DrugPatentWatch Database Preview

TREXIMET Drug Profile

« Back to Dashboard

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

DrugPatentWatch^® Generic Entry Outlook for Treximet

There have been two 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

Summary for TREXIMET

International Patents:	16
US Patents:	1
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
What excipients (inactive ingredients) are in TREXIMET?	TREXIMET excipients list
DailyMed Link:	TREXIMET at DailyMed

See drug prices for TREXIMET

Recent Clinical Trials for TREXIMET

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

Sponsor	Phase
Dent Neurologic Institute	N/A
Premiere Research Institute	Phase 2/Phase 3
GlaxoSmithKline	Phase 2/Phase 3

See all TREXIMET clinical trials

Pharmacology for TREXIMET

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

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					Y
Currax	TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926-001	Apr 15, 2008	AB	RX	Yes	Yes					Y

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
Currax	TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926-001	Apr 15, 2008
Currax	TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926-002	May 14, 2015

International Patents for TREXIMET

Country	Patent Number	Estimated Expiration
Japan	3712420
Mexico	159672
Denmark	351185

Supplementary Protection Certificates for TREXIMET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1411900	18/2011	Austria		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
1411900	SPC/GB11/015	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0984957	PA2011005,C0984957	Lithuania		PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126