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Last Updated: August 3, 2021

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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, Hikma, Novitium Pharma, Actavis Elizabeth, Fosun Pharma, Mylan Pharms Inc, Nuvo Pharms Inc, Pliva, Teva, Amneal Pharms Ny, Aurobindo Pharma Ltd, Chartwell Molecules, Dava Pharms Inc, Glenmark Generics, Granules, Hamilton Pharms, Hikma Intl Pharms, Invagen Pharms, Ivax Sub Teva Pharms, Marksans Pharma, Mylan, Perrigo Pharms Co, Purepac Pharm, Roxane, Sciegen Pharms Inc, Teva Pharms, Watson Labs, Watson Labs Teva, Zydus Pharms Usa, Bionpharma Inc, Catalent, Puracap Pharm Llc, Almatica, Actavis Labs Fl Inc, Bayer, Able, Contract Pharmacal, Dr Reddys Labs Inc, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Granules India, Lnk Intl Inc, Novelgenix Theraps, Perrigo, Pld Acquisitions Llc, Sandoz, Sun Pharm Inds Ltd, Yichang Humanwell, Sun Pharm, and Currax, and is included in eighty-three NDAs. There are five 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-one suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for NAPROXEN

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Drug Sales Revenue Trends for NAPROXEN

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Recent Clinical Trials for NAPROXEN

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

SponsorPhase
Turku University HospitalPhase 4
Eurofarma Laboratorios S.A.Phase 3
University of PennsylvaniaPhase 4

See all NAPROXEN clinical trials

Generic filers with tentative approvals for NAPROXEN
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it Free500MGTABLET;ORAL
⤷  Try it Free⤷  Try it Free375MGTABLET;ORAL
⤷  Try it Free⤷  Try it Free250MGTABLET;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
Medical Subject Heading (MeSH) Categories for NAPROXEN

US Patents and Regulatory Information for NAPROXEN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma NAPROXEN SODIUM naproxen sodium TABLET;ORAL 074480-001 May 14, 1996 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Dava Pharms Inc NAPROXEN naproxen TABLET;ORAL 074105-001 Dec 21, 1993 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Aurobindo Pharma Ltd NAPROXEN naproxen TABLET;ORAL 200429-002 Nov 8, 2011 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Teva Pharms NAPROXEN naproxen TABLET;ORAL 074207-001 Dec 21, 1993 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Roxane NAPROXEN SODIUM naproxen sodium TABLET;ORAL 074257-002 Dec 21, 1993 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Mylan NAPROXEN naproxen TABLET;ORAL 074121-001 Dec 21, 1993 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Catalent NAPROXEN SODIUM naproxen sodium CAPSULE;ORAL 202807-001 Jan 4, 2019 OTC No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Atnahs Pharma Us NAPROSYN naproxen TABLET;ORAL 017581-002 Approved Prior to Jan 1, 1982 ⤷  Try it Free ⤷  Try it Free
Atnahs Pharma Us NAPROSYN naproxen TABLET;ORAL 017581-003 Approved Prior to Jan 1, 1982 ⤷  Try it Free ⤷  Try it Free
Atnahs Pharma Us NAPROSYN naproxen TABLET;ORAL 017581-002 Approved Prior to Jan 1, 1982 ⤷  Try it Free ⤷  Try it Free
Atnahs Pharma Us NAPROSYN naproxen SUSPENSION;ORAL 018965-001 Mar 23, 1987 ⤷  Try it Free ⤷  Try it Free
Atnahs Pharma Us NAPROSYN naproxen TABLET;ORAL 017581-003 Approved Prior to Jan 1, 1982 ⤷  Try it Free ⤷  Try it Free
Atnahs Pharma Us NAPROSYN naproxen TABLET;ORAL 017581-002 Approved Prior to Jan 1, 1982 ⤷  Try it Free ⤷  Try it Free
Atnahs Pharma Us NAPROSYN naproxen TABLET;ORAL 017581-004 Apr 15, 1982 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Harvard Business School
McKesson
AstraZeneca
Mallinckrodt
Moodys
Johnson and Johnson

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