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Last Updated: March 18, 2024

Naproxen sodium; sumatriptan succinate - Generic Drug Details


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What are the generic drug 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 Second Affiliated Hospital of Kunming Medical UniversityPhase 3
Second Hospital of Jilin UniversityPhase 3
Beijing Friendship 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
Currax TREXIMET naproxen sodium; sumatriptan succinate TABLET;ORAL 021926-002 May 14, 2015 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Sun Pharm SUMATRIPTAN AND NAPROXEN SODIUM naproxen sodium; sumatriptan succinate TABLET;ORAL 202803-001 Jul 20, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Currax TREXIMET naproxen sodium; sumatriptan succinate TABLET;ORAL 021926-001 Apr 15, 2008 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Aurobindo Pharma Ltd SUMATRIPTAN AND NAPROXEN SODIUM naproxen sodium; sumatriptan succinate TABLET;ORAL 207457-001 Feb 15, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rising SUMATRIPTAN AND NAPROXEN SODIUM naproxen sodium; sumatriptan succinate TABLET;ORAL 090872-001 Sep 4, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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; sumatriptan succinate

International Patents for naproxen sodium; sumatriptan succinate

Country Patent Number Title Estimated Expiration
Spain 2380827 ⤷  Try a Trial
Japan 2006515856 ⤷  Try a Trial
Canada 2509023 FORMES GALENIQUES MULTICOUCHES CONTENANT DES AINS ET DES TRIPTANES (MULTILAYER DOSAGE FORMS CONTAINING NSAIDS AND TRIPTANS) ⤷  Try a Trial
Mexico PA05006954 FORMAS DE DOSIFICACION DE CAPAS MULTIPLES QUE CONTIENEN NSAIDS Y TRIPTANOS. (Multilayer Dosage Forms Containing NSAIDs and Triptans.) ⤷  Try a Trial
Norway 336458 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for naproxen sodium; sumatriptan succinate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1411900 2011C/016 Belgium ⤷  Try a Trial PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214
1411900 2011/016 Ireland ⤷  Try a Trial PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
0984957 CR 2012 00035 Denmark ⤷  Try a Trial 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
1411900 1190013-1 Sweden ⤷  Try a Trial PRODUCT NAME: NAPROXEN OCH ESOMEPRAZOL; NAT. REG. NO/DATE: MTNR 43248 20101203; FIRST REG.: GB PL 17901/0263 20101105
1411900 SPC/GB11/015 United Kingdom ⤷  Try a Trial PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.