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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 are five patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-three patent family members in sixteen 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.

Summary for TREXIMET

International Patents:	33
US Patents:	5
Applicants:	1
NDAs:	1
Suppliers / Packagers:	3
Bulk Api Vendors:	1
Clinical Trials:	22
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TREXIMET
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TREXIMET
DailyMed Link:	TREXIMET at DailyMed

Pharmacology for TREXIMET

Ingredient-type	Nonsteroidal Anti-inflammatory Compounds
Drug Class	Serotonin-1b and Serotonin-1d Receptor Agonist Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Serotonin 1d Receptor Agonists Serotonin 1b Receptor Agonists Cyclooxygenase Inhibitors

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					Y
Pernix Ireland Ltd	TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926-001	Apr 15, 2008	AB	RX	Yes	Yes
Pernix Ireland Ltd	TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926-002	May 14, 2015		DISCN	Yes	No
Pernix Ireland Ltd	TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926-001	Apr 15, 2008	AB	RX	Yes	Yes
Pernix Ireland Ltd	TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926-002	May 14, 2015		DISCN	Yes	No
Pernix Ireland Ltd	TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926-002	May 14, 2015		DISCN	Yes	No
Pernix Ireland Ltd	TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926-002	May 14, 2015		DISCN	Yes	No

Expired US Patents for TREXIMET

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

Paragraph IV (Patent) Challenges for TREXIMET

Drugname	Dosage	Strength	RLD	Date
	Tablets	500 mg/85 mg

International Patents for TREXIMET

Country	Document Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2004060355
Australia	2003303631
Canada	2260943
Spain	2380827
Slovenia	1575566
Australia	3596500
Cyprus	1112640

Supplementary Protection Certificates for TREXIMET

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1411900/01	Switzerland		PRODUCT NAME: ESOMEPRAZOL + NAPROXEN; REGISTRATION NO/DATE: SWISSMEDIC 61330 06.05.2011
00481	Netherlands		PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105
11/016	Ireland		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
2012 00035	Denmark		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
C/GB11/013	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
2011005	Lithuania		PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
2012000051	Germany		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