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Last Updated: February 22, 2024

Naproxen sodium - Generic Drug Details


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What are the generic drug sources for naproxen sodium and what is the scope of freedom to operate?

Naproxen sodium is the generic ingredient in nine branded drugs marketed by Bionpharma, Catalent, Patheon Softgels, Puracap Pharm Llc, Strides Pharma, Twi Pharms, 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, Hetero Labs Ltd V, 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, Aurobindo Pharma, Rising, Sun Pharm, and Currax, and is included in fifty-one NDAs. There are six 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 twenty-two drug master file entries for naproxen sodium. One hundred and thirty-six 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
Johnson & Johnson Consumer Inc. (J&JCI)Phase 1
Johnson & Johnson Consumer Inc. (J&JCI)Phase 3
Ciusss de L'Est de l'Île de MontréalN/A

See all naproxen sodium clinical trials

Pharmacology for naproxen sodium
Paragraph IV (Patent) Challenges for NAPROXEN SODIUM
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
NAPROXEN SODIUM Capsules naproxen sodium 200 mg 021920 1 2017-11-15

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
Dr Reddys Labs Inc NAPROXEN SODIUM naproxen sodium TABLET;ORAL 075168-001 Jul 28, 1998 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma NAPROXEN SODIUM naproxen sodium TABLET;ORAL 074480-001 May 14, 1996 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE naproxen sodium; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 211360-001 Jun 1, 2022 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Roxane NAPROXEN SODIUM naproxen sodium TABLET;ORAL 074257-001 Dec 21, 1993 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz NAPROXEN SODIUM naproxen sodium TABLET;ORAL 074495-002 Dec 5, 1994 DISCN 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 sodium

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

International Patents for naproxen sodium

Country Patent Number Title Estimated Expiration
Canada 2600023 SYSTEME DE SOLVANT DESTINE A AMELIORER LA SOLUBILITE DES AGENTS PHARMACEUTIQUES (SOLVENT SYSTEM FOR ENHANCING THE SOLUBILITY OF PHARMACEUTICAL AGENTS) ⤷  Try a Trial
Slovenia 1863458 ⤷  Try a Trial
Hungary E030784 ⤷  Try a Trial
Mexico 2007011039 SISTEMA DE SOLVENTE PARA AUMENTAR LA SOLUBILIDAD DE AGENTES FARMACEUTICOS. (SOLVENT SYSTEM FOR ENHANCING THE SOLUBILITY OF PHARMACEUTICAL AGENTS.) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2006096580 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for naproxen sodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1411900 2011/016 Ireland ⤷  Try a Trial PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
0984957 PA2011005 Lithuania ⤷  Try a Trial PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
0984957 CR 2012 00035 Denmark ⤷  Try a Trial 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
0984957 PA2011005,C0984957 Lithuania ⤷  Try a Trial PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
0984957 SPC/GB11/013 United Kingdom ⤷  Try a Trial PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
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Dow
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