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Last Updated: March 29, 2020

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TREXIMET Drug Profile


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When do Treximet patents expire, and when can generic versions of Treximet launch?

Treximet is a drug marketed by Currax and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has sixteen patent family members in fourteen countries.

The generic ingredient in TREXIMET is naproxen sodium; sumatriptan succinate. There are forty-two drug master file entries for this compound. Additional details are available on the naproxen sodium; sumatriptan succinate profile page.

US ANDA Litigation and Generic Entry Outlook for Treximet

There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for TREXIMET
Drug Prices for TREXIMET

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Recent Clinical Trials for TREXIMET

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SponsorPhase
Dent Neurologic InstituteN/A
Premiere Research InstitutePhase 2/Phase 3
GlaxoSmithKlinePhase 2/Phase 3

See all TREXIMET clinical trials

Recent Litigation for TREXIMET

Identify potential future generic entrants

District Court Litigation
Case NameDate
NAUTILUS NEUROSCIENCES, INC. v. EDICT PHARMACEUTICALS PVT. LTD.2011-07-20
Pozen Inc. v. Sun Pharma Global FZE2011-05-26
Pozen Inc. v. Teva Pharmaceuticals USA Inc.2009-04-24

See all TREXIMET litigation

PTAB Litigation
PetitionerDate
2015-11-12

See all TREXIMET litigation

Synonyms for TREXIMET
811794-26-0
Naproxen / sumatriptan
Naproxen mixture with sumatriptan
Naproxen sodium mixture with sumatriptan succinate
Sumatriptan mixture with naproxen
Sumatriptan succinate and naproxen sodium
Sumatriptan succinate mixture with naproxen sodium
Trexima
Paragraph IV (Patent) Challenges for TREXIMET
Tradename Dosage Ingredient NDA Submissiondate
TREXIMET TABLET;ORAL naproxen sodium; sumatriptan succinate 021926 2008-07-23

US Patents and Regulatory Information for TREXIMET

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Currax TREXIMET naproxen sodium; sumatriptan succinate TABLET;ORAL 021926-002 May 14, 2015 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Currax TREXIMET naproxen sodium; sumatriptan succinate TABLET;ORAL 021926-001 Apr 15, 2008 AB RX Yes Yes   Start Trial   Start Trial Y   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 TREXIMET

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Currax TREXIMET naproxen sodium; sumatriptan succinate TABLET;ORAL 021926-002 May 14, 2015   Start Trial   Start Trial
Currax TREXIMET naproxen sodium; sumatriptan succinate TABLET;ORAL 021926-001 Apr 15, 2008   Start Trial   Start Trial
Currax TREXIMET naproxen sodium; sumatriptan succinate TABLET;ORAL 021926-002 May 14, 2015   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for TREXIMET

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1411900 18/2011 Austria   Start Trial PRODUCT NAME: NAPROXEN UND ESOMEPRAZOL SOWIE DEREN PHARMAZEUTISCH ANNEHMBARE SALZE; NAT. REGISTRATION NO/DATE: 1-29937 20110105; FIRST REGISTRATION: GB PL 17901/0263-0001 20101105
0984957 122012000051 Germany   Start Trial PRODUCT NAME: KOMBINATIONSPRODUKT UMFASSEND NAPROXEN UND ESOMEPRAZOL-MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105
0984957 PA2011005 Lithuania   Start Trial PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
McKinsey
Merck
Baxter
Boehringer Ingelheim
McKesson

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