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Serving leading biopharmaceutical companies globally:

Harvard Business School
Federal Trade Commission
Covington
Chubb
Colorcon
Medtronic
Cerilliant
Queensland Health
McKinsey
Novartis

Generated: February 25, 2018

DrugPatentWatch Database Preview

TRACLEER Drug Profile

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When do Tracleer patents expire, 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.

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.

US Patents and Regulatory Information for TRACLEER

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;ORAL 209279-001 Sep 5, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Actelion Pharms TRACLEER bosentan TABLET, FOR SUSPENSION;ORAL 209279-001 Sep 5, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Actelion Pharms TRACLEER bosentan TABLET, FOR SUSPENSION;ORAL 209279-001 Sep 5, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Actelion Pharms TRACLEER bosentan TABLET, FOR SUSPENSION;ORAL 209279-001 Sep 5, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Actelion Pharms Ltd TRACLEER bosentan TABLET;ORAL 021290-002 Nov 20, 2001 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Actelion Pharms Ltd TRACLEER bosentan TABLET;ORAL 021290-001 Nov 20, 2001 RX 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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International Patents for TRACLEER

Supplementary Protection Certificates for TRACLEER

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90017-3 Sweden ➤ Sign Up PRODUCT NAME: BOSENTAN ELLER ETT SALT DAERAV; NAT. REGISTZRATION NO/DATE: EU/1/02/220/001 20020515; FIRST REGISTRATION: CH 55841 01 20020228
C0042 France ➤ Sign Up PRODUCT NAME: BOSENTAN MONOHYDRATE; NAT. REGISTRATION NO/DATE: EU/1/02/220/001 20020515; FIRST REGISTRATION: LI - 55841 20020228
00097 Netherlands ➤ Sign Up PRODUCT 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
C/GB02/030 United Kingdom ➤ Sign Up PRODUCT 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Express Scripts
McKesson
Julphar
Federal Trade Commission
US Army
Cantor Fitzgerald
Chubb
Cipla

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