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Last Updated: November 2, 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, Norvium Bioscience, 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-three 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 AND PSEUDOEPHEDRINE HYDROCHLORIDE naproxen sodium; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 077381-001 Sep 27, 2006 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Twi Pharms NAPRELAN naproxen sodium TABLET, EXTENDED RELEASE;ORAL 020353-002 Jan 5, 1996 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Actavis Labs Fl Inc NAPROXEN SODIUM naproxen sodium TABLET, EXTENDED RELEASE;ORAL 075416-002 Apr 23, 2003 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dr Reddys Labs Ltd NAPROXEN SODIUM naproxen sodium TABLET;ORAL 078486-001 Jul 26, 2007 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Granules India NAPROXEN SODIUM naproxen sodium TABLET;ORAL 091353-001 Sep 20, 2011 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Twi Pharms NAPRELAN naproxen sodium TABLET, EXTENDED RELEASE;ORAL 020353-001 Jan 5, 1996 ⤷  Sign Up ⤷  Sign Up
Atnahs Pharma Us ANAPROX DS naproxen sodium TABLET;ORAL 018164-003 Sep 30, 1987 ⤷  Sign Up ⤷  Sign Up
Atnahs Pharma Us ANAPROX DS naproxen sodium TABLET;ORAL 018164-003 Sep 30, 1987 ⤷  Sign Up ⤷  Sign Up
Twi Pharms NAPRELAN naproxen sodium TABLET, EXTENDED RELEASE;ORAL 020353-003 Jan 5, 1996 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for NAPROXEN SODIUM

Country Patent Number Title Estimated Expiration
Spain 2606767 ⤷  Sign Up
Hungary E030784 ⤷  Sign Up
European Patent Office 3061447 SYSTÈME DE SOLVANT DESTINÉ À AMÉLIORER LA SOLUBILITÉ D'AGENTS PHARMACEUTIQUES (SOLVENT SYSTEM FOR ENHANCING THE SOLUBILITY OF PHARMACEUTICAL AGENTS) ⤷  Sign Up
Denmark 1863458 ⤷  Sign Up
Slovenia 1863458 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NAPROXEN SODIUM

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0984957 122012000051 Germany ⤷  Sign Up PRODUCT NAME: KOMBINATIONSPRODUKT UMFASSEND NAPROXEN UND ESOMEPRAZOL-MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105
1411900 2011C/016 Belgium ⤷  Sign Up PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214
0984957 CR 2012 00035 Denmark ⤷  Sign Up 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 ⤷  Sign Up PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105
0984957 PA2011005,C0984957 Lithuania ⤷  Sign Up 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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