BEDAQUILINE FUMARATE - Generic Drug Details

What are the generic drug sources for bedaquiline fumarate and what is the scope of 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-seven 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:	97
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	37
Patent Applications:	157
What excipients (inactive ingredients) are in BEDAQUILINE FUMARATE?	BEDAQUILINE FUMARATE excipients list
DailyMed Link:	BEDAQUILINE FUMARATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for BEDAQUILINE FUMARATE

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for BEDAQUILINE FUMARATE

Drug Class

Diarylquinoline Antimycobacterial

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	204384-002	May 27, 2020		RX	Yes	No
Janssen Therap	SIRTURO	bedaquiline fumarate	TABLET;ORAL	204384-002	May 27, 2020		RX	Yes	No			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
Janssen Therap	SIRTURO	bedaquiline fumarate	TABLET;ORAL	204384-001	Dec 28, 2012		RX	Yes	Yes
Janssen Therap	SIRTURO	bedaquiline fumarate	TABLET;ORAL	204384-002	May 27, 2020		RX	Yes	No			Y	Y

International Patents for BEDAQUILINE FUMARATE

Country	Patent Number	Title	Estimated Expiration
Denmark	2086940
Croatia	P20050045	QUINOLINE DERIVATIVES AND THEIR USE AS MYCROBACETRIAL INHIBITORS
Spain	2395237
Argentina	064149	SAL FUMARATO DE (ALFA S , BETA R)-6 BROMO- ALFA-[ 2(DIMETILAMINO ) ETIL)-2- METOXI - ALFA-1-NAFTALENIL- BETA- FENIL-3- QUINOLINAETANOL
Austria	463482
Israel	199077	תכשיר רוקחי למתן פומי המכיל מלח פומאראט של (אלפא s, בטא r)-6-ברומו-אלפא-[2-(דימתילאמינו)אתיל]-2-מתוקסי-אלפא-1-נפתלניל-בטא-פניל-3-קווינולינאתנול וגורם הרטבה, שימושים ותהליך להכנת חומר פעיל (Pharmaceutical composition suitable for oral administration comprising fumarate salt of (alpha s, beta r)-6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-1-naphthalenyl-beta-phenyl-3-quinolineethanol and a wetting agent, uses and process for active compound preparation)

Supplementary Protection Certificates for BEDAQUILINE FUMARATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1527050	CA 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	C300684	Netherlands		PRODUCT NAME: BEDAQUILINE, OF EEN FARMACEUTISCH AANVAARDBAAR ZUUR- OF BASE-ADDITIEZOUT DAARVAN, WAARONDER BEDAQUILINEFUMARAAT; REGISTRATION NO/DATE: EU/1/13/901 20140307
1527050	C20140026 00112	Estonia		PRODUCT NAME: BEDAKVILIIN;REG NO/DATE: K(2014)1616 (LOPLIK) 07.03.2014
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
1527050	132014902288493	Italy		PRODUCT NAME: BEDAQUILINA O UN SUO SALE DI ADDIZIONE DI ACIDO O BASE FARMACEUTICAMENTE ACCETTABILE INCLUSO BEDAQUILINA FUMARATO(SIRTURO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/901, 20140305