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Last Updated: February 4, 2023

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-seven 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:97
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 33
Patent Applications: 180
What excipients (inactive ingredients) are in bedaquiline fumarate?bedaquiline fumarate excipients list
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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Janssen Therap SIRTURO bedaquiline fumarate TABLET;ORAL 204384-002 May 27, 2020 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Janssen Therap SIRTURO bedaquiline fumarate TABLET;ORAL 204384-001 Dec 28, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Janssen Therap SIRTURO bedaquiline fumarate TABLET;ORAL 204384-001 Dec 28, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Janssen Therap SIRTURO bedaquiline fumarate TABLET;ORAL 204384-001 Dec 28, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for bedaquiline fumarate

Country Patent Number Title Estimated Expiration
Norway 20092535 See Plans and Pricing
South Africa 200500680 Quinoline derivatives and their use as mycrobacterial inhibitors See Plans and Pricing
Ukraine 97813 ФУМАРАТНАЯ СОЛЬ (АЛЬФА S, БЕТА R)-6-БРОМ-АЛЬФА-[2-(ДИМЕТИЛАМИНО)ЭТИЛ]-2-МЕТОКСИ-АЛЬФА-1-НАФТАЛЕНИЛ-БЕТА-ФЕНИЛ-3-ХИНОЛИНЭТАНОЛА;ФУМАРАТНА СІЛЬ (АЛЬФА S, БЕТА R)-6-БРОМ-АЛЬФА-[2-(ДИМЕТИЛАМІНО)ЕТИЛ]-2-МЕТОКСІ-АЛЬФА-1-НАФТАЛЕНІЛ-БЕТА-ФЕНІЛ-3-ХІНОЛІНЕТАНОЛУ (FUMARATE SALT OF (ALPHA S, BETA R)-6-BROMO-ALPHA-[2-(DIMETHYLAMINO)ETHYL]-2-METHOXY-ALPHA-1-NAPHTHALENYL-BETA-PHENYL-3-QUINOLINEETHANOL) See Plans and Pricing
African Regional IP Organization (ARIPO) 2498 Fumarate salt of (ALPHA S, BETA R)-6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-1-naphthalenyl-beta-phenyl-3-quinolineethanol See Plans and Pricing
China 101070304 Quinoline derivatives and their use as mycrobacterial inhibitors See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for bedaquiline fumarate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1527050 2014/045 Ireland See Plans and Pricing PRODUCT NAME: BEDAQUILINE, OR A PHARMACEUTICALLY ACCEPTABLE ACID OR BASE ADDITION SALT THEREOF, INCLUDING BEDAQUILINE FUMARATE; REGISTRATION NO/DATE: EU/1/13/901 20140305
1527050 178 5021-2014 Slovakia See Plans and Pricing PRODUCT NAME: BEDACHILIN FUMARAT; REGISTRATION NO/DATE: EU/1/13/901 20140305
1527050 C 2014 034 Romania See Plans and Pricing PRODUCT NAME: BEDAQUILINA SAU O SARE DE ADITIE A UNUI ACID SAU A UNEI BAZEACCEPTABILA FARMACEUTIC A IN-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 ACESTEIA, INCLUSIV FUMARAT DE BEDAQUILINA - FUMARAT DE BEDAQUILINA (1R,2S)-1-(6-BROMO-2-METOXIQUINOL
1527050 PA2014032 Lithuania See Plans and Pricing PRODUCT NAME: BEDAQUILINUM; REGISTRATION NO/DATE: EU/1/13/901 20140305
1527050 SPC/GB14/057 United Kingdom See Plans and Pricing PRODUCT NAME: BEDAQUILINE, OR A PHARMACEUTICALLY ACCEPTABLE ACID OR BASE ADDITION SALT THEREOF, INCLUDING BEDAQUILINE FUMARATE; REGISTERED: UK EU/1/13/901 20140307
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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