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TREXIMET Drug Patent Profile

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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

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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
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

Drug patent expirations by year 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	Nonsteroidal Anti-inflammatory Drug Serotonin-1b and Serotonin-1d Receptor Agonist
Mechanism of Action	Cyclooxygenase Inhibitors Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists

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

Multilayer dosage forms containing NSAIDs and triptans
Patent Number: ⤷ Sign Up
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Glossary

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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	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Currax	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

Expired US Patents for TREXIMET

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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	⤷ Sign Up	⤷ Sign Up
Currax	TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926-001	Apr 15, 2008	⤷ Sign Up	⤷ Sign Up
Currax	TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926-001	Apr 15, 2008	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for TREXIMET

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

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Country	Patent Number	Title	Estimated Expiration
Norway	20053193		⤷ Sign Up
Czech Republic	9104041		⤷ Sign Up
Japan	4616009		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for TREXIMET

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	PA2011005,C0984957	Lithuania	⤷ Sign Up	PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description