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Bedaquiline fumarate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for bedaquiline fumarate?

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

Bedaquiline fumarate has eighty patent family members in thirty-eight countries.

One supplier is listed for this compound.

Summary for Generic Name: bedaquiline fumarate

Tradenames:1
Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Clinical Trials: see list236
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:bedaquiline fumarate at DailyMed

Pharmacology for Ingredient: bedaquiline fumarate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Therap
SIRTURO
bedaquiline fumarate
TABLET;ORAL204384-001Dec 28, 2012RXYesYes► Subscribe► Subscribe
Janssen Therap
SIRTURO
bedaquiline fumarate
TABLET;ORAL204384-001Dec 28, 2012RXYesYes8,546,428► SubscribeYY ► Subscribe
Janssen Therap
SIRTURO
bedaquiline fumarate
TABLET;ORAL204384-001Dec 28, 2012RXYesYes► Subscribe► Subscribe
Janssen Therap
SIRTURO
bedaquiline fumarate
TABLET;ORAL204384-001Dec 28, 2012RXYesYes7,498,343► SubscribeYY ► Subscribe
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International Patent Family for Ingredient: bedaquiline fumarate

Country Document Number Estimated Expiration
Slovenia2086940► Subscribe
South Korea20050033607► Subscribe
Denmark2086940► Subscribe
Iceland7620► Subscribe
Serbia52408► 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
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
2014032Lithuania► SubscribePRODUCT NAME: BEDAQUILINUM; REGISTRATION NO/DATE: EU/1/13/901 20140305
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
520Luxembourg► SubscribePRODUCT NAME: BEDAQUILINE, OU SON SEL D ADDITION D ACIDE OU DE BASE PHARMACEUTIQUEMENT ACCEPTABLE, Y COMPRIS LE FUMARATE DE BEDAQUILINE. FIRST REGISTRATION: 20140307
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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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