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Serving leading biopharmaceutical companies globally:

Citi
Mallinckrodt
Express Scripts
Federal Trade Commission
McKinsey
Daiichi Sankyo
Moodys
Farmers Insurance
Queensland Health
Deloitte

Generated: October 23, 2017

DrugPatentWatch Database Preview

Bosentan - Generic Drug Details

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What are the generic drug sources for bosentan and what is the scope of bosentan freedom to operate?

Bosentan
is the generic ingredient in one branded drug marketed by Actelion Pharms and Actelion Pharms Ltd, and is included in two NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are eighteen drug master file entries for bosentan. One supplier is listed for this compound.

Summary for Generic Name: bosentan

US Patents:2
Tradenames:1
Applicants:2
NDAs:2
Drug Master File Entries: see list18
Suppliers / Packagers: see list1
Bulk Api Vendors: see list66
Clinical Trials: see list115
Patent Applications: see list4,649
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:bosentan at DailyMed

Pharmacology for Ingredient: bosentan

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actelion Pharms Ltd
TRACLEER
bosentan
TABLET;ORAL021290-001Nov 20, 2001RXYesNo► Subscribe► Subscribe► 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
TRACLEER
bosentan
TABLET, FOR SUSPENSION;ORAL209279-001Sep 5, 2017RXYesYes► Subscribe► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: bosentan

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 Ingredient: bosentan

Country Document Number Estimated Expiration
Mexico2007014454► Subscribe
New Zealand564167► Subscribe
China101175484► Subscribe
South Africa200710903► Subscribe
South Korea20100093105► Subscribe
World Intellectual Property Organization (WIPO)2006123285► Subscribe
Denmark1883397► Subscribe
Hong Kong1120212► Subscribe
Russian Federation2010129460► Subscribe
Slovenia1883397► 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: BOSENTAN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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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Serving leading biopharmaceutical companies globally:

McKinsey
Novartis
Cantor Fitzgerald
Accenture
Boehringer Ingelheim
Chinese Patent Office
Moodys
Colorcon
US Department of Justice
Covington

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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