FDA Orange Book · active-ingredient family
Sumatriptan succinate
Sumatriptan succinate is approved as 7 brand and 38 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ZEMBRACE SYMTOUCH · NDA 208223
7
Brand (NDA)
38
Generics (ANDA)
27
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, powder, solution, system, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ZEMBRACE SYMTOUCHRLD | TONIX MEDS | NDA 208223 | — | Jan 28, 2016 | |
| ONZETRA XSAILRLD | CURRAX | NDA 206099 | — | Jan 27, 2016 | |
| SUMAVEL DOSEPRORLD×2 | ENDO OPERATIONS | NDA 022239 | — | Nov 26, 2013 | |
| ZECUITYRLD | TEVA BRANDED PHARM | NDA 202278 | — | Jan 17, 2013 | |
| IMITREXRLD×3 | GLAXOSMITHKLINE | NDA 020132 | AB | Jun 01, 1995 | |
| IMITREXRLD×3 | GLAXOSMITHKLINE | NDA 020080 | — | Dec 28, 1992 | |
| ALSUMA | MERIDIAN MEDCL | NDA 022377 | — | Jun 29, 2010 |
Generic (ANDA) products (38)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SUMATRIPTAN SUCCINATE×2 | ALEMBIC | ANDA 213518 | AB | Nov 06, 2025 | |
| SUMATRIPTAN SUCCINATE×3 | IPCA LABS LTD | ANDA 206019 | AB | Jul 15, 2025 | |
| SUMATRIPTAN SUCCINATE×3 | VKT PHARMA | ANDA 219036 | AB | Dec 31, 2024 | |
| SUMATRIPTAN SUCCINATE | ONESOURCE SPECIALTY | ANDA 215651 | AP | Nov 21, 2024 | |
| SUMATRIPTAN SUCCINATE | BAXTER HLTHCARE CORP | ANDA 207101 | — | Jan 19, 2023 | |
| SUMATRIPTAN SUCCINATE | CAPLIN | ANDA 213998 | AP | Jul 13, 2021 | |
| SUMATRIPTAN SUCCINATE×2 | ANTARES PHARMA INC | ANDA 078319 | — | Dec 10, 2015 | |
| SUMATRIPTAN SUCCINATE | NORVIUM BIOSCIENCE | ANDA 203322 | — | Apr 14, 2014 | |
| SUMATRIPTAN SUCCINATE | DR REDDYS | ANDA 090495 | AB | Jan 29, 2014 | |
| SUMATRIPTAN SUCCINATE | HIKMA | ANDA 200183 | AP | Sep 16, 2013 | |
| SUMATRIPTAN SUCCINATE×3 | HIKMA PHARMS | ANDA 078298 | — | May 21, 2013 | |
| SUMATRIPTAN SUCCINATE | EUGIA PHARMA | ANDA 202758 | AP | Apr 23, 2013 | |
| SUMATRIPTAN SUCCINATE×3 | ZHEJIANG | ANDA 200263 | AB | Jun 19, 2012 | |
| SUMATRIPTAN SUCCINATE | SUN PHARM | ANDA 090358 | AB | Jun 21, 2011 | |
| SUMATRIPTAN SUCCINATE | ZYDUS | ANDA 090310 | — | Aug 11, 2010 | |
| SUMATRIPTAN SUCCINATE | ONESOURCE SPECIALTY | ANDA 090641 | — | Jul 28, 2010 | |
| SUMATRIPTAN SUCCINATE | ONESOURCE SPECIALTY | ANDA 090314 | AP | Jun 10, 2010 | |
| SUMATRIPTAN SUCCINATE×3 | MYLAN | ANDA 077163 | — | Nov 02, 2009 | |
| SUMATRIPTAN SUCCINATE | PH HEALTH | ANDA 077332 | — | Oct 09, 2009 | |
| SUMATRIPTAN SUCCINATE×2 | FRESENIUS KABI USA | ANDA 079240 | — | Sep 18, 2009 | |
| SUMATRIPTAN SUCCINATE×3 | AUROBINDO PHARMA | ANDA 078327 | AB | Aug 10, 2009 | |
| SUMATRIPTAN SUCCINATE×3 | DR REDDYS LABS INC | ANDA 076847 | AB | Aug 10, 2009 | |
| SUMATRIPTAN SUCCINATE×3 | FOSUN PHARMA | ANDA 076976 | — | Aug 10, 2009 | |
| SUMATRIPTAN SUCCINATE×3 | MYLAN | ANDA 077744 | AB | Aug 10, 2009 | |
| SUMATRIPTAN SUCCINATE×3 | ORBION PHARMS | ANDA 078284 | AB | Aug 10, 2009 | |
| SUMATRIPTAN SUCCINATE×3 | ROXANE | ANDA 078241 | — | Aug 10, 2009 | |
| SUMATRIPTAN SUCCINATE×3 | SUN PHARM INDS | ANDA 078295 | — | Aug 10, 2009 | |
| SUMATRIPTAN SUCCINATE×2 | SUN PHARM INDS LTD | ANDA 076554 | — | Aug 10, 2009 | |
| SUMATRIPTAN SUCCINATE×3 | WATSON LABS | ANDA 076933 | AB | Aug 10, 2009 | |
| SUMATRIPTAN SUCCINATE | PH HEALTH | ANDA 077871 | — | Jul 09, 2009 | |
| SUMATRIPTAN SUCCINATE | FRESENIUS KABI USA | ANDA 079242 | AP | Mar 02, 2009 | |
| SUMATRIPTAN SUCCINATE | SUN PHARM INDS LTD | ANDA 076572 | — | Feb 09, 2009 | |
| SUMATRIPTAN SUCCINATE×3 | TEVA | ANDA 076840 | — | Feb 09, 2009 | |
| SUMATRIPTAN SUCCINATE | HIKMA | ANDA 079123 | AP | Feb 06, 2009 | |
| SUMATRIPTAN SUCCINATE×2 | SANDOZ | ANDA 078067 | — | Feb 06, 2009 | |
| SUMATRIPTAN SUCCINATE×2 | TEVA PARENTERAL | ANDA 078318 | — | Feb 06, 2009 | |
| SUMATRIPTAN SUCCINATE | TEVA PHARMS USA | ANDA 077907 | — | Feb 06, 2009 | |
| SUMATRIPTAN SUCCINATE | WOCKHARDT BIO AG | ANDA 078593 | AP | Feb 06, 2009 |
Listed patents (27)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11571531 | Feb 23, 2026 | 4 mo ago | U-1809 |
| 7901385 | Jul 31, 2026 | in 1 mo | Product |
| 7776007 | Nov 22, 2026 | in 5 mo | Product |
| 10124132 | Mar 06, 2027 | in 9 mo | ProductU-2010 |
| 7973058 | Apr 12, 2027 | in 10 mo | U-1328 |
| 8155737 | Apr 12, 2027 | in 10 mo | U-1328 |
| 8470853 | Apr 12, 2027 | in 10 mo | U-1328 |
| 9427578 | Apr 12, 2027 | in 10 mo | ProductU-1328 |
| 8597272 | Apr 12, 2027 | in 10 mo | Product |
| 7811254 | Aug 26, 2027 | in 1 yr 2 mo | ProductU-1083 |
| 9272137 | Sep 07, 2027 | in 1 yr 3 mo | Product |
| 10398859 | Dec 19, 2027 | in 1 yr 6 mo | Product |
| 8875704 | Apr 07, 2028 | in 1 yr 10 mo | ProductU-1809 |
| 10722667 | Dec 30, 2028 | in 2 yr 7 mo | Product |
| 8366600 | Apr 21, 2029 | in 2 yr 11 mo | U-1327 |
| 10076615 | Jul 30, 2029 | in 3 yr 2 mo | U-2011 |
| 8550073 | Oct 22, 2029 | in 3 yr 5 mo | Product |
| 8899229 | Aug 18, 2030 | in 4 yr 3 mo | Product |
| 9649456 | Oct 21, 2030 | in 4 yr 5 mo | ProductU-1719 |
| 8983594 | Nov 19, 2030 | in 4 yr 6 mo | ProductU-1328 |
| 8978647 | Dec 06, 2030 | in 4 yr 6 mo | Product |
| 9327114 | Oct 08, 2032 | in 6 yr 5 mo | ProductU-1328 |
| 10478574 | Nov 04, 2033 | in 7 yr 6 mo | U-2404 |
| 10076614 | Oct 20, 2034 | in 8 yr 6 mo | Product |
| 10537554 | Jan 29, 2036 | in 9 yr 9 mo | U-72 |
| 11364224 | Jan 29, 2036 | in 9 yr 9 mo | U-72 |
| 12097183 | Jan 29, 2036 | in 9 yr 9 mo | Product |
Sumatriptan succinate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
