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Last Updated: August 3, 2021

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Naproxen sodium - Generic Drug Details

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

Naproxen sodium is the generic ingredient in nine branded drugs marketed by Bionpharma Inc, Catalent, Puracap Pharm Llc, Almatica, Actavis Labs Fl Inc, Bayer, Atnahs Pharma Us, Able, Amneal Pharms Ny, Aurobindo Pharma Ltd, Contract Pharmacal, Dr Reddys Labs Inc, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Granules India, Hamilton Pharms, Hikma, Ivax Sub Teva Pharms, Lnk Intl Inc, Marksans Pharma, Mylan, Novelgenix Theraps, Perrigo, Pld Acquisitions Llc, Pliva, Purepac Pharm, Roxane, Sandoz, Sciegen Pharms Inc, Sun Pharm Inds Ltd, Teva, Teva Pharms, Watson Labs, Yichang Humanwell, Sun Pharm, and Currax, and is included in forty-seven NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Naproxen sodium has fifteen patent family members in thirteen countries.

There are forty-two drug master file entries for naproxen sodium. One hundred and twenty-five suppliers are listed for this compound.

Drug Prices for naproxen sodium

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Drug Sales Revenue Trends for naproxen sodium

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Recent Clinical Trials for naproxen sodium

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

SponsorPhase
University of PennsylvaniaPhase 4
Hersh, Elliot V., DMD, MS, PhDPhase 4
Ege UniversityN/A

See all naproxen sodium clinical trials

Pharmacology for naproxen sodium
Paragraph IV (Patent) Challenges for NAPROXEN SODIUM
Tradename Dosage Ingredient NDA Submissiondate
NAPROXEN SODIUM CAPSULE;ORAL naproxen sodium 021920 2017-11-15
NAPRELAN TABLET, EXTENDED RELEASE;ORAL naproxen sodium 020353

US Patents and Regulatory Information for naproxen sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glenmark Pharms Ltd NAPROXEN SODIUM naproxen sodium TABLET;ORAL 078314-001 Apr 27, 2007 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Contract Pharmacal NAPROXEN SODIUM naproxen sodium TABLET;ORAL 074635-001 Jan 13, 1997 OTC No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Sandoz NAPROXEN SODIUM naproxen sodium TABLET;ORAL 074162-002 Dec 21, 1993 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Amneal Pharms Ny NAPROXEN SODIUM naproxen sodium TABLET;ORAL 078432-002 Apr 25, 2007 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Able NAPROXEN SODIUM naproxen sodium TABLET;ORAL 076544-001 Aug 22, 2003 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Atnahs Pharma Us ANAPROX naproxen sodium TABLET;ORAL 018164-001 Approved Prior to Jan 1, 1982 ⤷  Try it Free ⤷  Try it Free
Atnahs Pharma Us ANAPROX DS naproxen sodium TABLET;ORAL 018164-003 Sep 30, 1987 ⤷  Try it Free ⤷  Try it Free
Atnahs Pharma Us ANAPROX DS naproxen sodium TABLET;ORAL 018164-003 Sep 30, 1987 ⤷  Try it Free ⤷  Try it Free
Almatica NAPRELAN naproxen sodium TABLET, EXTENDED RELEASE;ORAL 020353-001 Jan 5, 1996 ⤷  Try it Free ⤷  Try it Free
Atnahs Pharma Us ANAPROX DS naproxen sodium TABLET;ORAL 018164-003 Sep 30, 1987 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for naproxen sodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0984957 CR 2012 00035 Denmark ⤷  Try it Free PRODUCT NAME: ET KOMBINATIONSPRODUKT AF NAPROXEN OG ESOMEPRAZOL MAGNESIUM TRIHYDRAT; NAT. REG. NO/DATE: 49583 20120327; FIRST REG. NO/DATE: GB PL 17901/0263-001 20101105
1411900 C300481 Netherlands ⤷  Try it Free PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105
1411900 1190013-1 Sweden ⤷  Try it Free PRODUCT NAME: NAPROXEN OCH ESOMEPRAZOL; NAT. REG. NO/DATE: MTNR 43248 20101203; FIRST REG.: GB PL 17901/0263 20101105
1411900 SPC/GB11/015 United Kingdom ⤷  Try it Free PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0984957 PA2011005,C0984957 Lithuania ⤷  Try it Free PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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McKinsey
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Baxter
Moodys

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