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Generated: April 24, 2019

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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 Pernix Ireland Ltd 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. Seven suppliers are listed for this compound. Additional details are available on the naproxen sodium; sumatriptan succinate profile page.

Drug patent expirations by year for TREXIMET
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

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

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Expired US Patents for TREXIMET

Paragraph IV (Patent) Challenges for TREXIMET
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 500 mg/85 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for TREXIMET

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0984957 122012000051 Germany ➤ Sign Up 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 SPC/GB11/013 United Kingdom ➤ Sign Up PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0984957 CR 2012 00035 Denmark ➤ Sign Up 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 ➤ Sign Up PRODUCT NAME: NAPROXEN MIT ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105
0984957 PA2011005 Lithuania ➤ Sign Up PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
1411900 SPC/GB11/015 United Kingdom ➤ Sign Up PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
1411900 1190013-1 Sweden ➤ Sign Up PRODUCT NAME: NAPROXEN OCH ESOMEPRAZOL; NAT. REG. NO/DATE: MTNR 43248 20101203; FIRST REG.: GB PL 17901/0263 20101105
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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