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Generated: May 20, 2019

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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-five 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:95
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1
Suppliers / Packagers: 1
Bulk Api Vendors: 18
DailyMed Link:bedaquiline fumarate at DailyMed
Pharmacology for bedaquiline fumarate
Synonyms for bedaquiline fumarate
(1R,2S)-1-(6-bromo-2-methoxyquinolin-3-yl)-4-(dimethylamino)-2-(1-naphthyl)-1-phenylbutan-2-ol bis[(2Z)-but-2-enedioate]
3-Quinolineethanol, 6-bromo-alpha-(2-(dimethylamino)ethyl)-2-methoxy-alpha-1-naphthalenyl- -phenyl-, (S,R)-, (2E)-2-butenedioate (1:1) (salt)
6-bromo-3-[(1R,2S)-4-(dimethylammonio)-2-hydroxy-2-(1-naphthyl)-1-phenylbutyl]-2-methoxyquinolinium (2E)-but-2-enedioate
845533-86-0
A1-04310
AC-28750
AKOS027326615
BCP11691
Bedaquiline (fumarate)
Bedaquiline fumarate (JAN/USAN)
Bedaquiline fumarate [USAN]
Bedaquiline fumarate; R403323
CHEBI:72295
CHEMBL2105700
CS-2922
D09873
EX-A2647
HY-14881A
KB-255911
P04QX2C1A5
R 403323
R-403323
R403323
SCHEMBL20496928
Sirturo
UNII-P04QX2C1A5

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 ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Janssen Therap SIRTURO bedaquiline fumarate TABLET;ORAL 204384-001 Dec 28, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Janssen Therap SIRTURO bedaquiline fumarate TABLET;ORAL 204384-001 Dec 28, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Supplementary Protection Certificates for bedaquiline fumarate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1527050 CR 2014 00044 Denmark ➤ Sign Up PRODUCT NAME: BEDAKILIN ELLER ET FARMACEUTISK ACCEPTABELT SYRE- ELLER BASEADDITIONSSALT DERAF, HERUNDER BEDAKILINFUMARAT; REG. NO/DATE: EU/1/13/901 20140305
1527050 122014000083 Germany ➤ Sign Up PRODUCT NAME: BEDAQUILIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SAEURE- ODER BASENADDITIONSSALZ DAVON; REGISTRATION NO/DATE: EU/1/13/901 20140305
1527050 178 5021-2014 Slovakia ➤ Sign Up PRODUCT NAME: BEDACHILIN FUMARAT; REGISTRATION NO/DATE: EU/1/13/901 20140305
1527050 PA2014032,C1527050 Lithuania ➤ Sign Up PRODUCT NAME: BEDAQUILINUM; REGISTRATION NO/DATE: EU/1/13/901 20140305
1527050 300684 Netherlands ➤ Sign Up PRODUCT NAME: BEDAQUILINE, OF EEN FARMACEUTISCH AANVAARDBAAR ZUUR- OF BASE-ADDITIEZOUT DAARVAN, WAARONDER BEDAQUILINEFUMARAAT; REGISTRATION NO/DATE: EU/1/13/901 20140307
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

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