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Last Updated: March 29, 2024

Sumatriptan - Generic Drug Details


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What are the generic drug 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, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hikma, Mylan Labs Ltd, Par Pharm, Par Sterile Products, Sandoz, Somerset, Steriscience, Sun Pharm, Teva Parenteral, Teva Pharms Usa, West-ward Pharms Int, Wockhardt, Zydus, Endo Ventures Ltd, 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 eighty-eight patent family members in twenty-nine countries.

There are twenty-four drug master file entries for sumatriptan. Eight 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

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SponsorPhase
Leiden University Medical CenterPhase 2
ZonMw: The Netherlands Organisation for Health Research and DevelopmentPhase 2
Radboud University Medical CenterPhase 2

See all sumatriptan clinical trials

Generic filers with tentative approvals for SUMATRIPTAN
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a TrialEQ 100MG BASETABLET;ORAL
⤷  Try a Trial⤷  Try a TrialEQ 50MG BASETABLET;ORAL
⤷  Try a Trial⤷  Try a TrialEQ 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

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
Tonix Meds TOSYMRA sumatriptan SPRAY;NASAL 210884-001 Jan 25, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Par Sterile Products SUMATRIPTAN SUCCINATE sumatriptan succinate INJECTABLE;SUBCUTANEOUS 077871-001 Jul 9, 2009 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline IMITREX sumatriptan succinate INJECTABLE;SUBCUTANEOUS 020080-001 Dec 28, 1992 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma SUMATRIPTAN SUCCINATE sumatriptan succinate TABLET;ORAL 078327-001 Aug 10, 2009 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan SUMATRIPTAN SUCCINATE sumatriptan succinate TABLET;ORAL 077744-001 Aug 10, 2009 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Fresenius Kabi Usa SUMATRIPTAN SUCCINATE sumatriptan succinate INJECTABLE;SUBCUTANEOUS 079242-001 Mar 2, 2009 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 020626-003 Aug 26, 1997 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline IMITREX sumatriptan SPRAY;NASAL 020626-001 Aug 26, 1997 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline IMITREX sumatriptan SPRAY;NASAL 020626-002 Aug 26, 1997 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline IMITREX sumatriptan SPRAY;NASAL 020626-003 Aug 26, 1997 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline IMITREX sumatriptan SPRAY;NASAL 020626-002 Aug 26, 1997 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline IMITREX sumatriptan SPRAY;NASAL 020626-002 Aug 26, 1997 ⤷  Try a Trial ⤷  Try a Trial
>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 101646079 ⤷  Try a Trial
Russian Federation 2012116452 КОМПОЗИЦИИ, СОДЕРЖАЩИЕ ТРИПТАНОВЫЕ СОЕДИНЕНИЯ ⤷  Try a Trial
European Patent Office 3082817 COMPOSITIONS POUR ADMINISTRATION DE MÉDICAMENTS (COMPOSITIONS FOR DRUG ADMINISTRATION) ⤷  Try a Trial
Mexico 356271 COMPOSICIONES DE ALQUILGLICÓSIDO PARA ADMINISTRACION DE FARMACOS. (COMPOSITIONS FOR DRUG ADMINISTRATION.) ⤷  Try a Trial
United Kingdom 2583051 Intranasal epinephrine formulations and methods for the treatment of disease ⤷  Try a Trial
Morocco 50106 FORMULATIONS D'ÉPINÉPHRINE INTRANASALE ET MÉTHODES DE TRAITEMENT D'UNE MALADIE ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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