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Generated: December 17, 2017

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TREXIMET Drug Profile

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When do Treximet patents expire, and what generic alternatives are available?

Treximet is a drug marketed by Pernix Ireland Ltd and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-three patent family members in sixteen countries and ten supplementary protection certificates in eight countries.

The generic ingredient in TREXIMET is naproxen sodium; sumatriptan succinate. There are forty-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the naproxen sodium; sumatriptan succinate profile page.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pernix Ireland LtdTREXIMETnaproxen sodium; sumatriptan succinateTABLET;ORAL021926-002May 14, 2015RXYesNo► Subscribe► SubscribeY► Subscribe
Pernix Ireland LtdTREXIMETnaproxen sodium; sumatriptan succinateTABLET;ORAL021926-001Apr 15, 2008RXYesYes► Subscribe► SubscribeY► Subscribe
Pernix Ireland LtdTREXIMETnaproxen sodium; sumatriptan succinateTABLET;ORAL021926-002May 14, 2015RXYesNo► Subscribe► SubscribeY► Subscribe
Pernix Ireland LtdTREXIMETnaproxen sodium; sumatriptan succinateTABLET;ORAL021926-001Apr 15, 2008RXYesYes► Subscribe► SubscribeY► Subscribe
Pernix Ireland LtdTREXIMETnaproxen sodium; sumatriptan succinateTABLET;ORAL021926-002May 14, 2015RXYesNo► Subscribe► SubscribeY► Subscribe
Pernix Ireland LtdTREXIMETnaproxen sodium; sumatriptan succinateTABLET;ORAL021926-002May 14, 2015RXYesNo► Subscribe► SubscribeY► Subscribe
Pernix Ireland LtdTREXIMETnaproxen sodium; sumatriptan succinateTABLET;ORAL021926-002May 14, 2015RXYesNo► Subscribe► Subscribe► Subscribe
Pernix Ireland LtdTREXIMETnaproxen sodium; sumatriptan succinateTABLET;ORAL021926-002May 14, 2015RXYesNo► Subscribe► Subscribe► Subscribe
Pernix Ireland LtdTREXIMETnaproxen sodium; sumatriptan succinateTABLET;ORAL021926-001Apr 15, 2008RXYesYes► Subscribe► SubscribeY► Subscribe
Pernix Ireland LtdTREXIMETnaproxen sodium; sumatriptan succinateTABLET;ORAL021926-001Apr 15, 2008RXYesYes► Subscribe► SubscribeY► Subscribe
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Paragraph IV (Patent) Challenges for TREXIMET

Drugname Dosage Strength RLD Submissiondate
naproxen sodium and sumatriptan succinateTablets500 mg/85 mgTreximet (Correction)7/23/2008

International Patent Family for Tradename: TREXIMET

Country Document Number Estimated Expiration
Denmark1575566► Subscribe
Norway336458► Subscribe
Australia2003303631► Subscribe
Japan2006515856► Subscribe
Portugal1575566► Subscribe
World Intellectual Property Organization (WIPO)2004060355► Subscribe
Hong Kong1023517► Subscribe
Portugal957914► Subscribe
Japan2002255855► Subscribe
Japan3712420► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: TREXIMET

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2012 00035Denmark► SubscribePRODUCT 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
1411900/01Switzerland► SubscribePRODUCT NAME: ESOMEPRAZOL + NAPROXEN; REGISTRATION NO/DATE: SWISSMEDIC 61330 06.05.2011
2011005,C0984957Lithuania► SubscribePRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
C/GB11/015United Kingdom► SubscribePRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
00481Netherlands► SubscribePRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105
11/016Ireland► SubscribePRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
2012000051Germany► SubscribePRODUCT NAME: KOMBINATIONSPRODUKT UMFASSEND NAPROXEN UND ESOMEPRAZOL-MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105
2011005Lithuania► SubscribePRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
90013-1Sweden► SubscribePRODUCT NAME: NAPROXEN OCH ESOMEPRAZOL; NAT. REG. NO/DATE: MTNR 43248 20101203; FIRST REG.: GB PL 17901/0263 20101105
C/GB11/013United Kingdom► SubscribePRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
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Serving leading biopharmaceutical companies globally:

Colorcon
AstraZeneca
Novartis
Deloitte
Fish and Richardson
Cerilliant
Mallinckrodt
Cantor Fitzgerald
Express Scripts
Healthtrust

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 verifification 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.

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