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Mallinckrodt
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Covington
Federal Trade Commission
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Generated: October 16, 2017

DrugPatentWatch Database Preview

Naproxen - Generic Drug Details

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

Naproxen
is the generic ingredient in eleven branded drugs marketed by Teva, Dava Pharms Inc, Invagen Pharms, Teva Pharms, Chartwell Molecules, Hamilton Pharms, Ivax Sub Teva Pharms, Roxane, Marksans Pharma, Zydus Pharms Usa, Mylan, Amneal Pharms Ny, Aurobindo Pharma Ltd, Actavis Elizabeth, Pliva, Perrigo R And D, Sandoz, Glenmark Generics, Watson Labs, Purepac Pharm, Watson Labs Teva, Atnahs Pharma Us, West-ward Pharms Int, Mylan Pharms Inc, Hikma Intl Pharms, Bayer, Glenmark Pharms Ltd, Actavis Labs Fl Inc, Bionpharma Inc, Contract Pharmacal, Able, Alvogen Malta, Granules India, Perrigo, Dr Reddys Labs Inc, Lnk Intl Inc, Hikma, Sun Pharm Inds Ltd, Dr Reddys Labs Ltd, and Pernix Ireland Ltd, and is included in seventy-two 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. Seventy-one suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: naproxen

US Patents:5
Tradenames:11
Applicants:40
NDAs:72
Drug Master File Entries: see list42
Suppliers / Packagers: see list71
Bulk Api Vendors: see list76
Clinical Trials: see list245
Patent Applications: see list7,157
Therapeutic Class:Anti-inflammatory Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:naproxen at DailyMed

Pharmacology for Ingredient: naproxen

Tentative approvals for NAPROXEN

Applicant Application No. Strength Dosage Form
u► Subscribe250MGTABLET;ORAL
u► Subscribe500MGTABLET;ORAL
u► Subscribe375MGTABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs
NAPROXEN
naproxen
TABLET;ORAL074457-001May 31, 1995DISCNNoNo► Subscribe► Subscribe► Subscribe
Sandoz
NAPROXEN SODIUM
naproxen sodium
TABLET;ORAL074162-001Dec 21, 1993DISCNNoNo► Subscribe► Subscribe► Subscribe
Purepac Pharm
NAPROXEN
naproxen
TABLET;ORAL074263-003Dec 21, 1993DISCNNoNo► Subscribe► Subscribe► Subscribe
Hamilton Pharms
NAPROXEN SODIUM
naproxen sodium
TABLET;ORAL074106-002Aug 31, 1993DISCNNoNo► Subscribe► Subscribe► Subscribe
Roxane
NAPROXEN SODIUM
naproxen sodium
TABLET;ORAL074257-001Dec 21, 1993DISCNNoNo► Subscribe► Subscribe► Subscribe
Watson Labs
NAPROXEN
naproxen
TABLET;ORAL074457-002May 31, 1995DISCNNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms
NAPROXEN SODIUM
naproxen sodium
TABLET;ORAL074289-002Jan 27, 1994DISCNNoNo► Subscribe► Subscribe► Subscribe
Dr Reddys Labs Inc
NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE
naproxen sodium; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL077381-001Sep 27, 2006OTCNoNo► Subscribe► Subscribe► Subscribe
Watson Labs Teva
NAPROXEN
naproxen
TABLET;ORAL074163-002Feb 10, 1995DISCNNoNo► Subscribe► Subscribe► Subscribe
Teva
NAPROXEN
naproxen
TABLET;ORAL074216-001Apr 11, 1996DISCNNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: naproxen

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Atnahs Pharma Us
NAPROSYN
naproxen
TABLET;ORAL017581-002Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Atnahs Pharma Us
NAPROSYN
naproxen
TABLET;ORAL017581-004Apr 15, 1982► Subscribe► Subscribe
Atnahs Pharma Us
NAPROSYN
naproxen
TABLET;ORAL017581-004Apr 15, 1982► Subscribe► Subscribe
Atnahs Pharma Us
NAPROSYN
naproxen
SUSPENSION;ORAL018965-001Mar 23, 1987► Subscribe► Subscribe
Atnahs Pharma Us
NAPROSYN
naproxen
TABLET;ORAL017581-002Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Atnahs Pharma Us
NAPROSYN
naproxen
TABLET;ORAL017581-004Apr 15, 1982► Subscribe► Subscribe
Atnahs Pharma Us
NAPROSYN
naproxen
TABLET;ORAL017581-003Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Atnahs Pharma Us
NAPROSYN
naproxen
SUSPENSION;ORAL018965-001Mar 23, 1987► Subscribe► Subscribe
Atnahs Pharma Us
NAPROSYN
naproxen
TABLET;ORAL017581-004Apr 15, 1982► Subscribe► Subscribe
Atnahs Pharma Us
NAPROSYN
naproxen
TABLET;ORAL017581-003Approved Prior to Jan 1, 1982► Subscribe► Subscribe
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Fuji
Dow
Teva
Julphar
Deloitte
Harvard Business School
QuintilesIMS
Daiichi Sankyo
Accenture
Novartis

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 verifification 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.

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