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Last Updated: August 10, 2020

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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 Inc, Catalent, Puracap Pharm Llc, Alvogen, 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, 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, Sun Pharm, and Currax, and is included in forty-seven NDAs. There are five 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 forty-two drug master file entries for naproxen sodium. One hundred and twenty-nine 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
National Institutes of Health (NIH)Phase 4
NorthShore University HealthSystemPhase 4
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Phase 4

See all NAPROXEN SODIUM clinical trials

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
Bionpharma Inc NAPROXEN SODIUM naproxen sodium CAPSULE;ORAL 021920-001 Feb 17, 2006 OTC Yes Yes   Start Trial   Start Trial Y   Start Trial
Teva NAPROXEN SODIUM naproxen sodium TABLET;ORAL 074142-002 Dec 21, 1993 DISCN No No   Start Trial   Start Trial   Start Trial
Roxane NAPROXEN SODIUM naproxen sodium TABLET;ORAL 074257-002 Dec 21, 1993 DISCN No No   Start Trial   Start Trial   Start Trial
Dr Reddys Labs Inc NAPROXEN SODIUM naproxen sodium TABLET;ORAL 075168-001 Jul 28, 1998 OTC No No   Start Trial   Start Trial   Start Trial
Sandoz NAPROXEN SODIUM naproxen sodium TABLET;ORAL 074495-001 Dec 5, 1994 DISCN No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd SUMATRIPTAN AND NAPROXEN SODIUM naproxen sodium; sumatriptan succinate TABLET;ORAL 207457-001 Feb 15, 2018 AB RX 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

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   Start Trial   Start Trial
Alvogen NAPRELAN naproxen sodium TABLET, EXTENDED RELEASE;ORAL 020353-001 Jan 5, 1996   Start Trial   Start Trial
Atnahs Pharma Us ANAPROX DS naproxen sodium TABLET;ORAL 018164-003 Sep 30, 1987   Start Trial   Start Trial
Alvogen NAPRELAN naproxen sodium TABLET, EXTENDED RELEASE;ORAL 020353-003 Jan 5, 1996   Start Trial   Start Trial
Atnahs Pharma Us ANAPROX DS naproxen sodium TABLET;ORAL 018164-003 Sep 30, 1987   Start Trial   Start Trial
Atnahs Pharma Us ANAPROX DS naproxen sodium TABLET;ORAL 018164-003 Sep 30, 1987   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for NAPROXEN SODIUM

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 122012000051 Germany   Start 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
1411900 C300481 Netherlands   Start Trial PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105
1411900 1190013-1 Sweden   Start Trial PRODUCT NAME: NAPROXEN OCH ESOMEPRAZOL; NAT. REG. NO/DATE: MTNR 43248 20101203; FIRST REG.: GB PL 17901/0263 20101105
1411900 122012000052 Germany   Start Trial PRODUCT NAME: NAPROXEN MIT ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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