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Last Updated: March 18, 2024

Sumatriptan succinate - Generic Drug Details


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

Sumatriptan succinate is the generic ingredient in eight branded drugs marketed by Meridian Medcl, Glaxosmithkline, 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, Tonix Meds, 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-one NDAs. There are thirty-one patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Sumatriptan succinate has three hundred and eighty-two patent family members in thirty-one countries.

There are seventeen drug master file entries for sumatriptan succinate. Thirty-four suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for sumatriptan succinate
Drug Prices for sumatriptan succinate

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Drug Sales Revenue Trends for sumatriptan succinate

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Recent Clinical Trials for sumatriptan succinate

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SponsorPhase
The Second Hospital of Nanjing Medical UniversityPhase 3
The Affiliated Hospital of Qingdao UniversityPhase 3
Jiangsu Provincial People's HospitalPhase 3

See all sumatriptan succinate clinical trials

Generic filers with tentative approvals for SUMATRIPTAN SUCCINATE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a TrialEQ 25MG BASETABLET;ORAL
⤷  Try a Trial⤷  Try a TrialEQ 100MG BASETABLET;ORAL
⤷  Try a Trial⤷  Try a TrialEQ 50MG 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.

Pharmacology for sumatriptan succinate

US Patents and Regulatory Information for sumatriptan succinate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Tonix Meds ZEMBRACE SYMTOUCH sumatriptan succinate SOLUTION;SUBCUTANEOUS 208223-001 Jan 28, 2016 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz SUMATRIPTAN SUCCINATE sumatriptan succinate INJECTABLE;SUBCUTANEOUS 078067-002 Feb 6, 2009 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs SUMATRIPTAN SUCCINATE sumatriptan succinate TABLET;ORAL 076933-003 Aug 10, 2009 AB 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 succinate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline IMITREX sumatriptan succinate TABLET;ORAL 020132-003 Jun 1, 1995 ⤷  Try a Trial ⤷  Try a Trial
Endo Ventures Ltd SUMAVEL DOSEPRO sumatriptan succinate INJECTABLE;SUBCUTANEOUS 022239-001 Jul 15, 2009 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline IMITREX sumatriptan succinate TABLET;ORAL 020132-001 Jun 1, 1995 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for sumatriptan succinate

Country Patent Number Title Estimated Expiration
European Patent Office 2012871 MÉTHODES ET SYSTÈMES TRANSDERMIQUES D'ADMINISTRATION DE COMPOSÉS ANTI-MIGRAINE (TRANSDERMAL METHODS AND SYSTEMS FOR THE DELIVERY OF ANTI-MIGRAINE COMPOUNDS) ⤷  Try a Trial
Canada 2904711 DISPOSITIFS DE DISTRIBUTION PAR VOIES NASALES (NASAL DELIVERY DEVICES) ⤷  Try a Trial
Spain 2603274 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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