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Last Updated: April 15, 2024

Naproxen - Generic Drug Details

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

Naproxen is the generic ingredient in twelve branded drugs marketed by Atnahs Pharma Us, Amneal, Hetero Labs Ltd Iii, Hikma, Novitium Pharma, Actavis Elizabeth, Aurobindo Pharma Usa, Fosun Pharma, Nuvo Pharms Inc, Pliva, Teva, Tulex Pharms Inc, Amneal Pharms Ny, Aurobindo Pharma, Chartwell Molecules, Dava Pharms Inc, Glenmark Generics, Granules, Hamilton Pharms, Hikma Intl Pharms, Invagen Pharms, Ivax Sub Teva Pharms, L Perrigo Co, Marksans Pharma, Mylan, Purepac Pharm, Roxane, Sciegen Pharms Inc, Teva Pharms, Watson Labs, Watson Labs Teva, Zydus Pharms Usa, Bionpharma, Catalent, Patheon Softgels, Puracap Pharm Llc, Strides Pharma, Twi Pharms, Actavis Labs Fl Inc, Bayer, Able, Aurobindo Pharma Ltd, Contract Pharmacal, Dr Reddys Labs Inc, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Granules India, Hetero Labs Ltd V, Lnk Intl Inc, Novelgenix Theraps, Perrigo, Pld Acquisitions Llc, Sandoz, Sun Pharm Inds Ltd, Yichang Humanwell, Rising, Sun Pharm, and Currax, and is included in eighty-nine NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are forty-two drug master file entries for naproxen. Fifty-six suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for naproxen

US Patents:	6
Tradenames:	12
Applicants:	58
NDAs:	89
Drug Master File Entries:	42
Finished Product Suppliers / Packagers:	56
Raw Ingredient (Bulk) Api Vendors:	135
Clinical Trials:	323
Patent Applications:	6,910
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for naproxen
Drug Sales Revenues:	Drug sales revenues for naproxen
What excipients (inactive ingredients) are in naproxen?	naproxen excipients list
DailyMed Link:	naproxen at DailyMed

See drug prices for naproxen

See drug sales revenues for naproxen

Recent Clinical Trials for naproxen

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

Sponsor	Phase
United States Department of Defense	Phase 4
Mclean Hospital	Phase 4
Johnson & Johnson Consumer Inc. (J&JCI)	Phase 1

See all naproxen clinical trials

Generic filers with tentative approvals for NAPROXEN

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	500MG	TABLET;ORAL
⤷ Try a Trial	⤷ Try a Trial	375MG	TABLET;ORAL
⤷ Try a Trial	⤷ Try a Trial	250MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for naproxen

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

Medical Subject Heading (MeSH) Categories for naproxen

Anti-Inflammatory Agents, Non-Steroidal
Cyclooxygenase Inhibitors
Gout Suppressants

US Patents and Regulatory Information for naproxen

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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
Mylan	NAPROXEN	naproxen	TABLET;ORAL	074121-002	Dec 21, 1993		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Fosun Pharma	NAPROXEN	naproxen	TABLET, DELAYED RELEASE;ORAL	075061-001	Feb 18, 1998		DISCN	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Atnahs Pharma Us	NAPROSYN	naproxen	SUSPENSION;ORAL	018965-001	Mar 23, 1987	⤷ Try a Trial	⤷ Try a Trial
Atnahs Pharma Us	NAPROSYN	naproxen	SUSPENSION;ORAL	018965-001	Mar 23, 1987	⤷ Try a Trial	⤷ Try a Trial
Atnahs Pharma Us	NAPROSYN	naproxen	TABLET;ORAL	017581-002	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.