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Last Updated: October 17, 2021

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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-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: 30
Patent Applications: 1
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 204384-002 May 27, 2020 RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Janssen Therap SIRTURO bedaquiline fumarate TABLET;ORAL 204384-002 May 27, 2020 RX Yes No ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
Janssen Therap SIRTURO bedaquiline fumarate TABLET;ORAL 204384-001 Dec 28, 2012 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Janssen Therap SIRTURO bedaquiline fumarate TABLET;ORAL 204384-001 Dec 28, 2012 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Janssen Therap SIRTURO bedaquiline fumarate TABLET;ORAL 204384-001 Dec 28, 2012 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Janssen Therap SIRTURO bedaquiline fumarate TABLET;ORAL 204384-002 May 27, 2020 RX Yes No ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
Janssen Therap SIRTURO bedaquiline fumarate TABLET;ORAL 204384-001 Dec 28, 2012 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
>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 50/2014 Austria ⤷  Try it Free PRODUCT NAME: BEDAQUILIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SAEURE- ODER BASENADDITIONSSALZ DAVON, EINSCHLIESSLICH BEDAQUILINFUMARAT; REGISTRATION NO/DATE: EU/1/13/901 20140307
1527050 CA 2014 00044 Denmark ⤷  Try it Free PRODUCT NAME: BEDAKILIN ELLER ET FARMACEUTISK ACCEPTABELT SYRE-ELLER BASEADDITIONSSALT DERAF, HERUNDER BEDAKILINFUMARAT; REG. NO/DATE: EU/1/13/901 20140305
1527050 PA2014032 Lithuania ⤷  Try it Free PRODUCT NAME: BEDAQUILINUM; REGISTRATION NO/DATE: EU/1/13/901 20140305
1527050 CR 2014 00044 Denmark ⤷  Try it Free PRODUCT NAME: BEDAKILIN ELLER ET FARMACEUTISK ACCEPTABELT SYRE- ELLER BASEADDITIONSSALT DERAF, HERUNDER BEDAKILINFUMARAT; REG. NO/DATE: EU/1/13/901 20140305
1527050 178 5021-2014 Slovakia ⤷  Try it Free PRODUCT NAME: BEDACHILIN FUMARAT; REGISTRATION NO/DATE: EU/1/13/901 20140305
1527050 92520 Luxembourg ⤷  Try it Free PRODUCT NAME: BEDAQUILINE, OU SON SEL D ADDITION D ACIDE OU DE BASE PHARMACEUTIQUEMENT ACCEPTABLE, Y COMPRIS LE FUMARATE DE BEDAQUILINE. FIRST REGISTRATION: 20140307
1527050 122014000083 Germany ⤷  Try it Free 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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Serving leading biopharmaceutical companies globally:

Merck
Moodys
McKesson
Harvard Business School
McKinsey
Baxter

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