FDA Orange Book · active-ingredient family
Sildenafil citrate
Sildenafil citrate is approved as 6 brand and 49 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:VYBRIQUE · NDA 210858
6
Brand (NDA)
49
Generics (ANDA)
6
Listed patents
8
Exclusivity periods
Brand (NDA) products · film, for suspension, solution, suspension, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VYBRIQUERLD×4 | IBSA | NDA 210858 | — | Dec 16, 2025 | |
| LIQREVRLD | CMP DEV LLC | NDA 214952 | — | Apr 28, 2023 | |
| REVATIORLD | VIATRIS | NDA 203109 | — | Aug 30, 2012 | |
| REVATIORLD | VIATRIS | NDA 022473 | AP | Nov 18, 2009 | |
| REVATIORLD | VIATRIS | NDA 021845 | AB | Jun 03, 2005 | |
| VIAGRARLD×3 | VIATRIS | NDA 020895 | AB | Mar 27, 1998 |
Generic (ANDA) products (49)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SILDENAFIL CITRATE | JUBILANT GENERICS | ANDA 202954 | AB | Mar 06, 2025 | |
| SILDENAFIL CITRATE×3 | JUBILANT GENERICS | ANDA 201156 | AB | Dec 20, 2024 | |
| SILDENAFIL CITRATE | GRANULES | ANDA 214556 | — | Dec 01, 2023 | |
| SILDENAFIL CITRATE×3 | CADILA PHARMS LTD | ANDA 218045 | AB | Nov 28, 2023 | |
| SILDENAFIL CITRATE×3 | NOVITIUM PHARMA | ANDA 216383 | AB | Aug 29, 2023 | |
| SILDENAFIL CITRATE×3 | MACLEODS PHARMS LTD | ANDA 202255 | AB | Apr 19, 2023 | |
| SILDENAFIL CITRATE | AUROBINDO PHARMA LTD | ANDA 214773 | AB | Dec 23, 2022 | |
| SILDENAFIL CITRATE | ZYDUS LIFESCIENCES | ANDA 215708 | AB | Sep 29, 2022 | |
| SILDENAFIL CITRATE | LUPIN | ANDA 211638 | — | Mar 23, 2022 | |
| SILDENAFIL CITRATE | MSN | ANDA 214641 | AB | Feb 08, 2022 | |
| SILDENAFIL CITRATE | TRIS PHARMA INC | ANDA 212312 | — | Nov 17, 2021 | |
| SILDENAFIL CITRATE | TARO | ANDA 215522 | — | Nov 16, 2021 | |
| SILDENAFIL CITRATE×3 | UMEDICA | ANDA 209302 | AB | Jun 15, 2021 | |
| SILDENAFIL CITRATE | HETERO LABS LTD V | ANDA 213014 | AB | May 11, 2021 | |
| SILDENAFIL CITRATE | CHARTWELL RX | ANDA 213814 | AB | Apr 29, 2021 | |
| SILDENAFIL CITRATE×3 | WATSON LABS INC | ANDA 202506 | — | Nov 25, 2020 | |
| SILDENAFIL CITRATE | INVAGEN PHARMS | ANDA 213041 | AB | Aug 06, 2020 | |
| SILDENAFIL CITRATE×3 | REYOUNG | ANDA 208494 | AB | Jun 12, 2020 | |
| SILDENAFIL CITRATE×3 | SUNSHINE | ANDA 213032 | AB | Jun 11, 2020 | |
| SILDENAFIL CITRATE | TEVA PHARMS USA | ANDA 211534 | AB | May 29, 2020 | |
| SILDENAFIL CITRATE×2 | PERRIGO R AND D | ANDA 205791 | — | Apr 23, 2020 | |
| SILDENAFIL CITRATE×3 | APPCO | ANDA 207178 | AB | Mar 02, 2020 | |
| SILDENAFIL CITRATE | AJANTA PHARMA LTD | ANDA 212883 | AB | Nov 27, 2019 | |
| SILDENAFIL CITRATE | ALKEM LABS LTD | ANDA 212440 | AB | Nov 27, 2019 | |
| SILDENAFIL CITRATE | AMNEAL PHARMS | ANDA 211092 | AB | Nov 27, 2019 | |
| SILDENAFIL CITRATE | NOVITIUM PHARMA | ANDA 212260 | AB | May 31, 2019 | |
| SILDENAFIL CITRATE×3 | MYLAN | ANDA 201171 | — | Mar 25, 2019 | |
| SILDENAFIL CITRATE×3 | CHARTWELL RX | ANDA 212051 | AB | Mar 22, 2019 | |
| SILDENAFIL CITRATE×3 | AJANTA PHARMA LTD | ANDA 206401 | AB | Oct 12, 2018 | |
| SILDENAFIL CITRATE×3 | AMNEAL PHARMS NY | ANDA 202023 | AB | Jun 27, 2018 | |
| SILDENAFIL CITRATE×3 | AUROBINDO PHARMA LTD | ANDA 203962 | AB | Jun 11, 2018 | |
| SILDENAFIL CITRATE×3 | HETERO LABS LTD V | ANDA 202659 | AB | Jun 11, 2018 | |
| SILDENAFIL CITRATE×3 | RUBICON RESEARCH | ANDA 204882 | AB | Jun 11, 2018 | |
| SILDENAFIL CITRATE×3 | TORRENT | ANDA 091448 | AB | Jun 11, 2018 | |
| SILDENAFIL CITRATE | AJANTA PHARMA LTD | ANDA 210394 | AB | May 04, 2018 | |
| SILDENAFIL CITRATE | RUBICON RESEARCH | ANDA 204883 | AB | Jun 20, 2016 | |
| SILDENAFIL CITRATE×3 | TEVA | ANDA 077342 | AB | Mar 09, 2016 | |
| SILDENAFIL CITRATE | AUROBINDO PHARMA LTD | ANDA 203963 | AB | Nov 18, 2015 | |
| SILDENAFIL CITRATE | EUGIA PHARMA | ANDA 203988 | AP | Apr 01, 2015 | |
| SILDENAFIL CITRATE | HETERO LABS LTD V | ANDA 203623 | AB | Nov 26, 2014 | |
| SILDENAFIL CITRATE | MACLEODS PHARMS LTD | ANDA 203814 | AB | Dec 17, 2013 | |
| SILDENAFIL CITRATE | AMNEAL PHARMS | ANDA 202025 | AB | Feb 28, 2013 | |
| SILDENAFIL CITRATE | ACTAVIS GRP PTC | ANDA 200149 | — | Feb 25, 2013 | |
| SILDENAFIL CITRATE | TEVA PHARMS | ANDA 078380 | — | Jan 07, 2013 | |
| SILDENAFIL CITRATE | MYLAN PHARMS INC | ANDA 201150 | — | Nov 09, 2012 | |
| SILDENAFIL CITRATE | APOTEX CORP | ANDA 091379 | — | Nov 06, 2012 | |
| SILDENAFIL CITRATE | CHARTWELL RX | ANDA 202598 | AB | Nov 06, 2012 | |
| SILDENAFIL CITRATE | TORRENT PHARMS LTD | ANDA 091479 | AB | Nov 06, 2012 | |
| SILDENAFIL CITRATE | WATSON LABS INC | ANDA 202503 | AB | Nov 06, 2012 |
Marketing exclusivity (8)
- NPNew product exclusivity (3 years)
Dec 16, 2028
in 2 yr 6 mo
- NPNew product exclusivity (3 years)
Dec 16, 2028
in 2 yr 6 mo
- NPNew product exclusivity (3 years)
Dec 16, 2028
in 2 yr 6 mo
- NPNew product exclusivity (3 years)
Dec 16, 2028
in 2 yr 6 mo
- M-287New use / labeling-change exclusivity (3 years)
Jan 31, 2026
5 mo ago
- M-287New use / labeling-change exclusivity (3 years)
Jan 31, 2026
5 mo ago
- M-287New use / labeling-change exclusivity (3 years)
Jan 31, 2026
5 mo ago
- ODE-469Orphan-drug exclusivity (7 years)
Jan 31, 2030
in 3 yr 8 mo
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11123287 | Dec 16, 2033 | in 7 yr 7 mo | Product |
| 11337979 | Dec 24, 2038 | in 12 yr 8 mo | ProductU-3582 |
| 11464778 | Dec 24, 2038 | in 12 yr 8 mo | ProductU-3582 |
| 12186321 | Dec 24, 2038 | in 12 yr 8 mo | ProductU-3582 |
| 11759468 | Dec 24, 2038 | in 12 yr 8 mo | ProductU-3582 |
| 12005062 | Dec 24, 2038 | in 12 yr 8 mo | ProductU-3582 |
Sildenafil citrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
