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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.

One supplier is listed for this compound.

Summary for bedaquiline fumarate

International Patents:	91
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	12
Clinical Trials:	567
Formulation / Manufacturing:	see details
Drug Prices:	see low prices
DailyMed Link:	bedaquiline fumarate at DailyMed

Pharmacology for bedaquiline fumarate

Ingredient-type	Diarylquinolines
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
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

International Patents for bedaquiline fumarate

Country	Document Number	Estimated Expiration
Japan	2006504658
Argentina	064149
South Korea	100733577
Slovenia	2086940

Supplementary Protection Certificates for bedaquiline fumarate

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
520	Luxembourg		PRODUCT NAME: BEDAQUILINE, OU SON SEL D ADDITION D ACIDE OU DE BASE PHARMACEUTIQUEMENT ACCEPTABLE, Y COMPRIS LE FUMARATE DE BEDAQUILINE. FIRST REGISTRATION: 20140307
00684	Netherlands		PRODUCT NAME: BEDAQUILINE, OF EEN FARMACEUTISCH AANVAARDBAAR ZUUR- OF BASE-ADDITIEZOUT DAARVAN, WAARONDER BEDAQUILINEFUMARAAT; REGISTRATION NO/DATE: EU/1/13/901 20140307
2014 00044	Denmark		PRODUCT NAME: BEDAKILIN ELLER ET FARMACEUTISK ACCEPTABELT SYRE- ELLER BASEADDITIONSSALT DERAF, HERUNDER BEDAKILINFUMARAT; REG. NO/DATE: EU/1/13/901 20140305
C0060	France		PRODUCT NAME: BEDAQUILINE OU UN DE SES SELS D'ADDITION D'ACIDE OU DE BASE PHARMACEUTIQUEMENT ACCEPTABLE, Y COMPRIS LE FUMARATE DE BEDAQUILINE; REGISTRATION NO/DATE: EU/1/13/901 20140307