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FDA Paragraph IV list

Drybench Patent.

FDA Paragraph IV list: O

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

Obeticholic Acid

NDA 207999 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 5 mg and 10 mg

    RLD/NDA as listed: Ocaliva 207999
    First PIV submission
    27 May 2020
    ANDAs
    5
    180-day status
    Eligible
    Decision posted
    12 Jun 2023
    First applicant approval
    30 May 2023
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    26 Apr 2036

Octreotide Acetate

NDA 019667 · 3 rows · Listed patents and exclusivities · Open in the app

  • Injection · 0.05 mg /mL, 0.1 mg /mL and 0.5 mg/mL, 1 mL vials

    RLD/NDA as listed: Sandostatin (Preservative-free) 19667
    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 · 0.05 mg/mL (base), 0.1 mg/mL (base) and 0.5 mg/mL (base) packaged in 1 mL pre-filled syringes (preservative-free)

    RLD/NDA as listed: Octreotide Acetate Injection 19667
    First PIV submission
    17 Jan 2008
    ANDAs
    1
    180-day status
    Extinguished Eligible
    Decision posted
    4/18/2023 2/8/2022
    First applicant approval
    10 Feb 2011
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    19 May 2015

  • Injection · 0.2 mg/mL and 1 mg /mL, 5 mL vials

    RLD/NDA as listed: Sandostatin 19667
    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

Octreotide Acetate

NDA 208232 · 1 row · Listed patents and exclusivities · Open in the app

  • Delayed-release Capsules · 20 mg

    RLD/NDA as listed: Mycapssa 208232
    First PIV submission
    29 Dec 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)
    28 Dec 2040

Ofloxacin

NDA 020799 · 1 row · Listed patents and exclusivities · Open in the app

  • Otic Solution · 0.3%

    RLD/NDA as listed: Floxin 20799
    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

Olanzapine

NDA 020592 · 2 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 2.5 mg, 5 mg, 7.5 mg, 10 mg and 15 mg

    RLD/NDA as listed: Zyprexa 20592
    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

  • Tablets · 20 mg

    RLD/NDA as listed: Zyprexa 20592
    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

Olanzapine

NDA 021086 · 1 row · Listed patents and exclusivities · Open in the app

  • Orally Disintegrating Tablets · 5 mg, 10 mg, 15 mg and 20 mg

    RLD/NDA as listed: Zyprexa Zydis 21086
    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

Olanzapine and Fluoxetine Hydrochloride

NDA 021520 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 6 mg/25 mg 12 mg/25 mg 6 mg/50 mg 12 mg/50 mg

    RLD/NDA as listed: Symbyax 21520
    First PIV submission
    10 Jan 2005
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    8 Feb 2022
    First applicant approval
    20 Jun 2012
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    1 Nov 2017

Olanzapine and Samidorphan L-Malate

NDA 213378 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 5 mg/10 mg 10 mg/10 mg 15 mg/10 mg 20 mg/10 mg

    RLD/NDA as listed: Lybalvi 213378
    First PIV submission
    28 May 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)
    12 Nov 2041

Olaparib

NDA 208558 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 100 mg and 150 mg

    RLD/NDA as listed: Lynparza 208558
    First PIV submission
    1 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)
    4 Aug 2031

Olmesartan Medoxomil

NDA 021286 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 5 mg, 20 mg and 40 mg

    RLD/NDA as listed: Benicar 21286
    First PIV submission
    25 Apr 2006
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    8 Feb 2022
    First applicant approval
    26 Oct 2016
    First marketing
    26 Oct 2016
    Last qualifying patent expiry (as listed by FDA)
    19 Nov 2021

Olmesartan Medoxomil and Hydrochlorothiazide

NDA 021532 · 2 rows · Listed patents and exclusivities · Open in the app

  • Tablets · 20 mg/12.5 mg

    RLD/NDA as listed: Benicar HCT 21532
    First PIV submission
    11 May 2007
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    8 Feb 2022
    First applicant approval
    26 Oct 2016
    First marketing
    26 Oct 2016
    Last qualifying patent expiry (as listed by FDA)
    19 Nov 2021

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

    RLD/NDA as listed: Benicar HCT 21532
    First PIV submission
    15 Feb 2007
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    8 Feb 2022
    First applicant approval
    26 Oct 2016
    First marketing
    26 Oct 2016
    Last qualifying patent expiry (as listed by FDA)
    19 Nov 2021

Olopatadine Hydrochloride

NDA 020688 · 1 row · Listed patents and exclusivities · Open in the app

  • Ophthalmic Solution · 0.1%

    RLD/NDA as listed: Pataday Twice Daily Relief OTC 20688
    First PIV submission
    17 Jul 2006
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    7 Apr 2020
    First applicant approval
    7 Dec 2015
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    6 Jun 2015

Olopatadine Hydrochloride

NDA 021545 · 1 row · Listed patents and exclusivities · Open in the app

  • Ophthalmic Solution · 0.2%

    RLD/NDA as listed: Pataday Once Daily Relief OTC 21545
    First PIV submission
    8 Sep 2008
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    18 Jun 2019
    First applicant approval
    13 Jul 2015
    First marketing
    8 Jun 2017
    Last qualifying patent expiry (as listed by FDA)
    12 Nov 2023

Olopatadine Hydrochloride

NDA 021861 · 1 row · Listed patents and exclusivities · Open in the app

  • Nasal Spray · 0.665 mg/ Spray

    RLD/NDA as listed: Patanase 21861
    First PIV submission
    29 Jun 2009
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    8 Feb 2022
    First applicant approval
    8 Oct 2014
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    18 Dec 2010

Olopatadine Hydrochloride

NDA 206276 · 1 row · Listed patents and exclusivities · Open in the app

  • Ophthalmic Solution · 7.0000000000000001E-3

    RLD/NDA as listed: Pataday Once Daily Relief OTC 206276
    First PIV submission
    10 Sep 2015
    ANDAs
    1
    180-day status
    Extinguished Non-forfeiture
    Decision posted
    12/22/2025 6/18/2019
    First applicant approval
    19 Feb 2020
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    19 May 2032

Omacetaxine Mepesuccinate

NDA 203585 · 1 row · Listed patents and exclusivities · Open in the app

  • for Injection · 3.5 mg/vial

    RLD/NDA as listed: Synribo 203585
    First PIV submission
    26 Oct 2016
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    8 Feb 2022
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    28 Jun 2023

Omega-3-Acid Ethyl Esters

NDA 021654 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 1 g

    RLD/NDA as listed: Lovaza 21654
    First PIV submission
    10 Nov 2008
    ANDAs
    3
    180-day status
    Deferred
    Decision posted
    22 Feb 2022
    First applicant approval
    7 Apr 2014
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    10 Apr 2017

Omeprazole

NDA 019810 · 1 row · Listed patents and exclusivities · Open in the app

  • Delayed-release Capsules · 10 mg, 20 mg and 40 mg

    RLD/NDA as listed: Prilosec 19810
    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

Omeprazole

NDA 022032 · 1 row · Listed patents and exclusivities · Open in the app

  • Delayed-release Tablets · 20 mg

    RLD/NDA as listed: Omeprazole 22032 (OTC)
    First PIV submission
    3 Jun 2015
    ANDAs
    1
    180-day status
    Extinguished Non-Forfeiture
    Decision posted
    2/11/2020 2/11/2020
    First applicant approval
    12 Oct 2018
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    16 Aug 2025

Omeprazole and Sodium Bicarbonate

NDA 021636 · 2 rows · Listed patents and exclusivities · Open in the app

  • Powder for Oral Suspension · 20mg/1680mg per packet

    RLD/NDA as listed: Zegerid 21636
    First PIV submission
    13 Nov 2007
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    8 Feb 2022
    First applicant approval
    19 Apr 2013
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    16 Jul 2016

  • Powder for Oral Suspension · 40 mg/1680 mg per packet

    RLD/NDA as listed: Zegerid 21636
    First PIV submission
    24 Aug 2007
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    8 Feb 2022
    First applicant approval
    19 Apr 2013
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    16 Jul 2016

Omeprazole and Sodium Bicarbonate

NDA 021849 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 20 mg/1100 mg and 40 mg/1100 mg

    RLD/NDA as listed: Zegerid 21849
    First PIV submission
    30 Apr 2007
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    8 Feb 2022
    First applicant approval
    25 May 2010
    First marketing
    1 Jul 2010
    Last qualifying patent expiry (as listed by FDA)
    16 Jul 2016

Omeprazole and Sodium Bicarbonate

NDA 022281 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 20 mg/1100 mg

    RLD/NDA as listed: Zegerid OTC 22281
    First PIV submission
    20 Apr 2010
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    8 Feb 2022
    First applicant approval
    15 Jul 2016
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    16 Jul 2016

Omeprazole Magnesium

NDA 021229 · 2 rows · Listed patents and exclusivities · Open in the app

  • Delayed-release Capsules · 20 mg

    RLD/NDA as listed: Prilosec OTC 21229
    First PIV submission
    19 Mar 2007
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    8 Feb 2022
    First applicant approval
    5 Jun 2009
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    15 Nov 2019

  • Delayed-release Tablets · 20 mg

    RLD/NDA as listed: Prilosec OTC 21229
    First PIV submission
    30 Mar 2012
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    8 Feb 2022
    First applicant approval
    30 Jul 2015
    First marketing
    1 Dec 2017
    Last qualifying patent expiry (as listed by FDA)
    15 Nov 2019

Ondansetron Hydrochloride

NDA 020007 · 2 rows · Listed patents and exclusivities · Open in the app

  • Injection · 2 mg/mL, 2 mL vials (Preservative-free)

    RLD/NDA as listed: Zofran 20007
    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 · 2 mg/mL, 20 mL vials

    RLD/NDA as listed: Zofran 20007
    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

Ondansetron Hydrochloride

NDA 020103 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 4 mg, 8 mg, 16 mg and 24 mg

    RLD/NDA as listed: Zofran 20103
    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

Ondansetron Hydrochloride

NDA 020403 · 1 row · Listed patents and exclusivities · Open in the app

  • Injection · 0.64 mg/mL, 50 mL container (plastic)

    RLD/NDA as listed: Zofran in Plastic Container 20403
    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

Ondansetron Hydrochloride

NDA 020605 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Solution · 4 mg/5 mL

    RLD/NDA as listed: Zofran 20605
    First PIV submission
    20 Dec 2004
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    22 Feb 2022
    First applicant approval
    26 Dec 2006
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    20 May 2016

Ondansetron Hydrochloride

NDA 020781 · 1 row · Listed patents and exclusivities · Open in the app

  • Orally Disintegrating Tablets · 4 mg and 8 mg

    RLD/NDA as listed: Zofran ODT 20781
    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

Orlistat

NDA 021887 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 60 mg

    RLD/NDA as listed: Alli 21887
    First PIV submission
    8 Sep 2010
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    8 Feb 2022
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    6 Jan 2018

Oseltamivir Phosphate

NDA 021087 · 2 rows · Listed patents and exclusivities · Open in the app

  • Capsules · 30 mg and 45 mg

    RLD/NDA as listed: Tamiflu 21087
    First PIV submission
    2 Aug 2011
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    8 Feb 2022
    First applicant approval
    3 Aug 2016
    First marketing
    12 Dec 2016
    Last qualifying patent expiry (as listed by FDA)
    27 Dec 2016

  • Capsules · 75 mg

    RLD/NDA as listed: Tamiflu 21087
    First PIV submission
    15 Nov 2010
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    8 Feb 2022
    First applicant approval
    3 Aug 2016
    First marketing
    12 Dec 2016
    Last qualifying patent expiry (as listed by FDA)
    27 Dec 2016

Oseltamivir Phosphate

NDA 021246 · 1 row · Listed patents and exclusivities · Open in the app

  • for Oral Suspension · 6 mg/mL

    RLD/NDA as listed: Tamiflu 21246
    First PIV submission
    18 Jun 2015
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    8 Oct 2019
    First applicant approval
    20 Feb 2018
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    27 Dec 2016

Osimertinib Mesylate

NDA 208065 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 40 mg and 80 mg

    RLD/NDA as listed: Tagrisso 208065
    First PIV submission
    13 Nov 2019
    ANDAs
    3
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    2 Jan 2035

Ospemifene

NDA 203505 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 60 mg

    RLD/NDA as listed: Osphena 203505
    First PIV submission
    29 Dec 2020
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    19 Feb 2024
    First applicant approval
    13 Feb 2024
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    9 Jul 2028

Oxaliplatin

NDA 021759 · 2 rows · Listed patents and exclusivities · Open in the app

  • Injection · 5 mg/mL, 10 mL and 20 mL vials

    RLD/NDA as listed: Eloxatin 21759
    First PIV submission
    9 Feb 2007
    ANDAs
    11
    180-day status
    Eligible
    Decision posted
    10 Mar 2020
    First applicant approval
    7 Aug 2009
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    9 Feb 2017

  • Injection · 5 mg/mL, 40 mL vials

    RLD/NDA as listed: Eloxatin 21759
    First PIV submission
    16 Jul 2007
    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)
    7 Aug 2015

Oxazepam

NDA 015539 · 1 row · Listed patents and exclusivities · Open in the app

  • Capsules · 10 mg, 15 mg and 30 mg

    RLD/NDA as listed: Serax 15539
    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

Oxcarbazepine

NDA 021014 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 150 mg, 300 mg and 600 mg

    RLD/NDA as listed: Trileptal 21014
    First PIV submission
    5 May 2006
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    8 Feb 2022
    First applicant approval
    9 Oct 2007
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    12 Feb 2018

Oxcarbazepine

NDA 021285 · 1 row · Listed patents and exclusivities · Open in the app

  • Oral Suspension · 300 mg/5 mL

    RLD/NDA as listed: Trileptal 21285
    First PIV submission
    26 Dec 2006
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    15 Jun 2021
    First applicant approval
    26 Jun 2009
    First marketing
    14 Dec 2009
    Last qualifying patent expiry (as listed by FDA)
    12 Feb 2018

Oxcarbazepine

NDA 202810 · 2 rows · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 150 mg and 300 mg

    RLD/NDA as listed: Oxtellar XR 202810
    First PIV submission
    12 Apr 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)
    13 Apr 2027

  • Extended-release Tablets · 600 mg

    RLD/NDA as listed: Oxtellar XR 202810
    First PIV submission
    20 Mar 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)
    13 Apr 2027

Oxybutynin

NDA 021351 · 1 row · Listed patents and exclusivities · Open in the app

  • Transdermal System Extended-release · 3.9 mg/24 hrs

    RLD/NDA as listed: Oxytrol 21351
    First PIV submission
    19 Aug 2008
    ANDAs
    1
    180-day status
    Deferred
    Decision posted
    8 Feb 2022
    First applicant approval
    4 Mar 2014
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    26 Apr 2020

Oxybutynin Chloride

NDA 020897 · 1 row · Listed patents and exclusivities · Open in the app

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

    RLD/NDA as listed: Ditropan XL 20897
    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

Oxybutynin Chloride

NDA 022204 · 1 row · Listed patents and exclusivities · Open in the app

  • Gel · 0.1

    RLD/NDA as listed: Gelnique 22204
    First PIV submission
    19 Jun 2014
    ANDAs
    1
    180-day status
    Extinguished Deferred
    Decision posted
    6/15/2020 6/18/2019
    First applicant approval
    31 May 2018
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    26 Apr 2020

Oxycodone

NDA 208090 · 1 row · Listed patents and exclusivities · Open in the app

  • Extended-release Capsules · 9 mg, 13.5 mg, 18 mg, 27 mg and 36 mg

    RLD/NDA as listed: Xtampza ER 208090
    First PIV submission
    15 Nov 2017
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    2 Sep 2036

Oxycodone Hydrochloride

NDA 022272 · 5 rows · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 10 mg

    RLD/NDA as listed: Oxycontin (NDA 022272)
    First PIV submission
    25 Oct 2010
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    8 Oct 2019
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    19 Apr 2025

  • Extended-release Tablets · 15 mg

    RLD/NDA as listed: Oxycontin (NDA 022272)
    First PIV submission
    28 Oct 2010
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    8 Oct 2019
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    19 Apr 2025

  • Extended-release Tablets · 20 mg

    RLD/NDA as listed: Oxycontin (NDA 022272)
    First PIV submission
    29 Oct 2010
    ANDAs
    2
    180-day status
    Extinguished
    Decision posted
    19 Nov 2019
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    19 Apr 2025

  • Extended-release Tablets · 30 mg, 60 mg and 80 mg

    RLD/NDA as listed: Oxycontin (NDA 022272)
    First PIV submission
    18 Oct 2010
    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)
    19 Apr 2025

  • Extended-release Tablets · 40 mg

    RLD/NDA as listed: Oxycontin (NDA 022272)
    First PIV submission
    4 Oct 2010
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    8 Oct 2019
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    19 Apr 2025

Oxycodone Hydrochloride

NDA 202080 · 1 row · Listed patents and exclusivities · Open in the app

  • Tablets · 5 mg and 7.5 mg

    RLD/NDA as listed: Oxaydo 202080
    First PIV submission
    7 Feb 2012
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    17 Nov 2020
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    16 Mar 2025

Oxymetazoline Hydrochloride

NDA 208552 · 1 row · Listed patents and exclusivities · Open in the app

  • Topical Cream · 0.01

    RLD/NDA as listed: Rhofade 208552
    First PIV submission
    20 Jun 2019
    ANDAs
    1
    180-day status
    Eligible
    Decision posted
    2 Nov 2021
    First applicant approval
    4 Oct 2021
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    11 Jun 2035

Oxymorphone Hydrochloride

NDA 201655 · 3 rows · Listed patents and exclusivities · Open in the app

  • Extended-release Tablets · 20 mg, 30 mg and 40 mg

    RLD/NDA as listed: Opana ER (NDA 201655)
    First PIV submission
    3 Apr 2012
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    8 Feb 2022
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    10 Jul 2029

  • Extended-release Tablets · 5 mg

    RLD/NDA as listed: Opana ER (NDA 201655)
    First PIV submission
    26 Mar 2012
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    8 Feb 2022
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    10 Jul 2029

  • Extended-release Tablets · 7.5 mg, 10 mg, and 15 mg

    RLD/NDA as listed: Opana ER (NDA 201655)
    First PIV submission
    23 Mar 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)
    10 Jul 2029