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Serving leading biopharmaceutical companies globally:

Express Scripts
Cipla
Daiichi Sankyo
Deloitte
Federal Trade Commission
Covington
Moodys
Dow
Johnson and Johnson
Teva

Generated: October 20, 2017

DrugPatentWatch Database Preview

TREXIMET Drug Profile

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What is the patent landscape for Treximet, and what generic Treximet 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.

Summary for Tradename: TREXIMET

US Patents:5
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Clinical Trials: see list22
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:TREXIMET at DailyMed
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;ORAL021926-002May 14, 2015RXYesNo► Subscribe► SubscribeY► Subscribe
Pernix Ireland Ltd
TREXIMET
naproxen sodium; sumatriptan succinate
TABLET;ORAL021926-001Apr 15, 2008RXYesYes► Subscribe► SubscribeY► Subscribe
Pernix Ireland Ltd
TREXIMET
naproxen sodium; sumatriptan succinate
TABLET;ORAL021926-002May 14, 2015RXYesNo► Subscribe► SubscribeY► Subscribe
Pernix Ireland Ltd
TREXIMET
naproxen sodium; sumatriptan succinate
TABLET;ORAL021926-001Apr 15, 2008RXYesYes► Subscribe► SubscribeY► Subscribe
Pernix Ireland Ltd
TREXIMET
naproxen sodium; sumatriptan succinate
TABLET;ORAL021926-002May 14, 2015RXYesNo► Subscribe► SubscribeY► Subscribe
Pernix Ireland Ltd
TREXIMET
naproxen sodium; sumatriptan succinate
TABLET;ORAL021926-002May 14, 2015RXYesNo► Subscribe► SubscribeY► Subscribe
Pernix Ireland Ltd
TREXIMET
naproxen sodium; sumatriptan succinate
TABLET;ORAL021926-002May 14, 2015RXYesNo► Subscribe► Subscribe► Subscribe
Pernix Ireland Ltd
TREXIMET
naproxen sodium; sumatriptan succinate
TABLET;ORAL021926-002May 14, 2015RXYesNo► Subscribe► Subscribe► Subscribe
Pernix Ireland Ltd
TREXIMET
naproxen sodium; sumatriptan succinate
TABLET;ORAL021926-001Apr 15, 2008RXYesYes► Subscribe► SubscribeY► Subscribe
Pernix Ireland Ltd
TREXIMET
naproxen sodium; sumatriptan succinate
TABLET;ORAL021926-001Apr 15, 2008RXYesYes► Subscribe► SubscribeY► Subscribe
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Expired Patents for Tradename: TREXIMET

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pernix Ireland Ltd
TREXIMET
naproxen sodium; sumatriptan succinate
TABLET;ORAL021926-001Apr 15, 2008► Subscribe► 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
MexicoPA05006954► Subscribe
European Patent Office1575566► Subscribe
Spain2380827► Subscribe
Cyprus1112640► Subscribe
Austria286393► Subscribe
Norway20053193► Subscribe
Australia711741► Subscribe
Australia2003303631► Subscribe
Israel169041► 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
2011005,C0984957Lithuania► SubscribePRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126
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
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
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
C/GB11/015United Kingdom► SubscribePRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
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
00481Netherlands► SubscribePRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105
1411900/01Switzerland► SubscribePRODUCT NAME: ESOMEPRAZOL + NAPROXEN; REGISTRATION NO/DATE: SWISSMEDIC 61330 06.05.2011
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Covington
Baxter
Teva
UBS
Citi
McKesson
Cerilliant
Farmers Insurance
US Army

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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