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TRACLEER Drug Profile

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Tracleer is a drug marketed by Actelion Pharms Ltd and is included in one NDA. It is available from one supplier. There is one patent protecting this drug.

This drug has forty-seven patent family members in thirty-six 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.

Summary for Tradename: TRACLEER

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Drug Prices: :see details

Pharmacology for Tradename: TRACLEER

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actelion Pharms Ltd
TRACLEER
bosentan
TABLET;ORAL021290-001Nov 20, 2001RXNo5,292,740► subscribe ► subscribe
Actelion Pharms Ltd
TRACLEER
bosentan
TABLET;ORAL021290-002Nov 20, 2001RXYes5,292,740► subscribe ► subscribe
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Expired Patents for Tradename: TRACLEER

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Actelion Pharms Ltd
TRACLEER
bosentan
TABLET;ORAL021290-001Nov 20, 20015,292,740► subscribe
Actelion Pharms Ltd
TRACLEER
bosentan
TABLET;ORAL021290-002Nov 20, 20015,292,740► subscribe
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International Patent Family for Tradename: TRACLEER

Country Document Number Estimated Expiration
South Africa9204126► subscribe
JapanH05222003► subscribe
Norway922323► 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
C0042France► subscribePRODUCT NAME: BOSENTAN MONOHYDRATE; NAT. REGISTRATION NO/DATE: EU/1/02/220/001 20020515; FIRST REGISTRATION: LI - 55841 20020228
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
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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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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