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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Express Scripts
Julphar
Chinese Patent Office
Queensland Health
Johnson and Johnson
US Department of Justice
Fuji
UBS

Generated: November 16, 2018

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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.

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
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 ➤ 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

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Supplementary Protection Certificates for bedaquiline fumarate

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

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Express Scripts
Julphar
Chinese Patent Office
Queensland Health
Johnson and Johnson
US Department of Justice
Fuji
UBS

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