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Last Updated: December 8, 2022

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, Cipla, Florida, Lannett Co Inc, Padagis Israel, Upsher Smith Labs, Meridian Medcl, Antares Pharma Inc, Caplin, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hikma, Mylan Labs Ltd, Par Pharm, Par Sterile Products, Sandoz Inc, 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-six 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 seventy-six patent family members in twenty-one 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
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
See Plans and PricingSee Plans and PricingEQ 100MG BASETABLET;ORAL
See Plans and PricingSee Plans and PricingEQ 50MG BASETABLET;ORAL
See Plans and PricingSee Plans and PricingEQ 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
Fresenius Kabi Usa SUMATRIPTAN SUCCINATE sumatriptan succinate INJECTABLE;SUBCUTANEOUS 079242-001 Mar 2, 2009 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva SUMATRIPTAN SUCCINATE sumatriptan succinate TABLET;ORAL 076840-003 Feb 9, 2009 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Steriscience SUMATRIPTAN SUCCINATE sumatriptan succinate INJECTABLE;SUBCUTANEOUS 090314-001 Jun 10, 2010 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Currax ONZETRA XSAIL sumatriptan succinate POWDER;NASAL 206099-001 Jan 27, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Lannett Co Inc SUMATRIPTAN sumatriptan SPRAY;NASAL 204841-001 Feb 19, 2016 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva Branded Pharm ZECUITY sumatriptan succinate SYSTEM;IONTOPHORESIS 202278-001 Jan 17, 2013 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva Branded Pharm ZECUITY sumatriptan succinate SYSTEM;IONTOPHORESIS 202278-001 Jan 17, 2013 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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

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
Australia 2019217643 Intranasal epinephrine formulations and methods for the treatment of disease See Plans and Pricing
China 102933198 Formulations comprising triptan compounds See Plans and Pricing
South Korea 102375232 See Plans and Pricing
Japan 2015108008 薬物投与のための組成物 (COMPOSITIONS FOR DRUG ADMINISTRATION) See Plans and Pricing
Australia 2021254650 Intranasal epinephrine formulations and methods for the treatment of disease See Plans and Pricing
Russian Federation 2011130526 КОМПОЗИЦИИ ДЛЯ ВВЕДЕНИЯ ЛЕКАРСТВЕННЫХ СРЕДСТВ See Plans and Pricing
World Intellectual Property Organization (WIPO) 2012054500 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Colorcon
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McKinsey

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.