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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
  • NDA 2082232016
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)SOLUTIONSUBCUTANEOUSRx
  • NDA 2060992016
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 11MG BASEPOWDERNASALRx
  • NDA 02223920132 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLESUBCUTANEOUSDiscontinued
    EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)INJECTABLESUBCUTANEOUSDiscontinued
  • NDA 2022782013
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 6.5MG BASE/4HRSYSTEMIONTOPHORESISDiscontinued
  • NDA 02013219953 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 100MG BASETABLETORALRxAB
    EQ 25MG BASETABLETORALRxAB
    EQ 50MG BASETABLETORALRxAB
  • NDA 02008019923 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLESUBCUTANEOUSDiscontinued
    EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)INJECTABLESUBCUTANEOUSRxAB
    EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLESUBCUTANEOUSRxAB
  • NDA 0223772010
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLESUBCUTANEOUSDiscontinued

Generic (ANDA) products (38)

Abbreviated applications
  • SUMATRIPTAN SUCCINATE
    ANDA 21351820252 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)INJECTABLESUBCUTANEOUSRxAB
    EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLESUBCUTANEOUSRxAB
  • SUMATRIPTAN SUCCINATE
    ANDA 20601920253 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 25MG BASETABLETORALRxAB
    EQ 50MG BASETABLETORALRxAB
    EQ 100MG BASETABLETORALRxAB
  • SUMATRIPTAN SUCCINATE
    ANDA 21903620243 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 25MG BASETABLETORALRxAB
    EQ 50MG BASETABLETORALRxAB
    EQ 100MG BASETABLETORALRxAB
  • SUMATRIPTAN SUCCINATE
    ANDA 2156512024
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLESUBCUTANEOUSRxAP
  • SUMATRIPTAN SUCCINATE
    ANDA 2071012023
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLESUBCUTANEOUSDiscontinued
  • SUMATRIPTAN SUCCINATE
    ANDA 2139982021
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLESUBCUTANEOUSRxAP
  • SUMATRIPTAN SUCCINATE
    ANDA 07831920152 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)INJECTABLESUBCUTANEOUSDiscontinued
    EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLESUBCUTANEOUSDiscontinued
  • SUMATRIPTAN SUCCINATE
    ANDA 2033222014
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLESUBCUTANEOUSDiscontinued
  • SUMATRIPTAN SUCCINATE
    ANDA 0904952014
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLESUBCUTANEOUSRxAB
  • SUMATRIPTAN SUCCINATE
    ANDA 2001832013
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLESUBCUTANEOUSRxAP
  • SUMATRIPTAN SUCCINATE
    ANDA 07829820133 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 25MG BASETABLETORALDiscontinued
    EQ 50MG BASETABLETORALDiscontinued
    EQ 100MG BASETABLETORALDiscontinued
  • SUMATRIPTAN SUCCINATERS
    ANDA 2027582013
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLESUBCUTANEOUSRxAP
  • SUMATRIPTAN SUCCINATE
    ANDA 20026320123 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 25MG BASETABLETORALRxAB
    EQ 50MG BASETABLETORALRxAB
    EQ 100MG BASETABLETORALRxAB
  • SUMATRIPTAN SUCCINATE
    ANDA 0903582011
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLESUBCUTANEOUSRxAB
  • SUMATRIPTAN SUCCINATE
    ANDA 0903102010
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLESUBCUTANEOUSDiscontinued
  • SUMATRIPTAN SUCCINATE
    ANDA 0906412010
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLESUBCUTANEOUSDiscontinued
  • SUMATRIPTAN SUCCINATE
    ANDA 09031420102 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLESUBCUTANEOUSDiscontinued
    EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLESUBCUTANEOUSRxAB
  • SUMATRIPTAN SUCCINATE
    ANDA 07716320093 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 25MG BASETABLETORALDiscontinued
    EQ 50MG BASETABLETORALDiscontinued
    EQ 100MG BASETABLETORALDiscontinued
  • SUMATRIPTAN SUCCINATE
    ANDA 0773322009
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLESUBCUTANEOUSDiscontinued
  • SUMATRIPTAN SUCCINATE
    ANDA 07924020092 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)INJECTABLESUBCUTANEOUSDiscontinued
    EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLESUBCUTANEOUSDiscontinued
  • SUMATRIPTAN SUCCINATE
    ANDA 07832720093 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 25MG BASETABLETORALRxAB
    EQ 50MG BASETABLETORALRxAB
    EQ 100MG BASETABLETORALRxAB
  • SUMATRIPTAN SUCCINATE
    ANDA 07684720093 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 25MG BASETABLETORALRxAB
    EQ 50MG BASETABLETORALRxAB
    EQ 100MG BASETABLETORALRxAB
  • SUMATRIPTAN SUCCINATE
    ANDA 07697620093 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 25MG BASETABLETORALDiscontinued
    EQ 50MG BASETABLETORALDiscontinued
    EQ 100MG BASETABLETORALDiscontinued
  • SUMATRIPTAN SUCCINATE
    ANDA 07774420093 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 25MG BASETABLETORALRxAB
    EQ 50MG BASETABLETORALRxAB
    EQ 100MG BASETABLETORALRxAB
  • SUMATRIPTAN SUCCINATE
    ANDA 07828420093 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 25MG BASETABLETORALRxAB
    EQ 50MG BASETABLETORALRxAB
    EQ 100MG BASETABLETORALRxAB
  • SUMATRIPTAN SUCCINATE
    ANDA 07824120093 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 25MG BASETABLETORALDiscontinued
    EQ 50MG BASETABLETORALDiscontinued
    EQ 100MG BASETABLETORALDiscontinued
  • SUMATRIPTAN SUCCINATE
    ANDA 07829520093 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 25MG BASETABLETORALDiscontinued
    EQ 50MG BASETABLETORALDiscontinued
    EQ 100MG BASETABLETORALDiscontinued
  • SUMATRIPTAN SUCCINATE
    ANDA 07655420092 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 25MG BASETABLETORALDiscontinued
    EQ 50MG BASETABLETORALDiscontinued
  • SUMATRIPTAN SUCCINATE
    ANDA 07693320093 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 25MG BASETABLETORALRxAB
    EQ 50MG BASETABLETORALRxAB
    EQ 100MG BASETABLETORALRxAB
  • SUMATRIPTAN SUCCINATE
    ANDA 0778712009
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLESUBCUTANEOUSDiscontinued
  • SUMATRIPTAN SUCCINATE
    ANDA 0792422009
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLESUBCUTANEOUSRxAP
  • SUMATRIPTAN SUCCINATE
    ANDA 0765722009
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 100MG BASETABLETORALDiscontinued
  • SUMATRIPTAN SUCCINATE
    ANDA 07684020093 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 25MG BASETABLETORALDiscontinued
    EQ 50MG BASETABLETORALDiscontinued
    EQ 100MG BASETABLETORALDiscontinued
  • SUMATRIPTAN SUCCINATE
    ANDA 0791232009
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLESUBCUTANEOUSRxAP
  • SUMATRIPTAN SUCCINATE
    ANDA 07806720092 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLESUBCUTANEOUSDiscontinued
    EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)INJECTABLESUBCUTANEOUSDiscontinued
  • SUMATRIPTAN SUCCINATE
    ANDA 07831820092 strengths
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)INJECTABLESUBCUTANEOUSDiscontinued
    EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLESUBCUTANEOUSDiscontinued
  • SUMATRIPTAN SUCCINATE
    ANDA 0779072009
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLESUBCUTANEOUSDiscontinued
  • SUMATRIPTAN SUCCINATE
    ANDA 0785932009
    Approved strengths under this FDA application.
    StrengthDosage formRouteStatusTE
    EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)INJECTABLESUBCUTANEOUSRxAP

Patent & exclusivity timeline

Protection horizon
202620282030203220342036TodayPatent 11571531: 2026-02-23Patent 11571531Patent 7901385: 2026-07-31Patent 7901385Patent 7776007: 2026-11-22Patent 7776007Patent 10124132: 2027-03-06Patent 10124132Patent 7973058: 2027-04-12Patent 7973058Patent 8155737: 2027-04-12Patent 8155737Patent 8470853: 2027-04-12Patent 8470853Patent 9427578: 2027-04-12Patent 9427578Patent 8597272: 2027-04-12Patent 8597272Patent 7811254: 2027-08-26Patent 7811254Patent 9272137: 2027-09-07Patent 9272137Patent 10398859: 2027-12-19Patent 10398859Patent 8875704: 2028-04-07Patent 8875704Patent 10722667: 2028-12-30Patent 10722667Patent 8366600: 2029-04-21Patent 8366600Patent 10076615: 2029-07-30Patent 10076615Patent 8550073: 2029-10-22Patent 8550073Patent 8899229: 2030-08-18Patent 8899229Patent 9649456: 2030-10-21Patent 9649456Patent 8983594: 2030-11-19Patent 8983594Patent 8978647: 2030-12-06Patent 8978647Patent 9327114: 2032-10-08Patent 9327114Patent 10478574: 2033-11-04Patent 10478574Patent 10076614: 2034-10-20Patent 10076614Patent 10537554: 2036-01-29Patent 10537554Patent 11364224: 2036-01-29Patent 11364224Patent 12097183: 2036-01-29Patent 12097183
Patent expiryExclusivity endToday

Listed patents

Orange Book patent file
Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
115715316 mo ago
U-1809
790138523 d ago
Product
7776007in 3 mo
Product
10124132in 7 mo
ProductU-2010
7973058in 8 mo
U-1328
8155737in 8 mo
U-1328
8470853in 8 mo
U-1328
9427578in 8 mo
ProductU-1328
8597272in 8 mo
Product
7811254in 1 yr
ProductU-1083
9272137in 1 yr 1 mo
Product
10398859in 1 yr 4 mo
Product
8875704in 1 yr 8 mo
ProductU-1809
10722667in 2 yr 5 mo
Product
8366600in 2 yr 8 mo
U-1327
10076615in 3 yr
U-2011
8550073in 3 yr 3 mo
Product
8899229in 4 yr 1 mo
Product
9649456in 4 yr 3 mo
ProductU-1719
8983594in 4 yr 4 mo
ProductU-1328
8978647in 4 yr 4 mo
Product
9327114in 6 yr 3 mo
ProductU-1328
10478574in 7 yr 4 mo
U-2404
10076614in 8 yr 3 mo
Product
10537554in 9 yr 7 mo
U-72
11364224in 9 yr 7 mo
U-72
12097183in 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

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