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Naproxen sodium - Generic Drug Details

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

Naproxen sodium is the generic ingredient in nine branded drugs marketed by Bionpharma Inc, Catalent, Puracap Pharm Llc, Almatica, Actavis Labs Fl Inc, Bayer, Atnahs Pharma Us, Able, Amneal Pharms Ny, Aurobindo Pharma Ltd, Contract Pharmacal, Dr Reddys Labs Inc, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Granules India, Hamilton Pharms, Hikma, Ivax Sub Teva Pharms, Lnk Intl Inc, Marksans Pharma, Mylan, Novelgenix Theraps, Perrigo, Pld Acquisitions Llc, Pliva, Purepac Pharm, Roxane, Sandoz, Sciegen Pharms Inc, Sun Pharm Inds Ltd, Teva, Teva Pharms, Watson Labs, Yichang Humanwell, Sun Pharm, and Currax, and is included in forty-seven NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Naproxen sodium has fifteen patent family members in thirteen countries.

There are forty-two drug master file entries for naproxen sodium. One hundred and twenty-one suppliers are listed for this compound.

Summary for naproxen sodium

International Patents:	15
US Patents:	5
Tradenames:	9
Applicants:	36
NDAs:	47
Drug Master File Entries:	42
Suppliers / Packagers:	121
Bulk Api Vendors:	84
Clinical Trials:	87
Patent Applications:	7,185
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for naproxen sodium
Drug Sales Revenues:	Drug sales revenues for naproxen sodium
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for naproxen sodium
What excipients (inactive ingredients) are in naproxen sodium?	naproxen sodium excipients list
DailyMed Link:	naproxen sodium at DailyMed

See drug prices for naproxen sodium

See drug sales revenues for naproxen sodium

Recent Clinical Trials for naproxen sodium

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

Sponsor	Phase
University of Pennsylvania	Phase 4
Hersh, Elliot V., DMD, MS, PhD	Phase 4
Ege University	N/A

See all naproxen sodium clinical trials

Pharmacology for naproxen sodium

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

Paragraph IV (Patent) Challenges for NAPROXEN SODIUM

Tradename	Dosage	Ingredient	NDA	Submissiondate
NAPROXEN SODIUM	CAPSULE;ORAL	naproxen sodium	021920	2017-11-15
NAPRELAN	TABLET, EXTENDED RELEASE;ORAL	naproxen sodium	020353

US Patents and Regulatory Information for naproxen sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva	NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	074142-001	Dec 21, 1993		DISCN	No	No
Contract Pharmacal	NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	074635-001	Jan 13, 1997		OTC	No	No
Sandoz	NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	074495-001	Dec 5, 1994		DISCN	No	No
Teva	NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	074142-002	Dec 21, 1993		DISCN	No	No
Mylan	SUMATRIPTAN AND NAPROXEN SODIUM	naproxen sodium; sumatriptan succinate	TABLET;ORAL	090872-001	Sep 4, 2018	AB	RX	No	No
Actavis Labs Fl Inc	NAPROXEN SODIUM	naproxen sodium	TABLET, EXTENDED RELEASE;ORAL	075416-003	Aug 11, 2016	AB	RX	No	No
Able	NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	076544-001	Aug 22, 2003		DISCN	No	No

Expired US Patents for naproxen sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Atnahs Pharma Us	ANAPROX DS	naproxen sodium	TABLET;ORAL	018164-003	Sep 30, 1987
Almatica	NAPRELAN	naproxen sodium	TABLET, EXTENDED RELEASE;ORAL	020353-001	Jan 5, 1996
Atnahs Pharma Us	ANAPROX	naproxen sodium	TABLET;ORAL	018164-001	Approved Prior to Jan 1, 1982
Atnahs Pharma Us	ANAPROX	naproxen sodium	TABLET;ORAL	018164-001	Approved Prior to Jan 1, 1982
Almatica	NAPRELAN	naproxen sodium	TABLET, EXTENDED RELEASE;ORAL	020353-002	Jan 5, 1996
Atnahs Pharma Us	ANAPROX DS	naproxen sodium	TABLET;ORAL	018164-003	Sep 30, 1987
Almatica	NAPRELAN	naproxen sodium	TABLET, EXTENDED RELEASE;ORAL	020353-003	Jan 5, 1996

International Patents for naproxen sodium

Country	Patent Number	Estimated Expiration
Lithuania	1863458
Slovenia	1863458
Canada	2600023
European Patent Office	1863458
World Intellectual Property Organization (WIPO)	2006096580
Hungary	E030784
China	102940887

Supplementary Protection Certificates for naproxen sodium

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