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Last Updated: March 19, 2024

Naproxen - Generic Drug Details


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What are the generic sources for naproxen and what is the scope of patent protection?

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-seven 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
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
⤷  Try a Trial⤷  Try a Trial500MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial375MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial250MGTABLET;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
Mylan NAPROXEN naproxen TABLET;ORAL 074121-002 Dec 21, 1993 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Pharms Usa NAPROXEN naproxen TABLET;ORAL 078620-001 Jun 7, 2007 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actavis Labs Fl Inc NAPROXEN SODIUM naproxen sodium TABLET, EXTENDED RELEASE;ORAL 075416-003 Aug 11, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bionpharma NAPROXEN SODIUM naproxen sodium CAPSULE;ORAL 021920-001 Feb 17, 2006 OTC Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Aurobindo Pharma Ltd NAPROXEN SODIUM naproxen sodium TABLET;ORAL 205497-001 Mar 18, 2016 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Patheon Softgels NAPROXEN SODIUM naproxen sodium CAPSULE;ORAL 214463-001 Jan 10, 2023 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

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 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 017581-004 Apr 15, 1982 ⤷  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
Atnahs Pharma Us NAPROSYN naproxen TABLET;ORAL 017581-004 Apr 15, 1982 ⤷  Try a Trial ⤷  Try a Trial
Atnahs Pharma Us NAPROSYN naproxen TABLET;ORAL 017581-004 Apr 15, 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.