NAPROXEN SODIUM Drug Patent Profile

When do Naproxen Sodium patents expire, and what generic alternatives are available?

Naproxen Sodium is a drug marketed by Bionpharma, Catalent, Patheon Softgels, Puracap Pharm Llc, Strides Pharma, Actavis Labs Fl Inc, Able, Amneal Pharms Ny, Aurobindo Pharma Ltd, Contract Pharmacal, Dr Reddys Labs Inc, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Granules India, Hamilton Pharms, Hetero Labs Ltd V, Hikma, Ivax Sub Teva Pharms, Lnk Intl Inc, Marksans Pharma, Norvium Bioscience, 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, Amneal Pharms Co, Corepharma, Granules, P And L, Perrigo R And D, and Aurobindo Pharma. and is included in forty-eight NDAs. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has fifteen patent family members in thirteen countries.

The generic ingredient in NAPROXEN SODIUM is naproxen sodium; pseudoephedrine hydrochloride. There are forty-two drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the naproxen sodium; pseudoephedrine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Naproxen Sodium

A generic version of NAPROXEN SODIUM was approved as naproxen sodium; pseudoephedrine hydrochloride by PERRIGO on March 17^th, 2004.

Summary for NAPROXEN SODIUM

International Patents:	15
US Patents:	5
Applicants:	40
NDAs:	48
Finished Product Suppliers / Packagers:	123
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	100
Patent Applications:	6,228
Drug Prices:	Drug price information 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
Johnson & Johnson Consumer Inc. (J&JCI)	Phase 1
Johnson & Johnson Consumer Inc. (J&JCI)	Phase 3
Ciusss de L'Est de l'Île de Montréal	N/A

See all NAPROXEN SODIUM clinical trials

Pharmacology for NAPROXEN SODIUM

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

Anatomical Therapeutic Chemical (ATC) Classes for NAPROXEN SODIUM

G02CC	Antiinflammatory products for vaginal administration
G02C	OTHER GYNECOLOGICALS
G02	OTHER GYNECOLOGICALS
G	Genito-urinary system and sex hormones

M01AE	Propionic acid derivatives
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

M02AA	Antiinflammatory preparations, non-steroids for topical use
M02A	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M02	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M	Musculo-skeletal system

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

NAPROXEN SODIUM is protected by eight US patents.

Patents protecting NAPROXEN SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Granules	NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride; naproxen sodium	TABLET;ORAL	213663-001	Sep 24, 2020		OTC	No	No
Norvium Bioscience	NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	074367-001	Aug 31, 1994		DISCN	No	No
Hamilton Pharms	NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	074106-001	Aug 31, 1993		DISCN	No	No
Purepac Pharm	NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	074319-002	Mar 20, 1995		DISCN	No	No
Teva	NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	074198-001	Dec 21, 1993		DISCN	No	No
Pld Acquisitions Llc	NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	074646-001	Jan 13, 1997		DISCN	No	No

International Patents for NAPROXEN SODIUM

See the table below for patents covering NAPROXEN SODIUM around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2606767
Hungary	E030784
European Patent Office	3061447	SYSTÈME DE SOLVANT DESTINÉ À AMÉLIORER LA SOLUBILITÉ D'AGENTS PHARMACEUTIQUES (SOLVENT SYSTEM FOR ENHANCING THE SOLUBILITY OF PHARMACEUTICAL AGENTS)
Denmark	1863458
Slovenia	1863458
Cyprus	1118321

Supplementary Protection Certificates for NAPROXEN SODIUM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1411900	2011C/016	Belgium		PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214
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	C300481	Netherlands		PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105
0984957	PA2011005,C0984957	Lithuania		PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
0984957	SPC/GB11/013	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105