NAPROXEN - Generic Drug Details

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What are the generic 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 Pharms Ltd, 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, 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-seven suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for NAPROXEN

US Patents:	6
Tradenames:	12
Applicants:	57
NDAs:	89
Drug Master File Entries:	42
Finished Product Suppliers / Packagers:	57
Raw Ingredient (Bulk) Api Vendors:	135
Clinical Trials:	323
Patent Applications:	3,391
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
⤷ Sign Up	⤷ Sign Up	500MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	375MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	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
Amneal Pharms Ny	NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	079096-001	Dec 16, 2008		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ivax Sub Teva Pharms	NAPROXEN	naproxen	TABLET;ORAL	074111-001	Feb 28, 1995		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal	NAPROXEN	naproxen	SUSPENSION;ORAL	212705-001	Jul 31, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Purepac Pharm	NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	074319-001	Mar 20, 1995		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Currax	TREXIMET	naproxen sodium; sumatriptan succinate	TABLET;ORAL	021926-001	Apr 15, 2008	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Chartwell Molecules	NAPROXEN	naproxen	TABLET;ORAL	074410-003	Apr 28, 1995		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Contract Pharmacal	NAPROXEN SODIUM	naproxen sodium	TABLET;ORAL	074635-001	Jan 13, 1997		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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	TABLET;ORAL	017581-003	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Atnahs Pharma Us	NAPROSYN	naproxen	TABLET;ORAL	017581-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Atnahs Pharma Us	NAPROSYN	naproxen	TABLET;ORAL	017581-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Atnahs Pharma Us	NAPROSYN	naproxen	SUSPENSION;ORAL	018965-001	Mar 23, 1987	⤷ Sign Up	⤷ Sign Up
Atnahs Pharma Us	NAPROSYN	naproxen	TABLET;ORAL	017581-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Atnahs Pharma Us	NAPROSYN	naproxen	TABLET;ORAL	017581-003	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Atnahs Pharma Us	NAPROSYN	naproxen	SUSPENSION;ORAL	018965-001	Mar 23, 1987	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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