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Naproxen sodium - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for naproxen sodium?

Naproxen sodium is the generic ingredient in eight branded drugs marketed by Bayer, Hamilton Pharms, Glenmark Generics, Actavis Labs Fl Inc, Purepac Pharm, Bionpharma Inc, Aurobindo Pharma Ltd, Ivax Sub Teva Pharms, Amneal Pharms Ny, Contract Pharmacal, Pliva, Teva, Able, Marksans Pharma, Sandoz, Alvogen Malta, Granules India, Watson Labs, Roxane, Perrigo, Atnahs Pharma Us, Mylan, Dr Reddys Labs Inc, Lnk Intl Inc, Hikma, Sun Pharm Inds Ltd, Dr Reddys Labs Ltd, Teva Pharms, and Pernix Ireland Ltd, and is included in thirty-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 sodium. One hundred and sixty-one suppliers are listed for this compound.

Summary for Generic Name: naproxen sodium

Tradenames:8
Patents:6
Applicants:29
NDAs:39
Drug Master File Entries: see list42
Suppliers / Packagers: see list161
Bulk Api Vendors: see list52
Clinical Trials: see list975
Patent Applications: see list6,919
Therapeutic Class:Anti-inflammatory Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:naproxen sodium at DailyMed

Pharmacology for Ingredient: naproxen sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Able
NAPROXEN SODIUM
naproxen sodium
TABLET;ORAL076544-002Aug 22, 2003DISCNNoNo► Subscribe► Subscribe
Pernix Ireland Ltd
TREXIMET
naproxen sodium; sumatriptan succinate
TABLET;ORAL021926-002May 14, 2015RXYesNo5,872,145*PED► SubscribeY► Subscribe
Aurobindo Pharma Ltd
NAPROXEN SODIUM
naproxen sodium
TABLET;ORAL200629-002Oct 31, 2011RXNoNo► Subscribe► Subscribe
Sun Pharm Inds Ltd
NAPROXEN SODIUM
naproxen sodium
TABLET;ORAL091183-001May 20, 2011OTCNoNo► Subscribe► Subscribe
Atnahs Pharma Us
ANAPROX
naproxen sodium
TABLET;ORAL018164-001Approved Prior to Jan 1, 1982RXYesNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: naproxen sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alvogen Malta
NAPRELAN
naproxen sodium
TABLET, EXTENDED RELEASE;ORAL020353-001Jan 5, 19965,637,320► Subscribe
Atnahs Pharma Us
ANAPROX
naproxen sodium
TABLET;ORAL018164-001Approved Prior to Jan 1, 19824,009,197► Subscribe
Atnahs Pharma Us
ANAPROX DS
naproxen sodium
TABLET;ORAL018164-003Sep 30, 19874,009,197► Subscribe
Atnahs Pharma Us
ANAPROX DS
naproxen sodium
TABLET;ORAL018164-003Sep 30, 19874,001,301► Subscribe
Alvogen Malta
NAPRELAN
naproxen sodium
TABLET, EXTENDED RELEASE;ORAL020353-002Jan 5, 19965,637,320► Subscribe
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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 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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