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Last Updated: April 19, 2024

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, Catalent, Patheon Softgels, Puracap Pharm Llc, Strides Pharma, Twi Pharms, 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, Hetero Labs Ltd V, 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 fifty-one NDAs. There are six 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 twenty-two drug master file entries for naproxen sodium. One hundred and thirty-five suppliers are listed for this compound.

Summary for NAPROXEN SODIUM

International Patents:	15
US Patents:	6
Tradenames:	9
Applicants:	41
NDAs:	51
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	135
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	100
Patent Applications:	7,012
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

Drug Sales Revenue Trends 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

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

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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
Puracap Pharm Llc	NAPROXEN SODIUM	naproxen sodium	CAPSULE;ORAL	208363-001	Mar 15, 2018		OTC	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sandoz	NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	074162-001	Dec 21, 1993		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hamilton Pharms	NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	074106-001	Aug 31, 1993		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sciegen Pharms Inc	NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	212199-001	Oct 30, 2019	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Contract Pharmacal	NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	074635-001	Jan 13, 1997		OTC	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Twi Pharms	NAPRELAN	naproxen sodium	TABLET, EXTENDED RELEASE;ORAL	020353-003	Jan 5, 1996	⤷ Try a Trial	⤷ Try a Trial
Atnahs Pharma Us	ANAPROX	naproxen sodium	TABLET;ORAL	018164-001	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
Atnahs Pharma Us	ANAPROX	naproxen sodium	TABLET;ORAL	018164-001	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
Twi Pharms	NAPRELAN	naproxen sodium	TABLET, EXTENDED RELEASE;ORAL	020353-001	Jan 5, 1996	⤷ Try a Trial	⤷ Try a Trial
Atnahs Pharma Us	ANAPROX	naproxen sodium	TABLET;ORAL	018164-001	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for NAPROXEN SODIUM

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Country	Patent Number	Title	Estimated Expiration
Slovenia	1863458		⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2006096580		⤷ Try a Trial
China	102940887	Solvent system for enhancing the solubility of pharmaceutical agents	⤷ Try a Trial
Canada	2600023	SYSTEME DE SOLVANT DESTINE A AMELIORER LA SOLUBILITE DES AGENTS PHARMACEUTIQUES (SOLVENT SYSTEM FOR ENHANCING THE SOLUBILITY OF PHARMACEUTICAL AGENTS)	⤷ Try a Trial
Lithuania	1863458		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for NAPROXEN SODIUM

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1411900	2011C/016	Belgium	⤷ Try a Trial	PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214
1411900	SPC/GB11/015	United Kingdom	⤷ Try a Trial	PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
1411900	18/2011	Austria	⤷ Try a Trial	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
0984957	PA2011005	Lithuania	⤷ Try a Trial	PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
1411900	1190013-1	Sweden	⤷ Try a Trial	PRODUCT NAME: NAPROXEN OCH ESOMEPRAZOL; NAT. REG. NO/DATE: MTNR 43248 20101203; FIRST REG.: GB PL 17901/0263 20101105
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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