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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

Drug Class

Diarylquinoline Antimycobacterial

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			Y	Y
Janssen Therap	SIRTURO	bedaquiline fumarate	TABLET;ORAL	204384-001	Dec 28, 2012		RX	Yes	Yes
Janssen Therap	SIRTURO	bedaquiline fumarate	TABLET;ORAL	204384-001	Dec 28, 2012		RX	Yes	Yes			Y	Y

International Patents for bedaquiline fumarate

Country	Patent Number	Estimated Expiration
Brazil	PI0312927
Uruguay	30762
Luxembourg	92520
Israel	166457
Jordan	2973

Supplementary Protection Certificates for bedaquiline fumarate

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