Drybench Patent.
FDA Paragraph IV list: P
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose group's drug name, as listed, starts with P, 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.
Paclitaxel
NDA 020262 · 1 row · Listed patents and exclusivities · Open in the app
Injection · 6 mg/mL, 5 mL, 16.7 mL, 25 mL, 33.3 mL and 50 mL vials
RLD/NDA as listed: Taxol 20262- 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
Paclitaxel Protein-Bound Particles
NDA 021660 · 1 row · Listed patents and exclusivities · Open in the app
For Injection Suspension · 100 mg/vial
RLD/NDA as listed: Abraxane 21660- First PIV submission
- 11 Dec 2015
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 4 Sep 2023
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 27 Oct 2024
Palbociclib
NDA 207103 · 1 row · Listed patents and exclusivities · Open in the app
Capsules · 75 mg, 100 mg and 125 mg
RLD/NDA as listed: Ibrance 207103- First PIV submission
- 4 Feb 2019
- ANDAs
- 12
- 180-day status
- Extinguished
- Decision posted
- 18 Apr 2023
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 22 Jan 2023
Palbociclib
NDA 212436 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 75 mg, 100 mg and 125 mg
RLD/NDA as listed: Ibrance 212436- First PIV submission
- 24 Nov 2020
- ANDAs
- 1
- 180-day status
- Deferred
- Decision posted
- 10 Jun 2024
- First applicant approval
- 5 Jun 2024
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 28 Feb 2034
Paliperidone Palmitate
NDA 022264 · 1 row · Listed patents and exclusivities · Open in the app
Extended-release Injectable Suspension · 39 mg/0.25 mL, 78 mg/0.5 mL, 117 mg/0.75 mL, 156 mg/mL and 234 mg/1.5 mL
RLD/NDA as listed: Invega Sustenna 22264- First PIV submission
- 21 Nov 2017
- ANDAs
- 1
- 180-day status
- Extinguished Non-Forfeiture Deferred
- Decision posted
- 11/11/2025 1/22/2024 8/24/2021
- First applicant approval
- 6 Jul 2021
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 26 Jan 2031
Paliperidone Palmitate
NDA 207946 · 3 rows · Listed patents and exclusivities · Open in the app
Extended-release Injectable Suspension · 273 mg/0.875 mL and 410 mg/1.315 mL
RLD/NDA as listed: Invega Trinza 207946- First PIV submission
- 14 Jul 2021
- ANDAs
- 1
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 5 Apr 2036
Extended-release Injectable Suspension · 546 mg/1.75 mL
RLD/NDA as listed: Invega Trinza 207946- First PIV submission
- 24 Jun 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)
- 5 Apr 2036
Extended-release Injectable Suspension · 819 mg/2.625 mL
RLD/NDA as listed: Invega Trinza 207946- First PIV submission
- 30 Apr 2021
- ANDAs
- 1
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 5 Apr 2036
Palonosetron Hydrochloride
NDA 021372 · 1 row · Listed patents and exclusivities · Open in the app
Injection · 0.05 mg/mL, 1.5 mL and 5 mL vials
RLD/NDA as listed: Aloxi 21372- First PIV submission
- 27 May 2011
- ANDAs
- 3
- 180-day status
- Eligible
- Decision posted
- 22 Feb 2022
- First applicant approval
- 13 Oct 2015
- First marketing
- 23 Mar 2018
- Last qualifying patent expiry (as listed by FDA)
- 30 Jan 2024
Pamidronate Disodium
NDA 020036 · 2 rows · Listed patents and exclusivities · Open in the app
For Injection · 30 mg/vial 60 mg/vial 90 mg/vial
RLD/NDA as listed: Aredia 20036- 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 · 30 mg/vial 60 mg/vial 90 mg/vial
RLD/NDA as listed: Aredia 20036- 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
Pantoprazole Sodium
NDA 020987 · 1 row · Listed patents and exclusivities · Open in the app
Delayed-release Tablets · 20 mg and 40 mg
RLD/NDA as listed: Protonix 20987- First PIV submission
- 2 Feb 2004
- 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
Pantoprazole Sodium
NDA 020988 · 1 row · Listed patents and exclusivities · Open in the app
For Injection · 40 mg/vial
RLD/NDA as listed: Prontonix IV 20988- First PIV submission
- 7 Apr 2005
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 27 Aug 2019
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 17 Nov 2021
Pantoprazole Sodium
NDA 022020 · 1 row · Listed patents and exclusivities · Open in the app
for Delayed-release Oral Suspension · 40 mg
RLD/NDA as listed: Protonix 22020- First PIV submission
- 13 Sep 2019
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 13 Jul 2020
- First applicant approval
- 30 Jun 2020
- First marketing
- 13 Aug 2020
- Last qualifying patent expiry (as listed by FDA)
- 7 Jun 2026
Paricalcitol
NDA 020819 · 1 row · Listed patents and exclusivities · Open in the app
Injection · 0.002 mg per mL in 1 mL vial and 0.005 mg per mL in 1 mL and 2 mL vials
RLD/NDA as listed: Zemplar 20819- First PIV submission
- 28 Nov 2008
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 10 Mar 2020
- First applicant approval
- 27 Jul 2011
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 8 Oct 2018
Paricalcitol
NDA 021606 · 2 rows · Listed patents and exclusivities · Open in the app
Capsules · 1 mcg and 2 mcg
RLD/NDA as listed: Zemplar 21606- First PIV submission
- 14 Oct 2008
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 22 Feb 2022
- First applicant approval
- 27 Sep 2013
- First marketing
- 30 Sep 2013
- Last qualifying patent expiry (as listed by FDA)
- 24 Jun 2014
Capsules · 4 mcg
RLD/NDA as listed: Zemplar 21606- First PIV submission
- 25 Aug 2008
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 22 Feb 2022
- First applicant approval
- 27 Sep 2013
- First marketing
- 30 Sep 2013
- Last qualifying patent expiry (as listed by FDA)
- 24 Jun 2014
Paroxetine
NDA 204516 · 1 row · Listed patents and exclusivities · Open in the app
Capsules · 7.5 mg
RLD/NDA as listed: Brisdelle 204516- First PIV submission
- 7 Apr 2014
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 13 Aug 2019
- First applicant approval
- 13 Mar 2019
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 6 Apr 2029
Paroxetine Hydrochloride
NDA 020031 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 10 mg, 20 mg, 30 mg and 40 mg
RLD/NDA as listed: Paxil 20031- 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
Paroxetine Hydrochloride
NDA 020710 · 1 row · Listed patents and exclusivities · Open in the app
Oral Suspension · 10 mg/5 mL
RLD/NDA as listed: Paxil 20710- 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
Paroxetine Hydrochloride
NDA 020885 · 1 row · Listed patents and exclusivities · Open in the app
Capsules · 10 mg and 20 mg
RLD/NDA as listed: Paxil 20885- 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
Paroxetine Hydrochloride
NDA 020936 · 2 rows · Listed patents and exclusivities · Open in the app
Extended-release Tablets · 25 mg
RLD/NDA as listed: Paxil CR 20936- First PIV submission
- 9 Sep 2005
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 22 Feb 2022
- First applicant approval
- 29 Jun 2007
- First marketing
- 14 May 2008
- Last qualifying patent expiry (as listed by FDA)
- 17 Sep 2017
Extended-release Tablets · 37.5 mg
RLD/NDA as listed: Paxil CR 20936- First PIV submission
- 19 May 2009
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 22 Feb 2022
- First applicant approval
- 14 Apr 2011
- First marketing
- 5 May 2011
- Last qualifying patent expiry (as listed by FDA)
- 17 Mar 2017
Patiromer Sorbitex Calcium
NDA 205739 · 1 row · Listed patents and exclusivities · Open in the app
for Oral Suspension · 8.4 g, 16.8 g and 25.2 g
RLD/NDA as listed: Veltassa 205739- First PIV submission
- 21 Oct 2019
- ANDAs
- 2
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 8 Oct 2033
Pemetrexed Disodium
NDA 021462 · 4 rows · Listed patents and exclusivities · Open in the app
For Injection · 100 mg/vial
RLD/NDA as listed: Alimta 21462- First PIV submission
- 1 Jul 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)
- 24 Jan 2017
For Injection · 1000 mg/vial
RLD/NDA as listed: Alimta 21462- First PIV submission
- 27 Jun 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)
- 24 Nov 2021
For Injection · 500 mg/vial
RLD/NDA as listed: Alimta 21462- First PIV submission
- 4 Feb 2008
- ANDAs
- 2
- 180-day status
- Extinguished
- Decision posted
- 10 Mar 2020
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 24 Jan 2017
For Injection · 750 mg/vial
RLD/NDA as listed: Alimta 21462- First PIV submission
- 6 Oct 2016
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 22 Feb 2022
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 24 Nov 2021
Pemigatinib
NDA 213736 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 4.5 mg, 9 mg and 13.5 mg
RLD/NDA as listed: Pemazyre 213736- First PIV submission
- 17 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)
- 30 Aug 2040
Perampanel
NDA 202834 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg
RLD/NDA as listed: Fycompa 202834- First PIV submission
- 24 Oct 2016
- ANDAs
- 2
- 180-day status
- Eligible
- Decision posted
- 27 May 2025
- First applicant approval
- 23 May 2025
- First marketing
- 29 May 2025
- Last qualifying patent expiry (as listed by FDA)
- 1 Jul 2026
Perampanel
NDA 208277 · 1 row · Listed patents and exclusivities · Open in the app
Oral Suspension · 0.5 mg/mL
RLD/NDA as listed: Fycompa 208277- First PIV submission
- 20 Dec 2022
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 9 Jun 2026
- First applicant approval
- 11 Jul 2025
- First marketing
- 16 Dec 2025
- Last qualifying patent expiry (as listed by FDA)
- 1 Jul 2026
Pergolide Mesylate
NDA 019385 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 0.05 mg, 0.25 mg and 1 mg
RLD/NDA as listed: Permax 19385- 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
Perindopril Arginine and Amlodipine
NDA 205003 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 3.5 mg/2.5 mg, 7 mg/5 mg and 14 mg/10 mg
RLD/NDA as listed: Prestalia 205003- First PIV submission
- 4 Nov 2016
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 25 Jul 2022
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 5 Oct 2029
Perindopril Erbumine
NDA 020184 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 2 mg, 4 mg and 8 mg
RLD/NDA as listed: Aceon 20184- First PIV submission
- 6 Jun 2006
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 22 Feb 2022
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 10 Nov 2009
Phentermine Hydrochloride
NDA 202088 · 2 rows · Listed patents and exclusivities · Open in the app
Orally Disintegrating Tablets · 15 mg and 30 mg
RLD/NDA as listed: Suprenza 202088- First PIV submission
- 19 Oct 2012
- ANDAs
- 1
- 180-day status
- Deferred
- Decision posted
- 22 Feb 2022
- First applicant approval
- 28 Jun 2017
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 23 Jul 2018
Orally Disintegrating Tablets · 37.5 mg
RLD/NDA as listed: Suprenza 202088- First PIV submission
- 22 Mar 2013
- ANDAs
- 1
- 180-day status
- Deferred
- Decision posted
- 22 Feb 2022
- First applicant approval
- 28 Jun 2017
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 23 Jul 2018
Phentermine Hydrochloride and Topiramate
NDA 022580 · 1 row · Listed patents and exclusivities · Open in the app
Extended-release Capsules · 3.75 mg/23 mg 7.5 mg/46 mg 11.25 mg/69 mg 15 mg/92 mg
RLD/NDA as listed: Qsymia 22580- First PIV submission
- 18 Jul 2013
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 22 Feb 2022
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 14 Jun 2020
Phentolamine Mesylate
NDA 217064 · 1 row · Listed patents and exclusivities · Open in the app
Ophthalmic Solution · 7.4999999999999997E-3
RLD/NDA as listed: Ryzumvi 217064- 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)
- blank
Phenylephrine and Ketorolac
NDA 205388 · 1 row · Listed patents and exclusivities · Open in the app
Solution · 1%/0.3%
RLD/NDA as listed: Omidria 205388- First PIV submission
- 29 May 2015
- 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)
- 30 Jul 2023
Pilocarpine Hydrochloride
NDA 214028 · 1 row · Listed patents and exclusivities · Open in the app
Ophthalmic Solution · 1.2500000000000001E-2
RLD/NDA as listed: Vuity 214028- First PIV submission
- 30 Dec 2022
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 28 Apr 2025
- First applicant approval
- 28 Apr 2025
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 24 Apr 2039
Pimavanserin
NDA 207318 · 2 rows · Listed patents and exclusivities · Open in the app
Tablets · 10 mg
RLD/NDA as listed: Nuplazid 207318- First PIV submission
- 29 Apr 2020
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 22 Jan 2024
- First applicant approval
- 16 Jan 2024
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 3 Jun 2028
Tablets · 34 mg
RLD/NDA as listed: Nuplazid 207318- First PIV submission
- 2 Jan 2025
- ANDAs
- 1
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 23 Mar 2037
Pimavanserin
NDA 210793 · 1 row · Listed patents and exclusivities · Open in the app
Capsules · 34 mg
RLD/NDA as listed: Nuplazid 210793- First PIV submission
- 29 Apr 2020
- ANDAs
- 5
- 180-day status
- Eligible
- Decision posted
- 22 Jan 2024
- First applicant approval
- 16 Jan 2024
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 27 Aug 2038
Pioglitazone Hydrochloride
NDA 021073 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 15 mg, 30 mg and 45 mg
RLD/NDA as listed: Actos 21073- 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
Pioglitazone Hydrochloride and Glimepiride
NDA 021925 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 30 mg/2 mg and 30 mg/4 mg
RLD/NDA as listed: Duetact 21925- First PIV submission
- 22 Dec 2009
- ANDAs
- 1
- 180-day status
- Deferred
- Decision posted
- 22 Mar 2022
- First applicant approval
- 4 Jan 2013
- First marketing
- 8 Jan 2013
- Last qualifying patent expiry (as listed by FDA)
- 8 Jun 2028
Pioglitazone Hydrochloride and Metformin Hydrochloride
NDA 022024 · 1 row · Listed patents and exclusivities · Open in the app
Extended-release Tablets · 15 mg/1000 mg and 30 mg/1000 mg
RLD/NDA as listed: Actoplus Met XR 22024- First PIV submission
- 23 Sep 2011
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 12 Jan 2021
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 31 Jul 2026
Piperacillin Sodium and Tazobactam Sodium
NDA 050684 · 3 rows · Listed patents and exclusivities · Open in the app
For Injection · 12 g/1.5 g per vial (pharmacy bulk)
RLD/NDA as listed: Zosyn 50684- First PIV submission
- 6 Dec 2011
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 22 Feb 2022
- First applicant approval
- 29 Oct 2014
- First marketing
- 24 Jan 2017
- Last qualifying patent expiry (as listed by FDA)
- 14 Apr 2023
For Injection · 2.25 g/vial 3.375 g/vial 4.5 g/vial
RLD/NDA as listed: Zosyn 50684- First PIV submission
- PIV received prior to 2/5/2009
- 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
For Injection · 36 mg/4.5 g per vial (pharmacy bulk)
RLD/NDA as listed: Zosyn 50684- First PIV submission
- PIV received prior to 2/5/2009
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 1 Dec 2020
- First applicant approval
- 15 Sep 2009
- First marketing
- 29 Oct 2009
- Last qualifying patent expiry (as listed by FDA)
- 14 Apr 2023
Pirfenidone
NDA 022535 · 1 row · Listed patents and exclusivities · Open in the app
Capsules · 267 mg
RLD/NDA as listed: Esbriet 22535- First PIV submission
- 15 Oct 2018
- ANDAs
- 9
- 180-day status
- Eligible
- Decision posted
- 25 Jan 2022
- First applicant approval
- 3 Jan 2022
- First marketing
- 13 Jun 2022
- Last qualifying patent expiry (as listed by FDA)
- 30 Aug 2033
Pirfenidone
NDA 208780 · 2 rows · Listed patents and exclusivities · Open in the app
Tablets · 267 mg and 801 mg
RLD/NDA as listed: Esbriet 208780- First PIV submission
- 15 Oct 2018
- ANDAs
- 17
- 180-day status
- Eligible
- Decision posted
- 8 Feb 2022
- First applicant approval
- 25 Jan 2022
- First marketing
- 2 May 2022
- Last qualifying patent expiry (as listed by FDA)
- 30 Aug 2033
Tablets · 534 mg
RLD/NDA as listed: Esbriet 208780- First PIV submission
- 15 Oct 2018
- ANDAs
- 2
- 180-day status
- Eligible
- Decision posted
- 25 Jul 2022
- First applicant approval
- 19 Jul 2022
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 30 Aug 2033
Pitavastatin Calcium
NDA 022363 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 1 mg, 2 mg, and 4 mg
RLD/NDA as listed: Livalo 22363- First PIV submission
- 5 Aug 2013
- ANDAs
- 7
- 180-day status
- Eligible
- Decision posted
- 25 Jul 2022
- First applicant approval
- 20 Dec 2016
- First marketing
- 2 Nov 2023
- Last qualifying patent expiry (as listed by FDA)
- 19 Feb 2024
Pitolisant Hydrochloride
NDA 211150 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 4.45 mg and 17.8 mg
RLD/NDA as listed: Wakix 211150- First PIV submission
- 14 Aug 2023
- ANDAs
- 7
- 180-day status
- Eligible
- Decision posted
- 3 Aug 2026
- First applicant approval
- 21 Jul 2026
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 7 Mar 2030
Plecanatide
NDA 208745 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 3 mg
RLD/NDA as listed: Trulance 208745- First PIV submission
- 19 Jan 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)
- 5 Jun 2034
Plerixafor
NDA 022311 · 1 row · Listed patents and exclusivities · Open in the app
Injection · 24 mg/1.2 mL vials (20 mg/mL)
RLD/NDA as listed: Mozobil 22311- First PIV submission
- 17 Dec 2012
- ANDAs
- 3
- 180-day status
- Extinguished
- Decision posted
- 87/2023
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 23 Jul 2023
Polyethylene Glycol 3350
NDA 022015 · 1 row · Listed patents and exclusivities · Open in the app
Powder for Oral Solution · 17g/Scoopful
RLD/NDA as listed: Miralax 22015- 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
Polyethylene Glycol 3350, Sodium Sulfate, Potassium Chloride, Magnesium Sulfate, Sodium Chloride
NDA 215344 · 1 row · Listed patents and exclusivities · Open in the app
For Oral Solution · 178.7 g/7.3 g/1.12 g/ 0.9g/0.5 g
RLD/NDA as listed: Suflave 215344- First PIV submission
- 4 Apr 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)
- 14 Jun 2044
Polyethylene Glycol 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate and Ascorbic Acid
NDA 021881 · 1 row · Listed patents and exclusivities · Open in the app
For Oral Solution · 100 g, 7.5 g, 2.691 g, 1.015 g, 5.9 g and 4.7 g per pouch
RLD/NDA as listed: Moviprep 21881- First PIV submission
- 27 Nov 2007
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 8 Sep 2020
- First applicant approval
- 25 Jan 2012
- First marketing
- 31 Aug 2020
- Last qualifying patent expiry (as listed by FDA)
- 1 Sep 2024
Polyethylene Glycol 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, Sodium Sulfate and Ascorbic Acid
NDA 209381 · 1 row · Listed patents and exclusivities · Open in the app
For Oral Solution · 140 g, 5.2 g, 2.2.g, 48.11 g, 9 g and 7.54 g per pouch
RLD/NDA as listed: Plenvu 209381- First PIV submission
- 6 Dec 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)
- 10 Sep 2033
Pomalidomide
NDA 204026 · 1 row · Listed patents and exclusivities · Open in the app
Capsules · 1 mg, 2 mg, 3 mg and 4 mg
RLD/NDA as listed: Pomalyst 204026- First PIV submission
- 8 Feb 2017
- ANDAs
- 6
- 180-day status
- Non-Forfeiture Deferred
- Decision posted
- 12/14/2021 1/12/2021
- First applicant approval
- 3 Oct 2020
- First marketing
- 2 Mar 2026
- Last qualifying patent expiry (as listed by FDA)
- 21 Jun 2031
Ponatinib Hydrochloride
NDA 203469 · 2 rows · Listed patents and exclusivities · Open in the app
Tablets · 10 mg and 30 mg
RLD/NDA as listed: Iclusig 203469- First PIV submission
- 12 Dec 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)
- 12 Dec 2033
Tablets · 15 mg and 45 mg
RLD/NDA as listed: Iclusig 203469- First PIV submission
- 31 Mar 2021
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 7 Aug 2023
- First applicant approval
- 14 Jul 2023
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 12 Dec 2033
Posaconazole
NDA 022003 · 1 row · Listed patents and exclusivities · Open in the app
Oral Suspension · 40 mg/mL
RLD/NDA as listed: Noxafil 22003- First PIV submission
- 28 Feb 2011
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 30 Jul 2019
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 19 Jul 2019
Posaconazole
NDA 205053 · 1 row · Listed patents and exclusivities · Open in the app
Delayed-release Tablets · 100 mg
RLD/NDA as listed: Noxafil 205053- First PIV submission
- 16 Jun 2014
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 30 Jul 2019
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 19 Jul 2019
Posaconazole
NDA 205596 · 1 row · Listed patents and exclusivities · Open in the app
Injection · 18 mg/mL, 16.7 mL vials
RLD/NDA as listed: Noxafil 205596- First PIV submission
- 24 Nov 2015
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 25 Jul 2022
- First applicant approval
- 25 May 2022
- First marketing
- 28 Jun 2023
- Last qualifying patent expiry (as listed by FDA)
- 4 Jul 2031
Pralatrexate
NDA 022468 · 1 row · Listed patents and exclusivities · Open in the app
Injection · 20 mg/mL and 40 mg/2 mL
RLD/NDA as listed: Folotyn 22468- First PIV submission
- 24 Sep 2013
- ANDAs
- 4
- 180-day status
- Extinguished Eligible
- Decision posted
- 6/9/2025 3/17/2025
- First applicant approval
- 10 Mar 2025
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 31 May 2025
Pramipexole Dihydrochloride
NDA 020667 · 3 rows · Listed patents and exclusivities · Open in the app
Tablets · 0.125 mg, 0.5 mg, 1 mg and 1.5 mg
RLD/NDA as listed: Mirapex 20667- First PIV submission
- 24 Jun 2005
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 22 Feb 2022
- First applicant approval
- 19 Feb 2008
- First marketing
- 4 Jan 2010
- Last qualifying patent expiry (as listed by FDA)
- 25 Mar 2011
Tablets · 0.25 mg
RLD/NDA as listed: Mirapex 20667- First PIV submission
- 27 May 2005
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 22 Feb 2022
- First applicant approval
- 19 Feb 2008
- First marketing
- 4 Jan 2010
- Last qualifying patent expiry (as listed by FDA)
- 25 Mar 2011
Tablets · 0.75 mg
RLD/NDA as listed: Mirapex 20667- First PIV submission
- 31 Jul 2008
- ANDAs
- 1
- 180-day status
- Extinguished Eligible
- Decision posted
- 4/18/2023 2/22/2022
- First applicant approval
- 9 Apr 2010
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 8 Oct 2010
Pramipexole Dihydrochloride
NDA 022421 · 2 rows · Listed patents and exclusivities · Open in the app
Extended-release Tablets · 0.375 mg, 0.75 mg, 1.5 mg, 3 mg and 4.5 mg
RLD/NDA as listed: Mirapex ER 22421- First PIV submission
- 1 Jun 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)
- 26 Apr 2028
Extended-release Tablets · 2.25 mg and 3.75 mg
RLD/NDA as listed: Mirapex ER 22421- First PIV submission
- 26 Jul 2011
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 8 Feb 2022
- First applicant approval
- 6 Feb 2014
- First marketing
- 11/20/2015 - 2.25 mg 3.75 mg - 7/5/2016
- Last qualifying patent expiry (as listed by FDA)
- 26 Apr 2028
Prasugrel Hydrochloride
NDA 022307 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 5 mg and 10 mg
RLD/NDA as listed: Effient 22307- First PIV submission
- 10 Jul 2013
- ANDAs
- 17
- 180-day status
- Eligible
- Decision posted
- 29 Jun 2020
- First applicant approval
- 12 Jul 2017
- First marketing
- 15 Aug 2017
- Last qualifying patent expiry (as listed by FDA)
- 2 Mar 2022
Pravastatin Sodium
NDA 019898 · 2 rows · Listed patents and exclusivities · Open in the app
Tablets · 10 mg, 20 mg, 40 mg and 80 mg
RLD/NDA as listed: Pravachol 19898- 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 · 30 mg
RLD/NDA as listed: Pravachol 19898- First PIV submission
- 1 Jun 2005
- ANDAs
- 1
- 180-day status
- Extinguished Eligible
- Decision posted
- 8/3/2026 2/22/2022
- First applicant approval
- 28 Nov 2006
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 22 Apr 2014
Prazosin Hydrochloride
NDA 017442 · 1 row · Listed patents and exclusivities · Open in the app
Capsules · 1 mg, 2 mg and 5 mg
RLD/NDA as listed: Minipress 17442- 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
Prednisolone Sodium Phosphate
NDA 019157 · 1 row · Listed patents and exclusivities · Open in the app
Oral Solution · 5 mg(base)/ 5 mL and 15 mg (base)/ 5 mL
RLD/NDA as listed: Pediapred 19157- 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
Prednisolone Sodium Phosphate
NDA 021959 · 1 row · Listed patents and exclusivities · Open in the app
Orally Disintegrating Tablets · 10 mg, 15 mg and 30 mg
RLD/NDA as listed: Orapred 21959- First PIV submission
- 22 Jul 2010
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 27 Aug 2019
- First applicant approval
- 10 Apr 2013
- First marketing
- 8 Dec 2014
- Last qualifying patent expiry (as listed by FDA)
- 24 Nov 2019
Prednisone
NDA 202020 · 2 rows · Listed patents and exclusivities · Open in the app
Delayed-release Tablets · 1 mg and 2 mg
RLD/NDA as listed: Rayos 202020- First PIV submission
- 26 Nov 2012
- ANDAs
- 1
- 180-day status
- Extinguished Deferred
- Decision posted
- 8/5/2024 2/22/2022
- First applicant approval
- 25 Apr 2017
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 23 Apr 2024
Delayed-release Tablets · 5 mg
RLD/NDA as listed: Rayos 202020- First PIV submission
- 26 Nov 2012
- ANDAs
- 1
- 180-day status
- Extinguished Non-Forfeiture Deferred
- Decision posted
- 6/9/2026 8/5/2024 2/22/2022
- First applicant approval
- 25 Apr 2017
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 7 Jan 2028
Pregabalin
NDA 021446 · 1 row · Listed patents and exclusivities · Open in the app
Capsules · 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg
RLD/NDA as listed: Lyrica 21446- First PIV submission
- 30 Dec 2008
- ANDAs
- 8
- 180-day status
- Extinguished
- Decision posted
- 13 Dec 2022
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 30 Dec 2018
Pregabalin
NDA 209501 · 2 rows · Listed patents and exclusivities · Open in the app
Extended-release Tablets · 330 mg
RLD/NDA as listed: Lyrica CR 209501- First PIV submission
- 29 Jan 2018
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 20 Apr 2021
- First applicant approval
- 12 Apr 2021
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 2 Nov 2026
Extended-release Tablets · 82.5 mg and 165 mg
RLD/NDA as listed: Lyrica CR 209501- First PIV submission
- 2 Feb 2018
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 20 Apr 2021
- First applicant approval
- 12 Apr 2021
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 2 Nov 2026
Pregablin
NDA 022488 · 1 row · Listed patents and exclusivities · Open in the app
Oral Solution · 20 mg/mL
RLD/NDA as listed: Lyrica 22488- First PIV submission
- 19 May 2010
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 25 Jul 2022
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 30 Dec 2018
Propafenone
NDA 021416 · 2 rows · Listed patents and exclusivities · Open in the app
Propafenone Hydrochloride · Extended-release Capsules · 225 mg and 425 mg
RLD/NDA as listed: Rythmol SR 21416- First PIV submission
- 11 Oct 2006
- ANDAs
- 1
- 180-day status
- Deferred
- Decision posted
- 25 Jul 2022
- First applicant approval
- 18 Oct 2010
- First marketing
- 3 Jan 2011
- Last qualifying patent expiry (as listed by FDA)
- 28 Oct 2014
Extended-release Capsules · 325 mg
RLD/NDA as listed: Rythmol SR 21416- First PIV submission
- 7 Nov 2006
- ANDAs
- 1
- 180-day status
- Deferred
- Decision posted
- 25 Jul 2022
- First applicant approval
- 18 Oct 2010
- First marketing
- 3 Jan 2011
- Last qualifying patent expiry (as listed by FDA)
- 28 Oct 2014
Propofol
NDA 019627 · 1 row · Listed patents and exclusivities · Open in the app
Injection · 10 mg/mL ; 20 mL, 50 mL and 100 mL vials and 20 mL syringe
RLD/NDA as listed: Diprivan 19627- 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
Propranolol Hydrochloride
NDA 018553 · 1 row · Listed patents and exclusivities · Open in the app
Extended-release Capsules · 60 mg, 80 mg, 120 mg and 160 mg
RLD/NDA as listed: Inderal LA 18553- 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
Propranolol Hydrochloride
NDA 205410 · 1 row · Listed patents and exclusivities · Open in the app
Oral Solution · 4.28 mg/mL
RLD/NDA as listed: Hemangeol 205410- First PIV submission
- 21 Jul 2022
- 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)
- 16 Oct 2028