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Last Updated: July 11, 2020

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IMITREX Drug Profile


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When do Imitrex patents expire, and what generic alternatives are available?

Imitrex is a drug marketed by Glaxosmithkline and is included in three NDAs.

The generic ingredient in IMITREX is sumatriptan. There are twenty-four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the sumatriptan profile page.

US ANDA Litigation and Generic Entry Outlook for Imitrex

A generic version of IMITREX was approved as sumatriptan by LANNETT CO INC on February 19th, 2016.

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Drug patent expirations by year for IMITREX
Drug Prices for IMITREX

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Drug Sales Revenue Trends for IMITREX

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Recent Clinical Trials for IMITREX

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SponsorPhase
Kimberly-Clark CorporationPhase 1
CoLucid PharmaceuticalsPhase 1
SNBL Clinical Pharmacology Center, Inc.Phase 1

See all IMITREX clinical trials

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

US Patents and Regulatory Information for IMITREX

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 INJECTABLE;SUBCUTANEOUS 020080-001 Dec 28, 1992 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Glaxosmithkline IMITREX sumatriptan succinate TABLET;ORAL 020132-001 Jun 1, 1995 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Glaxosmithkline IMITREX sumatriptan SPRAY;NASAL 020626-003 Aug 26, 1997 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Glaxosmithkline IMITREX STATDOSE sumatriptan succinate INJECTABLE;SUBCUTANEOUS 020080-002 Feb 1, 2006 AB RX Yes Yes   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 IMITREX

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 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 succinate INJECTABLE;SUBCUTANEOUS 020080-001 Dec 28, 1992   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
Medtronic
Johnson and Johnson
AstraZeneca
Baxter
Merck

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