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Last Updated: August 8, 2020

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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, Hikma, Actavis Elizabeth, Fosun Pharma, Mylan Pharms Inc, Pliva, Sunrise Pharm Inc, Teva, Amneal Pharms Ny, Aurobindo Pharma Ltd, Chartwell Molecules, Dava Pharms Inc, Glenmark Generics, 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, Alvogen, 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-one 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. Forty-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

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SponsorPhase
Eurofarma Laboratorios S.A.Phase 3
Assistance Publique - Hôpitaux de ParisPhase 3
Humber River HospitalPhase 4

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Generic filers with tentative approvals for NAPROXEN
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial500MGTABLET;ORAL
  Start Trial  Start Trial375MGTABLET;ORAL
  Start Trial  Start 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
Pliva NAPROXEN naproxen TABLET, DELAYED RELEASE;ORAL 075337-002 May 26, 1999 DISCN No No   Start Trial   Start Trial   Start Trial
Purepac Pharm NAPROXEN naproxen TABLET;ORAL 074263-002 Dec 21, 1993 DISCN No No   Start Trial   Start Trial   Start Trial
Teva NAPROXEN naproxen TABLET, DELAYED RELEASE;ORAL 075227-001 Jun 30, 1998 AB RX No No   Start Trial   Start Trial   Start Trial
Bayer ALEVE naproxen sodium TABLET;ORAL 020204-002 Jan 11, 1994 OTC Yes Yes   Start Trial   Start Trial   Start Trial
Teva Pharms NAPROXEN naproxen TABLET;ORAL 074207-002 Dec 21, 1993 DISCN No No   Start Trial   Start Trial   Start 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 017581-004 Apr 15, 1982   Start Trial   Start Trial
Atnahs Pharma Us NAPROSYN naproxen TABLET;ORAL 017581-003 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Atnahs Pharma Us NAPROSYN naproxen TABLET;ORAL 017581-002 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Atnahs Pharma Us NAPROSYN naproxen SUSPENSION;ORAL 018965-001 Mar 23, 1987   Start Trial   Start Trial
Atnahs Pharma Us NAPROSYN naproxen TABLET;ORAL 017581-004 Apr 15, 1982   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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