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Last Updated: October 22, 2020

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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, 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, Upsher Smith Labs, 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 thirty-nine NDAs. There are forty patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Sumatriptan succinate has four hundred and twelve patent family members in thirty countries.

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

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
Kimberly-Clark CorporationPhase 1
GlaxoSmithKlinePhase 4
Cady, Roger, M.D.Phase 4

See all sumatriptan succinate clinical trials

Generic filers with tentative approvals for SUMATRIPTAN SUCCINATE
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.

Paragraph IV (Patent) Challenges for SUMATRIPTAN SUCCINATE
Tradename Dosage Ingredient NDA Submissiondate
IMITREX TABLET;ORAL sumatriptan succinate 020132

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
Endo Ventures Ltd SUMAVEL DOSEPRO sumatriptan succinate INJECTABLE;SUBCUTANEOUS 022239-001 Jul 15, 2009 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Teva Parenteral SUMATRIPTAN SUCCINATE sumatriptan succinate INJECTABLE;SUBCUTANEOUS 078318-002 Feb 6, 2009 DISCN No No   Start Trial   Start Trial   Start Trial
Hikma Pharms SUMATRIPTAN SUCCINATE sumatriptan succinate TABLET;ORAL 078298-002 May 21, 2013 DISCN No No   Start Trial   Start Trial   Start Trial
Wockhardt SUMATRIPTAN SUCCINATE sumatriptan succinate INJECTABLE;SUBCUTANEOUS 078593-001 Feb 6, 2009 AP RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd SUMATRIPTAN SUCCINATE sumatriptan succinate INJECTABLE;SUBCUTANEOUS 202758-001 Apr 23, 2013 AP RX 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 succinate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline IMITREX sumatriptan succinate TABLET;ORAL 020132-002 Jun 1, 1995   Start Trial   Start Trial
Glaxosmithkline IMITREX sumatriptan succinate TABLET;ORAL 020132-001 Jun 1, 1995   Start Trial   Start Trial
Currax ONZETRA XSAIL sumatriptan succinate POWDER;NASAL 206099-001 Jan 27, 2016   Start Trial   Start Trial
Glaxosmithkline IMITREX sumatriptan succinate TABLET;ORAL 020132-001 Jun 1, 1995   Start Trial   Start Trial
Glaxosmithkline IMITREX sumatriptan succinate TABLET;ORAL 020132-001 Jun 1, 1995   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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