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Bedaquiline fumarate - Generic Drug Details

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.

One supplier is listed for this compound.

Summary for bedaquiline fumarate

US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	41
Patent Applications:	34
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

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Glossary

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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
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

International Patents for bedaquiline fumarate

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Country	Document Number	Estimated Expiration
South Korea	100733577	➤ Sign Up
Malaysia	143564	➤ Sign Up
Netherlands	300684	➤ Sign Up
Taiwan	200410939	➤ Sign Up
Country	Document Number	Estimated Expiration

Supplementary Protection Certificates for bedaquiline fumarate

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
/2014	Austria	➤ Sign Up	PRODUCT NAME: BEDAQUILIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SAEURE- ODER BASENADDITIONSSALZ DAVON, EINSCHLIESSLICH BEDAQUILINFUMARAT; REGISTRATION NO/DATE: EU/1/13/901 20140307
520	Luxembourg	➤ Sign Up	PRODUCT NAME: BEDAQUILINE, OU SON SEL D ADDITION D ACIDE OU DE BASE PHARMACEUTIQUEMENT ACCEPTABLE, Y COMPRIS LE FUMARATE DE BEDAQUILINE. FIRST REGISTRATION: 20140307
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
14/045	Ireland	➤ Sign Up	PRODUCT NAME: BEDAQUILINE, OR A PHARMACEUTICALLY ACCEPTABLE ACID OR BASE ADDITION SALT THEREOF, INCLUDING BEDAQUILINE FUMARATE; REGISTRATION NO/DATE: EU/1/13/901 20140305
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description