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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-one 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:	91
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	43
Patent Applications:	34
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

AC-28750

AK322169

AKOS027326615

Bedaquiline (fumarate)

Bedaquiline fumarate (JAN/USAN)

Bedaquiline fumarate [USAN]

CHEBI:72295

CHEMBL2105700

CS-2922

D09873

HY-14881A

P04QX2C1A5

R 403323

R-403323

R403323

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

International Patents for bedaquiline fumarate

Country	Document Number	Estimated Expiration
Eurasian Patent Organization	017091
Slovenia	1527050
European Patent Office	2301544
Hong Kong	1083496

Supplementary Protection Certificates for bedaquiline fumarate

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
/2014	Austria		PRODUCT NAME: BEDAQUILIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SAEURE- ODER BASENADDITIONSSALZ DAVON, EINSCHLIESSLICH BEDAQUILINFUMARAT; REGISTRATION NO/DATE: EU/1/13/901 20140307
0140026 00112	Estonia		PRODUCT NAME: BEDAKVILIIN;REG NO/DATE: K(2014)1616 (LOPLIK) 07.03.2014
2014032	Lithuania		PRODUCT NAME: BEDAQUILINUM; REGISTRATION NO/DATE: EU/1/13/901 20140305
8 5021-2014	Slovakia		PRODUCT NAME: BEDACHILIN FUMARAT; REGISTRATION NO/DATE: EU/1/13/901 20140305