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Last Updated: February 25, 2021

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Sumatriptan - Generic Drug Details

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What are the generic sources for sumatriptan and what is the scope of freedom to operate?

Sumatriptan is the generic ingredient in ten branded drugs marketed by Glaxosmithkline, Lannett Co Inc, Perrigo Uk Finco, Upsher Smith Labs, Meridian Medcl, Antares Pharma Inc, Aurobindo Pharma Ltd, Dr Reddys, Fresenius Kabi Usa, Hikma, Mylan Asi, Mylan Labs Ltd, Par Pharm, Par Sterile Products, Sandoz Inc, 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, Orchid Hlthcare, Roxane, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, and Watson Labs, and is included in forty-four NDAs. There are forty-seven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Sumatriptan has sixty-one patent family members in nineteen countries.

There are twenty-four drug master file entries for sumatriptan. Six 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
Cambridge University Hospitals NHS Foundation TrustEarly Phase 1
PfizerPhase 1
Zagazig UniversityN/A

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Generic filers with tentative approvals for SUMATRIPTAN
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialEQ 100MG BASETABLET;ORAL
  Start Trial  Start TrialEQ 50MG BASETABLET;ORAL
  Start Trial  Start 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
Currax ONZETRA XSAIL sumatriptan succinate POWDER;NASAL 206099-001 Jan 27, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Fosun Pharma SUMATRIPTAN SUCCINATE sumatriptan succinate TABLET;ORAL 076976-003 Aug 10, 2009 DISCN No No   Start Trial   Start Trial   Start Trial
Upsher Smith Labs TOSYMRA sumatriptan SPRAY;NASAL 210884-001 Jan 25, 2019 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Upsher Smith Labs TOSYMRA sumatriptan SPRAY;NASAL 210884-001 Jan 25, 2019 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Teva Branded Pharm ZECUITY sumatriptan succinate SYSTEM;IONTOPHORESIS 202278-001 Jan 17, 2013 DISCN Yes No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa SUMATRIPTAN SUCCINATE sumatriptan succinate INJECTABLE;SUBCUTANEOUS 079240-002 Sep 18, 2009 DISCN No No   Start Trial   Start Trial   Start 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   Start Trial   Start Trial
Glaxosmithkline IMITREX sumatriptan SPRAY;NASAL 020626-001 Aug 26, 1997   Start Trial   Start Trial
Glaxosmithkline IMITREX sumatriptan SPRAY;NASAL 020626-001 Aug 26, 1997   Start Trial   Start Trial
Glaxosmithkline IMITREX sumatriptan SPRAY;NASAL 020626-002 Aug 26, 1997   Start Trial   Start Trial
Glaxosmithkline IMITREX sumatriptan SPRAY;NASAL 020626-003 Aug 26, 1997   Start Trial   Start Trial
Glaxosmithkline IMITREX sumatriptan SPRAY;NASAL 020626-001 Aug 26, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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