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Last Updated: November 2, 2024

SUMATRIPTAN - Generic Drug Details


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What are the generic sources for sumatriptan and what is the scope of patent protection?

Sumatriptan is the generic ingredient in ten branded drugs marketed by Glaxosmithkline, Cipla, Florida, Lannett Co Inc, Padagis Israel, Tonix Meds, Meridian Medcl, Antares Pharma Inc, Baxter Hlthcare Corp, Caplin, Dr Reddys, Endo Operations, Eugia Pharma, Fresenius Kabi Usa, Hikma, Norvium Bioscience, Sandoz, Steriscience, Sun Pharm, Teva Parenteral, Teva Pharms Usa, West-ward Pharms Int, Wockhardt, Zydus, Currax, Teva Branded Pharm, Aurobindo Pharma, Corepharma, Dr Reddys Labs Inc, Fosun Pharma, Hikma Pharms, Mylan, Orbion Pharms, Roxane, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, and Watson Labs, and is included in forty-seven NDAs. There are thirty-nine patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Sumatriptan has ninety-one patent family members in twenty-nine countries.

There are twenty-four drug master file entries for sumatriptan. Ten suppliers are listed for this compound. There are six tentative approvals for this compound.

Drug Prices for SUMATRIPTAN

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Drug Sales Revenue Trends for SUMATRIPTAN

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Recent Clinical Trials for SUMATRIPTAN

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Radboud University Medical CenterPhase 2
Canisius-Wilhelmina HospitalPhase 2
Leiden University Medical CenterPhase 2

See all SUMATRIPTAN clinical trials

Generic filers with tentative approvals for SUMATRIPTAN
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign UpEQ 100MG BASETABLET;ORAL
⤷  Sign Up⤷  Sign UpEQ 50MG BASETABLET;ORAL
⤷  Sign Up⤷  Sign UpEQ 25MG BASETABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Medical Subject Heading (MeSH) Categories for SUMATRIPTAN
Anatomical Therapeutic Chemical (ATC) Classes for SUMATRIPTAN

US Patents and Regulatory Information for SUMATRIPTAN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs SUMATRIPTAN SUCCINATE sumatriptan succinate TABLET;ORAL 076933-002 Aug 10, 2009 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Branded Pharm ZECUITY sumatriptan succinate SYSTEM;IONTOPHORESIS 202278-001 Jan 17, 2013 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Tonix Meds TOSYMRA sumatriptan SPRAY;NASAL 210884-001 Jan 25, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Tonix Meds TOSYMRA sumatriptan SPRAY;NASAL 210884-001 Jan 25, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Hikma SUMATRIPTAN SUCCINATE sumatriptan succinate INJECTABLE;SUBCUTANEOUS 200183-001 Sep 16, 2013 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Steriscience SUMATRIPTAN SUCCINATE sumatriptan succinate INJECTABLE;SUBCUTANEOUS 090314-001 Jun 10, 2010 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Antares Pharma Inc SUMATRIPTAN SUCCINATE sumatriptan succinate INJECTABLE;SUBCUTANEOUS 078319-002 Dec 10, 2015 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for SUMATRIPTAN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline IMITREX sumatriptan SPRAY;NASAL 020626-001 Aug 26, 1997 ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline IMITREX sumatriptan SPRAY;NASAL 020626-003 Aug 26, 1997 ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline IMITREX sumatriptan SPRAY;NASAL 020626-001 Aug 26, 1997 ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline IMITREX sumatriptan SPRAY;NASAL 020626-003 Aug 26, 1997 ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline IMITREX sumatriptan SPRAY;NASAL 020626-003 Aug 26, 1997 ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline IMITREX sumatriptan SPRAY;NASAL 020626-003 Aug 26, 1997 ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline IMITREX sumatriptan SPRAY;NASAL 020626-002 Aug 26, 1997 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for SUMATRIPTAN

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Galpharm Healthcare Ltd. Sumatriptan Galpharm sumatriptan EMEA/H/C/002140
Refused yes no no 2012-02-09
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for SUMATRIPTAN

Country Patent Number Title Estimated Expiration
South Korea 20200121818 비강내 에피네프린 제제 및 질환의 치료 방법 ⤷  Sign Up
Denmark 2381773 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2011014797 ⤷  Sign Up
Mexico 2011006790 COMPOSICIONES PARA ADMINISTRACION DE FARMACOS. (COMPOSITIONS FOR DRUG ADMINISTRATION.) ⤷  Sign Up
South Korea 101646079 ⤷  Sign Up
Mexico 2012003519 FORMULACIONES QUE COMPRENDEN COMPUESTOS DE TRIPTANO. (FORMULATIONS COMPRISING TRIPTAN COMPOUNDS.) ⤷  Sign Up
Russian Federation 2011130526 КОМПОЗИЦИИ ДЛЯ ВВЕДЕНИЯ ЛЕКАРСТВЕННЫХ СРЕДСТВ ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.