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FDA Paragraph IV list

Drybench Patent.

FDA Paragraph IV list: T

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose group's drug name, as listed, starts with T, 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

Tacrolimus

NDA 050777 · 2 rows · Listed patents and exclusivities · Open in the app

  • Ointment · 1E-3

    RLD/NDA as listed: Protopic 50777
    First PIV submission
    9 Sep 2010
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    24 Aug 2020
    First applicant approval
    9 Sep 2014
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    9 Sep 2014

  • Ointment · 2.9999999999999997E-4

    RLD/NDA as listed: Protopic 50777
    First PIV submission
    22 Nov 2010
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    24 Aug 2020
    First applicant approval
    9 Sep 2014
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    9 Sep 2014

Tacrolimus

NDA 204096 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Capsules · 0.5 mg, 1 mg, and 5 mg

    RLD/NDA as listed: Astagraf XL 204096
    First PIV submission
    24 Sep 2013
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    24 Aug 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    25 Mar 2019

Tacrolimus

NDA 206406 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 0.75 mg, 1 mg and 4 mg

    RLD/NDA as listed: Envarsus XR 206406
    First PIV submission
    31 Mar 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 Aug 2028

Tadalafil

NDA 021368 · 2 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 2.5 mg

    RLD/NDA as listed: Cialis 21368
    First PIV submission
    14 Oct 2008
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    18 Jun 2019
    First applicant approval
    22 May 2018
    First marketing
    27 Sep 2018
    Last qualifying patent expiry (as listed by FDA)
    19 Nov 2020

  • Tablets · 5 mg, 10 mg and 20 mg

    RLD/NDA as listed: Cialis 21368
    First PIV submission
    21 Nov 2007
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    18 Jun 2019
    First applicant approval
    22 May 2018
    First marketing
    27 Sep 2018
    Last qualifying patent expiry (as listed by FDA)
    19 Nov 2020

Tadalafil

NDA 022332 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 20 mg

    RLD/NDA as listed: Adcirca 22332
    First PIV submission
    15 Oct 2009
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    18 Jun 2019
    First applicant approval
    3 Aug 2018
    First marketing
    8 Aug 2018
    Last qualifying patent expiry (as listed by FDA)
    26 Apr 2020

Tadalafil

NDA 214522 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Suspension · 20 mg/5 mL

    RLD/NDA as listed: Tadliq 214522
    First PIV submission
    3 Dec 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 Dec 2038

Tafamidis

NDA 212161 · 2 rows · Listed patents and exclusivities · Open in the app

  • Capsules · 61 mg

    RLD/NDA as listed: Vyndamax 212161
    First PIV submission
    3 May 2023
    ANDAs
    3
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    31 Aug 2035

  • Tafamidis New · Tablets · 61 mg

    RLD/NDA as listed: Vyndamax 212161
    First PIV submission
    24 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)
    31 Aug 2035

Tafamidis Meglumine

NDA 211996 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 20 mg

    RLD/NDA as listed: Vyndaqel 211996
    First PIV submission
    3 May 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 Dec 2026

Tafluprost

NDA 202514 · 1 row · Listed patents and exclusivities · Open in the app

  • Ophthalmic Solution · 1.5E-5

    RLD/NDA as listed: Zioptan 202514
    First PIV submission
    10 Feb 2016
    ANDAs
    2
    180-day status
    Eligible Deferred
    Decision posted
    2/20/2023 12/14/2021
    First applicant approval
    19 Aug 2019
    First marketing
    6 Dec 2022
    Last qualifying patent expiry (as listed by FDA)
    18 Dec 2022

Tamoxifen Citrate

NDA 017970 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 10 mg and 20 mg

    RLD/NDA as listed: Nolvadex 17970
    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

Tamsulosin Hydrochloride

NDA 020579 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 0.4 mg

    RLD/NDA as listed: Flomax 20579
    First PIV submission
    20 Dec 2004
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    24 Aug 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Tapentadol

NDA 203794 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Solution · 20 mg/mL

    RLD/NDA as listed: Nucynta 203794
    First PIV submission
    20 Dec 2013
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Jul 2025
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    27 Jun 2025

Tapentadol Hydrochloride

NDA 022304 · 1 row · Listed patents and exclusivities · Open in the app

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

    RLD/NDA as listed: Nucynta 22304
    First PIV submission
    20 Nov 2012
    ANDAs
    4
    180-day status
    Extinguished
    Decision posted
    7 Jul 2025
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    27 Jun 2025

Tapentadol Hydrochloride

NDA 200533 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg

    RLD/NDA as listed: Nucynta ER 200533
    First PIV submission
    20 Nov 2012
    ANDAs
    2
    180-day status
    Extinguished
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    27 Jun 2025

Tapinarof

NDA 215272 · 1 row · Listed patents and exclusivities · Open in the app

  • Cream · 0.01

    RLD/NDA as listed: Vtama 215272
    First PIV submission
    26 May 2026
    ANDAs
    4
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    18 Dec 2039

Tasimelteon

NDA 205677 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 20 mg

    RLD/NDA as listed: Hetlioz 205677
    First PIV submission
    31 Jan 2018
    ANDAs
    3
    180-day status
    Eligible Deferred
    Decision posted
    1/10/2023 12/13/2022
    First applicant approval
    12 Dec 2022
    First marketing
    29 Dec 2022
    Last qualifying patent expiry (as listed by FDA)
    17 May 2034

Tasimelteon

NDA 214517 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Suspension · 4 mg/mL

    RLD/NDA as listed: Hetlioz LQ 214517
    First PIV submission
    1 Apr 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)
    21 Feb 2041

Tavaborole

NDA 204427 · 1 row · Listed patents and exclusivities · Open in the app

  • Topical Solution · 0.05

    RLD/NDA as listed: Kerydin 204427
    First PIV submission
    9 Jul 2018
    ANDAs
    13
    180-day status
    Eligible
    Decision posted
    17 Nov 2020
    First applicant approval
    13 Oct 2020
    First marketing
    19 Oct 2020
    Last qualifying patent expiry (as listed by FDA)
    26 May 2027

Tazarotene

NDA 211882 · 1 row · Listed patents and exclusivities · Open in the app

  • Topical Lotion · 4.4999999999999999E-4

    RLD/NDA as listed: Arazlo 211882
    First PIV submission
    12 May 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)
    11 May 2038

Technetium TC-99M Tetrofosmin Kit

NDA 020372 · 1 row · Listed patents and exclusivities · Open in the app

  • Intravenous Injection · 1.38 mg/vial

    RLD/NDA as listed: Myoview 30 mL 20372
    First PIV submission
    20 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)
    10 Mar 2030

Teduglutide

NDA 203441 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 5 mg/vial

    RLD/NDA as listed: Gattex Kit 203441
    First PIV submission
    21 Dec 2016
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    15 Dec 2025
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    1 Nov 2025

Telmisartan

NDA 020850 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 20 mg, 40 mg and 80 mg

    RLD/NDA as listed: Micardis 20850
    First PIV submission
    26 Dec 2006
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    24 Aug 2020
    First applicant approval
    8 Jan 2014
    First marketing
    8 Jan 2014
    Last qualifying patent expiry (as listed by FDA)
    10 Jan 2020

Telmisartan and Hydrochlorothiazide

NDA 021162 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 80 mg/12.5 mg and 40 mg/12.5 mg

    RLD/NDA as listed: Micardis HCT 21162
    First PIV submission
    31 Dec 2008
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    24 Aug 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    10 Jan 2020

Temazepam

NDA 018163 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 7.5 mg

    RLD/NDA as listed: Restoril 18163
    First PIV submission
    1 Nov 2006
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    24 Aug 2020
    First applicant approval
    8 Sep 2009
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    18 May 2010

Temozolomide

NDA 021029 · 2 rows · Listed patents and exclusivities · Open in the app

  • Capsules · 140 mg and 180 mg

    RLD/NDA as listed: Temodar 21029
    First PIV submission
    24 Mar 2008
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    24 Aug 2020
    First applicant approval
    1 Mar 2010
    First marketing
    12 Aug 2013
    Last qualifying patent expiry (as listed by FDA)
    11 Aug 2013

  • Capsules · 5 mg, 20 mg, 100 mg and 250 mg

    RLD/NDA as listed: Temodar 21029
    First PIV submission
    20 Mar 2007
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    24 Aug 2020
    First applicant approval
    1 Mar 2010
    First marketing
    12 Aug 2013
    Last qualifying patent expiry (as listed by FDA)
    11 Aug 2013

Temsirolimus

NDA 022088 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 25 mg/mL, 1.8 mL vial

    RLD/NDA as listed: Torisel 22088
    First PIV submission
    25 May 2011
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    10 Mar 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    18 Apr 2014

Tenofovir Alafenamide Fumarate

NDA 208464 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 25 mg

    RLD/NDA as listed: Vemlidy 208464
    First PIV submission
    5 Nov 2019
    ANDAs
    6
    180-day status
    Eligible
    Decision posted
    18 Apr 2023
    First applicant approval
    30 Mar 2023
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    15 Aug 2032

Tenofovir Disoproxil Fumarate

NDA 021356 · 2 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 150 mg, 200 mg, and 250 mg

    RLD/NDA as listed: Viread 21356
    First PIV submission
    17 May 2012
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    18 Jun 2019
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    25 Jan 2018

  • Tablets · 300 mg

    RLD/NDA as listed: Viread 21356
    First PIV submission
    26 Jan 2010
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    18 Jun 2019
    First applicant approval
    18 Mar 2015
    First marketing
    15 Dec 2017
    Last qualifying patent expiry (as listed by FDA)
    25 Jan 2018

Terazosin Hydrochloride

NDA 019057 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 1 mg, 2 mg, 5 mg and 10 mg

    RLD/NDA as listed: Hytrin 19057
    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

Terazosin Hydrochloride

NDA 020347 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 1 mg, 2 mg, 5 mg and 10 mg

    RLD/NDA as listed: Hytrin 20347
    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

Terbinafine Hydrochloride

NDA 020539 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 250 mg

    RLD/NDA as listed: Lamisil 20539
    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

Teriflunomide

NDA 202992 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 7 mg and 14 mg

    RLD/NDA as listed: Aubagio 202992
    First PIV submission
    12 Sep 2016
    ANDAs
    21
    180-day status
    Eligible
    Decision posted
    18 Jun 2019
    First applicant approval
    27 Jul 2018
    First marketing
    12 Mar 2023
    Last qualifying patent expiry (as listed by FDA)
    4 Feb 2034

Teriparatide

NDA 021318 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 250 mcg/mL, 2.4 mL prefilled Pen

    RLD/NDA as listed: Forteo 21318
    First PIV submission
    27 Jul 2015
    ANDAs
    1
    180-day status
    Extinguished Non-Forfeiture
    Decision posted
    11/16/2023 11/16/2023
    First applicant approval
    16 Nov 2023
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    25 Mar 2025

Testosterone

NDA 021454 · 1 row · Listed patents and exclusivities · Open in the app

  • Gel · 1%

    RLD/NDA as listed: Testim 21454
    First PIV submission
    21 Aug 2008
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    10 Mar 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    11 Jun 2008

Testosterone

NDA 021463 · 1 row · Listed patents and exclusivities · Open in the app

  • Gel · 10 mg/actuation

    RLD/NDA as listed: Fortesta 21463
    First PIV submission
    14 Aug 2012
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    24 Aug 2020
    First applicant approval
    5 Aug 2015
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    9 Nov 2018

Testosterone

NDA 022309 · 1 row · Listed patents and exclusivities · Open in the app

  • Gel · 1.62% (1.25 g and 2.5 g packets)

    RLD/NDA as listed: Androgel 22309
    First PIV submission
    19 Jun 2013
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    27 Apr 2026
    First applicant approval
    12 Jul 2017
    First marketing
    12 Oct 2018
    Last qualifying patent expiry (as listed by FDA)
    12 Oct 2026

Testosterone

NDA 022504 · 1 row · Listed patents and exclusivities · Open in the app

  • Topical Solution · 30 mg/1.5 mL

    RLD/NDA as listed: Axiron 22504
    First PIV submission
    29 Jan 2013
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    24 Aug 2020
    First applicant approval
    7 Aug 2017
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    19 Feb 2017

Testosterone Undecanoate

NDA 022219 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 250 mg/mL

    RLD/NDA as listed: Aveed 22219
    First PIV submission
    11 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)
    14 Mar 2027

Thalidomide

NDA 020785 · 3 rows · Listed patents and exclusivities · Open in the app

  • Capsules · 150 mg

    RLD/NDA as listed: Thalomid 20785
    First PIV submission
    3 Feb 2014
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    18 Mar 2024
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    9 Dec 2023

  • Capsules · 200 mg

    RLD/NDA as listed: Thalomid 20785
    First PIV submission
    25 Sep 2006
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    13 Aug 2019
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    23 Oct 2020

  • Capsules · 50 mg and 100 mg

    RLD/NDA as listed: Thalomid 20785
    First PIV submission
    18 Dec 2006
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    13 Aug 2019
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    23 Oct 2020

Tiagabine Hydrochloride

NDA 020646 · 2 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 12 mg and 16 mg

    RLD/NDA as listed: Gabitril 20646
    First PIV submission
    24 Jan 2014
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    24 Aug 2020
    First applicant approval
    13 Oct 2017
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    10 Jun 2017

  • Tablets · 2 mg and 4 mg

    RLD/NDA as listed: Gabitril 20646
    First PIV submission
    1 Feb 2005
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    24 Aug 2020
    First applicant approval
    4 Nov 2011
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    10 Jun 2017

Ticagrelor

NDA 022433 · 2 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 60 mg

    RLD/NDA as listed: Brilinta 22433
    First PIV submission
    30 Sep 2015
    ANDAs
    3
    180-day status
    Eligible
    Decision posted
    13 Aug 2019
    First applicant approval
    4 Sep 2018
    First marketing
    1 May 2025
    Last qualifying patent expiry (as listed by FDA)
    17 Apr 2030

  • Tablets · 90 mg

    RLD/NDA as listed: Brilinta 22433
    First PIV submission
    20 Jul 2015
    ANDAs
    16
    180-day status
    Eligible
    Decision posted
    19 Nov 2019
    First applicant approval
    4 Sep 2018
    First marketing
    1 May 2025
    Last qualifying patent expiry (as listed by FDA)
    17 Apr 2030

Timolol Maleate

NDA 021516 · 1 row · Listed patents and exclusivities · Open in the app

  • Ophthalmic Solution · 5.0000000000000001E-3

    RLD/NDA as listed: Istalol 21516
    First PIV submission
    19 Oct 2012
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    10 Aug 2020
    First applicant approval
    17 Apr 2015
    First marketing
    17 Apr 2015
    Last qualifying patent expiry (as listed by FDA)
    16 Nov 2018

Tiopronin

NDA 211843 · 2 rows · Listed patents and exclusivities · Open in the app

  • Delayed-release Tablets · 100 mg

    RLD/NDA as listed: Thiola EC 211843
    First PIV submission
    11 Oct 2022
    ANDAs
    2
    180-day status
    Eligible
    Decision posted
    6 Mar 2023
    First applicant approval
    24 Feb 2023
    First marketing
    24 Feb 2023
    Last qualifying patent expiry (as listed by FDA)
    14 Nov 2038

  • Delayed-release Tablets · 300 mg

    RLD/NDA as listed: Thiola EC 211843
    First PIV submission
    11 Oct 2022
    ANDAs
    2
    180-day status
    Eligible
    Decision posted
    6 Mar 2023
    First applicant approval
    24 Feb 2023
    First marketing
    24 Feb 2023
    Last qualifying patent expiry (as listed by FDA)
    14 Nov 2038

Tiotropium Bromide

NDA 021395 · 1 row · Listed patents and exclusivities · Open in the app

  • Inhalation Powder Capsules · 18 mcg

    RLD/NDA as listed: Spiriva 21395
    First PIV submission
    11 May 2018
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    26 Jun 2023
    First applicant approval
    20 Jun 2023
    First marketing
    16 Aug 2023
    Last qualifying patent expiry (as listed by FDA)
    19 Apr 2030

Tiotropium Bromide

NDA 021936 · 1 row · Listed patents and exclusivities · Open in the app

  • Inhalation Aerosol · 2.5 mcg per actuation

    RLD/NDA as listed: Spiriva Respimat 21936
    First PIV submission
    7 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 Apr 2031

Tiotropium Bromide and Olodaterol Hydrochloride

NDA 206756 · 1 row · Listed patents and exclusivities · Open in the app

  • Inhalation Spray · 2.5 mcg/2.5 mcg per spray

    RLD/NDA as listed: Stiolto Respimat 206756
    First PIV submission
    24 May 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)
    16 Oct 2030

Tirbanibulin

NDA 213189 · 1 row · Listed patents and exclusivities · Open in the app

  • Ointment · 0.01

    RLD/NDA as listed: Klisyri 213189
    First PIV submission
    16 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)
    7 Sep 2038

Tirofiban Hydrochloride

NDA 020913 · 2 rows · Listed patents and exclusivities · Open in the app

  • Injection · 12.5 mg/250 mL

    RLD/NDA as listed: Aggrastat 20913
    First PIV submission
    3 Oct 2018
    ANDAs
    1
    180-day status
    Extinguished Non-Forfeiture Deferred
    Decision posted
    5/2/2023 2/6/2023 5/4/2021
    First applicant approval
    8 Apr 2021
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    1 May 2023

  • Injection · 5 mg/100 mL

    RLD/NDA as listed: Aggrastat 20913
    First PIV submission
    29 Aug 2019
    ANDAs
    1
    180-day status
    Extinguished Deferred
    Decision posted
    5/2/2023 2/6/2023
    First applicant approval
    7 Feb 2023
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    1 May 2023

Tirzepatide

NDA 215866 · 7 rows · Listed patents and exclusivities · Open in the app

  • Subcutaneous Solution · 10 mg/0.5 mL 12.5 mg/0.5 mL 15 mg/0.5 mL

    RLD/NDA as listed: Mounjaro (Autoinjector) 215866
    First PIV submission
    13 May 2026
    ANDAs
    12
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    30 Dec 2041

  • Subcutaneous Solution · 10 mg/2.4 mL and 60 mg/2.4 mL

    RLD/NDA as listed: Mounjaro Kwikpen 215866
    First PIV submission
    26 Jun 2026
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    30 Dec 2041

  • Subcutaneous Solution · 12.5 mg/0.5 mL

    RLD/NDA as listed: Mounjaro 215866
    First PIV submission
    13 May 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)
    30 Dec 2041

  • Subcutaneous Solution · 2.5 mg/0.5 mL 5 mg/0.5 mL

    RLD/NDA as listed: Mounjaro (Autoinjector) 215866
    First PIV submission
    13 May 2026
    ANDAs
    13
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    30 Dec 2041

  • Subcutaneous Solution · 2.5 mg/0.5 mL 5mg/0.5 mL 7.5 mg/0.5 mL 10 mg/0.5 mL 15 mg/0.5 mL

    RLD/NDA as listed: Mounjaro 215866
    First PIV submission
    13 May 2026
    ANDAs
    2
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    30 Dec 2041

  • Subcutaneous Solution · 20 mg/2.4 mL and 30 mg/2.4 mL

    RLD/NDA as listed: Mounjaro Kwikpen 215866
    First PIV submission
    24 Aug 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)
    30 Dec 2041

  • Subcutaneous Solution · 7.5 mg/0.5 mL

    RLD/NDA as listed: Mounjaro (Autoinjector) 215866
    First PIV submission
    13 May 2026
    ANDAs
    13
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    30 Dec 2041

Tirzepatide

NDA 217806 · 9 rows · Listed patents and exclusivities · Open in the app

  • Subcutaneous Solution · 10 mg/0.5 mL 12.5 mg/0.5 mL 15 mg/0.5 mL

    RLD/NDA as listed: Zepbound (Autoinjector) 217806
    First PIV submission
    13 May 2026
    ANDAs
    11
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    22 Jul 2039

  • Subcutaneous Solution · 10 mg/2.4 mL and 60 mg/2.4 mL

    RLD/NDA as listed: Zepbound Kwikpen 217806
    First PIV submission
    26 Jun 2026
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    22 Jul 2039

  • Subcutaneous Solution · 12.5 mg/0.5 mL

    RLD/NDA as listed: Zepbound 217806
    First PIV submission
    13 May 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)
    22 Jul 2039

  • Subcutaneous Solution · 2.5 mg/0.5 mL 5 mg/0.5 mL

    RLD/NDA as listed: Zepbound 217806
    First PIV submission
    13 May 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)
    22 Jul 2039

  • Subcutaneous Solution · 2.5 mg/0.5 mL 5 mg/0.5 mL

    RLD/NDA as listed: Zepbound (Autoinjector) 217806
    First PIV submission
    13 May 2026
    ANDAs
    12
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    22 Jul 2039

  • Subcutaneous Solution · 20 mg/2.4 mL and 30 mg/2.4 mL

    RLD/NDA as listed: Zepbound Kwikpen 217806
    First PIV submission
    24 Aug 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)
    22 Jul 2039

  • Subcutaneous Solution · 40 mg/2.4 mL and 50 mg/2.4 mL

    RLD/NDA as listed: Zepbound Kwikpen 217806
    First PIV submission
    26 Aug 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)
    22 Jul 2039

  • Subcutaneous Solution · 7.5 mg/0.5 mL

    RLD/NDA as listed: Zepbound (Autoinjector) 217806
    First PIV submission
    13 May 2026
    ANDAs
    12
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    22 Jul 2039

  • Subcutaneous Solution · 7.5 mg/0.5 mL 10 mg/0.5 mL 15 mg/0.5 mL

    RLD/NDA as listed: Zepbound 217806
    First PIV submission
    13 May 2026
    ANDAs
    2
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    22 Jul 2039

Tivozanib Hydrochloride

NDA 212904 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 0.89 mg and 1.34 mg

    RLD/NDA as listed: Fotivda 212904
    First PIV submission
    10 Mar 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)
    5 Nov 2039

Tizanidine Hydrochloride

NDA 021447 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 2 mg, 4 mg and 6 mg

    RLD/NDA as listed: Zanaflex 21447
    First PIV submission
    10 Aug 2007
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    10 Aug 2020
    First applicant approval
    3 Feb 2012
    First marketing
    3 Feb 2012
    Last qualifying patent expiry (as listed by FDA)
    28 Nov 2021

Tobramycin

NDA 050753 · 1 row · Listed patents and exclusivities · Open in the app

  • Inhalation Solution · 300 mg/5 mL

    RLD/NDA as listed: Tobi 50753
    First PIV submission
    29 Jun 2009
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    10 Aug 2020
    First applicant approval
    10 Oct 2013
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    19 Oct 2014

Tobramycin

NDA 201820 · 1 row · Listed patents and exclusivities · Open in the app

  • Inhalation Solution · 300 mg/4 mL

    RLD/NDA as listed: Bethkis 201820
    First PIV submission
    31 Aug 2017
    ANDAs
    1
    180-day status
    Extinguished Eligible
    Decision posted
    4/18/2023 7/2/2019
    First applicant approval
    26 Jun 2019
    First marketing
    26 Jun 2019
    Last qualifying patent expiry (as listed by FDA)
    22 Sep 2022

Tofacitinib Citrate

NDA 203214 · 2 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 10 mg

    RLD/NDA as listed: Xeljanz 203214
    First PIV submission
    24 Jul 2019
    ANDAs
    1
    180-day status
    Extinguished Eligible
    Decision posted
    1/20/2026 7/13/2021
    First applicant approval
    1 Jun 2021
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    8 Dec 2025

  • Tablets · 5 mg

    RLD/NDA as listed: Xeljanz 203214
    First PIV submission
    7 Nov 2016
    ANDAs
    3
    180-day status
    Extinguished Eligible
    Decision posted
    1/20/2026 3/20/2023
    First applicant approval
    13 Mar 2023
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    8 Dec 2025

Tofacitinib Citrate

NDA 208246 · 2 rows · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 11 mg

    RLD/NDA as listed: Xeljanz XR 208246
    First PIV submission
    7 Nov 2016
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    10 Aug 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    25 Mar 2023

  • Extended-release Tablets · 22 mg

    RLD/NDA as listed: Xeljanz XR 208246
    First PIV submission
    28 Dec 2020
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    24 Aug 2021
    First applicant approval
    19 Aug 2021
    First marketing
    19 Aug 2021
    Last qualifying patent expiry (as listed by FDA)
    14 Mar 2034

Tofacitinib Citrate

NDA 213082 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Solution · 1 mg/mL

    RLD/NDA as listed: Xeljanz 213082
    First PIV submission
    12 Nov 2021
    ANDAs
    1
    180-day status
    Extinguished Eligible
    Decision posted
    1/20/2026 10/16/2023
    First applicant approval
    25 Sep 2023
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    8 Dec 2025

Tolterodine Tartrate

NDA 020771 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 1 mg and 2 mg

    RLD/NDA as listed: Detrol 20771
    First PIV submission
    blank
    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

Tolterodine Tartrate

NDA 021228 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Capsules · 2 mg and 4 mg

    RLD/NDA as listed: Detrol LA 21228
    First PIV submission
    30 Jul 2007
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    10 Aug 2020
    First applicant approval
    22 Nov 2016
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    11 Nov 2019

Tolvaptan

NDA 022275 · 3 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 15 mg

    RLD/NDA as listed: Samsca 22275
    First PIV submission
    10 Oct 2013
    ANDAs
    1
    180-day status
    Non-Forfeiture
    Decision posted
    19 May 2020
    First applicant approval
    15 Feb 2022
    First marketing
    10 Mar 2022
    Last qualifying patent expiry (as listed by FDA)
    1 Sep 2026

  • Tablets · 30mg

    RLD/NDA as listed: Samsca 22275
    First PIV submission
    23 Sep 2013
    ANDAs
    1
    180-day status
    Extinguished Non-Forfeiture
    Decision posted
    6/15/2020 6/15/2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    19 May 2020

  • Tablets · 60 mg

    RLD/NDA as listed: Samsca 22275
    First PIV submission
    26 Mar 2018
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    15 Jun 2020
    First applicant approval
    19 May 2020
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    1 Sep 2026

Tolvaptan

NDA 204441 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 15 mg, 30 mg, 45 mg, 60 mg, 90 mg

    RLD/NDA as listed: Jynarque 204441
    First PIV submission
    8 Apr 2021
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    28 Apr 2025
    First applicant approval
    23 Apr 2025
    First marketing
    12 May 2025
    Last qualifying patent expiry (as listed by FDA)
    7 Apr 2030

Topiramate

NDA 020505 · 2 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 25 mg, 100 mg and 200 mg

    RLD/NDA as listed: Topamax 20505
    First PIV submission
    26 Dec 2001
    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

  • Tablets · 50 mg

    RLD/NDA as listed: Topamax 20505
    First PIV submission
    8 Sep 2005
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    10 Aug 2020
    First applicant approval
    27 Mar 2009
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    26 Sep 2008

Topiramate

NDA 020844 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 15 mg and 25 mg

    RLD/NDA as listed: Topamax Sprinkle 20844
    First PIV submission
    7 Sep 2005
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    10 Aug 2020
    First applicant approval
    15 Apr 2009
    First marketing
    15 Apr 2009
    Last qualifying patent expiry (as listed by FDA)
    1 Sep 2019

Topiramate

NDA 201635 · 2 rows · Listed patents and exclusivities · Open in the app

  • Extended-release Capsules · 200 mg

    RLD/NDA as listed: Trokendi XR 201635
    First PIV submission
    3 Apr 2014
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    6 Mar 2023
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    18 Mar 2029

  • Extended-release Capsules · 25 mg, 50 mg, and 100 mg

    RLD/NDA as listed: Trokendi XR 201635
    First PIV submission
    12 May 2014
    ANDAs
    1
    180-day status
    Extinguished Non-Forfeiture Deferred
    Decision posted
    3/20/2023 3/20/2023 11/19/2019
    First applicant approval
    24 Nov 2017
    First marketing
    4 Jan 2023
    Last qualifying patent expiry (as listed by FDA)
    18 Mar 2029

Topiramate

NDA 205122 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Capsules · 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg

    RLD/NDA as listed: Qudexy XR 205122
    First PIV submission
    24 Dec 2015
    ANDAs
    1
    180-day status
    Extinguished Non-Forfeiture
    Decision posted
    12/1/2020 8/27/2019
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    19 Mar 2033

Topiramate

NDA 214679 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Solution · 25 mg/mL

    RLD/NDA as listed: Epronita 214679
    First PIV submission
    6 Oct 2022
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    11 Nov 2024
    First applicant approval
    31 Oct 2024
    First marketing
    9 Jul 2025
    Last qualifying patent expiry (as listed by FDA)
    21 Aug 2040

Torsemide

NDA 020136 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 5 mg, 10 mg, 20 mg, and 100 mg

    RLD/NDA as listed: Demadex 20136
    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

Trabectedin

NDA 207953 · 1 row · Listed patents and exclusivities · Open in the app

  • Powder for Injection · 1 mg/vial

    RLD/NDA as listed: Yondelis 207953
    First PIV submission
    23 Apr 2020
    ANDAs
    2
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    7 Jan 2028

Tramadol Hydrochloride

NDA 020281 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 50 mg

    RLD/NDA as listed: Ultram 20281
    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

Tramadol Hydrochloride

NDA 021692 · 3 rows · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 100 mg

    RLD/NDA as listed: Ultram ER 21692
    First PIV submission
    8 Jan 2007
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    10 Aug 2020
    First applicant approval
    13 Nov 2009
    First marketing
    13 Nov 2009
    Last qualifying patent expiry (as listed by FDA)
    10 May 2014

  • Extended-release Tablets · 200 mg

    RLD/NDA as listed: Ultram ER 21692
    First PIV submission
    28 Mar 2007
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    10 Aug 2020
    First applicant approval
    13 Nov 2009
    First marketing
    13 Nov 2009
    Last qualifying patent expiry (as listed by FDA)
    10 May 2014

  • Extended-release Tablets · 300 mg

    RLD/NDA as listed: Ultram ER 21692
    First PIV submission
    25 Sep 2007
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    10 Aug 2020
    First applicant approval
    20 Sep 2011
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    10 May 2014

Tramadol Hydrochloride

NDA 021745 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 100 mg, 200 mg and 300 mg

    RLD/NDA as listed: Ryzolt 21745
    First PIV submission
    18 Jun 2009
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    10 Aug 2020
    First applicant approval
    30 Dec 2011
    First marketing
    30 Dec 2011
    Last qualifying patent expiry (as listed by FDA)
    29 Jun 2020

Tramadol Hydrochloride

NDA 214044 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Solution · 5 mg/mL

    RLD/NDA as listed: Qdolo 214044
    First PIV submission
    16 Sep 2024
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    15 Jul 2026
    First applicant approval
    26 Jun 2026
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    1 Sep 2040

Trametinib Dimethyl Sulfoxide

NDA 204114 · 2 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 0.5 mg and 2 mg

    RLD/NDA as listed: Mekinist 204114
    First PIV submission
    28 Sep 2023
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    19 Aug 2024
    First applicant approval
    6 Aug 2024
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    28 Jan 2032

  • Tablets · 1 mg

    RLD/NDA as listed: Mekinist 204114
    First PIV submission
    31 Aug 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 Jan 2032

Trandolapril

NDA 020528 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 1 mg, 2 mg and 4 mg

    RLD/NDA as listed: Mavik 20528
    First PIV submission
    4 Oct 2004
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    10 Aug 2020
    First applicant approval
    12 Jun 2007
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    12 Jun 2007

Trandolapril and Verapamil Hydrochloride

NDA 020591 · 3 rows · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 1 mg/240 mg

    RLD/NDA as listed: Tarka 20591
    First PIV submission
    20 Feb 2008
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    10 Aug 2020
    First applicant approval
    30 Aug 2010
    First marketing
    20 Sep 2010
    Last qualifying patent expiry (as listed by FDA)
    24 Feb 2015

  • Extended-release Tablets · 2 mg/180 mg and 2 mg/240 mg

    RLD/NDA as listed: Tarka 20591
    First PIV submission
    9 Nov 2007
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    10 Aug 2020
    First applicant approval
    26 May 2010
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    24 Feb 2015

  • Extended-release Tablets · 4 mg/ 240 mg

    RLD/NDA as listed: Tarka 20591
    First PIV submission
    24 Jul 2007
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    10 Aug 2020
    First applicant approval
    5 May 2010
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    24 Feb 2015

Tranexamic Acid

NDA 022430 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 650 mg

    RLD/NDA as listed: Lysteda 22430
    First PIV submission
    24 May 2011
    ANDAs
    2
    180-day status
    Eligible
    Decision posted
    10 Aug 2020
    First applicant approval
    27 Dec 2012
    First marketing
    3 Jan 2013
    Last qualifying patent expiry (as listed by FDA)
    4 Mar 2025

Travoprost

NDA 021257 · 1 row · Listed patents and exclusivities · Open in the app

  • Ophthalmic Solution · 0.004%

    RLD/NDA as listed: Travatan 21257
    First PIV submission
    28 Nov 2008
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    10 Aug 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    22 Dec 2014

Travoprost

NDA 204822 · 1 row · Listed patents and exclusivities · Open in the app

  • Ophthalmic Solution · 0.003%

    RLD/NDA as listed: Izba 204822
    First PIV submission
    30 Dec 2015
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    10 Aug 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    10 Oct 2029

Travoprost (Preserved)

NDA 021994 · 1 row · Listed patents and exclusivities · Open in the app

  • Ophthalmic Solution · 0.004%

    RLD/NDA as listed: Travatan Z 21994
    First PIV submission
    19 Feb 2009
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    13 Aug 2019
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    2 Dec 2014

Trazodone Hydrochloride

NDA 018207 · 2 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 25 mg and 75 mg

    RLD/NDA as listed: Desyrel 18207
    First PIV submission
    27 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)
    13 Mar 2029

  • Tablets · 50 mg, 100 mg, 150 mg, 300 mg

    RLD/NDA as listed: Desyrel 18207
    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

Trazodone Hydrochloride

NDA 022411 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 150 mg and 300 mg

    RLD/NDA as listed: Oleptro 22411
    First PIV submission
    18 Oct 2010
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    10 Aug 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    29 Jun 2020

Trazodone Hydrochloride

NDA 218637 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Solution · 10 mg/mL

    RLD/NDA as listed: Raldesy 218637
    First PIV submission
    17 Jun 2026
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    13 Mar 2029

Treprostinil

NDA 203496 · 3 rows · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 0.125 mg and 5 mg

    RLD/NDA as listed: Orenitram 203496
    First PIV submission
    28 Dec 2020
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    11 Aug 2031

  • Extended-release Tablets · 0.25 mg and 1 mg

    RLD/NDA as listed: Orenitram 203496
    First PIV submission
    19 May 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)
    22 Jan 2031

  • Extended-release Tablets · 2.5 mg

    RLD/NDA as listed: Orenitram 203496
    First PIV submission
    24 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)
    22 Jan 2031

Treprostinil Sodium

NDA 021272 · 2 rows · Listed patents and exclusivities · Open in the app

  • Injection · 1 mg/mL, 2.5 mg/mL, and 5 mg/mL, 20 mL vial

    RLD/NDA as listed: Remodulin 21272
    First PIV submission
    7 Dec 2012
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    18 Jun 2019
    First applicant approval
    30 Nov 2017
    First marketing
    25 Mar 2019
    Last qualifying patent expiry (as listed by FDA)
    29 Mar 2029

  • Injection · 10 mg/mL, 20 mL vial

    RLD/NDA as listed: Remodulin 21272
    First PIV submission
    2 Dec 2011
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    18 Jun 2019
    First applicant approval
    30 Nov 2017
    First marketing
    25 Mar 2019
    Last qualifying patent expiry (as listed by FDA)
    29 Mar 2029

Treprostinil Sodium

NDA 022387 · 1 row · Listed patents and exclusivities · Open in the app

  • Inhalation Solution · 0.6 mg/mL, 2.9 mL ampules

    RLD/NDA as listed: Tyvaso 22387
    First PIV submission
    13 Apr 2015
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    14 Dec 2021
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    15 Dec 2028

Tretinoin

NDA 017579 · 1 row · Listed patents and exclusivities · Open in the app

  • Gel · 0.025%

    RLD/NDA as listed: Retin-A 17579
    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

Tretinoin

NDA 020475 · 2 rows · Listed patents and exclusivities · Open in the app

  • Gel · 0.1%

    RLD/NDA as listed: Retin-A Micro 20475
    First PIV submission
    8 Jul 2010
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    10 Aug 2020
    First applicant approval
    17 Jul 2013
    First marketing
    31 Jul 2013
    Last qualifying patent expiry (as listed by FDA)
    21 Sep 2016

  • Gel · 4.0000000000000002E-4

    RLD/NDA as listed: Retin-A Micro 20475
    First PIV submission
    20 Dec 2010
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    10 Aug 2020
    First applicant approval
    17 Jul 2013
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    21 Sep 2016

Triamterene/ Hydrochlorothiazide

NDA 019129 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 37.5 mg/25 mg and 75 mg/50 mg

    RLD/NDA as listed: Maxzide 19129
    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

Trientine Tetrahydrochloride

NDA 215760 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 300 mg

    RLD/NDA as listed: Cuvrior 215760
    First PIV submission
    21 Jun 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)
    3 May 2039

Trifarotene

NDA 211527 · 1 row · Listed patents and exclusivities · Open in the app

  • Cream · 5.0000000000000002E-5

    RLD/NDA as listed: Aklief 211527
    First PIV submission
    4 Oct 2023
    ANDAs
    2
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    30 May 2033

Trifluridine Hydrochloride and Tipiracil

NDA 207981 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 15 mg/6.14 mg and 20 mg/8.19 mg

    RLD/NDA as listed: Lonsurf 207981
    First PIV submission
    23 Sep 2019
    ANDAs
    4
    180-day status
    Deferred
    Decision posted
    26 Jun 2023
    First applicant approval
    13 Jun 2023
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    17 Jun 2034

Triheptanoin

NDA 213687 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Liquid · 100% w/w

    RLD/NDA as listed: Dojolvi 213687
    First PIV submission
    1 Jul 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)
    28 Apr 2029

Trilaciclib Dihydrochloride

NDA 214200 · 1 row · Listed patents and exclusivities · Open in the app

  • Powder for Injection · 300 mg base/vial

    RLD/NDA as listed: Cosela 214200
    First PIV submission
    12 Feb 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)
    13 Nov 2040

Trospium Chloride

NDA 022103 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Capsules · 60 mg

    RLD/NDA as listed: Sanctura XR 22103
    First PIV submission
    2 Mar 2009
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    10 Aug 2020
    First applicant approval
    12 Oct 2012
    First marketing
    12 Oct 2012
    Last qualifying patent expiry (as listed by FDA)
    1 Feb 2025