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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Fish and Richardson
McKesson
Cantor Fitzgerald
Argus Health
Daiichi Sankyo
UBS
Healthtrust
Moodys

Generated: December 17, 2018

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SIRTURO Drug Profile

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Which patents cover Sirturo, and what generic alternatives are available?

Sirturo is a drug marketed by Janssen Therap and is included in one NDA. There are two patents protecting this drug.

This drug has ninety-one patent family members in thirty-nine countries.

The generic ingredient in SIRTURO is bedaquiline fumarate. One supplier is listed for this compound. Additional details are available on the bedaquiline fumarate profile page.

Summary for SIRTURO
Drug patent expirations by year for SIRTURO
Generic Entry Opportunity Date for SIRTURO
Generic Entry Date for SIRTURO*:
Constraining patent/regulatory exclusivity:
NDA:
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 SIRTURO
Synonyms for SIRTURO
(|AS,|AR)-Bedaquiline
(1R,2S)-1-(6-bromo-2-methoxy-3-quinolyl)-4-(dimethylamino)-2-(1-naphthyl)-1-phenyl-butan-2-ol
(1R,2S)-1-(6-Bromo-2-methoxy-quinolin-3-yl)-4-methyl-amino-2-naphthalen-1-yl-1-phenyl-butan-2-ol
(1R,2S)-1-(6-bromo-2-methoxyquinolin-3-yl)-4-(dimethylamino)-2-(1-naphthyl)-1-phenylbutan-2-ol
(1R,2S)-1-(6-bromo-2-methoxyquinolin-3-yl)-4-(dimethylamino)-2-(naphthalen-1-yl)-1-phenylbutan-2-ol
(1R,2S)-1-(6-bromo-2-methoxyquinolin-3-yl)-4-(dimethylamino)-2-naphthalen-1-yl-1-phenylbutan-2-ol
(alphaS,betaR)-6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-1-naphthalenyl-beta-phenyl-3-quinolineethanol
1-(1R)-(6-Bromo-2-methoxy-quinolin-3-yl)-4-dimethylamino-2-(2S)-(naphthalen-1-yl)-1-phenyl-butan-2-ol
1-(6-bromo-2-methoxy-quinolin-3-yl)-4-dimethylamino-2-(3-fluorophenyl)-1-phenyl-butan-2-ol
1-(6-Bromo-2-methoxy-quinolin-3-yl)-4-dimethylamino-2-naphthalen-1-yl-1-phenyl-butan-2-ol
3-Quinolineethanol, 6-bromo-alpha-(2-(dimethylamino)ethyl)-2-methoxy-alpha-1-naphthalenyl-beta-phenyl-, (alphaR,betaS)-rel-
3-Quinolineethanol, 6-bromo-alpha-(2-(dimethylamino)ethyl)-2-methoxy-alpha-1-naphthalenyl-beta-phenyl-, (alphaS,betaR)-
654653-93-7
78846I289Y
843663-66-1
AC-28385
AC1NTUPQ
AIDS 222089
AIDS-222089
AIDS222089
AK145620
AKOS022186476
AOB87357
AX8257016
BDBM50063995
bedaquilina
Bedaquiline
Bedaquiline (TMC-207)
Bedaquiline (USAN/INN)
Bedaquiline [USAN:INN]
bedaquilinum
BROMO-2-METHOXY-(QUINOLIN-3-YL))-4-DIMETHYLAMINO-2-NAPHTHALEN-1-YL-1-PHENYL-BUTAN-2-OL
bromo-2-methoxy-quinolin-3-yl)-4-dimethylamino-2-naphthalen-1-yl-1-phenyl-butan-2-ol
CHEBI:72292
CHEMBL376488
CS-2921
D09872
DB08903
HE375738
HSDB 8217
HY-14881
J-500265
KS-0000002K
MMV689758
MolPort-035-683-920
NCGC00348215-01
R 207910
R-207910
R207910
SCHEMBL295482
TMC 207
TMC-207
TMC207
Tube401
UNII-78846I289Y
ZINC4655029

US Patents and Regulatory Information for SIRTURO

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 ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Janssen Therap SIRTURO bedaquiline fumarate TABLET;ORAL 204384-001 Dec 28, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Janssen Therap SIRTURO bedaquiline fumarate TABLET;ORAL 204384-001 Dec 28, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Supplementary Protection Certificates for SIRTURO

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0060 France ➤ Try a Free Trial 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
14/045 Ireland ➤ Try a Free Trial PRODUCT NAME: BEDAQUILINE, OR A PHARMACEUTICALLY ACCEPTABLE ACID OR BASE ADDITION SALT THEREOF, INCLUDING BEDAQUILINE FUMARATE; REGISTRATION NO/DATE: EU/1/13/901 20140305
8 5021-2014 Slovakia ➤ Try a Free Trial PRODUCT NAME: BEDACHILIN FUMARAT; REGISTRATION NO/DATE: EU/1/13/901 20140305
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Fish and Richardson
McKesson
Cantor Fitzgerald
Argus Health
Daiichi Sankyo
UBS
Healthtrust
Moodys

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