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Last Updated: October 1, 2022

SIRTURO Drug Patent 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

See drug prices for SIRTURO

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
Beijing Chest HospitalPhase 4
Harvard Medical School (HMS and HSDM)Phase 2
WestatPhase 2

See all SIRTURO clinical trials

Pharmacology for SIRTURO

US Patents and Regulatory Information for SIRTURO

SIRTURO is protected by two US patents and three FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of SIRTURO is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting SIRTURO

Mycobacterial inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PULMONARY MULTI-DRUG RESISTANT TUBERCULOSIS

Fumarate salt of (alpha S, beta R)-6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-1-naphthalenyl-- beta-phenyl-3-quinolineethanol
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PULMONARY MULTI-DRUG RESISTANT TUBERCULOSIS

FDA Regulatory Exclusivity protecting SIRTURO

INDICATED AS PART OF COMBINATION THERAPY IN THE TREATMENT OF PEDIATRIC PATIENTS 5 YEARS AND OLDER TO LESS THAN 12 YEARS OF AGE AND WEIGHING AT LEAST 15 KG WITH PULMONARY MULTI-DRUG RESISTANT TUBERCULOSIS (MDR-TB)
Exclusivity Expiration: See Plans and Pricing

INDICATED AS PART OF COMBINATION THERAPY IN THE TREATMENT OF PEDIATRIC PATIENTS (12 TO LESS THAN 18 YEARS OF AGE AND WEIGHING AT LEAST 30 KG) WITH PULMONARY MULTI-DRUG RESISTANT TUBERCULOSIS
Exclusivity Expiration: See Plans and Pricing

NEW PATIENT POPULATION
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Janssen Therap SIRTURO bedaquiline fumarate TABLET;ORAL 204384-001 Dec 28, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Janssen Therap SIRTURO bedaquiline fumarate TABLET;ORAL 204384-001 Dec 28, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Janssen Therap SIRTURO bedaquiline fumarate TABLET;ORAL 204384-001 Dec 28, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Janssen Therap SIRTURO bedaquiline fumarate TABLET;ORAL 204384-002 May 27, 2020 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Janssen Therap SIRTURO bedaquiline fumarate TABLET;ORAL 204384-002 May 27, 2020 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 SIRTURO

When does loss-of-exclusivity occur for SIRTURO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Patent: 98
Estimated Expiration: See Plans and Pricing

Argentina

Patent: 4149
Estimated Expiration: See Plans and Pricing

Australia

Patent: 07328945
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0719693
Estimated Expiration: See Plans and Pricing

Canada

Patent: 68512
Estimated Expiration: See Plans and Pricing

Chile

Patent: 07003472
Estimated Expiration: See Plans and Pricing

China

Patent: 1547904
Estimated Expiration: See Plans and Pricing

Patent: 5012303
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0120639
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 13594
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 86940
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 7091
Estimated Expiration: See Plans and Pricing

Patent: 0970532
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 86940
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 14513
Estimated Expiration: See Plans and Pricing

Israel

Patent: 9077
Estimated Expiration: See Plans and Pricing

Japan

Patent: 94239
Estimated Expiration: See Plans and Pricing

Patent: 10511663
Estimated Expiration: See Plans and Pricing

Patent: 15028049
Estimated Expiration: See Plans and Pricing

Jordan

Patent: 73
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 8844
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 09005909
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 456
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 6485
Estimated Expiration: See Plans and Pricing

Norway

Patent: 2773
Estimated Expiration: See Plans and Pricing

Patent: 092535
Estimated Expiration: See Plans and Pricing

Peru

Patent: 081350
Estimated Expiration: See Plans and Pricing

Poland

Patent: 86940
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 86940
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 408
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 86940
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0903907
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1514700
Estimated Expiration: See Plans and Pricing

Patent: 090087020
Estimated Expiration: See Plans and Pricing

Spain

Patent: 87923
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 17098
Estimated Expiration: See Plans and Pricing

Patent: 0838527
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 813
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 762
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering SIRTURO around the world.

Country Patent Number Title Estimated Expiration
Uruguay 30762 SAL FUMARATO DE (ALFA S, BETA R)-6-BROMO-ALFA-[2(DIMETILAMINO) ETIL]-2-METOXI-ALFA-1-NAFTALENIL-BETA-FENIL-3-QUINOLINAETANOL See Plans and Pricing
Hong Kong 1214513 ,β -溴-α- 二甲胺基 乙基 -甲氧基-α- -萘基-β-苯基- -喹啉乙醇的富馬酸鹽 (FUMARATE SALT OF (ALPHA S, BETA R)-6-BROMO-ALPHA-[2- (DIMETHYLAMINO)ETHYL]-2-METHOXY-ALPHA-1-NAPHTHALENYL- BETA-PHENYL-3- QUINOLINEETHANOL (SR)-6---[2-()]-2---1----3-) See Plans and Pricing
Malaysia 148844 FUMARATE SALT OF (ALPHA S, BETA R)-6- BROMO-ALPHA-[2-(DIMETHYLAMINO)ETHYL]-2-METHOXY-ALPHA-1-NAPHTHALENYL-BETA-PHENYL-3-QUINOLINEETHANOL See Plans and Pricing
Croatia P20120639 See Plans and Pricing
Japan 2015028049 (アルファS,ベータR)−6−ブロモ−アルファ−[2−(ジメチルアミノ)エチル]−2−メトキシ−アルファ−1−ナフタレニル−ベータ−フェニル−3−キノリンエタノールのフマル酸塩 (FUMARATE SALT OF (ALPHA S, BETA R)-6-BROMO-ALPHA-[2-(DIMETHYLAMINO)ETHYL]-2-METHOXY-ALPHA-1-NAPHTHALENYL-BETA-PHENYL-3-QUINOLINEETHANOL) See Plans and Pricing
Argentina 040673 INHIBIDORES MICOBACTERIANOS, COMPOSICION FARMACEUTICA Y PROCESO DE PREPARACION DEL COMPUESTO See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SIRTURO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1527050 PA2014032 Lithuania See Plans and Pricing PRODUCT NAME: BEDAQUILINUM; REGISTRATION NO/DATE: EU/1/13/901 20140305
1527050 CR 2014 00044 Denmark See Plans and Pricing 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 See Plans and Pricing 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 300684 Netherlands See Plans and Pricing PRODUCT NAME: BEDAQUILINE, OF EEN FARMACEUTISCH AANVAARDBAAR ZUUR- OF BASE-ADDITIEZOUT DAARVAN, WAARONDER BEDAQUILINEFUMARAAT; REGISTRATION NO/DATE: EU/1/13/901 20140307
1527050 178 5021-2014 Slovakia See Plans and Pricing PRODUCT NAME: BEDACHILIN FUMARAT; REGISTRATION NO/DATE: EU/1/13/901 20140305
1527050 14C0060 France See Plans and Pricing 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
>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.