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Last Updated: June 24, 2021

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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-seven patent family members in thirty-nine countries.

The generic ingredient in SIRTURO is bedaquiline fumarate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the bedaquiline fumarate profile page.

DrugPatentWatch® Generic Entry Outlook for Sirturo

Sirturo was eligible for patent challenges on December 28, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 19, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for SIRTURO
Drug patent expirations by year for SIRTURO
Drug Prices for SIRTURO

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DrugPatentWatch® Estimated 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.

Recent Clinical Trials for SIRTURO

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Otsuka Pharmaceutical Co., Ltd.Phase 3
Boston UniversityPhase 3
PfizerPhase 3

See all SIRTURO clinical trials

Pharmacology for SIRTURO

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 204384-002 May 27, 2020 RX Yes No   Try Before You Buy   Try Before You Buy Y Y   Try Before You Buy
Janssen Therap SIRTURO bedaquiline fumarate TABLET;ORAL 204384-001 Dec 28, 2012 RX Yes Yes   Try Before You Buy   Try Before You Buy   Try Before You Buy
Janssen Therap SIRTURO bedaquiline fumarate TABLET;ORAL 204384-001 Dec 28, 2012 RX Yes Yes   Try Before You Buy   Try Before You Buy Y Y   Try Before You Buy
Janssen Therap SIRTURO bedaquiline fumarate TABLET;ORAL 204384-001 Dec 28, 2012 RX Yes Yes   Try Before You Buy   Try Before You Buy   Try Before You Buy
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for SIRTURO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1527050 CR 2014 00044 Denmark   Try Before You Buy PRODUCT NAME: BEDAKILIN ELLER ET FARMACEUTISK ACCEPTABELT SYRE- ELLER BASEADDITIONSSALT DERAF, HERUNDER BEDAKILINFUMARAT; REG. NO/DATE: EU/1/13/901 20140305
1527050 2014/045 Ireland   Try Before You Buy 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 552 Finland   Try Before You Buy
1527050 50/2014 Austria   Try Before You Buy PRODUCT NAME: BEDAQUILIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SAEURE- ODER BASENADDITIONSSALZ DAVON, EINSCHLIESSLICH BEDAQUILINFUMARAT; REGISTRATION NO/DATE: EU/1/13/901 20140307
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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