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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Moodys
Citi
Medtronic
Harvard Business School
Federal Trade Commission
Fish and Richardson
Chubb
Deloitte
Farmers Insurance

Generated: February 19, 2018

DrugPatentWatch Database Preview

NAPROXEN SODIUM Drug Profile

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Which patents cover Naproxen Sodium, and what generic alternatives are available?

Naproxen Sodium is a drug marketed by Bionpharma Inc, 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, Perrigo, Pliva, Purepac Pharm, Roxane, Sandoz, Sun Pharm Inds Ltd, Teva, Teva Pharms, and Watson Labs. and is included in thirty-three NDAs. There are two 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.
Summary for NAPROXEN SODIUM
Drug patent expirations by year for NAPROXEN SODIUM
Pharmacology for NAPROXEN SODIUM

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
Sandoz NAPROXEN SODIUM naproxen sodium TABLET;ORAL 074162-002 Dec 21, 1993 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Perrigo NAPROXEN SODIUM naproxen sodium TABLET;ORAL 074661-001 Jan 13, 1997 OTC No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Teva Pharms NAPROXEN SODIUM naproxen sodium TABLET;ORAL 074289-002 Jan 27, 1994 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Teva NAPROXEN SODIUM naproxen sodium TABLET;ORAL 074198-001 Dec 21, 1993 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Watson Labs NAPROXEN SODIUM naproxen sodium TABLET;ORAL 074195-001 Dec 21, 1993 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Perrigo NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE naproxen sodium; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 076518-001 Mar 17, 2004 OTC No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Lnk Intl Inc NAPROXEN SODIUM naproxen sodium TABLET;ORAL 204872-001 Jan 23, 2017 OTC No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pliva NAPROXEN SODIUM naproxen sodium TABLET;ORAL 074242-001 Jun 20, 1996 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Marksans Pharma NAPROXEN SODIUM naproxen sodium TABLET;ORAL 090545-001 Mar 16, 2011 OTC No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Bionpharma Inc NAPROXEN SODIUM naproxen sodium CAPSULE;ORAL 021920-001 Feb 17, 2006 OTC Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for NAPROXEN SODIUM
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Capsules 200 mg ➤ Subscribe 11/15/2017

International Patents for NAPROXEN SODIUM

Supplementary Protection Certificates for NAPROXEN SODIUM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB11/013 United Kingdom ➤ Sign Up PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
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
90013-1 Sweden ➤ Sign Up PRODUCT NAME: NAPROXEN OCH ESOMEPRAZOL; NAT. REG. NO/DATE: MTNR 43248 20101203; FIRST REG.: GB PL 17901/0263 20101105
2012000051 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
2011005 Lithuania ➤ Sign Up PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
2011005,C0984957 Lithuania ➤ Sign Up PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
11/016 Ireland ➤ Sign Up PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
C/GB11/015 United Kingdom ➤ Sign Up PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
1411900/01 Switzerland ➤ Sign Up PRODUCT NAME: ESOMEPRAZOL + NAPROXEN; REGISTRATION NO/DATE: SWISSMEDIC 61330 06.05.2011
00481 Netherlands ➤ Sign Up PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
QuintilesIMS
Chubb
Queensland Health
Johnson and Johnson
Mallinckrodt
Colorcon
Chinese Patent Office
Teva

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