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FDA Paragraph IV list

Drybench Patent.

FDA Paragraph IV list: H

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

Halobetasol Propionate

NDA 208183 · 1 row · Listed patents and exclusivities · Open in the app

  • Lotion · 5.0000000000000001E-4

    RLD/NDA as listed: Ultavate 208183
    First PIV submission
    24 Jan 2018
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    13 Jul 2020
    First applicant approval
    4 Jun 2020
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    19 Jun 2033

Halobetasol Propionate

NDA 209355 · 1 row · Listed patents and exclusivities · Open in the app

  • Lotion · 1E-4

    RLD/NDA as listed: Bryhali 209355
    First PIV submission
    15 May 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)
    2 Nov 2031

Halobetasol Propionate

NDA 210566 · 1 row · Listed patents and exclusivities · Open in the app

  • Topical Foam · 5.0000000000000001E-4

    RLD/NDA as listed: Lexette 210566
    First PIV submission
    28 Jan 2021
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    4 Sep 2023
    First applicant approval
    11 Aug 2023
    First marketing
    27 Dec 2023
    Last qualifying patent expiry (as listed by FDA)
    30 Nov 2036

Halobetasol Propionate and Tazarotene

NDA 209354 · 1 row · Listed patents and exclusivities · Open in the app

  • Lotion · 0.01%/0.045%

    RLD/NDA as listed: Duobrii 209354
    First PIV submission
    11 Jun 2020
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    17 Feb 2025
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    6 Jun 2036

Hydrocodone Bitartrate

NDA 202880 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Capsules · 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, and 50 mg

    RLD/NDA as listed: Zohydro ER 202880
    First PIV submission
    26 Feb 2014
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    15 Jun 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    1 Nov 2019

Hydrocodone Bitartrate

NDA 206627 · 2 rows · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 20 mg, 60 mg, and 120 mg

    RLD/NDA as listed: Hysingla ER 206627
    First PIV submission
    15 Apr 2015
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    9 Mar 2021
    First applicant approval
    1 Mar 2021
    First marketing
    1 Mar 2021
    Last qualifying patent expiry (as listed by FDA)
    21 Dec 2031

  • Extended-release Tablets · 30 mg, 40 mg, 80 mg, and 100 mg

    RLD/NDA as listed: Hysingla ER 206627
    First PIV submission
    8 May 2015
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    9 Mar 2021
    First applicant approval
    1 Mar 2021
    First marketing
    1 Mar 2021
    Last qualifying patent expiry (as listed by FDA)
    21 Dec 2031

Hydrocodone Bitartrate and Ibuprofen

NDA 020716 · 3 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 10 mg/200 mg

    RLD/NDA as listed: Vicoprofen 20716
    First PIV submission
    20 Mar 2006
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    15 Jun 2020
    First applicant approval
    6 Nov 2006
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    10 Jun 2017

  • Tablets · 2.5 mg/200 mg

    RLD/NDA as listed: Vicoprofen 20716
    First PIV submission
    24 Feb 2006
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    25 Jul 2022
    First applicant approval
    19 Oct 2007
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    10 Jun 2017

  • Tablets · 7.5 mg/200 mg

    RLD/NDA as listed: Vicoprofen 20716
    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

Hydrocortisone Butyrate

NDA 020769 · 1 row · Listed patents and exclusivities · Open in the app

  • Cream · 1E-3

    RLD/NDA as listed: Locoid Lipocream 20769
    First PIV submission
    28 Jun 2010
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    29 Jun 2020
    First applicant approval
    27 Sep 2013
    First marketing
    5 Dec 2013
    Last qualifying patent expiry (as listed by FDA)
    3 Jun 2014

Hydrocortisone Butyrate

NDA 022076 · 1 row · Listed patents and exclusivities · Open in the app

  • Lotion · 1E-3

    RLD/NDA as listed: Locoid 22076
    First PIV submission
    31 Aug 2016
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    29 Jun 2020
    First applicant approval
    21 Nov 2017
    First marketing
    12 Feb 2018
    Last qualifying patent expiry (as listed by FDA)
    19 Dec 2026

Hydromorphone Hydrochloride

NDA 019034 · 4 rows · Listed patents and exclusivities · Open in the app

  • Injection · 0.2 mg/mL

    RLD/NDA as listed: Dilaudid 19034
    First PIV submission
    19 Dec 2023
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    10 Jun 2024
    First applicant approval
    9 Feb 2024
    First marketing
    14 Oct 2024
    Last qualifying patent expiry (as listed by FDA)
    12 Mar 2034

  • Injection · 0.5 mg/0.5 mL and 1 mg/mL

    RLD/NDA as listed: Dilaudid 19034
    First PIV submission
    13 Dec 2022
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    10 Jun 2024
    First applicant approval
    9 Feb 2024
    First marketing
    0.5 mg-5/15/2024 1 mg - 6/5/2024
    Last qualifying patent expiry (as listed by FDA)
    12 Mar 2034

  • Injection · 10 mg/mL

    RLD/NDA as listed: Dilaudid-HP 19034
    First PIV submission
    4 Nov 2011
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    29 Jun 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    blank

  • Injection · 2 mg/mL

    RLD/NDA as listed: Dilaudid 19034
    First PIV submission
    22 Jun 2011
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    8 Jan 2024
    First applicant approval
    27 Apr 2018
    First marketing
    1 Oct 2018
    Last qualifying patent expiry (as listed by FDA)
    9 Nov 2020

Hydromorphone Hydrochloride

NDA 019891 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Solution · 5 mg/5mL

    RLD/NDA as listed: Dilaudid 19891
    First PIV submission
    25 Feb 2011
    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)
    9 Nov 2020

Hydromorphone Hydrochloride

NDA 019892 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 2 mg, 4 mg, and 8 mg

    RLD/NDA as listed: Dilaudid 19892
    First PIV submission
    5 Aug 2013
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    29 Jun 2020
    First applicant approval
    13 May 2016
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    9 Nov 2020

Hydromorphone Hydrochloride

NDA 021217 · 2 rows · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 16 mg

    RLD/NDA as listed: Exlago 21217
    First PIV submission
    2 Aug 2010
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    29 Jun 2020
    First applicant approval
    12 May 2014
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    7 Jul 2014

  • Extended-release Tablets · 8 mg and 12 mg

    RLD/NDA as listed: Exlago 21217
    First PIV submission
    2 Sep 2010
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    29 Jun 2020
    First applicant approval
    12 May 2014
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    7 Jul 2014