
    3 Sep 2029

Atenolol

NDA 018240 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 25 mg, 50 mg and 100 mg

    RLD/NDA as listed: Tenormin 18240
    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

Atenolol/ Chlorthalidone

NDA 018760 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 50 mg/25 mg and 100 mg/25 mg

    RLD/NDA as listed: Tenoretic 18760
    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

Atogepant

NDA 215206 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 10 mg, 30 mg and 60 mg

    RLD/NDA as listed: Qulipta 215206
    First PIV submission
    29 Sep 2025
    ANDAs
    6
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    10 mg - 2/27/2043 30 mg and 60 mg - 7/29/2041

Atomoxetine Hydrochloride

NDA 021411 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg

    RLD/NDA as listed: Strattera 21411
    First PIV submission
    29 May 2007
    ANDAs
    10
    180-day status
    Extinguished
    Decision posted
    11 Feb 2020
    First applicant approval
    30 May 2017
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    26 Nov 2016

Atorvastatin Calcium

NDA 020702 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 10 mg, 20 mg, 40 mg and 80 mg

    RLD/NDA as listed: Lipitor 20702
    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

Atovaquone

NDA 020500 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Suspension · 750 mg/5 mL

    RLD/NDA as listed: Mepron 20500
    First PIV submission
    20 Oct 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)
    blank

Atovaquone and Proguanil Hydrochloride

NDA 021078 · 2 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 250 mg/100 mg

    RLD/NDA as listed: Malarone 21078
    First PIV submission
    3 Apr 2009
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    11 Feb 2020
    First applicant approval
    12 Jan 2011
    First marketing
    15 Sep 2011
    Last qualifying patent expiry (as listed by FDA)
    25 Nov 2013

  • Tablets · 62.5 mg/25 mg

    RLD/NDA as listed: Malarone 21078
    First PIV submission
    14 Sep 2010
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    11 Feb 2020
    First applicant approval
    27 May 2014
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    25 Nov 2013

Avacopan

NDA 214487 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 10 mg

    RLD/NDA as listed: Tavneos 214487
    First PIV submission
    13 Nov 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)
    29 May 2041

Avanafil

NDA 202276 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 50 mg, 100 mg and 200 mg

    RLD/NDA as listed: Stendra 202276
    First PIV submission
    27 Apr 2016
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    8 Jul 2024
    First applicant approval
    14 Jun 2024
    First marketing
    29 Oct 2024
    Last qualifying patent expiry (as listed by FDA)
    27 Apr 2025

Avibactam Sodium and Ceftazidime

NDA 206494 · 1 row · Listed patents and exclusivities · Open in the app

  • For Injection · 0.5 g/2 g per vial

    RLD/NDA as listed: Avycaz 206494
    First PIV submission
    26 Feb 2024
    ANDAs
    2
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    15 Jun 2032

Axitinib

NDA 202324 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 1 mg and 5 mg

    RLD/NDA as listed: Inlyta 202324
    First PIV submission
    23 Feb 2018
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    11 Nov 2025
    First applicant approval
    30 Oct 2025
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    14 Dec 2030

Azacitidine

NDA 214120 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 200 mg and 300 mg

    RLD/NDA as listed: Onureg 214120
    First PIV submission
    30 Sep 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)
    3 Jun 2030

Azelaic Acid

NDA 021470 · 1 row · Listed patents and exclusivities · Open in the app

  • Gel · 0.15

    RLD/NDA as listed: Finacea 21470
    First PIV submission
    27 Jul 2012
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    11 Feb 2020
    First applicant approval
    19 Nov 2018
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    18 Nov 2018

Azelaic Acid

NDA 207071 · 1 row · Listed patents and exclusivities · Open in the app

  • Topical Foam · 0.15

    RLD/NDA as listed: Finacea 207071
    First PIV submission
    14 Sep 2017
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    6 Sep 2022
    First applicant approval
    7 Oct 2020
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    28 Feb 2029

Azelastine Hydrochloride

NDA 020114 · 1 row · Listed patents and exclusivities · Open in the app

  • Nasal Spray · 0.125 mg base/spray

    RLD/NDA as listed: Astelin 20114
    First PIV submission
    14 Nov 2005
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    11 Feb 2020
    First applicant approval
    30 Apr 2009
    First marketing
    23 Jun 2010
    Last qualifying patent expiry (as listed by FDA)
    1 May 2011

Azelastine Hydrochloride

NDA 021127 · 1 row · Listed patents and exclusivities · Open in the app

  • Ophthalmic Solution · 0.05%

    RLD/NDA as listed: Optivar 21127
    First PIV submission
    13 Dec 2006
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    11 Feb 2020
    First applicant approval
    3 Aug 2009
    First marketing
    1 Dec 2009
    Last qualifying patent expiry (as listed by FDA)
    1 May 2011

Azelastine Hydrochloride

NDA 022203 · 1 row · Listed patents and exclusivities · Open in the app

  • Nasal Spray · 205.5 mcg/spray

    RLD/NDA as listed: Astepro 22203
    First PIV submission
    15 Dec 2011
    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

Azelastine Hydrochloride

NDA 213872 · 2 rows · Listed patents and exclusivities · Open in the app

  • Nasal Spray · 205.5 mcg/spray

    RLD/NDA as listed: Astepro Allergy (OTC) 213872
    First PIV submission
    12 Jul 2021
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    13 May 2024
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    4 Jun 2028

  • Nasal Spray · 205.5 mcg/spray

    RLD/NDA as listed: Children's Astepro Allergy (OTC) 213872
    First PIV submission
    12 Jul 2021
    ANDAs
    1
    180-day status
    Non-Forfeiture Deferred
    Decision posted
    2/17/2025 6/10/2024
    First applicant approval
    29 May 2024
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    4 Jun 2028

Azelastine Hydrochloride and Fluticasone Propionate

NDA 202236 · 1 row · Listed patents and exclusivities · Open in the app

  • Nasal Spray · 137 mcg/50 mcg per spray

    RLD/NDA as listed: Dymista 202236
    First PIV submission
    13 Jun 2014
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    18 Jun 2019
    First applicant approval
    28 Apr 2017
    First marketing
    2 Mar 2020
    Last qualifying patent expiry (as listed by FDA)
    24 Aug 2026

Azilsartan Kamedoxomil

NDA 200796 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 40 mg and 80 mg

    RLD/NDA as listed: Edarbi 200796
    First PIV submission
    10 Apr 2020
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    6 Sep 2022
    First applicant approval
    20 Jul 2022
    First marketing
    15 Jun 2026
    Last qualifying patent expiry (as listed by FDA)
    26 Mar 2028

Azilsartan Kamedoxomil and Chlorthalidone

NDA 202331 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 40 mg/12.5 mg and 40 mg/25 mg

    RLD/NDA as listed: Edarbyclor 202331
    First PIV submission
    19 Apr 2022
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    17 Feb 2025
    First applicant approval
    21 Jan 2025
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    1 Jul 2031

Azithromycin

NDA 020733 · 1 row · Listed patents and exclusivities · Open in the app

  • for Injection · 500 mg/vial

    RLD/NDA as listed: Zithromax 20733
    First PIV submission
    26 Jan 2009
    ANDAs
    2
    180-day status
    Eligible
    Decision posted
    11 Feb 2020
    First applicant approval
    24 Mar 2009
    First marketing
    11 May 2009
    Last qualifying patent expiry (as listed by FDA)
    31 Jul 2018

Azithromycin

NDA 050810 · 1 row · Listed patents and exclusivities · Open in the app

  • Ophthalmic Solution · 0.01

    RLD/NDA as listed: Azasite 50810
    First PIV submission
    3 Mar 2011
    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)
    31 Mar 2019