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Last Updated: August 11, 2020

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NAPROXEN SODIUM Drug 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 Inc, Catalent, Puracap Pharm Llc, 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, 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, Apotex, P And L, and Perrigo R And D. and is included in forty-three NDAs. There are four 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. Twelve suppliers are listed for this compound. Additional details are available on the naproxen sodium; pseudoephedrine hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Naproxen Sodium

Annual sales in 2018 were $6mm indicating the motivation for generic entry (peak sales were $55mm in 2002).

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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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

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SponsorPhase
NorthShore University HealthSystemPhase 4
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Phase 4
National Institutes of Health (NIH)Phase 4

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Pharmacology for NAPROXEN SODIUM
Paragraph IV (Patent) Challenges for NAPROXEN SODIUM
Tradename Dosage Ingredient NDA Submissiondate
NAPROXEN SODIUM CAPSULE;ORAL naproxen sodium 021920 2017-11-15
NAPRELAN TABLET, EXTENDED RELEASE;ORAL naproxen sodium 020353

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
Pliva NAPROXEN SODIUM naproxen sodium TABLET;ORAL 074242-001 Jun 20, 1996 DISCN No No   Start Trial   Start Trial   Start Trial
Ivax Sub Teva Pharms NAPROXEN SODIUM naproxen sodium TABLET;ORAL 074230-001 Mar 14, 1995 DISCN No No   Start Trial   Start Trial   Start Trial
Sandoz NAPROXEN SODIUM naproxen sodium TABLET;ORAL 074162-002 Dec 21, 1993 DISCN No No   Start Trial   Start Trial   Start Trial
Watson Labs NAPROXEN SODIUM naproxen sodium TABLET;ORAL 074195-001 Dec 21, 1993 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for NAPROXEN SODIUM

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0984957 CR 2012 00035 Denmark   Start 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 SPC/GB11/015 United Kingdom   Start Trial PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0984957 PA2011005,C0984957 Lithuania   Start 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   Start 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:

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Johnson and Johnson
Express Scripts
McKinsey

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