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Last Updated: January 18, 2020

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TREXIMET Drug Profile

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

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. Six suppliers are listed for this compound. Additional details are available on the naproxen sodium; sumatriptan succinate profile page.

US ANDA Litigation and Generic Entry Outlook for Treximet

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Treximet was eligible for patent challenges on December 31st, 1968.

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.

Drug patent expirations by year for TREXIMET
Drug Prices for TREXIMET

See drug prices for TREXIMET

Recent Clinical Trials for TREXIMET

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Dent Neurologic InstituteN/A
GlaxoSmithKlinePhase 2/Phase 3
Premiere Research InstitutePhase 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
Graybar Pharmaceuticals, LLC2015-11-12

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

Supplementary Protection Certificates for TREXIMET

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1411900 1190013-1 Sweden   Start Trial PRODUCT NAME: NAPROXEN OCH ESOMEPRAZOL; NAT. REG. NO/DATE: MTNR 43248 20101203; FIRST REG.: GB PL 17901/0263 20101105
1411900 2011/016 Ireland   Start Trial PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
0984957 PA2011005 Lithuania   Start Trial PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
0984957 SPC/GB11/013 United Kingdom   Start Trial PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0984957 CR 2012 00035 Denmark   Start Trial PRODUCT NAME: ET KOMBINATIONSPRODUKT AF NAPROXEN OG ESOMEPRAZOL MAGNESIUM TRIHYDRAT; NAT. REG. NO/DATE: 49583 20120327; FIRST REG. NO/DATE: GB PL 17901/0263-001 20101105
1411900 122012000052 Germany   Start Trial PRODUCT NAME: NAPROXEN MIT ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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