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Last Updated: March 19, 2024

NAPROXEN SODIUM Drug Patent Profile


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When do Naproxen Sodium patents expire, and what generic alternatives are available?

Naproxen Sodium is a drug marketed by Bionpharma, Catalent, Patheon Softgels, Puracap Pharm Llc, Strides Pharma, Actavis Labs Fl Inc, 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, Amneal Pharms Co, Corepharma, Granules, P And L, Perrigo R And D, and Aurobindo Pharma. and is included in forty-eight NDAs. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has fifteen patent family members in thirteen countries.

The generic ingredient in NAPROXEN SODIUM is naproxen sodium; pseudoephedrine hydrochloride. There are forty-two drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the naproxen sodium; pseudoephedrine hydrochloride profile page.

Drug patent expirations by year for NAPROXEN SODIUM
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

NAPROXEN SODIUM is protected by eight US patents.

Patents protecting NAPROXEN SODIUM

Liquid dosage forms of sodium naproxen
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TEMPORARY RELIEF OF MINOR ACHES AND PAINS

Liquid dosage forms of sodium naproxen
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TEMPORARY REDUCTION OF FEVER

Liquid dosage forms of sodium naproxen
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TEMPORARY RELIEF OF MINOR ACHES AND PAINS

Liquid dosage forms of sodium naproxen
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TEMPORARY REDUCTION OF FEVER

Liquid dosage forms of sodium naproxen
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TEMPORARY RELIEF OF MINOR ACHES AND PAINS

Liquid dosage forms of sodium naproxen
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TEMPORARY REDUCTION OF FEVER

Solvent system for enhancing the solubility of pharmaceutical agents
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Liquid dosage forms of sodium naproxen
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  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
Granules NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride; naproxen sodium TABLET;ORAL 213663-001 Sep 24, 2020 OTC No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan NAPROXEN SODIUM naproxen sodium TABLET;ORAL 074367-001 Aug 31, 1994 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hamilton Pharms NAPROXEN SODIUM naproxen sodium TABLET;ORAL 074106-001 Aug 31, 1993 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Purepac Pharm NAPROXEN SODIUM naproxen sodium TABLET;ORAL 074319-002 Mar 20, 1995 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva NAPROXEN SODIUM naproxen sodium TABLET;ORAL 074198-001 Dec 21, 1993 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pld Acquisitions Llc NAPROXEN SODIUM naproxen sodium TABLET;ORAL 074646-001 Jan 13, 1997 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for NAPROXEN SODIUM

See the table below for patents covering NAPROXEN SODIUM around the world.

Country Patent Number Title Estimated Expiration
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
Portugal 1863458 ⤷  Try a Trial
Denmark 1863458 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2006096580 ⤷  Try a Trial
Poland 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
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NAPROXEN SODIUM

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
0984957 122012000051 Germany ⤷  Try a Trial 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
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
1411900 2011C/016 Belgium ⤷  Try a Trial PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214
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 18/2011 Austria ⤷  Try a Trial 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
0984957 PA2011005 Lithuania ⤷  Try a Trial 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.