NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE - Generic Drug Details

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What are the generic 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
Jiangsu Provincial People's Hospital	Phase 3
West China Hospital	Phase 3
The Second Affiliated Hospital of Kunming Medical 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
Rising	SUMATRIPTAN AND NAPROXEN SODIUM	naproxen sodium; sumatriptan succinate	TABLET;ORAL	090872-001	Sep 4, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm	SUMATRIPTAN AND NAPROXEN SODIUM	naproxen sodium; sumatriptan succinate	TABLET;ORAL	202803-001	Jul 20, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Currax	TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926-002	May 14, 2015		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Aurobindo Pharma Ltd	SUMATRIPTAN AND NAPROXEN SODIUM	naproxen sodium; sumatriptan succinate	TABLET;ORAL	207457-001	Feb 15, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ 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 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	⤷ 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
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 NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE

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Country	Patent Number	Title	Estimated Expiration
Cyprus	1112640		⤷ Sign Up
European Patent Office	1575566	FORMES GALENIQUES MULTICOUCHES CONTENANT DE NAPROXENE ET DES TRIPTANES (MULTILAYER DOSAGE FORMS CONTAINING NAPROXEN AND TRIPTANS)	⤷ Sign Up
Australia	2003303631	Multilayer Dosage Forms Containing NSAIDs and Triptans	⤷ Sign Up
Portugal	1575566		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2004060355		⤷ Sign Up
>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
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
0984957	CR 2012 00035	Denmark	⤷ Sign Up	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
1411900	C300481	Netherlands	⤷ Sign Up	PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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