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Generated: September 19, 2018

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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 naproxen sodium; sumatriptan succinate freedom to operate?

Naproxen sodium; sumatriptan succinate is the generic ingredient in two branded drugs marketed by Aurobindo Pharma Ltd, Mylan Pharms Inc, Sun Pharma Global, and Pernix Ireland Ltd, and is included in four NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are forty-two drug master file entries for naproxen sodium; sumatriptan succinate. Six suppliers are listed for this compound.

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
Pernix Ireland Ltd TREXIMET naproxen sodium; sumatriptan succinate TABLET;ORAL 021926-001 Apr 15, 2008 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Pharms Inc 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
Pernix Ireland Ltd TREXIMET naproxen sodium; sumatriptan succinate TABLET;ORAL 021926-001 Apr 15, 2008 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Pernix Ireland Ltd TREXIMET naproxen sodium; sumatriptan succinate TABLET;ORAL 021926-002 May 14, 2015 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pernix Ireland Ltd TREXIMET naproxen sodium; sumatriptan succinate TABLET;ORAL 021926-001 Apr 15, 2008 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pernix Ireland Ltd TREXIMET naproxen sodium; sumatriptan succinate TABLET;ORAL 021926-002 May 14, 2015 DISCN Yes 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

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Expired US Patents for naproxen sodium; sumatriptan succinate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pernix Ireland Ltd TREXIMET naproxen sodium; sumatriptan succinate TABLET;ORAL 021926-002 May 14, 2015 ➤ Sign Up ➤ Sign Up
Pernix Ireland Ltd TREXIMET naproxen sodium; sumatriptan succinate TABLET;ORAL 021926-001 Apr 15, 2008 ➤ Sign Up ➤ Sign Up
Pernix Ireland Ltd TREXIMET naproxen sodium; sumatriptan succinate TABLET;ORAL 021926-001 Apr 15, 2008 ➤ Sign Up ➤ Sign Up
Pernix Ireland Ltd TREXIMET naproxen sodium; sumatriptan succinate TABLET;ORAL 021926-001 Apr 15, 2008 ➤ Sign Up ➤ Sign Up
Pernix Ireland Ltd TREXIMET naproxen sodium; sumatriptan succinate TABLET;ORAL 021926-002 May 14, 2015 ➤ Sign Up ➤ Sign Up
Pernix Ireland Ltd TREXIMET naproxen sodium; sumatriptan succinate TABLET;ORAL 021926-002 May 14, 2015 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for naproxen sodium; sumatriptan succinate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00481 Netherlands ➤ Sign Up PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105
1411900/01 Switzerland ➤ Sign Up PRODUCT NAME: ESOMEPRAZOL + NAPROXEN; REGISTRATION NO/DATE: SWISSMEDIC 61330 06.05.2011
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,C0984957 Lithuania ➤ Sign Up PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
2011005 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Dow
Boehringer Ingelheim
QuintilesIMS
Accenture
Daiichi Sankyo
Cerilliant
Express Scripts
Harvard Business School

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