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Last Updated: March 3, 2024

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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 Loss of Exclusivity (LOE) 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
Centers for Disease Control and PreventionPhase 2/Phase 3
Tuberculosis Trials ConsortiumPhase 2/Phase 3
Beijing Chest HospitalPhase 4

See all SIRTURO clinical trials

Pharmacology for SIRTURO

US Patents and Regulatory Information for SIRTURO

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of SIRTURO is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial

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: ⤷  Try a Trial

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 a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Janssen Therap SIRTURO bedaquiline fumarate TABLET;ORAL 204384-001 Dec 28, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Therap SIRTURO bedaquiline fumarate TABLET;ORAL 204384-001 Dec 28, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Janssen Therap SIRTURO bedaquiline fumarate TABLET;ORAL 204384-002 May 27, 2020 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Janssen Therap SIRTURO bedaquiline fumarate TABLET;ORAL 204384-002 May 27, 2020 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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: ⤷  Try a Trial

Argentina

Patent: 4149
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 07328945
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0719693
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 68512
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 07003472
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1547904
Estimated Expiration: ⤷  Try a Trial

Patent: 5012303
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0120639
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 13594
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 86940
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 7091
Estimated Expiration: ⤷  Try a Trial

Patent: 0970532
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 86940
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 14513
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 9077
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 94239
Estimated Expiration: ⤷  Try a Trial

Patent: 10511663
Estimated Expiration: ⤷  Try a Trial

Patent: 15028049
Estimated Expiration: ⤷  Try a Trial

Jordan

Patent: 73
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 8844
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 09005909
Estimated Expiration: ⤷  Try a Trial

Montenegro

Patent: 456
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 6485
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 2773
Estimated Expiration: ⤷  Try a Trial

Patent: 092535
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 081350
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 86940
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 86940
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 408
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 86940
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0903907
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1514700
Estimated Expiration: ⤷  Try a Trial

Patent: 090087020
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 87923
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 17098
Estimated Expiration: ⤷  Try a Trial

Patent: 0838527
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 813
Estimated Expiration: ⤷  Try a Trial

Uruguay

Patent: 762
Estimated Expiration: ⤷  Try a Trial

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
Norway 20092535 ⤷  Try a Trial
Brazil 0312927 Derivados de quinolina e seu uso como inibidores micobacterias ⤷  Try a Trial
Norway 329935 ⤷  Try a Trial
Argentina 064149 SAL FUMARATO DE (ALFA S , BETA R)-6 BROMO- ALFA-[ 2(DIMETILAMINO ) ETIL)-2- METOXI - ALFA-1-NAFTALENIL- BETA- FENIL-3- QUINOLINAETANOL ⤷  Try a Trial
Israel 199077 תכשיר רוקחי למתן פומי המכיל מלח פומאראט של (אלפא s, בטא r)-6-ברומו-אלפא-[2-(דימתילאמינו)אתיל]-2-מתוקסי-אלפא-1-נפתלניל-בטא-פניל-3-קווינולינאתנול וגורם הרטבה, שימושים ותהליך להכנת חומר פעיל (Pharmaceutical composition suitable for oral administration comprising fumarate salt of (alpha s, beta r)-6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-1-naphthalenyl-beta-phenyl-3-quinolineethanol and a wetting agent, uses and process for active compound preparation) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SIRTURO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1527050 178 5021-2014 Slovakia ⤷  Try a Trial PRODUCT NAME: BEDACHILIN FUMARAT; REGISTRATION NO/DATE: EU/1/13/901 20140305
1527050 300684 Netherlands ⤷  Try a Trial PRODUCT NAME: BEDAQUILINE, OF EEN FARMACEUTISCH AANVAARDBAAR ZUUR- OF BASE-ADDITIEZOUT DAARVAN, WAARONDER BEDAQUILINEFUMARAAT; REGISTRATION NO/DATE: EU/1/13/901 20140307
1527050 PA2014032 Lithuania ⤷  Try a Trial PRODUCT NAME: BEDAQUILINUM; REGISTRATION NO/DATE: EU/1/13/901 20140305
1527050 C 2014 034 Romania ⤷  Try a Trial PRODUCT NAME: BEDAQUILINA SAU O SARE DE ADITIE A UNUI ACID SAU A UNEI BAZEACCEPTABILA FARMACEUTIC A IN-3-IL)-4-(DIMETILAMINO)-2-(NAFTALEN-1-IL)-1-FENILBUTAN-2-OL; NATIONAL AUTHORISATION NUMBER: EU/1/13/901; DATE OF NATIONAL AUTHORISATION: 20140305; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/901; DATE OF FIRST AUTHORISATION IN EEA: 20140305 ACESTEIA, INCLUSIV FUMARAT DE BEDAQUILINA - FUMARAT DE BEDAQUILINA (1R,2S)-1-(6-BROMO-2-METOXIQUINOL
1527050 PA2014032,C1527050 Lithuania ⤷  Try a Trial PRODUCT NAME: BEDAQUILINUM; REGISTRATION NO/DATE: EU/1/13/901 20140305
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.