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Last Updated: August 6, 2020

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NAPROSYN Drug Profile

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When do Naprosyn patents expire, and when can generic versions of Naprosyn launch?

Naprosyn is a drug marketed by Atnahs Pharma Us and is included in two NDAs.

The generic ingredient in NAPROSYN is naproxen. There are forty-two drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the naproxen profile page.

US ANDA Litigation and Generic Entry Outlook for Naprosyn

A generic version of NAPROSYN was approved as naproxen by TEVA on December 21st, 1993.

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Drug patent expirations by year for NAPROSYN
Drug Prices for NAPROSYN

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Recent Clinical Trials for NAPROSYN

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SponsorPhase
Western University, CanadaN/A
Antibe Therapeutics Inc.Phase 1/Phase 2
BioHealthonomics Inc.Phase 2

See all NAPROSYN clinical trials

Pharmacology for NAPROSYN

US Patents and Regulatory Information for NAPROSYN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Atnahs Pharma Us NAPROSYN naproxen SUSPENSION;ORAL 018965-001 Mar 23, 1987 AB RX Yes No   Start Trial   Start Trial   Start Trial
Atnahs Pharma Us NAPROSYN naproxen TABLET;ORAL 017581-004 Apr 15, 1982 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Atnahs Pharma Us NAPROSYN naproxen TABLET;ORAL 017581-002 Approved Prior to Jan 1, 1982 DISCN Yes 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 NAPROSYN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Atnahs Pharma Us NAPROSYN naproxen TABLET;ORAL 017581-004 Apr 15, 1982   Start Trial   Start Trial
Atnahs Pharma Us NAPROSYN naproxen TABLET;ORAL 017581-003 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Atnahs Pharma Us NAPROSYN naproxen TABLET;ORAL 017581-002 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for NAPROSYN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 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
1411900 C300481 Netherlands   Start Trial PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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