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Last Updated: April 16, 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-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
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
Sandoz NAPROXEN SODIUM naproxen sodium TABLET;ORAL 074162-002 Dec 21, 1993 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sciegen Pharms Inc NAPROXEN SODIUM naproxen sodium TABLET;ORAL 212199-002 Oct 30, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lnk Intl Inc NAPROXEN SODIUM naproxen sodium TABLET;ORAL 204872-001 Jan 23, 2017 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz NAPROXEN SODIUM naproxen sodium TABLET;ORAL 074495-001 Dec 5, 1994 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bayer ALEVE naproxen sodium TABLET;ORAL 020204-002 Jan 11, 1994 OTC Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Twi Pharms NAPRELAN naproxen sodium TABLET, EXTENDED RELEASE;ORAL 020353-001 Jan 5, 1996 AB RX Yes 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 020353-003 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 naproxen sodium TABLET;ORAL 018164-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for naproxen sodium

Country Patent Number Title Estimated Expiration
Poland 1863458 ⤷  Try a Trial
European Patent Office 3061447 SYSTÈME DE SOLVANT DESTINÉ À AMÉLIORER LA SOLUBILITÉ D'AGENTS PHARMACEUTIQUES (SOLVENT SYSTEM FOR ENHANCING THE SOLUBILITY OF PHARMACEUTICAL AGENTS) ⤷  Try a Trial
European Patent Office 1863458 SYSTEME DE SOLVANT DESTINE A AMELIORER LA SOLUBILITE DES AGENTS PHARMACEUTIQUES (SOLVENT SYSTEM FOR ENHANCING THE SOLUBILITY OF PHARMACEUTICAL AGENTS) ⤷  Try a Trial
China 102940887 Solvent system for enhancing the solubility of pharmaceutical agents ⤷  Try a Trial
Denmark 1863458 ⤷  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 C300481 Netherlands ⤷  Try a Trial PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105
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
1411900 122012000052 Germany ⤷  Try a Trial PRODUCT NAME: NAPROXEN MIT ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105
1411900 SPC/GB11/015 United Kingdom ⤷  Try a Trial PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
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 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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