BEDAQUILINE FUMARATE - Generic Drug Details

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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

Generic Entry Date for BEDAQUILINE FUMARATE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Anatomical Therapeutic Chemical (ATC) Classes for BEDAQUILINE FUMARATE

J04AK	Other drugs for treatment of tuberculosis
J04A	DRUGS FOR TREATMENT OF TUBERCULOSIS
J04	ANTIMYCOBACTERIALS
J	Antiinfectives for systemic use

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	204384-002	May 27, 2020		RX	Yes	No	⤷ 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				⤷ 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	Patent Number	Title	Estimated Expiration
European Patent Office	2086940	SEL DE FUMARATE DE (ALPHA S, BÊTA R)-6-BROMO-ALPHA-[2-(DIMÉTHYLAMINO)ÉTHYL]-2-MÉTHOXY-ALPHA-1-NAPHTALÉNYL-BÊTA-PHÉNYL-3-QUINOLÉINEÉTHANOL (FUMARATE SALT OF (ALPHA S, BETA R)-6-BROMO-ALPHA-[2-(DIMETHYLAMINO)ETHYL]-2-METHOXY-ALPHA-1-NAPHTHALENYL-BETA-PHENYL-3-QUINOLINEETHANOL)	⤷ Sign Up
Croatia	P20120639		⤷ Sign Up
China	101547904	Fumarate salt of (alpha s, beta r)-6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-1-naphthalenyl-beta-phenyl-3-quinolineethanol	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for BEDAQUILINE FUMARATE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1527050	2014/045	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
1527050	132014902288493	Italy	⤷ Sign Up	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
1527050	SPC/GB14/057	United Kingdom	⤷ Sign Up	PRODUCT NAME: BEDAQUILINE, OR A PHARMACEUTICALLY ACCEPTABLE ACID OR BASE ADDITION SALT THEREOF, INCLUDING BEDAQUILINE FUMARATE; REGISTERED: UK EU/1/13/901 20140307
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Summary for BEDAQUILINE FUMARATE

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

Pharmacology for BEDAQUILINE FUMARATE

Anatomical Therapeutic Chemical (ATC) Classes for BEDAQUILINE FUMARATE

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