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Last Updated: April 18, 2024

Naproxen sodium; sumatriptan succinate - Generic Drug Details

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What are the generic drug sources for naproxen sodium; sumatriptan succinate and what is the scope of freedom to operate?

Naproxen sodium; sumatriptan succinate is the generic ingredient in two branded drugs marketed by Aurobindo Pharma Ltd, Rising, Sun Pharm, and Currax, and is included in four NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Naproxen sodium; sumatriptan succinate has sixteen patent family members in fourteen countries.

Five suppliers are listed for this compound.

Summary for naproxen sodium; sumatriptan succinate

International Patents:	16
US Patents:	1
Tradenames:	2
Applicants:	4
NDAs:	4
Finished Product Suppliers / Packagers:	5
Clinical Trials:	11
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for naproxen sodium; sumatriptan succinate
DailyMed Link:	naproxen sodium; sumatriptan succinate at DailyMed

Recent Clinical Trials for naproxen sodium; sumatriptan succinate

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

Sponsor	Phase
Second Hospital of Jilin University	Phase 3
Beijing Friendship Hospital	Phase 3
The Third Xiangya Hospital of Central South University	Phase 3

See all naproxen sodium; sumatriptan succinate clinical trials

Pharmacology for naproxen sodium; sumatriptan succinate

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 NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE

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 naproxen sodium; sumatriptan succinate

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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
Aurobindo Pharma Ltd	SUMATRIPTAN AND NAPROXEN SODIUM	naproxen sodium; sumatriptan succinate	TABLET;ORAL	207457-001	Feb 15, 2018	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Rising	SUMATRIPTAN AND NAPROXEN SODIUM	naproxen sodium; sumatriptan succinate	TABLET;ORAL	090872-001	Sep 4, 2018	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Currax	TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926-002	May 14, 2015		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Currax	TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926-001	Apr 15, 2008	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
>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 naproxen sodium; sumatriptan succinate

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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	⤷ Try a Trial	⤷ Try a Trial
Currax	TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926-001	Apr 15, 2008	⤷ Try a Trial	⤷ Try a Trial
Currax	TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926-001	Apr 15, 2008	⤷ Try a Trial	⤷ Try a Trial
Currax	TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926-002	May 14, 2015	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for naproxen sodium; sumatriptan succinate

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	1575566	FORMES GALENIQUES MULTICOUCHES CONTENANT DE NAPROXENE ET DES TRIPTANES (MULTILAYER DOSAGE FORMS CONTAINING NAPROXEN AND TRIPTANS)	⤷ Try a Trial
Austria	546134		⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2004060355		⤷ Try a Trial
Mexico	PA05006954	FORMAS DE DOSIFICACION DE CAPAS MULTIPLES QUE CONTIENEN NSAIDS Y TRIPTANOS. (Multilayer Dosage Forms Containing NSAIDs and Triptans.)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for naproxen sodium; sumatriptan succinate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0984957	CR 2012 00035	Denmark	⤷ Try a Trial	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
0984957	PA2011005	Lithuania	⤷ Try a Trial	PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
0984957	SPC/GB11/013	United Kingdom	⤷ Try a Trial	PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0984957	122012000051	Germany	⤷ Try a Trial	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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