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Last Updated: April 14, 2021

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Sumatriptan succinate - Generic Drug Details

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What are the generic 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 sixteen patent family members in thirty countries.

There are twenty-four drug master file entries for sumatriptan succinate. Thirty-one 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
Cady, Roger, M.D.Phase 4
GlaxoSmithKlinePhase 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
Glaxosmithkline IMITREX sumatriptan succinate TABLET;ORAL 020132-003 Jun 1, 1995 AB RX Yes No   Start Trial   Start Trial   Start Trial
Glaxosmithkline IMITREX sumatriptan succinate TABLET;ORAL 020132-002 Jun 1, 1995 AB RX Yes No   Start Trial   Start Trial   Start Trial
Teva Parenteral SUMATRIPTAN SUCCINATE sumatriptan succinate INJECTABLE;SUBCUTANEOUS 078318-002 Feb 6, 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 succinate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline IMITREX STATDOSE sumatriptan succinate INJECTABLE;SUBCUTANEOUS 020080-002 Feb 1, 2006   Start Trial   Start Trial
Endo Ventures Ltd SUMAVEL DOSEPRO sumatriptan succinate INJECTABLE;SUBCUTANEOUS 022239-001 Jul 15, 2009   Start Trial   Start Trial
Endo Ventures Ltd SUMAVEL DOSEPRO sumatriptan succinate INJECTABLE;SUBCUTANEOUS 022239-001 Jul 15, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
Baxter
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McKesson

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.