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Last Updated: November 21, 2024

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, Trupharma, Adaptis, 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, Norvium Bioscience, 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, Marksans Pharma, Novelgenix Theraps, Perrigo, Pld Acquisitions Llc, Sandoz, Sun Pharm Inds Ltd, Yichang Humanwell, Rising, Sun Pharm, and Currax, and is included in ninety 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-eight 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

See drug sales revenues for NAPROXEN

Recent Clinical Trials for NAPROXEN

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

SponsorPhase
Mclean HospitalPhase 4
United States Department of DefensePhase 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 Up500MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up375MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up250MGTABLET;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
Contract Pharmacal NAPROXEN SODIUM naproxen sodium TABLET;ORAL 074635-001 Jan 13, 1997 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Roxane NAPROXEN SODIUM naproxen sodium TABLET;ORAL 074257-001 Dec 21, 1993 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm SUMATRIPTAN AND NAPROXEN SODIUM naproxen sodium; sumatriptan succinate TABLET;ORAL 202803-001 Jul 20, 2018 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma Usa NAPROXEN naproxen TABLET, DELAYED RELEASE;ORAL 075390-001 Apr 19, 2001 DISCN 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Atnahs Pharma Us NAPROSYN naproxen TABLET;ORAL 017581-004 Apr 15, 1982 ⤷  Sign Up ⤷  Sign Up
Atnahs Pharma Us NAPROSYN naproxen TABLET;ORAL 017581-004 Apr 15, 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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