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FDA Paragraph IV list

Drybench Patent.

FDA Paragraph IV list: E

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

Edaravone

NDA 215446 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Suspension · 105 mg/5 mL

    RLD/NDA as listed: Radicava ORS 215446
    First PIV submission
    20 Apr 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)
    1 Nov 2039

Edoxaban Tosylate

NDA 206316 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 15 mg, 30 mg and 60 mg

    RLD/NDA as listed: Savaysa 206316
    First PIV submission
    28 Jan 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)
    28 Mar 2028

Efavirenz

NDA 020972 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 50 mg, 100 mg and 200 mg

    RLD/NDA as listed: Sustiva 20972
    First PIV submission
    3 Nov 2016
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    2 Jul 2019
    First applicant approval
    15 Dec 2017
    First marketing
    21 Dec 2017
    Last qualifying patent expiry (as listed by FDA)
    6 Apr 2019

Efavirenz

NDA 021360 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 600 mg

    RLD/NDA as listed: Sustiva 21360
    First PIV submission
    9 Apr 2009
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    7 Apr 2020
    First applicant approval
    17 Feb 2016
    First marketing
    30 Jan 2018
    Last qualifying patent expiry (as listed by FDA)
    20 Jan 2018

Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate

NDA 021937 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 600 mg/200 mg/300 mg

    RLD/NDA as listed: Atripla 21937
    First PIV submission
    29 Dec 2008
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    9 Nov 2018
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    9 Mar 2021

Efinaconazole

NDA 203567 · 1 row · Listed patents and exclusivities · Open in the app

  • Topical Solution · 0.1

    RLD/NDA as listed: Jublia 203567
    First PIV submission
    6 Jun 2018
    ANDAs
    19
    180-day status
    Eligible
    Decision posted
    9 Feb 2021
    First applicant approval
    16 Dec 2020
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    2 Oct 2034

Elagolix Sodium

NDA 210450 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 150 mg and 200 mg

    RLD/NDA as listed: Orilissa 210450
    First PIV submission
    25 Jul 2022
    ANDAs
    9
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    1 Sep 2036

Elagolix Sodium, Estradiol, Norethindrone Acetate; Elagolix Sodium

NDA 213388 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 300 mg/1 mg/ 0.5 mg; 300 mg

    RLD/NDA as listed: Oriahnn (Co-Packaged) 213388
    First PIV submission
    3 Nov 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)
    14 Mar 2034

Eletriptan Hydrobromide

NDA 021016 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 20 mg and 40 mg

    RLD/NDA as listed: Relpax 21016
    First PIV submission
    29 Mar 2010
    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)
    29 Aug 2017

Eliglustat Tartrate

NDA 205494 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 84 mg

    RLD/NDA as listed: Cerdelga 205494
    First PIV submission
    20 Aug 2018
    ANDAs
    6
    180-day status
    Eligible Deferred
    Decision posted
    2/17/2025 10/5/2021
    First applicant approval
    8 Sep 2021
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    26 Jun 2026

Eltrombopag Olamine

NDA 022291 · 2 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 12.5 mg and 25 mg

    RLD/NDA as listed: Promacta 22291
    First PIV submission
    4 Feb 2014
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    17 Feb 2025
    First applicant approval
    17 Jan 2025
    First marketing
    13 May 2025
    Last qualifying patent expiry (as listed by FDA)
    1 Feb 2028

  • Tablets · 50 mg and 75 mg

    RLD/NDA as listed: Promacta 22291
    First PIV submission
    7 Jan 2014
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    17 Feb 2025
    First applicant approval
    17 Jan 2025
    First marketing
    13 May 2025
    Last qualifying patent expiry (as listed by FDA)
    1 Feb 2028

Eltrombopag Olamine

NDA 207027 · 1 row · Listed patents and exclusivities · Open in the app

  • For Oral Suspension · 12.5 mg/packet and 25 mg/packet

    RLD/NDA as listed: Promacta Kit 207027
    First PIV submission
    22 Apr 2022
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    13 May 2024
    First applicant approval
    18 Apr 2024
    First marketing
    13 May 2025
    Last qualifying patent expiry (as listed by FDA)
    13 Jul 2025

Eluxadoline

NDA 206940 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 75 mg and 100 mg

    RLD/NDA as listed: Viberzi 206940
    First PIV submission
    28 May 2019
    ANDAs
    6
    180-day status
    Eligible
    Decision posted
    14 Apr 2025
    First applicant approval
    14 Mar 2025
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    14 Mar 2033

Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Alafenamide

NDA 207561 · 1 row · Listed patents and exclusivities · Open in the app

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

    RLD/NDA as listed: Genvoya 207561
    First PIV submission
    12 Apr 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)
    6 Oct 2032

Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate

NDA 203100 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 150 mg/150 mg/ 200 mg/300 mg

    RLD/NDA as listed: Stribild 203100
    First PIV submission
    4 Oct 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)
    24 Apr 2030

Empagliflozin

NDA 204629 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 10 mg and 25 mg

    RLD/NDA as listed: Jardiance 204629
    First PIV submission
    1 Aug 2018
    ANDAs
    14
    180-day status
    Eligible
    Decision posted
    6 Sep 2022
    First applicant approval
    3 Aug 2022
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    11 Jun 2034

Empagliflozin and Linagliptin

NDA 206073 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 10 mg/5 mg and 25 mg/5 mg

    RLD/NDA as listed: Glyxambi 206073
    First PIV submission
    1 Aug 2018
    ANDAs
    9
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    11 Jun 2034

Empagliflozin and Metformin Hydrochloride

NDA 206111 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 5 mg/500 mg 5 mg/1000 mg 12.5 mg/500 mg 12.5 mg/1000 mg

    RLD/NDA as listed: Synjardy 206111
    First PIV submission
    1 Aug 2018
    ANDAs
    4
    180-day status
    Eligible
    Decision posted
    6 Sep 2022
    First applicant approval
    7 Jul 2022
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    1 Aug 2028

Empagliflozin and Metformin Hydrochloride

NDA 208658 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 5 mg/1000 mg 10 mg/1000 mg 12.5 mg/1000 mg 25 mg/1000 mg

    RLD/NDA as listed: Synjardy XR 208658
    First PIV submission
    1 Aug 2018
    ANDAs
    3
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    11 Jun 2034

Empagliflozin, Linagliptan and Metformin Hydrochloride

NDA 212614 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 5 mg/2.5 mg/1 g, 10 mg/5 mg/1 g, 12.5 mg/5 mg/1 g, 25 mg/5 mg/1 g

    RLD/NDA as listed: Trijardy XR 212614
    First PIV submission
    26 May 2020
    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)
    3 Apr 2034

Emtricitabine

NDA 021500 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 200 mg

    RLD/NDA as listed: Emtriva 21500
    First PIV submission
    16 Jul 2012
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    17 Nov 2020
    First applicant approval
    2 Jul 2018
    First marketing
    31 Aug 2020
    Last qualifying patent expiry (as listed by FDA)
    9 Mar 2021

Emtricitabine and Tenofovir Alafenamide Fumarate

NDA 208215 · 2 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 120 mg/15 mg

    RLD/NDA as listed: Descovy 208215
    First PIV submission
    31 Oct 2022
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    27 May 2024
    First applicant approval
    17 May 2024
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    15 Aug 2032

  • Tablets · 200 mg/25 mg

    RLD/NDA as listed: Descovy 208215
    First PIV submission
    5 Nov 2019
    ANDAs
    6
    180-day status
    Deferred
    Decision posted
    27 May 2024
    First applicant approval
    17 May 2024
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    15 Aug 2032

Emtricitabine and Tenofovir Disoproxil Fumarate

NDA 021752 · 2 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 100 mg/150 mg 133 mg/200 mg 167 mg/250 mg

    RLD/NDA as listed: Truvada 21752
    First PIV submission
    19 May 2017
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    13 Aug 2019
    First applicant approval
    22 Aug 2018
    First marketing
    18 Jan 2021
    Last qualifying patent expiry (as listed by FDA)
    9 Mar 2021

  • Tablets · 200 mg/300 mg

    RLD/NDA as listed: Truvada 21752
    First PIV submission
    26 Sep 2008
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    13 Aug 2019
    First applicant approval
    8 Jun 2017
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    9 Mar 2021

Emtricitabine, Rilpivirine Hydrochloride and Tenofovir Alafenamide Fumarate

NDA 208351 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 200 mg/25 mg/ 25 mg

    RLD/NDA as listed: Odefsey 208351
    First PIV submission
    5 Nov 2019
    ANDAs
    3
    180-day status
    Deferred
    Decision posted
    2 Mar 2026
    First applicant approval
    30 Jan 2026
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    15 Aug 2032

Emtricitabine, Rilpivirine Hydrochloride and Tenofovir Disoproxil Fumarate

NDA 202123 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 200 mg/25 mg/ 300 mg

    RLD/NDA as listed: Complera 202123
    First PIV submission
    20 May 2015
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    27 May 2025
    First applicant approval
    20 May 2025
    First marketing
    27 May 2025
    Last qualifying patent expiry (as listed by FDA)
    9 Dec 2025

Enalapril Maleate

NDA 018998 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 2.5 mg, 5 mg, 10 mg and 20 mg

    RLD/NDA as listed: Vasotec 18998
    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

Enalapril Maleate

NDA 204308 · 1 row · Listed patents and exclusivities · Open in the app

  • Powder for Oral Solution · 1 mg/mL

    RLD/NDA as listed: Epaned Kit 204308
    First PIV submission
    21 Jun 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)
    6 Nov 2032

Enalapril Maleate

NDA 208686 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Solution · 1 mg/mL

    RLD/NDA as listed: Epaned 208686
    First PIV submission
    31 Aug 2018
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    7 Sep 2021
    First applicant approval
    10 Aug 2021
    First marketing
    17 Aug 2021
    Last qualifying patent expiry (as listed by FDA)
    25 Mar 2036

Encorafenib

NDA 210496 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 75 mg

    RLD/NDA as listed: Braftovi 210496
    First PIV submission
    27 Jun 2022
    ANDAs
    3
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    5 Aug 2033

Enoxaparin Sodium

NDA 020164 · 3 rows · Listed patents and exclusivities · Open in the app

  • Injection · 100 mg/mL, 3 mL vials

    RLD/NDA as listed: Lovenox 20164
    First PIV submission
    7 Dec 2006
    ANDAs
    1
    180-day status
    Non-Forfeiture
    Decision posted
    7 Apr 2020
    First applicant approval
    28 Nov 2011
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    14 Feb 2012

  • Injection · 100 mg/mL, 0.3 mL, 0.4 mL, 0.6 mL, 0.8 mL and 1 mL prefilled syringes

    RLD/NDA as listed: Lovenox 20164
    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

  • Injection · 150 mg/mL, 0.6 mL, 0.8 mL and 1 mL prefilled syringes

    RLD/NDA as listed: Lovenox 20164
    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

Entacapone

NDA 020796 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 200 mg

    RLD/NDA as listed: Comtan 20796
    First PIV submission
    11 Apr 2007
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    16 Aug 2012
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    14 Sep 2018

Entecavir

NDA 021797 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 0.5 mg and 1 mg

    RLD/NDA as listed: Baraclude 21797
    First PIV submission
    14 Jun 2010
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    7 Apr 2020
    First applicant approval
    26 Aug 2014
    First marketing
    4 Sep 2014
    Last qualifying patent expiry (as listed by FDA)
    21 Aug 2015

Enzalutamide

NDA 203415 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 40 mg

    RLD/NDA as listed: Xtandi 203415
    First PIV submission
    31 Aug 2016
    ANDAs
    3
    180-day status
    Non-Forfeiture Deferred
    Decision posted
    9/18/2023 6/15/2021
    First applicant approval
    14 May 2021
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    13 Aug 2027

Enzalutamide

NDA 213674 · 2 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 120 mg and 160 mg

    RLD/NDA as listed: Xtandi 213674
    First PIV submission
    27 Dec 2024
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    11 Sep 2033

  • Tablets · 40 mg and 80 mg

    RLD/NDA as listed: Xtandi 213674
    First PIV submission
    31 Mar 2021
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    27 Apr 2026
    First applicant approval
    20 Apr 2026
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    13 Aug 2027

Ephedrine Sulfate

NDA 213407 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 50 mg/10 mL

    RLD/NDA as listed: Emerphed 213407
    First PIV submission
    14 Oct 2021
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    3 Oct 2024
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    16 May 2040

Ephedrine Sulfate

NDA 213994 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 25 mg/5 mL and 50 mg/10 mL

    RLD/NDA as listed: Ephedrine Sulfate 213994
    First PIV submission
    17 Mar 2023
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    17 Mar 2025
    First applicant approval
    11 Mar 2025
    First marketing
    25 Aug 2025
    Last qualifying patent expiry (as listed by FDA)
    22 Jan 2040

Epinastine Hydrochloride

NDA 021565 · 1 row · Listed patents and exclusivities · Open in the app

  • Ophthalmic Solution · 0.05%

    RLD/NDA as listed: Elestat 21565
    First PIV submission
    14 Oct 2008
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    7 Apr 2020
    First applicant approval
    14 Mar 2011
    First marketing
    2 May 2011
    Last qualifying patent expiry (as listed by FDA)
    29 Nov 2020

Epinephrine

NDA 019430 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection (Auto-injector) · 0.15 mg/0.3 mL and 0.3 mg/0.3 mL

    RLD/NDA as listed: Epipen and Epipen Jr. 19430
    First PIV submission
    20 Jul 2009
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    27 Aug 2019
    First applicant approval
    16 Aug 2018
    First marketing
    19 Aug 2019
    Last qualifying patent expiry (as listed by FDA)
    11 Sep 2025

Epinephrine

NDA 204200 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 1 mg/mL ampules

    RLD/NDA as listed: Adrenalin 204200
    First PIV submission
    9 Mar 2016
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    7 Apr 2020
    First applicant approval
    6 Jul 2018
    First marketing
    31 Jan 2023
    Last qualifying patent expiry (as listed by FDA)
    13 Mar 2035

Epinephrine

NDA 204640 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 30 mg/30 mL

    RLD/NDA as listed: Adrenalin 204640
    First PIV submission
    20 Aug 2018
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    6 Sep 2022
    First applicant approval
    24 Apr 2020
    First marketing
    19 May 2020
    Last qualifying patent expiry (as listed by FDA)
    13 Mar 2035

Epinephrine

NDA 205029 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 1 mg/mL

    RLD/NDA as listed: Epinephrine Injection 205029
    First PIV submission
    13 Aug 2020
    ANDAs
    1
    180-day status
    Non-Forfeiture Deferred
    Decision posted
    3/17/2025 11/25/2024
    First applicant approval
    20 Nov 2024
    First marketing
    5 Dec 2024
    Last qualifying patent expiry (as listed by FDA)
    15 Aug 2034

Epinephrine

NDA 214697 · 2 rows · Listed patents and exclusivities · Open in the app

  • Nasal Spray · 1 mg/spray

    RLD/NDA as listed: Neffy 214697
    First PIV submission
    29 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)
    6 Feb 2039

  • Nasal Spray · 2 mg/spray

    RLD/NDA as listed: Neffy 214697
    First PIV submission
    30 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)
    6 Feb 2039

Eplerenone

NDA 021437 · 2 rows · Listed patents and exclusivities · Open in the app

  • Eptifibatide · Injection · 0.75 mg/mL, 100 mL vial

    RLD/NDA as listed: Integrilin 21437
    First PIV submission
    5 Jun 2009
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    7 Apr 2020
    First applicant approval
    5 Jun 2015
    First marketing
    14 Dec 2015
    Last qualifying patent expiry (as listed by FDA)
    15 Sep 2015

  • Tablets · 25 mg and 50 mg

    RLD/NDA as listed: Inspra 21437
    First PIV submission
    27 Sep 2006
    ANDAs
    2
    180-day status
    Eligible
    Decision posted
    7 Apr 2020
    First applicant approval
    30 Jul 2008
    First marketing
    30 Jul 2008
    Last qualifying patent expiry (as listed by FDA)
    10 Apr 2020

Epoprostenol Sodium

NDA 022260 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 0. 5m/vial and 1.5 mg/vial

    RLD/NDA as listed: Veletri 22260
    First PIV submission
    31 Mar 2017
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    9 Feb 2021
    First applicant approval
    15 Jan 2021
    First marketing
    27 Jan 2021
    Last qualifying patent expiry (as listed by FDA)
    15 Mar 2027

Eprosartan Mesylate

NDA 020738 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 400 mg and 600 mg

    RLD/NDA as listed: Teveten 20738
    First PIV submission
    10 May 2010
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    7 Apr 2020
    First applicant approval
    16 Nov 2011
    First marketing
    20 Dec 2011
    Last qualifying patent expiry (as listed by FDA)
    12 Aug 2014

Eptifibatide

NDA 020718 · 2 rows · Listed patents and exclusivities · Open in the app

  • Injection · 2 mg/mL, 100 mL vial

    RLD/NDA as listed: Integrilin 20718
    First PIV submission
    18 Dec 2008
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    12 Jun 2015
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    15 Sep 2015

  • Injection · 2 mg/mL, 10 mL vial

    RLD/NDA as listed: Integrilin 20718
    First PIV submission
    30 Sep 2008
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    12 Jun 2015
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    15 Sep 2015

Erdafitinib

NDA 212018 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 3 mg, 4 mg and 5 mg

    RLD/NDA as listed: Balversa 212018
    First PIV submission
    12 Apr 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)
    2 Feb 2038

Eribulin Mesylate

NDA 201532 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 1 mg/2 mL

    RLD/NDA as listed: Halaven 201532
    First PIV submission
    20 Dec 2019
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    15 Apr 2024
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    8 Jan 2027

Erlotinib Hydrochloride

NDA 021743 · 2 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 100 mg and 150 mg

    RLD/NDA as listed: Tarceva 21743
    First PIV submission
    18 Nov 2008
    ANDAs
    2
    180-day status
    Eligible
    Decision posted
    18 Jun 2019
    First applicant approval
    11 Jun 2014
    First marketing
    9 May 2019
    Last qualifying patent expiry (as listed by FDA)
    9 Nov 2020

  • Tablets · 25 mg

    RLD/NDA as listed: Tarceva 21743
    First PIV submission
    18 Nov 2008
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    18 Jun 2019
    First applicant approval
    11 Jun 2014
    First marketing
    9 May 2019
    Last qualifying patent expiry (as listed by FDA)
    9 Nov 2020

Ertapenem

NDA 021337 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 1 g/vial

    RLD/NDA as listed: Invanz 21337
    First PIV submission
    21 Dec 2012
    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)
    15 May 2017

Ertugliflozin

NDA 209803 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 5 mg and 15 mg

    RLD/NDA as listed: Steglatro 209803
    First PIV submission
    20 Dec 2021
    ANDAs
    3
    180-day status
    Eligible
    Decision posted
    7 Aug 2023
    First applicant approval
    13 Jul 2023
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    13 Jul 2030

Escitalopram Oxalate

NDA 021323 · 3 rows · Listed patents and exclusivities · Open in the app

  • Capsules · 10 mg and 20 mg

    RLD/NDA as listed: Lexapro 21323
    First PIV submission
    30 Mar 2005
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    7 Apr 2020
    First applicant approval
    3 Aug 2007
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    25 Jul 2022

  • Capsules · 5 mg

    RLD/NDA as listed: Lexapro 21323
    First PIV submission
    17 Aug 2005
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    7 Apr 2020
    First applicant approval
    3 Aug 2007
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    25 Jul 2022

  • Tablets · 5 mg, 10 mg and 20 mg

    RLD/NDA as listed: Lexapro 21323
    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

Esketamine Hydrochloride

NDA 211243 · 1 row · Listed patents and exclusivities · Open in the app

  • Nasal Spray · 28 mg

    RLD/NDA as listed: Spravato 211243
    First PIV submission
    6 Mar 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)
    10 Sep 2035

Eslicarbazepine Acetate

NDA 022416 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 200 mg, 400 mg, 600 mg and 800 mg

    RLD/NDA as listed: Aptiom 22416
    First PIV submission
    8 Nov 2017
    ANDAs
    7
    180-day status
    Eligible
    Decision posted
    13 Jul 2021
    First applicant approval
    29 Jun 2021
    First marketing
    6 May 2025
    Last qualifying patent expiry (as listed by FDA)
    24 Aug 2032

Esmolol Hydrochloride

NDA 019386 · 2 rows · Listed patents and exclusivities · Open in the app

  • Injection · 10 mg/mL, 10 mL vial

    RLD/NDA as listed: Brevibloc 19386
    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

  • Injection · 10 mg/mL, 250 mL infusion bags and 20 mg/mL, 100 mL infusion bags

    RLD/NDA as listed: Brevibloc 19386
    First PIV submission
    31 Jan 2014
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    8 Jun 2016
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    12 Jan 2021

Esomeprazole

NDA 207920 · 1 row · Listed patents and exclusivities · Open in the app

  • Delayed-release Tablets · 20 mg

    RLD/NDA as listed: Nexium 24HR (OTC) 207920
    First PIV submission
    9 Sep 2016
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    2 Jul 2019
    First applicant approval
    5 Mar 2019
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    3 Nov 2019

Esomeprazole Magnesium

NDA 021153 · 1 row · Listed patents and exclusivities · Open in the app

  • Delayed-release Capsules · 20 mg and 40 mg

    RLD/NDA as listed: Nexium 21153
    First PIV submission
    5 Aug 2005
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    1 Mar 2008

Esomeprazole Magnesium

NDA 021957 · 2 rows · Listed patents and exclusivities · Open in the app

  • Delayed-release for Oral Suspension · 2.5 mg and 5 mg

    RLD/NDA as listed: Nexium 21957
    First PIV submission
    24 Sep 2018
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    27 Jan 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    3 Nov 2019

  • Delayed-release for Oral Suspension · 20 mg and 40 mg

    RLD/NDA as listed: Nexium 21957
    First PIV submission
    1 Aug 2013
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    4 Oct 2022
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    3 Nov 2019

Esomeprazole Magnesium

NDA 022101 · 1 row · Listed patents and exclusivities · Open in the app

  • Delayed-release for Oral Suspension · 10 mg

    RLD/NDA as listed: Nexium 22101
    First PIV submission
    6 Jul 2018
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    27 Jan 2020
    First applicant approval
    23 Mar 2020
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    3 Nov 2019

Esomeprazole Magnesium

NDA 204655 · 1 row · Listed patents and exclusivities · Open in the app

  • Delayed-release Capsules · 20 mg

    RLD/NDA as listed: Nexium (OTC) 204655
    First PIV submission
    24 Apr 2014
    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

Esomeprazole Sodium

NDA 021689 · 1 row · Listed patents and exclusivities · Open in the app

  • For Injection · 20 mg/vial and 40 mg/vial

    RLD/NDA as listed: Nexium IV 21689
    First PIV submission
    23 Nov 2009
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    7 Apr 2020
    First applicant approval
    18 Mar 2013
    First marketing
    15 Jan 2014
    Last qualifying patent expiry (as listed by FDA)
    27 May 2014

Estradiol

NDA 020375 · 2 rows · Listed patents and exclusivities · Open in the app

  • Transdermal System · 0.0375 mg/day and 0.06 mg/day

    RLD/NDA as listed: Climara 20375
    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

  • Transdermal System · 0.05 mg/day and 0.1 mg/day

    RLD/NDA as listed: Climara 20375
    First PIV submission
    12 Sep 2005
    ANDAs
    blank
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

Estradiol

NDA 020538 · 1 row · Listed patents and exclusivities · Open in the app

  • Transdermal System · 0.025 mg/day 0.0375 mg/day 0.05 mg/days 0.075 mg/day 0.1 mg/day

    RLD/NDA as listed: Vivelle Dot 20538
    First PIV submission
    27 Apr 2010
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    19 Dec 2014
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    12 Aug 2014

Estradiol

NDA 020908 · 1 row · Listed patents and exclusivities · Open in the app

  • Vaginal Tablets · 10 mcg

    RLD/NDA as listed: Vagifem 20908
    First PIV submission
    2 Jan 2013
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    7 Apr 2020
    First applicant approval
    29 May 2015
    First marketing
    17 Oct 2016
    Last qualifying patent expiry (as listed by FDA)
    17 Sep 2022

Estradiol

NDA 203752 · 2 rows · Listed patents and exclusivities · Open in the app

  • Transdermal System · 0.025 mg/day

    RLD/NDA as listed: Minivelle 203752
    First PIV submission
    8 May 2015
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    8 Oct 2019
    First applicant approval
    15 Aug 2018
    First marketing
    1 Nov 2018
    Last qualifying patent expiry (as listed by FDA)
    4 Jul 2030

  • Transdermal System · 0.0375 mg/day 0.05 mg/day 0.075 mg/day 0.1 mg/day

    RLD/NDA as listed: Minivelle 203752
    First PIV submission
    18 Aug 2014
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    8 Oct 2019
    First applicant approval
    15 Aug 2018
    First marketing
    1 Nov 2018
    Last qualifying patent expiry (as listed by FDA)
    4 Jul 2030

Estradiol

NDA 208564 · 1 row · Listed patents and exclusivities · Open in the app

  • Vaginal Inserts · 4 mcg and 10 mcg

    RLD/NDA as listed: Imvexxy 208564
    First PIV submission
    30 Dec 2019
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    15 Dec 2025
    First applicant approval
    8 Dec 2025
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    20 Dec 2033

Estradiol and Progesterone

NDA 210132 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 1 mg/100 mg

    RLD/NDA as listed: Bijuva NDA 210132
    First PIV submission
    6 Jan 2020
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    31 May 2022
    First applicant approval
    16 May 2022
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    21 Nov 2032

Estradiol Valerate and Dienogest

NDA 022252 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 3 mg;2 mg/2 mg; 2 mg/3 mg and 1 mg

    RLD/NDA as listed: Natazia 22252
    First PIV submission
    22 Oct 2010
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    25 Oct 2016

Estradiol, Norethindrone Acetate and Relugolix

NDA 214846 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 1 mg/0.5 mg/40 mg

    RLD/NDA as listed: Myfembree 214846
    First PIV submission
    18 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)
    3 May 2038

Estradiol; Estradiol and Norgestimate

NDA 021040 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 1 mg; 1 mg and 0.09 mg

    RLD/NDA as listed: Prefest 21040
    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

Eszopiclone

NDA 021476 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 1 mg, 2 mg and 3 mg

    RLD/NDA as listed: Lunesta 21476
    First PIV submission
    15 Dec 2008
    ANDAs
    10
    180-day status
    Eligible
    Decision posted
    7 Apr 2020
    First applicant approval
    23 May 2011
    First marketing
    15 Apr 2014
    Last qualifying patent expiry (as listed by FDA)
    30 Aug 2012

Etelcalcetide

NDA 208325 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 2.5 mg/0.5 mL 5 mg/mL 10 mg/2 mL

    RLD/NDA as listed: Parsabiv 208325
    First PIV submission
    8 Feb 2021
    ANDAs
    2
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    27 Jun 2034

Ethinyl Estradiol and Etonogestrel

NDA 021187 · 1 row · Listed patents and exclusivities · Open in the app

  • Vaginal Ring · 0.015 mg/24 hour 0.12 mg/24 hour

    RLD/NDA as listed: Nuvaring 21187
    First PIV submission
    17 Jun 2013
    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)
    8 Apr 2018

Etodolac

NDA 020584 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 400 mg, 500 mg and 600 mg

    RLD/NDA as listed: Lodine XL 20584
    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

Etonogestrel

NDA 021529 · 1 row · Listed patents and exclusivities · Open in the app

  • Implant · 68 mg

    RLD/NDA as listed: Nexplanon 21529
    First PIV submission
    31 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)
    28 Jul 2030

Everolimus

NDA 021560 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 0.25 mg, 0.5 mg, and 0.75 mg

    RLD/NDA as listed: Zortress 21560
    First PIV submission
    30 Sep 2013
    ANDAs
    3
    180-day status
    Extinguished Deferred
    Decision posted
    4/7/2020 4/7/2020
    First applicant approval
    12 Apr 2018
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    9 Sep 2019

Everolimus

NDA 022334 · 2 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 10 mg

    RLD/NDA as listed: Afinitor 22334
    First PIV submission
    18 Jun 2014
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    25 Feb 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    6 Dec 2019

  • Tablets · 2.5 mg, 5 mg, and 7.5 mg

    RLD/NDA as listed: Afinitor 22334
    First PIV submission
    10 Dec 2014
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    25 Feb 2020
    First applicant approval
    9 Dec 2019
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    6 Dec 2019

Everolimus

NDA 203985 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets for Oral Suspension · 2 mg, 3 mg and 5 mg

    RLD/NDA as listed: Afinitor Disperz 203985
    First PIV submission
    30 Dec 2016
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    27 Jan 2020
    First applicant approval
    19 Apr 2019
    First marketing
    1 Oct 2021
    Last qualifying patent expiry (as listed by FDA)
    27 Sep 2022

Exenatide

NDA 021773 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 250 mg/mL, 1.2 mL and 2.4 mL prefilled syringe

    RLD/NDA as listed: Byetta 21773
    First PIV submission
    11 Jun 2014
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    11 Feb 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    14 Jan 2020

Ezetimibe

NDA 021445 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 10 mg

    RLD/NDA as listed: Zetia 21445
    First PIV submission
    25 Oct 2006
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    18 Jun 2019
    First applicant approval
    26 Jun 2015
    First marketing
    12 Dec 2016
    Last qualifying patent expiry (as listed by FDA)
    25 Jan 2022

Ezetimibe and Simvastatin

NDA 021687 · 1 row · Listed patents and exclusivities · Open in the app

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

    RLD/NDA as listed: Vytorin 21687
    First PIV submission
    27 Jul 2009
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    10 Mar 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    25 Oct 2016