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Last Updated: July 16, 2024

NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE - Generic Drug Details


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What are the generic sources for naproxen sodium; sumatriptan succinate and what is the scope of freedom to operate?

Naproxen sodium; sumatriptan succinate is the generic ingredient in two branded drugs marketed by Aurobindo Pharma Ltd, Rising, Sun Pharm, and Currax, and is included in four NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Naproxen sodium; sumatriptan succinate has sixteen patent family members in fourteen countries.

Five suppliers are listed for this compound.

Summary for NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE
Recent Clinical Trials for NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
The Affiliated Hospital of Qingdao UniversityPhase 3
Jiangsu Provincial People's HospitalPhase 3
West China HospitalPhase 3

See all NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE clinical trials

Paragraph IV (Patent) Challenges for NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TREXIMET Tablets naproxen sodium; sumatriptan succinate 500 mg/85 mg 021926 1 2008-07-23

US Patents and Regulatory Information for NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Rising SUMATRIPTAN AND NAPROXEN SODIUM naproxen sodium; sumatriptan succinate TABLET;ORAL 090872-001 Sep 4, 2018 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Currax TREXIMET naproxen sodium; sumatriptan succinate TABLET;ORAL 021926-001 Apr 15, 2008 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Aurobindo Pharma Ltd SUMATRIPTAN AND NAPROXEN SODIUM naproxen sodium; sumatriptan succinate TABLET;ORAL 207457-001 Feb 15, 2018 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Currax TREXIMET naproxen sodium; sumatriptan succinate TABLET;ORAL 021926-002 May 14, 2015 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Sun Pharm SUMATRIPTAN AND NAPROXEN SODIUM naproxen sodium; sumatriptan succinate TABLET;ORAL 202803-001 Jul 20, 2018 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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; SUMATRIPTAN SUCCINATE

Supplementary Protection Certificates for NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1411900 C300481 Netherlands ⤷  Sign Up PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105
1411900 2011C/016 Belgium ⤷  Sign Up PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214
0984957 SPC/GB11/013 United Kingdom ⤷  Sign Up PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
1411900 SPC/GB11/015 United Kingdom ⤷  Sign Up PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0984957 PA2011005,C0984957 Lithuania ⤷  Sign Up PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
0984957 PA2011005 Lithuania ⤷  Sign Up PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
1411900 122012000052 Germany ⤷  Sign Up 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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