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Last Updated: September 21, 2020

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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 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-six patent family members in thirty-nine countries.

There is one drug master file entry for bedaquiline fumarate. One supplier is listed for this compound.

Summary for bedaquiline fumarate
International Patents:96
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1
Suppliers / Packagers: 1
Bulk Api Vendors: 23
Patent Applications: 1
DailyMed Link:bedaquiline fumarate at DailyMed
Pharmacology for bedaquiline fumarate

US Patents and Regulatory Information 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;ORAL 204384-001 Dec 28, 2012 RX Yes Yes   Start Trial   Start Trial   Start Trial
Janssen Therap SIRTURO bedaquiline fumarate TABLET;ORAL 204384-002 May 27, 2020 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Janssen Therap SIRTURO bedaquiline fumarate TABLET;ORAL 204384-001 Dec 28, 2012 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Janssen Therap SIRTURO bedaquiline fumarate TABLET;ORAL 204384-002 May 27, 2020 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for bedaquiline fumarate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1527050 178 5021-2014 Slovakia   Start Trial PRODUCT NAME: BEDACHILIN FUMARAT; REGISTRATION NO/DATE: EU/1/13/901 20140305
1527050 C 2014 034 Romania   Start Trial PRODUCT NAME: BEDAQUILINA SAU O SARE DE ADITIE A UNUI ACID SAU A UNEI BAZEACCEPTABILA FARMACEUTIC A ACESTEIA, INCLUSIV FUMARAT DE BEDAQUILINA - FUMARAT DE BEDAQUILINA (1R,2S)-1-(6-BROMO-2-METOXIQUINOLIN-3-IL)-4-(DIMETILAMINO)-2-(NAFTALEN-1-IL)-1-FENILBUTAN-2-OL; NATIONAL AUTHORISATION NUMBER: EU/1/13/901; DATE OF NATIONAL AUTHORISATION: 20140305; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/901; DATE OF FIRST AUTHORISATION IN EEA: 20140305
1527050 C300684 Netherlands   Start Trial PRODUCT NAME: BEDAQUILINE, OF EEN FARMACEUTISCH AANVAARDBAAR ZUUR- OF BASE-ADDITIEZOUT DAARVAN, WAARONDER BEDAQUILINEFUMARAAT; REGISTRATION NO/DATE: EU/1/13/901 20140307
1527050 122014000083 Germany   Start Trial PRODUCT NAME: BEDAQUILIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SAEURE- ODER BASENADDITIONSSALZ DAVON; REGISTRATION NO/DATE: EU/1/13/901 20140305
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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