FDA Orange Book · active-ingredient family
Sumatriptan succinate
Sumatriptan succinate: 7 brands, 38 generics; first approved Dec 28, 1992; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 38 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
7
Generics (ANDA)
38
Listed patents
27
Next patent expiry
Feb 23, 2026
6 mo ago
Brand (NDA) products
Originator applications
- TONIX MEDSNDA 2082232016
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) SOLUTION SUBCUTANEOUS Rx — - CURRAXNDA 2060992016
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 11MG BASE POWDER NASAL Rx — - ENDO OPERATIONSNDA 02223920132 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE SUBCUTANEOUS Discontinued — EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) INJECTABLE SUBCUTANEOUS Discontinued — - ZECUITYRLDTEVA BRANDED PHARMNDA 2022782013
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6.5MG BASE/4HR SYSTEM IONTOPHORESIS Discontinued — - IMITREXRLDGLAXOSMITHKLINENDA 02013219953 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE TABLET ORAL Rx AB EQ 25MG BASE TABLET ORAL Rx AB EQ 50MG BASE TABLET ORAL Rx AB - IMITREXRLDGLAXOSMITHKLINENDA 02008019923 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE SUBCUTANEOUS Discontinued — EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) INJECTABLE SUBCUTANEOUS Rx AB EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE SUBCUTANEOUS Rx AB - MERIDIAN MEDCLNDA 0223772010
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE SUBCUTANEOUS Discontinued —
Generic (ANDA) products (38)
Abbreviated applications
- SUMATRIPTAN SUCCINATEALEMBICANDA 21351820252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) INJECTABLE SUBCUTANEOUS Rx AB EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE SUBCUTANEOUS Rx AB - SUMATRIPTAN SUCCINATEIPCA LABS LTDANDA 20601920253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Rx AB EQ 50MG BASE TABLET ORAL Rx AB EQ 100MG BASE TABLET ORAL Rx AB - SUMATRIPTAN SUCCINATEVKT PHARMAANDA 21903620243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Rx AB EQ 50MG BASE TABLET ORAL Rx AB EQ 100MG BASE TABLET ORAL Rx AB - SUMATRIPTAN SUCCINATEONESOURCE SPECIALTYANDA 2156512024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE SUBCUTANEOUS Rx AP - SUMATRIPTAN SUCCINATEBAXTER HLTHCARE CORPANDA 2071012023
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE SUBCUTANEOUS Discontinued — - SUMATRIPTAN SUCCINATECAPLINANDA 2139982021
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE SUBCUTANEOUS Rx AP - SUMATRIPTAN SUCCINATEANTARES PHARMA INCANDA 07831920152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) INJECTABLE SUBCUTANEOUS Discontinued — EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE SUBCUTANEOUS Discontinued — - SUMATRIPTAN SUCCINATENORVIUM BIOSCIENCEANDA 2033222014
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE SUBCUTANEOUS Discontinued — - SUMATRIPTAN SUCCINATEDR REDDYSANDA 0904952014
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE SUBCUTANEOUS Rx AB - SUMATRIPTAN SUCCINATEHIKMAANDA 2001832013
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE SUBCUTANEOUS Rx AP - SUMATRIPTAN SUCCINATEHIKMA PHARMSANDA 07829820133 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Discontinued — EQ 50MG BASE TABLET ORAL Discontinued — EQ 100MG BASE TABLET ORAL Discontinued — - SUMATRIPTAN SUCCINATERSEUGIA PHARMAANDA 2027582013
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE SUBCUTANEOUS Rx AP - SUMATRIPTAN SUCCINATEZHEJIANGANDA 20026320123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Rx AB EQ 50MG BASE TABLET ORAL Rx AB EQ 100MG BASE TABLET ORAL Rx AB - SUMATRIPTAN SUCCINATESUN PHARMANDA 0903582011
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE SUBCUTANEOUS Rx AB - SUMATRIPTAN SUCCINATEZYDUSANDA 0903102010
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE SUBCUTANEOUS Discontinued — - SUMATRIPTAN SUCCINATEONESOURCE SPECIALTYANDA 0906412010
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE SUBCUTANEOUS Discontinued — - SUMATRIPTAN SUCCINATEONESOURCE SPECIALTYANDA 09031420102 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE SUBCUTANEOUS Discontinued — EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE SUBCUTANEOUS Rx AB - SUMATRIPTAN SUCCINATEMYLANANDA 07716320093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Discontinued — EQ 50MG BASE TABLET ORAL Discontinued — EQ 100MG BASE TABLET ORAL Discontinued — - SUMATRIPTAN SUCCINATEPH HEALTHANDA 0773322009
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE SUBCUTANEOUS Discontinued — - SUMATRIPTAN SUCCINATEFRESENIUS KABI USAANDA 07924020092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) INJECTABLE SUBCUTANEOUS Discontinued — EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE SUBCUTANEOUS Discontinued — - SUMATRIPTAN SUCCINATEAUROBINDO PHARMAANDA 07832720093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Rx AB EQ 50MG BASE TABLET ORAL Rx AB EQ 100MG BASE TABLET ORAL Rx AB - SUMATRIPTAN SUCCINATEDR REDDYS LABS INCANDA 07684720093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Rx AB EQ 50MG BASE TABLET ORAL Rx AB EQ 100MG BASE TABLET ORAL Rx AB - SUMATRIPTAN SUCCINATEFOSUN PHARMAANDA 07697620093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Discontinued — EQ 50MG BASE TABLET ORAL Discontinued — EQ 100MG BASE TABLET ORAL Discontinued — - SUMATRIPTAN SUCCINATEMYLANANDA 07774420093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Rx AB EQ 50MG BASE TABLET ORAL Rx AB EQ 100MG BASE TABLET ORAL Rx AB - SUMATRIPTAN SUCCINATEORBION PHARMSANDA 07828420093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Rx AB EQ 50MG BASE TABLET ORAL Rx AB EQ 100MG BASE TABLET ORAL Rx AB - SUMATRIPTAN SUCCINATEROXANEANDA 07824120093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Discontinued — EQ 50MG BASE TABLET ORAL Discontinued — EQ 100MG BASE TABLET ORAL Discontinued — - SUMATRIPTAN SUCCINATESUN PHARM INDSANDA 07829520093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Discontinued — EQ 50MG BASE TABLET ORAL Discontinued — EQ 100MG BASE TABLET ORAL Discontinued — - SUMATRIPTAN SUCCINATESUN PHARM INDS LTDANDA 07655420092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Discontinued — EQ 50MG BASE TABLET ORAL Discontinued — - SUMATRIPTAN SUCCINATEWATSON LABSANDA 07693320093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Rx AB EQ 50MG BASE TABLET ORAL Rx AB EQ 100MG BASE TABLET ORAL Rx AB - SUMATRIPTAN SUCCINATEPH HEALTHANDA 0778712009
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE SUBCUTANEOUS Discontinued — - SUMATRIPTAN SUCCINATEFRESENIUS KABI USAANDA 0792422009
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE SUBCUTANEOUS Rx AP - SUMATRIPTAN SUCCINATESUN PHARM INDS LTDANDA 0765722009
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE TABLET ORAL Discontinued — - SUMATRIPTAN SUCCINATETEVAANDA 07684020093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 25MG BASE TABLET ORAL Discontinued — EQ 50MG BASE TABLET ORAL Discontinued — EQ 100MG BASE TABLET ORAL Discontinued — - SUMATRIPTAN SUCCINATEHIKMAANDA 0791232009
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE SUBCUTANEOUS Rx AP - SUMATRIPTAN SUCCINATESANDOZANDA 07806720092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE SUBCUTANEOUS Discontinued — EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) INJECTABLE SUBCUTANEOUS Discontinued — - SUMATRIPTAN SUCCINATETEVA PARENTERALANDA 07831820092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) INJECTABLE SUBCUTANEOUS Discontinued — EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE SUBCUTANEOUS Discontinued — - SUMATRIPTAN SUCCINATETEVA PHARMS USAANDA 0779072009
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE SUBCUTANEOUS Discontinued — - SUMATRIPTAN SUCCINATEWOCKHARDT BIO AGANDA 0785932009
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) INJECTABLE SUBCUTANEOUS Rx AP
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 11571531 | 6 mo ago | U-1809 | |
| 7901385 | 23 d ago | Product | |
| 7776007 | in 3 mo | Product | |
| 10124132 | in 7 mo | ProductU-2010 | |
| 7973058 | in 8 mo | U-1328 | |
| 8155737 | in 8 mo | U-1328 | |
| 8470853 | in 8 mo | U-1328 | |
| 9427578 | in 8 mo | ProductU-1328 | |
| 8597272 | in 8 mo | Product | |
| 7811254 | in 1 yr | ProductU-1083 | |
| 9272137 | in 1 yr 1 mo | Product | |
| 10398859 | in 1 yr 4 mo | Product | |
| 8875704 | in 1 yr 8 mo | ProductU-1809 | |
| 10722667 | in 2 yr 5 mo | Product | |
| 8366600 | in 2 yr 8 mo | U-1327 | |
| 10076615 | in 3 yr | U-2011 | |
| 8550073 | in 3 yr 3 mo | Product | |
| 8899229 | in 4 yr 1 mo | Product | |
| 9649456 | in 4 yr 3 mo | ProductU-1719 | |
| 8983594 | in 4 yr 4 mo | ProductU-1328 | |
| 8978647 | in 4 yr 4 mo | Product | |
| 9327114 | in 6 yr 3 mo | ProductU-1328 | |
| 10478574 | in 7 yr 4 mo | U-2404 | |
| 10076614 | in 8 yr 3 mo | Product | |
| 10537554 | in 9 yr 7 mo | U-72 | |
| 11364224 | in 9 yr 7 mo | U-72 | |
| 12097183 | in 9 yr 7 mo | Product |
Approval history
FDA approval span
First approval
34 yr 2 mo ago
Most recent approval
7 mo ago
Approvals span 1992–2026 across 45 FDA applications.
Brand (NDA) 716%
Generic (ANDA) 3884%
Sumatriptan succinate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.

