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Last Updated: August 5, 2021

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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 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, Granules, P And L, and Perrigo R And D. and is included in forty-four 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. Seven 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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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 ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Ivax Sub Teva Pharms NAPROXEN SODIUM naproxen sodium TABLET;ORAL 074230-001 Mar 14, 1995 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Sandoz NAPROXEN SODIUM naproxen sodium TABLET;ORAL 074162-002 Dec 21, 1993 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Watson Labs NAPROXEN SODIUM naproxen sodium TABLET;ORAL 074195-001 Dec 21, 1993 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Roxane NAPROXEN SODIUM naproxen sodium TABLET;ORAL 074257-001 Dec 21, 1993 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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
1411900 C01411900/01 Switzerland ⤷  Try it Free PRODUCT NAME: ESOMEPRAZOL + NAPROXEN; REGISTRATION NO/DATE: SWISSMEDIC 61330 06.05.2011
1411900 SPC/GB11/015 United Kingdom ⤷  Try it Free PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0984957 PA2011005 Lithuania ⤷  Try it Free PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
0984957 PA2011005,C0984957 Lithuania ⤷  Try it Free PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
1411900 2011/016 Ireland ⤷  Try it Free PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Baxter
Moodys
Johnson and Johnson
Express Scripts
McKinsey

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