Drybench Patent.
FDA Paragraph IV list: R
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose group's drug name, as listed, starts with R, 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.
Rabeprazole Sodium
NDA 020973 · 1 row · Listed patents and exclusivities · Open in the app
Delayed-release Tablets · 20 mg
RLD/NDA as listed: Aciphex 20973- 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
Raloxifene Hydrochloride
NDA 020815 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 60 mg
RLD/NDA as listed: Evista 20815- 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
Raltegravir Potassium
NDA 022145 · 2 rows · Listed patents and exclusivities · Open in the app
Tablets · 400 mg
RLD/NDA as listed: Isentress 22145- First PIV submission
- 12 Oct 2011
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 17 Feb 2025
- First applicant approval
- 19 Dec 2024
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 11 Mar 2029
Tablets · 600 mg
RLD/NDA as listed: Isentress HD 22145- First PIV submission
- 21 Oct 2022
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 12 May 2025
- First applicant approval
- 8 May 2025
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 30 Mar 2032
Ramelteon
NDA 021782 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 8 mg
RLD/NDA as listed: Rozerem 21782- First PIV submission
- 22 Jul 2009
- ANDAs
- 2
- 180-day status
- Deferred
- Decision posted
- 18 Jun 2019
- First applicant approval
- 26 Jul 2013
- First marketing
- 22 Jul 2019
- Last qualifying patent expiry (as listed by FDA)
- 22 Jul 2019
Ramipril
NDA 019901 · 1 row · Listed patents and exclusivities · Open in the app
Capsules · 1.25 mg, 2.5 mg, 5 mg and 10 mg
RLD/NDA as listed: Altace 19901- 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
Ranitidine Hydrochloride
NDA 021698 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 150 mg
RLD/NDA as listed: Zantac 150 (NDA 21698/Product 002)- First PIV submission
- 30 Oct 2007
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 23 Mar 2021
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 20 Dec 2010
Ranolazine
NDA 021526 · 1 row · Listed patents and exclusivities · Open in the app
Extended-release · 500 mg and 1000 mg
RLD/NDA as listed: Renexa 21526- First PIV submission
- 17 May 2010
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 23 Mar 2021
- First applicant approval
- 29 Jul 2013
- First marketing
- 27 Jan 2019
- Last qualifying patent expiry (as listed by FDA)
- 27 May 2019
Rasagiline Mesylate
NDA 021641 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 0.5 mg and 1 mg
RLD/NDA as listed: Azilect 21641- First PIV submission
- 17 May 2010
- ANDAs
- 5
- 180-day status
- Eligible
- Decision posted
- 23 Mar 2021
- First applicant approval
- 12 Sep 2013
- First marketing
- 2 Jan 2017
- Last qualifying patent expiry (as listed by FDA)
- 5 Dec 2026
Regadenoson
NDA 022161 · 1 row · Listed patents and exclusivities · Open in the app
Injection · 0.08 mg/mL, 5 mL vial
RLD/NDA as listed: Lexiscan 22161- First PIV submission
- 10 Apr 2012
- 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)
- 2 Feb 2027
Regorafenib
NDA 203085 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 40 mg
RLD/NDA as listed: Stivarga 203085- First PIV submission
- 27 Sep 2016
- ANDAs
- 2
- 180-day status
- Deferred
- Decision posted
- 17 Feb 2025
- First applicant approval
- 13 Jan 2025
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 16 Feb 2031
Relugolix
NDA 214621 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 120 mg
RLD/NDA as listed: Orgovyx 214621- First PIV submission
- 18 Dec 2024
- ANDAs
- 6
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 29 Sep 2037
Remdesivir
NDA 214787 · 1 row · Listed patents and exclusivities · Open in the app
Powder for Injection · 100 mg/vial
RLD/NDA as listed: Veklury 214787- First PIV submission
- 22 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)
- 28 May 2041
Remifentanil Hydrochloride
NDA 020630 · 1 row · Listed patents and exclusivities · Open in the app
for Injection · 1 mg/vial, 2 mg/vial and 5 mg/vial
RLD/NDA as listed: Ultiva 20630- First PIV submission
- 27 Dec 2013
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 2 Jul 2019
- First applicant approval
- 16 Jan 2018
- First marketing
- 26 Jan 2018
- Last qualifying patent expiry (as listed by FDA)
- 10 Sep 2017
Remimazolam Besylate
NDA 212295 · 1 row · Listed patents and exclusivities · Open in the app
Powder for Injection · 20 mg/vial
RLD/NDA as listed: Byfavo 212295- First PIV submission
- 7 Oct 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)
- 13 Jan 2034
Repaglinide
NDA 020741 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 0.5 mg, 1 mg and 2 mg
RLD/NDA as listed: Prandin 20741- First PIV submission
- 10 Feb 2005
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 23 Mar 2021
- First applicant approval
- 11 Jul 2013
- First marketing
- 24 Jul 2013
- Last qualifying patent expiry (as listed by FDA)
- 12 Jun 2018
Repaglinide and Metformin Hydrochloride
NDA 022386 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 1 mg/500 mg and 2 mg/500 mg
RLD/NDA as listed: Prandimet 22386- First PIV submission
- 9 Apr 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)
- 12 Jun 2018
Revefenacin
NDA 210598 · 1 row · Listed patents and exclusivities · Open in the app
Inhalation Solution · 175 mcg/3 mL
RLD/NDA as listed: Yupelri 210598- First PIV submission
- 9 Nov 2022
- ANDAs
- 7
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 23 Oct 2039
Ribavirin
NDA 018859 · 1 row · Listed patents and exclusivities · Open in the app
for Inhalation Solution · 6 gm/vial
RLD/NDA as listed: Virazole 18859- First PIV submission
- 22 May 2014
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 23 Mar 2021
- First applicant approval
- 6 Oct 2016
- First marketing
- 15 Dec 2016
- Last qualifying patent expiry (as listed by FDA)
- 21 Nov 2017
Ribavirin
NDA 020903 · 1 row · Listed patents and exclusivities · Open in the app
Capsules · 200 mg
RLD/NDA as listed: Rebetol 20903- 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
Ribociclib Succinate
NDA 209092 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 200 mg
RLD/NDA as listed: Kisqali 209092- First PIV submission
- 15 Mar 2021
- ANDAs
- 4
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 14 Apr 2036
Ribociclib Succinate and Letrozole (Copackaged)
NDA 209935 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 200 mg and 2.5 mg
RLD/NDA as listed: Kisqali Femara Co-Pack 209935- First PIV submission
- 15 Mar 2021
- ANDAs
- 4
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 14 Apr 2036
Rifaximin
NDA 021361 · 2 rows · Listed patents and exclusivities · Open in the app
Tablets · 200 mg
RLD/NDA as listed: Xifaxan 21361- 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)
- 24 Jul 2029
Tablets · 550 mg
RLD/NDA as listed: Xifaxan 21361- First PIV submission
- 18 Dec 2015
- ANDAs
- 1
- 180-day status
- Eligible Non-Forfeiture Non-Forfeiture
- Decision posted
- 3/19/2026 2/17/2025 8/24/2021
- First applicant approval
- 19 Mar 2026
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 2 Oct 2029
Riluzole
NDA 209080 · 1 row · Listed patents and exclusivities · Open in the app
Oral Suspension · 50 mg/10 mL
RLD/NDA as listed: Tiglutik Kit 209080- First PIV submission
- 12 Mar 2021
- ANDAs
- 1
- 180-day status
- Deferred
- Decision posted
- 2 Sep 2024
- First applicant approval
- 22 Aug 2024
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 12 Mar 2029
Rimegepant Sulfate
NDA 212728 · 1 row · Listed patents and exclusivities · Open in the app
Orally Disintegrating Tablets · 75 mg
RLD/NDA as listed: Nurtec ODT 212728- First PIV submission
- 27 Feb 2024
- ANDAs
- 7
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 25 Mar 2039
Riociguat
NDA 204819 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg
RLD/NDA as listed: Adempas 204819- First PIV submission
- 10 Oct 2017
- ANDAs
- 3
- 180-day status
- Deferred
- Decision posted
- 4 Oct 2022
- First applicant approval
- 1 Sep 2022
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 4 Dec 2026
Risdiplam
NDA 213535 · 1 row · Listed patents and exclusivities · Open in the app
For Oral Solution · 0.75 mg/mL
RLD/NDA as listed: Evrysdi 213535- First PIV submission
- 7 Aug 2024
- ANDAs
- 2
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 4 Oct 2038
Risdiplam
NDA 219285 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 5 mg
RLD/NDA as listed: Evrysdi 219285- First PIV submission
- 17 Feb 2026
- ANDAs
- 1
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 15 Apr 2041
Risedronate Sodium
NDA 020835 · 3 rows · Listed patents and exclusivities · Open in the app
Tablets · 150 mg
RLD/NDA as listed: Actonel 20835- First PIV submission
- 12 Aug 2008
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 10 Mar 2020
- First applicant approval
- 13 Jun 2014
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 6 May 2023
Tablets · 5 mg, 30 mg and 35 mg
RLD/NDA as listed: Actonel 20835- First PIV submission
- 23 Apr 2004
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 10 Mar 2020
- First applicant approval
- 5 Oct 2007
- First marketing
- 1 Jun 2015
- Last qualifying patent expiry (as listed by FDA)
- 6/10/2018 - 5 mg and 30 mg 7/17/2018 - 35 mg
Tablets · 75 mg
RLD/NDA as listed: Actonel 20835- First PIV submission
- 7 Sep 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)
- 10 Jun 2018
Risedronate Sodium
NDA 022560 · 1 row · Listed patents and exclusivities · Open in the app
Delayed-release Tablets · 35 mg
RLD/NDA as listed: Atelvia 22560- First PIV submission
- 9 Jun 2011
- ANDAs
- 1
- 180-day status
- Deferred
- Decision posted
- 23 Mar 2021
- First applicant approval
- 18 May 2015
- First marketing
- 18 May 2015
- Last qualifying patent expiry (as listed by FDA)
- 9 Jan 2028
Risperidone
NDA 020272 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 0.25 mg, 1 mg, 2 mg, 3 mg and 4 mg
RLD/NDA as listed: Risperdal 20272- 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
Risperidone
NDA 020588 · 1 row · Listed patents and exclusivities · Open in the app
Oral Solution · 1 mg/mL
RLD/NDA as listed: Risperdal 20588- 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
Risperidone
NDA 021444 · 3 rows · Listed patents and exclusivities · Open in the app
Orally Disintegrating Tablets · 0.25 mg
RLD/NDA as listed: Risperdal 21444- First PIV submission
- 11 Apr 2005
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 23 Mar 2021
- First applicant approval
- 30 Apr 2009
- First marketing
- 1 Jun 2009
- Last qualifying patent expiry (as listed by FDA)
- 10 Jun 2017
Orally Disintegrating Tablets · 0.5 mg, 1 mg and 2 mg
RLD/NDA as listed: Risperdal 21444- 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
Orally Disintegrating Tablets · 3 mg and 4 mg
RLD/NDA as listed: Risperdal 21444- First PIV submission
- 23 Mar 2005
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 23 Mar 2021
- First applicant approval
- 30 Apr 2009
- First marketing
- 1 Jun 2009
- Last qualifying patent expiry (as listed by FDA)
- 10 Jun 2017
Ritonavir
NDA 022417 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 100 mg
RLD/NDA as listed: Norvir 22417- First PIV submission
- 21 Dec 2010
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 18 Jun 2019
- First applicant approval
- 15 Jan 2015
- First marketing
- 20 Mar 2018
- Last qualifying patent expiry (as listed by FDA)
- 10 May 2021
Rivaroxaban
NDA 022406 · 3 rows · Listed patents and exclusivities · Open in the app
Capsules · 10 mg, 15 mg and 20 mg
RLD/NDA as listed: Xarelto 22406- First PIV submission
- 17 Jun 2022
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 9 Jun 2025
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 17 Feb 2034
Tablets · 10 mg, 15 mg, and 20 mg
RLD/NDA as listed: Xarelto 22406- First PIV submission
- 1 Jul 2015
- ANDAs
- 8
- 180-day status
- Extinguished
- Decision posted
- 3 Oct 2024
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 28 Aug 2024
Tablets · 2.5 mg
RLD/NDA as listed: Xarelto 22406- First PIV submission
- 19 Nov 2018
- ANDAs
- 4
- 180-day status
- Extinguished
- Decision posted
- 3 Mar 2025
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 13 Nov 2024
Rivastigmine
NDA 022083 · 2 rows · Listed patents and exclusivities · Open in the app
Transdermal System Extended-release · 13.3 mg/24 hr
RLD/NDA as listed: Exelon 22083- First PIV submission
- 22 Jan 2013
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 23 Mar 2021
- First applicant approval
- 31 Aug 2015
- First marketing
- 2 Sep 2015
- Last qualifying patent expiry (as listed by FDA)
- 8 Jan 2019
Transdermal System Extended-release · 4.6 mg/24 hr and 9.5 mg/24 hr
RLD/NDA as listed: Exelon 22083- First PIV submission
- 27 Apr 2011
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 23 Mar 2021
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 8 Jan 2019
Rivastigmine Tartrate
NDA 020823 · 1 row · Listed patents and exclusivities · Open in the app
Capsules · 1.5 mg, 3 mg, 4.5 mg and 6 mg
RLD/NDA as listed: Exelon 20823- First PIV submission
- 21 Apr 2004
- ANDAs
- 3
- 180-day status
- Eligible
- Decision posted
- 23 Mar 2021
- First applicant approval
- 22 Oct 2007
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 11 Feb 2014
Rivastigmine Tartrate
NDA 021025 · 1 row · Listed patents and exclusivities · Open in the app
Oral Solution · 2 mg/mL
RLD/NDA as listed: Exelon 21025- First PIV submission
- 5 Nov 2004
- 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)
- 11 Feb 2014
Rizatriptan Benzoate
NDA 020864 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 5 mg and 10 mg
RLD/NDA as listed: Maxalt 20864- First PIV submission
- 2 Sep 2004
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 23 Mar 2021
- First applicant approval
- 31 Dec 2012
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 11 Feb 2014
Rizatriptan Benzoate
NDA 020865 · 1 row · Listed patents and exclusivities · Open in the app
Orally Disintegrating Tablets · 5 mg and 10 mg
RLD/NDA as listed: Maxalt-MLT 20865- First PIV submission
- 17 Feb 2006
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 23 Mar 2021
- First applicant approval
- 31 Dec 2012
- First marketing
- 31 Dec 2012
- Last qualifying patent expiry (as listed by FDA)
- 11 Feb 2014
Rofecoxib
NDA 021052 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 12.5 mg, 25 mg and 50 mg
RLD/NDA as listed: Vioxx 21052- 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
Roflumilast
NDA 022522 · 2 rows · Listed patents and exclusivities · Open in the app
Tablets · 250 mcg
RLD/NDA as listed: Daliresp 22522- First PIV submission
- 25 Jan 2019
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 20 Sep 2022
- First applicant approval
- 7 Sep 2022
- First marketing
- 20 Oct 2022
- Last qualifying patent expiry (as listed by FDA)
- 8 Mar 2024
Tablets · 500 mcg
RLD/NDA as listed: Daliresp 22522- First PIV submission
- 2 Mar 2015
- ANDAs
- 7
- 180-day status
- Eligible
- Decision posted
- 18 Jun 2019
- First applicant approval
- 13 Jul 2018
- First marketing
- 19 Oct 2022
- Last qualifying patent expiry (as listed by FDA)
- 8 Mar 2024
Roflumilast
NDA 215985 · 1 row · Listed patents and exclusivities · Open in the app
Cream · 3.0000000000000001E-3
RLD/NDA as listed: Zoryve 215985- First PIV submission
- 27 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)
- 7 Jun 2037
Romidepsin
NDA 022393 · 1 row · Listed patents and exclusivities · Open in the app
Injection · 10 mg/vial
RLD/NDA as listed: Istodax 22393- First PIV submission
- 5 Nov 2013
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 2 Nov 2021
- First applicant approval
- 12 Oct 2021
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 22 Aug 2021
Ropinirole Hydrochloride
NDA 020658 · 2 rows · Listed patents and exclusivities · Open in the app
Tablets · 0.25 mg, 0.5 mg, 1 mg and 2 mg
RLD/NDA as listed: Requip 20658- First PIV submission
- 22 Dec 2004
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 10 Mar 2020
- First applicant approval
- 5 May 2008
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 19 May 2008
Tablets · 3 mg, 4 mg and 5 mg
RLD/NDA as listed: Requip 20658- First PIV submission
- 4 Feb 2005
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 10 Mar 2020
- First applicant approval
- 5 May 2008
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 19 May 2008
Ropinirole Hydrochloride
NDA 022008 · 6 rows · Listed patents and exclusivities · Open in the app
Extended-release Tablets · 12 mg
RLD/NDA as listed: Requip XL 22008- First PIV submission
- 5 Feb 2009
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 10 Mar 2020
- First applicant approval
- 17 May 2012
- First marketing
- 17 May 2012
- Last qualifying patent expiry (as listed by FDA)
- 6 Jun 2012
Extended-release Tablets · 2 mg
RLD/NDA as listed: Requip XL 22008- First PIV submission
- 14 Oct 2008
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 10 Mar 2020
- First applicant approval
- 17 May 2012
- First marketing
- 17 May 2012
- Last qualifying patent expiry (as listed by FDA)
- 6 Jun 2012
Extended-release Tablets · 3 mg
RLD/NDA as listed: Requip XL 22008- First PIV submission
- 8 Jan 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)
- 6 Jun 2012
Extended-release Tablets · 4 mg
RLD/NDA as listed: Requip XL 22008- First PIV submission
- 31 Oct 2008
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 10 Mar 2020
- First applicant approval
- 17 May 2012
- First marketing
- 17 May 2012
- Last qualifying patent expiry (as listed by FDA)
- 6 Jun 2012
Extended-release Tablets · 6 mg
RLD/NDA as listed: Requip XL 22008- First PIV submission
- 14 Jul 2009
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 10 Mar 2020
- First applicant approval
- 17 May 2012
- First marketing
- 17 May 2012
- Last qualifying patent expiry (as listed by FDA)
- 6 Jun 2012
Extended-release Tablets · 8 mg
RLD/NDA as listed: Requip XL 22008- First PIV submission
- 3 Nov 2008
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 10 Mar 2020
- First applicant approval
- 17 May 2012
- First marketing
- 17 May 2012
- Last qualifying patent expiry (as listed by FDA)
- 6 Jun 2012
Ropivacaine Hydrochloride
NDA 020533 · 3 rows · Listed patents and exclusivities · Open in the app
Injection · 2 mg/mL, 100 mL
RLD/NDA as listed: Naropin 20533- First PIV submission
- 30 Jan 2015
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 23 Mar 2021
- First applicant approval
- 13 Jul 2016
- First marketing
- 15 Sep 2016
- Last qualifying patent expiry (as listed by FDA)
- 28 Nov 2026
Injection · 2 mg/mL, 200 mL
RLD/NDA as listed: Naropin 20533- First PIV submission
- 3 Sep 2015
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 18 Jun 2019
- First applicant approval
- 16 Mar 2018
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 28 Nov 2026
Injection · 2 mg/mL, 5 mg/mL and 10 mg/mL, 20 mL, 30 mL and 20 mL vials
RLD/NDA as listed: Naropin 20533- First PIV submission
- 13 Nov 2006
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 23 Mar 2021
- First applicant approval
- 17 Jul 2014
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 23 Sep 2014
Rosiglitazone Maleate
NDA 021071 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 2 mg, 4 mg and 8 mg
RLD/NDA as listed: Avandia 21071- 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
Rosiglitazone Maleate and Metformin Hydrochloride
NDA 021410 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 1 mg/ 500 mg, 2 mg/ 500mg 4 mg/ 500 mg 2 mg/ 1000 mg 4 mg/ 1000 mg
RLD/NDA as listed: Avandamet 21410- First PIV submission
- 22 Oct 2004
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 23 Mar 2021
- First applicant approval
- 5/7/2014 5/19/2017 1mg/500mg
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 11 Feb 2017
Rosuvastatin Calcium
NDA 021366 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 5 mg, 10 mg, 20 mg and 40 mg
RLD/NDA as listed: Crestor 21366- First PIV submission
- 13 Aug 2007
- ANDAs
- 9
- 180-day status
- Non-Forfeiture
- Decision posted
- 27 Aug 2019
- First applicant approval
- 29 Apr 2016
- First marketing
- 2 May 2016
- Last qualifying patent expiry (as listed by FDA)
- 4 Aug 2020
Rotigotine
NDA 021829 · 1 row · Listed patents and exclusivities · Open in the app
Extended-release Transdermal Film · 1 mg/24 hr 2 mg/24 hr 3 mg/24 hr 4 mg/24 hr 6 mg/24 hr 8 mg/24 hr
RLD/NDA as listed: Neupro 21829- First PIV submission
- 26 Nov 2013
- 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 Sep 2027
Rufinamide
NDA 021911 · 2 rows · Listed patents and exclusivities · Open in the app
Tablets · 100 mg
RLD/NDA as listed: Banzel 21911- First PIV submission
- 14 Nov 2012
- ANDAs
- 1
- 180-day status
- Extinguished Deferred
- Decision posted
- 4/18/2023 9/6/2022
- First applicant approval
- 17 Aug 2022
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 14 Nov 2022
Tablets · 200 mg and 400 mg
RLD/NDA as listed: Banzel 21911- First PIV submission
- 14 Nov 2012
- ANDAs
- 5
- 180-day status
- Eligible
- Decision posted
- 23 Mar 2021
- First applicant approval
- 16 May 2016
- First marketing
- 1 Jun 2021
- Last qualifying patent expiry (as listed by FDA)
- 14 Nov 2022
Rufinamide
NDA 201367 · 1 row · Listed patents and exclusivities · Open in the app
Oral Suspension · 40 mg/mL
RLD/NDA as listed: Banzel 201367- First PIV submission
- 16 Jun 2014
- 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)
- 14 Nov 2022
Ruxolitinib Phosphate
NDA 202192 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg
RLD/NDA as listed: Jakafi 202192- First PIV submission
- 17 Dec 2015
- ANDAs
- 1
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 12 Jun 2028
Ruxolitinib Phosphate
NDA 215309 · 1 row · Listed patents and exclusivities · Open in the app
Cream · 1.4999999999999999E-2
RLD/NDA as listed: Opzelura 215309- First PIV submission
- 31 Jul 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)
- 5 May 2041
Ruxolitinib Phosphate New
NDA 217180 · 1 row · Listed patents and exclusivities · Open in the app
Extended-release Tablets · 11 mg, 22 mg, 33 mg, 44 mg and 55 mg
RLD/NDA as listed: Jakafi XR 217180- First PIV submission
- 13 Aug 2026
- ANDAs
- 1
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 14 Nov 2033