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Last Updated: July 6, 2020

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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-six 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.

US ANDA Litigation and 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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Drug patent expirations by year for SIRTURO
Drug Prices for SIRTURO

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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
Boston UniversityPhase 3
LSHTM Clinical Research DepartmentPhase 2/Phase 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   Start Trial   Start Trial   Start Trial
Janssen Therap SIRTURO bedaquiline fumarate TABLET;ORAL 204384-001 Dec 28, 2012 RX Yes Yes   Start Trial   Start Trial   Start Trial
Janssen Therap SIRTURO bedaquiline fumarate TABLET;ORAL 204384-001 Dec 28, 2012 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
>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 122014000083 Germany   Start Trial PRODUCT NAME: BEDAQUILIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SAEURE- ODER BASENADDITIONSSALZ DAVON; REGISTRATION NO/DATE: EU/1/13/901 20140305
1527050 C20140026 00112 Estonia   Start Trial PRODUCT NAME: BEDAKVILIIN;REG NO/DATE: K(2014)1616 (LOPLIK) 07.03.2014
1527050 CR 2014 00044 Denmark   Start Trial PRODUCT NAME: BEDAKILIN ELLER ET FARMACEUTISK ACCEPTABELT SYRE- ELLER BASEADDITIONSSALT DERAF, HERUNDER BEDAKILINFUMARAT; REG. NO/DATE: EU/1/13/901 20140305
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Merck
Moodys
Johnson and Johnson
McKesson
Express Scripts

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.