Drybench Patent.
FDA Paragraph IV list: S
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose group's drug name, as listed, starts with S, 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.
Sacubitril and Valsartan
NDA 207620 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 24 mg/26 mg, 49 mg/51 mg 97 mg/103 mg
RLD/NDA as listed: Entresto 207620- First PIV submission
- 8 Jul 2019
- ANDAs
- 18
- 180-day status
- Non-Forfeiture Deferred
- Decision posted
- 12/15/2025 6/10/2024
- First applicant approval
- 28 May 2024
- First marketing
- 23 Jul 2025
- Last qualifying patent expiry (as listed by FDA)
- 27 May 2027
Sapropterin Dihydrochloride
NDA 022181 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 100 mg
RLD/NDA as listed: Kuvan 22181- First PIV submission
- 5 Jun 2014
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 19 Nov 2019
- First applicant approval
- 10 May 2019
- First marketing
- 1 Oct 2020
- Last qualifying patent expiry (as listed by FDA)
- 16 Nov 2025
Sapropterin Dihydrochloride
NDA 205065 · 2 rows · Listed patents and exclusivities · Open in the app
Powder for Oral Solution · 100 mg per packet
RLD/NDA as listed: Kuvan 205065- First PIV submission
- 9 Nov 2015
- ANDAs
- 1
- 180-day status
- Eligible Deferred
- Decision posted
- 1/27/2020 8/27/2019
- First applicant approval
- 20 Aug 2019
- First marketing
- 1 Oct 2020
- Last qualifying patent expiry (as listed by FDA)
- 17 May 2025
Powder for Oral Solution · 500 mg per packet
RLD/NDA as listed: Kuvan 205065- First PIV submission
- 23 Feb 2017
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 19 Nov 2019
- First applicant approval
- 20 Aug 2019
- First marketing
- 1 Oct 2020
- Last qualifying patent expiry (as listed by FDA)
- 1 Nov 2032
Saxagliptin Hydrochloride
NDA 022350 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 2.5 mg and 5 mg
RLD/NDA as listed: Onglyza 22350- First PIV submission
- 31 Jul 2013
- ANDAs
- 8
- 180-day status
- Eligible
- Decision posted
- 7 Aug 2023
- First applicant approval
- 31 Jul 2023
- First marketing
- 31 Jul 2023
- Last qualifying patent expiry (as listed by FDA)
- 30 Nov 2028
Saxagliptin Hydrochloride and Metformin Hydrochloride
NDA 200678 · 1 row · Listed patents and exclusivities · Open in the app
Extended-release Tablets · 5 mg/500 mg 2.5 mg/1000 mg 5 mg/1000 mg
RLD/NDA as listed: Kombiglyze XR 200678- First PIV submission
- 31 Jul 2013
- ANDAs
- 3
- 180-day status
- Extinguished
- Decision posted
- 7 Aug 2023
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 31 Jul 2023
Selenious Acid
NDA 209379 · 3 rows · Listed patents and exclusivities · Open in the app
Intravenous Solution · 12 mcg/2 mL
RLD/NDA as listed: Selenious Acid 209379- First PIV submission
- 11 Jun 2024
- ANDAs
- 4
- 180-day status
- Eligible
- Decision posted
- 7 Jul 2025
- First applicant approval
- 11 Jun 2025
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 1 Jul 2041
Intravenous Solution · 60 mcg/mL
RLD/NDA as listed: Selenious Acid 209379- First PIV submission
- 11 Jun 2024
- ANDAs
- 5
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 1 Jul 2041
Intravenous Solution · 600 mcg/10 mL
RLD/NDA as listed: Selenious Acid 209379- First PIV submission
- 11 Jun 2024
- ANDAs
- 11
- 180-day status
- Eligible
- Decision posted
- 3 Mar 2025
- First applicant approval
- 10 Feb 2025
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 1 Jul 2041
Selexipag
NDA 207947 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg and 1.6 mg
RLD/NDA as listed: Uptravi 207947- First PIV submission
- 23 Dec 2019
- ANDAs
- 4
- 180-day status
- Eligible
- Decision posted
- 10 Jan 2023
- First applicant approval
- 21 Dec 2022
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 1 Aug 2030
Selexipag
NDA 214275 · 1 row · Listed patents and exclusivities · Open in the app
For Injection · 1.8 mg/vial
RLD/NDA as listed: Uptravi 214275- First PIV submission
- 29 Jul 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)
- 1 Aug 2030
Selpercatinib
NDA 213246 · 1 row · Listed patents and exclusivities · Open in the app
Capsules · 40 mg and 80 mg
RLD/NDA as listed: Retevmo 213246- First PIV submission
- 8 May 2024
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 19 Aug 2024
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 10 Oct 2037
Selumetinib Sulfate
NDA 213756 · 1 row · Listed patents and exclusivities · Open in the app
Capsules · 10 mg and 25 mg
RLD/NDA as listed: Koselugo 213756- First PIV submission
- 4 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)
- 26 Mar 2029
Semaglutide
NDA 209637 · 3 rows · Listed patents and exclusivities · Open in the app
Injection · 2 mg/1.5 mL and 4 mg/3 mL
RLD/NDA as listed: Ozempic 209637- First PIV submission
- 6 Dec 2021
- ANDAs
- 7
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 21 Jun 2033
Injection · 2 mg/3 mL
RLD/NDA as listed: Ozempic 209637- First PIV submission
- 11 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)
- 21 Jun 2033
Injection · 8 mg/3 mL
RLD/NDA as listed: Ozempic 209637- First PIV submission
- 21 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)
- 1 Feb 2032
Semaglutide
NDA 213051 · 2 rows · Listed patents and exclusivities · Open in the app
Tablets · 1.5 mg, 4 mg and 9 mg
RLD/NDA as listed: Ozempic 213051- First PIV submission
- 11 Dec 2025
- ANDAs
- 1
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 1 Feb 2039
Tablets · 3 mg, 7 mg and 14 mg
RLD/NDA as listed: Rybelsus 213051- First PIV submission
- 15 Jul 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)
- 2 May 2034
Semaglutide
NDA 215256 · 2 rows · Listed patents and exclusivities · Open in the app
Injection · 0.25 mg/0.5 mL 0.5 mg/0.5 mL 1 mg/0.5 mL 1.7 mg/0.75 mL 2.4 mg/0.75 mL
RLD/NDA as listed: Wegovy 215256- First PIV submission
- 20 Oct 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)
- 17 Feb 2041
Injection · 7.2 mg/0.75 mL
RLD/NDA as listed: Wegovy HD 215256- First PIV submission
- 22 Jun 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)
- 17 Feb 2041
Semaglutide
NDA 218316 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 1.5 mg, 4 mg and 9 mg
RLD/NDA as listed: Wegovy 218316- First PIV submission
- 11 Mar 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)
- 1 Feb 2039
Sertraline Hydrochloride
NDA 019839 · 2 rows · Listed patents and exclusivities · Open in the app
Tablets · 150 mg and 200 mg
RLD/NDA as listed: Zoloft 19839- First PIV submission
- 9 Nov 2005
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 24 Aug 2020
- First applicant approval
- 6 Feb 2007
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 13 Aug 2012
Tablets · 25 mg, 50 mg and 100 mg
RLD/NDA as listed: Zoloft 19839- 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
Sertraline Hydrochloride
NDA 020990 · 1 row · Listed patents and exclusivities · Open in the app
Oral Concentrate · 20 mg/mL
RLD/NDA as listed: Zoloft 20990- First PIV submission
- 9 Dec 2003
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 27 Aug 2019
- First applicant approval
- 30 Jun 2006
- First marketing
- 7 Aug 2007
- Last qualifying patent expiry (as listed by FDA)
- 11 Oct 2019
Sevelamer Carbonate
NDA 022127 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 800 mg
RLD/NDA as listed: Renvela 22127- First PIV submission
- 4 Dec 2008
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 27 Aug 2019
- First applicant approval
- 23 Oct 2017
- First marketing
- 16 Apr 2014
- Last qualifying patent expiry (as listed by FDA)
- 16 Sep 2014
Sevelamer Carbonate
NDA 022318 · 1 row · Listed patents and exclusivities · Open in the app
Powder for Oral Suspension · 0.8 g/packet and 2.4 g/packet
RLD/NDA as listed: Renvela 22318- First PIV submission
- 30 Dec 2009
- 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)
- 16 Sep 2014
Sevelamer Hydrochloride
NDA 021179 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 400 mg and 800 mg
RLD/NDA as listed: Renagel 21179- First PIV submission
- 22 May 2008
- 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)
- 18 Oct 2020
Sevoflurane
NDA 020478 · 1 row · Listed patents and exclusivities · Open in the app
Inhalation · 100%, 250 mL
RLD/NDA as listed: Ultane 20478- 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
Sibutramine Hydrochloride
NDA 020632 · 1 row · Listed patents and exclusivities · Open in the app
Capsules · 10 mg and 15 mg
RLD/NDA as listed: Meridia 20632- First PIV submission
- 14 Aug 2009
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 24 Aug 2020
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 25 Jul 2012
Sildenafil Citrate
NDA 020895 · 2 rows · Listed patents and exclusivities · Open in the app
Tablets · 100 mg
RLD/NDA as listed: Viagra 20895- First PIV submission
- 25 Oct 2004
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 24 Aug 2020
- First applicant approval
- 9 Mar 2016
- First marketing
- 11 Dec 2017
- Last qualifying patent expiry (as listed by FDA)
- 22 Oct 2019
Tablets · 25 mg and 50 mg
RLD/NDA as listed: Viagra 20895- First PIV submission
- 19 Nov 2004
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 24 Aug 2020
- First applicant approval
- 9 Mar 2016
- First marketing
- 11 Dec 2017
- Last qualifying patent expiry (as listed by FDA)
- 22 Oct 2019
Silodosin
NDA 022206 · 1 row · Listed patents and exclusivities · Open in the app
Capsules · 4 mg and 8 mg
RLD/NDA as listed: Rapaflo 22206- First PIV submission
- 9 Oct 2012
- ANDAs
- 3
- 180-day status
- Deferred
- Decision posted
- 24 Aug 2020
- First applicant approval
- 31 Mar 2017
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 1 Dec 2018
Silver Sulfadiazine
NDA 017381 · 1 row · Listed patents and exclusivities · Open in the app
Cream · 1%
RLD/NDA as listed: Silvadene 17381- 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
Simvastatin
NDA 019766 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 5 mg, 10 mg, 20 mg, 40 mg and 80 mg
RLD/NDA as listed: Zocor 19766- 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
Siponimod Fumaric Acid
NDA 209884 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 0.25 mg, 1 mg and 2 mg
RLD/NDA as listed: Mayzent 209884- First PIV submission
- 27 Mar 2023
- ANDAs
- 5
- 180-day status
- Eligible
- Decision posted
- 28 Apr 2025
- First applicant approval
- 22 Apr 2025
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 30 Nov 2030
Sirolimus
NDA 021110 · 2 rows · Listed patents and exclusivities · Open in the app
Tablets · 0.5 mg
RLD/NDA as listed: Rapamune 21110- First PIV submission
- 28 Sep 2010
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 10 Mar 2020
- First applicant approval
- 8 Jan 2014
- First marketing
- 16 Jan 2014
- Last qualifying patent expiry (as listed by FDA)
- 11 Mar 2018
Tablets · 1 mg and 2 mg
RLD/NDA as listed: Rapamune 21110- First PIV submission
- 17 Dec 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)
- 11 Mar 2018
Sitagliptin Phosphate
NDA 021995 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 25 mg, 50 mg and 100 mg
RLD/NDA as listed: Januvia 21995- First PIV submission
- 18 Oct 2010
- ANDAs
- 6
- 180-day status
- Eligible
- Decision posted
- 5 Jan 2026
- First applicant approval
- 30 Dec 2025
- First marketing
- 28 May 2026
- Last qualifying patent expiry (as listed by FDA)
- 24 Nov 2026
Sitagliptin Phosphate and Metformin Hydrochloride
NDA 022044 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 50 mg/500 mg and 50 mg/1000 mg
RLD/NDA as listed: Janumet 22044- First PIV submission
- 18 Oct 2010
- ANDAs
- 5
- 180-day status
- Eligible
- Decision posted
- 15 Dec 2025
- First applicant approval
- 2 Dec 2025
- First marketing
- 28 May 2026
- Last qualifying patent expiry (as listed by FDA)
- 24 Nov 2026
Sitagliptin Phosphate and Metformin Hydrochloride
NDA 202270 · 2 rows · Listed patents and exclusivities · Open in the app
Extended-release Tablets · 100 mg/1000 mg
RLD/NDA as listed: Janumet XR 202270- First PIV submission
- 22 Oct 2012
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 9 Jun 2025
- First applicant approval
- 4 Jun 2025
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 24 Nov 2026
Extended-release Tablets · 50 mg/500 mg and 50 mg/1000 mg
RLD/NDA as listed: Janumet XR 202270- First PIV submission
- 16 Mar 2012
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 9 Jun 2025
- First applicant approval
- 4 Jun 2025
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 24 Nov 2026
Sitagliptin Phosphate and Simvastatin
NDA 202343 · 3 rows · Listed patents and exclusivities · Open in the app
Tablets · 100 mg/10 mg and 100 mg/40 mg
RLD/NDA as listed: Juvisync 202343- First PIV submission
- 19 Jun 2012
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 24 Aug 2020
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 11 Apr 2026
Tablets · 100 mg/20 mg
RLD/NDA as listed: Juvisync 202343- First PIV submission
- 25 Jun 2012
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 24 Aug 2020
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 11 Apr 2026
Tablets · 50 mg/10 mg 50 mg/20 mg 50 mg/40 mg
RLD/NDA as listed: Juvisync 202343- First PIV submission
- 6 Nov 2012
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 24 Aug 2020
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 11 Apr 2026
Sodium Oxybate
NDA 021196 · 1 row · Listed patents and exclusivities · Open in the app
Oral Solution · 500 mg/mL
RLD/NDA as listed: Xyrem 21196- First PIV submission
- 8 Jul 2010
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 2 Jul 2019
- First applicant approval
- 17 Jan 2017
- First marketing
- 17 Jan 2017
- Last qualifying patent expiry (as listed by FDA)
- 16 Jun 2024
Sodium Oxybate
NDA 214755 · 1 row · Listed patents and exclusivities · Open in the app
For Extended-release Oral Suspension · 4.5 g/packet 6 g/packet 7.5 g/packet 9 g/packet
RLD/NDA as listed: Lumryz 214755- First PIV submission
- 22 May 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)
- 16 Mar 2042
Sodium Phosphate Monobasic Monohydrate and Sodium PhosphateDibasic Anhydrous, USP
NDA 021892 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 1.102 g and 0.398 g
RLD/NDA as listed: Osmoprep 21892- First PIV submission
- 9 Apr 2008
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 24 Aug 2020
- First applicant approval
- 30 Dec 2011
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 18 May 2013
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid
NDA 202535 · 1 row · Listed patents and exclusivities · Open in the app
Oral Solution · 10 mg, 3.5 g, and 12 g
RLD/NDA as listed: Prepopik 202535- First PIV submission
- 21 May 2014
- 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)
- 10 Oct 2028
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid
NDA 209589 · 1 row · Listed patents and exclusivities · Open in the app
Oral Solution · 10 mg, 3.5 g, and 12 g
RLD/NDA as listed: Clenpiq 209589- First PIV submission
- 11 Feb 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)
- 26 Jun 2034
Sodium Sulfate, Magnesium Sulfate and Potassium Chloride
NDA 213135 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 1.479 g/0.225 g/ 0.188 g
RLD/NDA as listed: Sutab 213135- First PIV submission
- 3 Mar 2023
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 9 Jun 2026
- First applicant approval
- 28 May 2026
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 4 Aug 2037
Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate
NDA 022372 · 1 row · Listed patents and exclusivities · Open in the app
Oral Solution · 17.5 g/3.13 g/1.6 g
RLD/NDA as listed: Suprep Bowel Prep Kit 22372- First PIV submission
- 8 Nov 2010
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 17 Nov 2020
- First applicant approval
- 23 Feb 2017
- First marketing
- 7 Sep 2022
- Last qualifying patent expiry (as listed by FDA)
- 7 Mar 2023
Sodium Thiosulfate
NDA 203923 · 1 row · Listed patents and exclusivities · Open in the app
Intravenous Injection · 12.5 g/50 mL
RLD/NDA as listed: Sodium Thiosulfate 203923- First PIV submission
- 29 Apr 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)
- 29 Mar 2031
Sodium Thiosulfate
NDA 212937 · 1 row · Listed patents and exclusivities · Open in the app
Intravenous Injection · 12.5 g/100 mL
RLD/NDA as listed: Pedmark 212937- First PIV submission
- 18 Oct 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)
- 1 Jul 2039
Sodium Zirconium Cyclosilicate
NDA 207078 · 1 row · Listed patents and exclusivities · Open in the app
for Oral Suspension · 5 g/packet and 10 g/packet
RLD/NDA as listed: Lokelma 207078- First PIV submission
- 18 May 2022
- ANDAs
- 5
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 14 Oct 2035
Sofosbuvir
NDA 204671 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 400 mg
RLD/NDA as listed: Sovaldi 204671- First PIV submission
- 6 Dec 2017
- ANDAs
- 2
- 180-day status
- Deferred
- Decision posted
- 8 Feb 2022
- First applicant approval
- 27 Jan 2022
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 11 Dec 2030
Solifenacin Succinate
NDA 021518 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 5 mg and 10 mg
RLD/NDA as listed: Vesicare 21518- First PIV submission
- 8 Apr 2009
- ANDAs
- 1
- 180-day status
- Deferred
- Decision posted
- 24 Aug 2020
- First applicant approval
- 2 Apr 2014
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 9 Nov 2018
Solifenacin Succinate
NDA 209529 · 1 row · Listed patents and exclusivities · Open in the app
Oral Suspension · 1 mg/mL
RLD/NDA as listed: Vesicare LS 209529- First PIV submission
- 27 May 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)
- 18 May 2031
Solriamfetol Hydrochloride
NDA 211230 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 75 mg and 150 mg
RLD/NDA as listed: Sunosi 211230- First PIV submission
- 20 Jun 2023
- ANDAs
- 6
- 180-day status
- Eligible
- Decision posted
- 22 Jun 2026
- First applicant approval
- 17 Jun 2026
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 19 Mar 2040
Sorafenib Tosylate
NDA 021923 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 200 mg
RLD/NDA as listed: Nexavar 21923- First PIV submission
- 28 Feb 2014
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 17 Nov 2020
- First applicant approval
- 10 Sep 2020
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 11 Feb 2023
Spironolactone
NDA 209478 · 1 row · Listed patents and exclusivities · Open in the app
Oral Suspension · 25 mg/5 mL
RLD/NDA as listed: Carospir 209478- First PIV submission
- 31 Dec 2020
- ANDAs
- 1
- 180-day status
- Eligible
- Decision posted
- 18 Sep 2023
- First applicant approval
- 5 Sep 2023
- First marketing
- 31 Oct 2023
- Last qualifying patent expiry (as listed by FDA)
- 28 Oct 2036
Sugammadex Sodium
NDA 022225 · 1 row · Listed patents and exclusivities · Open in the app
Injection · 200 mg/2 mL and 500 mg/5 mL
RLD/NDA as listed: Bridion 22225- First PIV submission
- 16 Dec 2019
- ANDAs
- 14
- 180-day status
- Extinguished Eligible
- Decision posted
- 4/13/2026 6/12/2023
- First applicant approval
- 9 Jun 2023
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 27 Jan 2026
Sumatriptan Succinate
NDA 020132 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 25 mg, 50 mg and 100 mg
RLD/NDA as listed: Imitrex 20132- 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
Sunitinib Malate
NDA 021938 · 1 row · Listed patents and exclusivities · Open in the app
Capsules · 12.5 mg, 25 mg, 37.5 mg and 50 mg
RLD/NDA as listed: Sutent 21938- First PIV submission
- 26 Jan 2010
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 7 Sep 2021
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 15 Feb 2021
Suvorexant
NDA 204569 · 1 row · Listed patents and exclusivities · Open in the app
Tablets · 5 mg, 10 mg, 15 mg and 20 mg
RLD/NDA as listed: Belsomra 204569- First PIV submission
- 4 Mar 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)
- 29 May 2033