TREXIMET Drug Patent Profile

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. Five 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 is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for TREXIMET

International Patents:	16
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (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
GlaxoSmithKline	Phase 2/Phase 3
Premiere Research Institute	Phase 2/Phase 3

See all TREXIMET clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for TREXIMET

G02CC	Antiinflammatory products for vaginal administration
G02C	OTHER GYNECOLOGICALS
G02	OTHER GYNECOLOGICALS
G	Genito-urinary system and sex hormones

M01AE	Propionic acid derivatives
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

M02AA	Antiinflammatory preparations, non-steroids for topical use
M02A	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M02	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M	Musculo-skeletal system

N02CC	Selective serotonin (5HT1) agonists
N02C	ANTIMIGRAINE PREPARATIONS
N02	ANALGESICS
N	Nervous system

Paragraph IV (Patent) Challenges for TREXIMET

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TREXIMET	Tablets	naproxen sodium; sumatriptan succinate	500 mg/85 mg	021926	1	2008-07-23

US Patents and Regulatory Information for TREXIMET

TREXIMET is protected by one US patents.

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

International Patents for TREXIMET

When does loss-of-exclusivity occur for TREXIMET?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Austria

Canada

Cyprus

Denmark

European Patent Office

Israel

Japan

Mexico

Norway

Portugal

Slovenia

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TREXIMET around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	8801788
Egypt	17283	AN INDOLE DERIVATIVE
Spain	8801204
Australia	573878
Spain	557480

Supplementary Protection Certificates for TREXIMET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1411900	2011/016	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
1411900	2011C/016	Belgium		PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214
1411900	SPC/GB11/015	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
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	122012000052	Germany		PRODUCT NAME: NAPROXEN MIT ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105