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Serving leading biopharmaceutical companies globally:

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Farmers Insurance
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Generated: November 18, 2017

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Bedaquiline fumarate - Generic Drug Details

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What are the generic sources for bedaquiline fumarate and what is the scope of bedaquiline fumarate patent protection?

Bedaquiline fumarate
is the generic ingredient in one branded drug marketed by Janssen Therap and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Bedaquiline fumarate has ninety-two patent family members in thirty-nine countries and twelve supplementary protection certificates in nine countries.

One supplier is listed for this compound.

Summary for bedaquiline fumarate

Pharmacology for bedaquiline fumarate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Therap
SIRTURO
bedaquiline fumarate
TABLET;ORAL204384-001Dec 28, 2012RXYesYes► Subscribe► SubscribeYY ► Subscribe
Janssen Therap
SIRTURO
bedaquiline fumarate
TABLET;ORAL204384-001Dec 28, 2012RXYesYes► Subscribe► Subscribe► Subscribe
Janssen Therap
SIRTURO
bedaquiline fumarate
TABLET;ORAL204384-001Dec 28, 2012RXYesYes► Subscribe► Subscribe► Subscribe
Janssen Therap
SIRTURO
bedaquiline fumarate
TABLET;ORAL204384-001Dec 28, 2012RXYesYes► Subscribe► SubscribeYY ► Subscribe
Janssen Therap
SIRTURO
bedaquiline fumarate
TABLET;ORAL204384-001Dec 28, 2012RXYesYes► Subscribe► SubscribeYY ► Subscribe
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International Patent Family for Ingredient: bedaquiline fumarate

Country Document Number Estimated Expiration
Slovenia2086940► Subscribe
Israel166457► Subscribe
Mexico2009005909► Subscribe
European Patent Office2086940► Subscribe
Israel202655► Subscribe
China101070304► Subscribe
African Regional IP Organization (ARIPO)2498► Subscribe
Ukraine97813► Subscribe
Hong Kong1083496► Subscribe
New Zealand538391► 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: BEDAQUILINE FUMARATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014032Lithuania► SubscribePRODUCT NAME: BEDAQUILINUM; REGISTRATION NO/DATE: EU/1/13/901 20140305
8 5021-2014Slovakia► SubscribePRODUCT NAME: BEDACHILIN FUMARAT; REGISTRATION NO/DATE: EU/1/13/901 20140305
2014 00044Denmark► SubscribePRODUCT NAME: BEDAKILIN ELLER ET FARMACEUTISK ACCEPTABELT SYRE-ELLER BASEADDITIONSSALT DERAF, HERUNDER BEDAKILINFUMARAT; REG. NO/DATE: EU/1/13/901 20140305
2014 00044Denmark► SubscribePRODUCT NAME: BEDAKILIN ELLER ET FARMACEUTISK ACCEPTABELT SYRE- ELLER BASEADDITIONSSALT DERAF, HERUNDER BEDAKILINFUMARAT; REG. NO/DATE: EU/1/13/901 20140305
C0060France► SubscribePRODUCT NAME: BEDAQUILINE OU UN DE SES SELS D'ADDITION D'ACIDE OU DE BASE PHARMACEUTIQUEMENT ACCEPTABLE, Y COMPRIS LE FUMARATE DE BEDAQUILINE; REGISTRATION NO/DATE: EU/1/13/901 20140307
0684Netherlands► SubscribePRODUCT NAME: BEDAQUILINE, OF EEN FARMACEUTISCH AANVAARDBAAR ZUUR- OF BASE-ADDITIEZOUT DAARVAN, WAARONDER BEDAQUILINEFUMARAAT; REGISTRATION NO/DATE: EU/1/13/901 20140307
0140026 00112Estonia► SubscribePRODUCT NAME: BEDAKVILIIN;REG NO/DATE: K(2014)1616 (LOPLIK) 07.03.2014
90050-0Sweden► SubscribePRODUCT NAME: BEDAQUILINE, OR A PHARMACEUTICALLY ACCEPTABLE ACID OR BASE ADDITION SALT THEREOF, INCLUDING BEDAQUILINE FUMARATE; REG. NO/DATE: EU/1/13/901 20140305
00684Netherlands► SubscribePRODUCT NAME: BEDAQUILINE, OF EEN FARMACEUTISCH AANVAARDBAAR ZUUR- OF BASE-ADDITIEZOUT DAARVAN, WAARONDER BEDAQUILINEFUMARAAT; REGISTRATION NO/DATE: EU/1/13/901 20140307
14/045Ireland► SubscribePRODUCT NAME: BEDAQUILINE, OR A PHARMACEUTICALLY ACCEPTABLE ACID OR BASE ADDITION SALT THEREOF, INCLUDING BEDAQUILINE FUMARATE; REGISTRATION NO/DATE: EU/1/13/901 20140305
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Serving leading biopharmaceutical companies globally:

AstraZeneca
Chinese Patent Office
Harvard Business School
Boehringer Ingelheim
Federal Trade Commission
Mallinckrodt
Cipla
Deloitte
Chubb
McKinsey

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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