FDA Orange Book · active-ingredient family
Sumatriptan
Sumatriptan is approved as 2 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TOSYMRA · NDA 210884
2
Brand (NDA)
4
Generics (ANDA)
9
Listed patents
0
Exclusivity periods
Brand (NDA) products · spray
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TOSYMRARLD | TONIX MEDS | NDA 210884 | — | Jan 25, 2019 | |
| IMITREXRLD×3 | GLAXOSMITHKLINE | NDA 020626 | AB | Aug 26, 1997 |
Generic (ANDA) products (4)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SUMATRIPTAN | CIPLA | ANDA 214209 | AB | Feb 22, 2021 | |
| SUMATRIPTAN | REGCON HOLDINGS | ANDA 208967 | AB | Feb 17, 2021 | |
| SUMATRIPTAN×2 | PADAGIS ISRAEL | ANDA 213465 | AB | Sep 21, 2020 | |
| SUMATRIPTAN×2 | LANNETT CO INC | ANDA 204841 | AB | Feb 19, 2016 |
Listed patents (9)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8440631 | May 09, 2026 | 1 mo ago | ProductU-1719 |
| 9283280 | May 09, 2026 | 1 mo ago | Product |
| 8268791 | May 09, 2026 | 1 mo ago | Product |
| 9974770 | Jun 16, 2030 | in 4 yr 1 mo | ProductU-1719 |
| 11337962 | Jun 16, 2030 | in 4 yr 1 mo | ProductU-1719 |
| 10603305 | Jun 16, 2030 | in 4 yr 1 mo | ProductU-1719 |
| 9610280 | Jun 16, 2030 | in 4 yr 1 mo | ProductU-1719 |
| 12090139 | Jun 16, 2030 | in 4 yr 1 mo | Product |
| 9211282 | Jul 19, 2031 | in 5 yr 2 mo | ProductU-1719 |
Sumatriptan — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
