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Serving leading biopharmaceutical companies globally:

Cipla
AstraZeneca
Harvard Business School
Baxter
Colorcon
Farmers Insurance
Cantor Fitzgerald
Accenture
McKesson
Moodys

Generated: November 22, 2017

DrugPatentWatch Database Preview

TRACLEER Drug Profile

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What is the patent landscape for Tracleer, and when can generic versions of Tracleer launch?

Tracleer is a drug marketed by Actelion Pharms and Actelion Pharms Ltd and is included in two NDAs. There are two patents protecting this drug.

This drug has twenty-seven patent family members in twenty-two countries and four supplementary protection certificates in four countries.

The generic ingredient in TRACLEER is bosentan. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the bosentan profile page.
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actelion Pharms
TRACLEER
bosentan
TABLET, FOR SUSPENSION;ORAL209279-001Sep 5, 2017RXYesYes► Subscribe► SubscribeY ► Subscribe
Actelion Pharms Ltd
TRACLEER
bosentan
TABLET;ORAL021290-002Nov 20, 2001RXYesYes► Subscribe► Subscribe► Subscribe
Actelion Pharms
TRACLEER
bosentan
TABLET, FOR SUSPENSION;ORAL209279-001Sep 5, 2017RXYesYes► Subscribe► SubscribeY ► Subscribe
Actelion Pharms Ltd
TRACLEER
bosentan
TABLET;ORAL021290-001Nov 20, 2001RXYesNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Tradename: TRACLEER

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Actelion Pharms Ltd
TRACLEER
bosentan
TABLET;ORAL021290-001Nov 20, 2001► Subscribe► Subscribe
Actelion Pharms Ltd
TRACLEER
bosentan
TABLET;ORAL021290-002Nov 20, 2001► Subscribe► Subscribe
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International Patent Family for Tradename: TRACLEER

Country Document Number Estimated Expiration
Germany602006011150► Subscribe
Cyprus1110610► Subscribe
Australia2006248593► Subscribe
Japan4219399► Subscribe
Mexico2007014454► Subscribe
Portugal1883397► Subscribe
Russian Federation2010129460► Subscribe
South Korea20100093105► Subscribe
Israel187383► Subscribe
Russian Federation2404774► 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: TRACLEER

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00097Netherlands► SubscribePRODUCT NAME: BOSENTAN, DESGEWENST IN DE VORM VAN EEN ZOUT OF EEN HYDRAAT OF IN DE VORM VAN EEN ESTER VAN DE HYDROXYLGROEP VAN DE 2-HYDROXYETHOXY REST MET EEN ZUUR MET DE FORMULE R5-OH, WAARIN R5 EEN C1-7-ALKANOYL, BENZOYL, OF HETEROCYCLYCARBONYL VOORSTELT; NATL. REGISTRATION NO/DATE: U/1/02/220/001 - 005 20020515; FIRST REGISTRATION: CH IKS 58841 01 - 02 20020228
90017-3Sweden► SubscribePRODUCT NAME: BOSENTAN ELLER ETT SALT DAERAV; NAT. REGISTZRATION NO/DATE: EU/1/02/220/001 20020515; FIRST REGISTRATION: CH 55841 01 20020228
C0042France► SubscribePRODUCT NAME: BOSENTAN MONOHYDRATE; NAT. REGISTRATION NO/DATE: EU/1/02/220/001 20020515; FIRST REGISTRATION: LI - 55841 20020228
C/GB02/030United Kingdom► SubscribePRODUCT NAME: BOSENTAN 4-(1,1-DIMETHYLETHYL)-N-(6-(2-HYDROXYETHOXY)-5-(2-METHOXYPHENOXY)-2(PYRIMIDIN-2-YL)PYRIMIDIN-4-YL)BENZENESULFONAMIDE AND ITS PHARMACEUTICALLY ACCEPTABLE SALTS
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Serving leading biopharmaceutical companies globally:

Deloitte
Healthtrust
Argus Health
Julphar
Dow
Fish and Richardson
Johnson and Johnson
US Department of Justice
Accenture
Merck

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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