Naproxen sodium - Generic Drug Details

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, Strides Pharma, 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, Aurobindo Pharma, Rising, Sun Pharm, and Currax, and is included in forty-nine NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Naproxen sodium has sixteen patent family members in fourteen countries.

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

Summary for naproxen sodium

International Patents:	16
US Patents:	6
Tradenames:	9
Applicants:	39
NDAs:	49
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	129
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	95
Patent Applications:	6,772
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
Hersh, Elliot V., DMD, MS, PhD	Phase 4
University of Pennsylvania	Phase 4
Massachusetts General Hospital	Phase 4

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	Strength	NDA	ANDAs Submitted	Submissiondate
NAPROXEN SODIUM	Capsules	naproxen sodium	200 mg	021920	1	2017-11-15

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
Watson Labs	NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	074195-002	Dec 21, 1993		DISCN	No	No
Granules India	NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	091353-001	Sep 20, 2011		OTC	No	No
Teva	NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	074142-001	Dec 21, 1993		DISCN	No	No
Actavis Labs Fl Inc	NAPROXEN SODIUM	naproxen sodium	TABLET, EXTENDED RELEASE;ORAL	075416-001	Aug 27, 2002	AB	RX	No	No
Almatica	NAPRELAN	naproxen sodium	TABLET, EXTENDED RELEASE;ORAL	020353-003	Jan 5, 1996	AB	RX	Yes	Yes
Sun Pharm	SUMATRIPTAN AND NAPROXEN SODIUM	naproxen sodium; sumatriptan succinate	TABLET;ORAL	202803-001	Jul 20, 2018	AB	RX	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
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 DS	naproxen sodium	TABLET;ORAL	018164-003	Sep 30, 1987
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

International Patents for naproxen sodium

Country	Patent Number	Title	Estimated Expiration
Hungary	E030784
Spain	2606767
Mexico	2007011039	SISTEMA DE SOLVENTE PARA AUMENTAR LA SOLUBILIDAD DE AGENTES FARMACEUTICOS. (SOLVENT SYSTEM FOR ENHANCING THE SOLUBILITY OF PHARMACEUTICAL AGENTS.)
Finland	1863458
Portugal	1863458
Lithuania	1863458

Supplementary Protection Certificates for naproxen sodium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	SPC/GB11/013	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
1411900	C300481	Netherlands		PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105
1411900	SPC/GB11/015	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105