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Last Updated: December 1, 2022

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 Inc, Catalent, Puracap Pharm Llc, Strides Pharma, 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, Aurobindo Pharma, Rising, Sun Pharm, and Currax, and is included in forty-nine NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Naproxen sodium has sixteen patent family members in fourteen countries.

There are twenty-two drug master file entries for naproxen sodium. One hundred and twenty-nine 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
Hersh, Elliot V., DMD, MS, PhDPhase 4
University of PennsylvaniaPhase 4
Massachusetts General HospitalPhase 4

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
Watson Labs NAPROXEN SODIUM naproxen sodium TABLET;ORAL 074195-002 Dec 21, 1993 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Granules India NAPROXEN SODIUM naproxen sodium TABLET;ORAL 091353-001 Sep 20, 2011 OTC No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva NAPROXEN SODIUM naproxen sodium TABLET;ORAL 074142-001 Dec 21, 1993 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Actavis Labs Fl Inc NAPROXEN SODIUM naproxen sodium TABLET, EXTENDED RELEASE;ORAL 075416-001 Aug 27, 2002 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Almatica NAPRELAN naproxen sodium TABLET, EXTENDED RELEASE;ORAL 020353-003 Jan 5, 1996 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sun Pharm SUMATRIPTAN AND NAPROXEN SODIUM naproxen sodium; sumatriptan succinate TABLET;ORAL 202803-001 Jul 20, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 DS naproxen sodium TABLET;ORAL 018164-003 Sep 30, 1987 See Plans and Pricing See Plans and Pricing
Atnahs Pharma Us ANAPROX DS naproxen sodium TABLET;ORAL 018164-003 Sep 30, 1987 See Plans and Pricing See Plans and Pricing
Almatica NAPRELAN naproxen sodium TABLET, EXTENDED RELEASE;ORAL 020353-001 Jan 5, 1996 See Plans and Pricing See Plans and Pricing
Atnahs Pharma Us ANAPROX DS naproxen sodium TABLET;ORAL 018164-003 Sep 30, 1987 See Plans and Pricing See Plans and Pricing
Atnahs Pharma Us ANAPROX naproxen sodium TABLET;ORAL 018164-001 Approved Prior to Jan 1, 1982 See Plans and Pricing See Plans and Pricing
Atnahs Pharma Us ANAPROX naproxen sodium TABLET;ORAL 018164-001 Approved Prior to Jan 1, 1982 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for naproxen sodium

Country Patent Number Title Estimated Expiration
Hungary E030784 See Plans and Pricing
Spain 2606767 See Plans and Pricing
Mexico 2007011039 SISTEMA DE SOLVENTE PARA AUMENTAR LA SOLUBILIDAD DE AGENTES FARMACEUTICOS. (SOLVENT SYSTEM FOR ENHANCING THE SOLUBILITY OF PHARMACEUTICAL AGENTS.) See Plans and Pricing
Finland 1863458 See Plans and Pricing
Portugal 1863458 See Plans and Pricing
Lithuania 1863458 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for naproxen sodium

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1411900 18/2011 Austria See Plans and Pricing PRODUCT NAME: NAPROXEN UND ESOMEPRAZOL SOWIE DEREN PHARMAZEUTISCH ANNEHMBARE SALZE; NAT. REGISTRATION NO/DATE: 1-29937 20110105; FIRST REGISTRATION: GB PL 17901/0263-0001 20101105
1411900 2011/016 Ireland See Plans and Pricing 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 SPC/GB11/013 United Kingdom See Plans and Pricing PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0984957 PA2011005,C0984957 Lithuania See Plans and Pricing PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
1411900 C300481 Netherlands See Plans and Pricing PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105
1411900 SPC/GB11/015 United Kingdom See Plans and Pricing 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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