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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Questions you can ask:
- What is the 5 year forecast for SIRTURO?
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Summary for SIRTURO
| International Patents: | 97 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 37 |
| Clinical Trials: | 16 |
| Patent Applications: | 46 |
| Drug Prices: | Drug price information for SIRTURO |
| What excipients (inactive ingredients) are in SIRTURO? | SIRTURO excipients list |
| DailyMed Link: | SIRTURO at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for SIRTURO
*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
| Sponsor | Phase |
|---|---|
| Tuberculosis Trials Consortium | Phase 2/Phase 3 |
| Centers for Disease Control and Prevention | Phase 2/Phase 3 |
| Beijing Chest Hospital | Phase 4 |
Pharmacology for SIRTURO
| Drug Class | Diarylquinoline Antimycobacterial |
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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
REVISIONS TO THE LABELING TO REFLECT THE RESULTS OF A CLINICAL STUDY TO FULFILL POST MARKETING REQUIREMENT 1988-001
Exclusivity Expiration: ⤷ Sign Up
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: ⤷ Sign Up
| 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 | ⤷ 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 | 204384-002 | May 27, 2020 | RX | Yes | No | ⤷ 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 | ⤷ Sign Up | ||||
| >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
Patent: Fumarate salt of (ALPHA S, BETA R)-6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-1-naphthalenyl-beta-phenyl-3-quinolineethanol
Estimated Expiration: ⤷ Sign Up
Argentina
Patent: 4149
Patent: SAL FUMARATO DE (ALFA S , BETA R)-6 BROMO- ALFA-[ 2(DIMETILAMINO ) ETIL)-2- METOXI - ALFA-1-NAFTALENIL- BETA- FENIL-3- QUINOLINAETANOL
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 07328945
Patent: Fumarate salt of (alpha S, beta R)-6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-1-naphthalenyl-beta-phenyl-3-quinolineethanol
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0719693
Patent: SAL FUMARATO DE (ALFA S, BETA R)-6-BROMO-ALFA-[2- (DEMETILAMINO)ETIL]-2-METÓXI-ALFA-1-NAFTALENIL-BETA- FENIL-3-QUINOLINAETANOL
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 68512
Patent: SEL DE FUMARATE DE (ALPHA S, BETA R)-6-BROMO-ALPHA-[2-(DIMETHYLAMINO)ETHYL]-2-METHOXY-ALPHA-1-NAPHTALENYL-BETA-PHENYL-3-QUINOLEINEETHANOL (FUMARATE SALT OF (ALPHA S, BETA R)-6-BROMO-ALPHA-[2-(DIMETHYLAMINO)ETHYL]-2-METHOXY-ALPHA-1-NAPHTHALENYL-BETA-PHENYL-3-QUINOLINEETHANOL)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 07003472
Patent: SAL FUMARATO DE (ALFA S,BETA R)-6-BROMO-ALFA-[2-(DIMETILAMINO)ETIL]-2-METOXI-ALFA-1-NAFTALENIL-BETA-FENIL-3-QUINOLINAETANOL; PROCESO DE PREPARACION; COMPOSICION FARMACEUTICA; PROCESO DE PREPARACION DE LA COMPOSICION FARMACEUTICA; Y USO EN EL TRATAMIE
Estimated Expiration: ⤷ Sign Up
China
Patent: 1547904
Patent: Fumarate salt of (alpha s, beta r)-6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-1-naphthalenyl-beta-phenyl-3-quinolineethanol
Estimated Expiration: ⤷ Sign Up
Patent: 5012303
Patent: Fumarate salt of (alpha S, beta R)-6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-1-naphthalenyl-beta-phenyl-3-quinolineethanol
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0120639
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 13594
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 86940
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 7091
Patent: ФУМАРАТНАЯ СОЛЬ (АЛЬФА S, БЕТА R)-6-БРОМ-АЛЬФА-[2-(ДИМЕТИЛАМИНО)ЭТИЛ]-2-МЕТОКСИ-АЛЬФА-1-НАФТАЛЕНИЛ-БЕТА-ФЕНИЛ-3-ХИНОЛИНЭТАНОЛА (FUMARATE SALT OF (ALPHA S, BETA R)-6-BROMO-ALPHA-[2-(DIMETHYLAMINO)ETHYL]-2-METHOXY-ALPHA-1-NAPHTHALENYL-BETA-PHENYL-3-QUINOLINEETHANOL)
Estimated Expiration: ⤷ Sign Up
Patent: 0970532
Patent: ФУМАРАТНАЯ СОЛЬ (АЛЬФА S, БЕТА R)-6-БРОМ-АЛЬФА-[2-(ДИМЕТИЛАМИНО)ЭТИЛ]-2-МЕТОКСИ-АЛЬФА-1-НАФТАЛЕНИЛ-БЕТА-ФЕНИЛ-3-ХИНОЛИНЭТАНОЛА
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 86940
Patent: SEL DE FUMARATE DE (ALPHA S, BÊTA R)-6-BROMO-ALPHA-[2-(DIMÉTHYLAMINO)ÉTHYL]-2-MÉTHOXY-ALPHA-1-NAPHTALÉNYL-BÊTA-PHÉNYL-3-QUINOLÉINEÉTHANOL (FUMARATE SALT OF (ALPHA S, BETA R)-6-BROMO-ALPHA-[2-(DIMETHYLAMINO)ETHYL]-2-METHOXY-ALPHA-1-NAPHTHALENYL-BETA-PHENYL-3-QUINOLINEETHANOL)
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 14513
Patent: ，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-)
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 9077
Patent: 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)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 94239
Estimated Expiration: ⤷ Sign Up
Patent: 10511663
Estimated Expiration: ⤷ Sign Up
Patent: 15028049
Patent: （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)
Estimated Expiration: ⤷ Sign Up
Jordan
Patent: 73
Patent: ملح فيوميريت ل(الفا اس، بيتا ار)-6-برومو-الفا-[2-(ميثيل امينو)ايثيل] -2- ميثوكسي -الفا-1- نفثالينيل- بيتا- فينيل-3- كوينولين ايثانول (Fumarate Salt Of (alphaS, betaR)-6-Bromo-alfa-[2-(dimethylamino)ethyl]-2- Methoxy-alpha-1-naphthalenyl-beta-phenyl-3- Quinolineethanol)
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 8844
Patent: FUMARATE SALT OF (ALPHA S, BETA R)-6- BROMO-ALPHA-[2-(DIMETHYLAMINO)ETHYL]-2-METHOXY-ALPHA-1-NAPHTHALENYL-BETA-PHENYL-3-QUINOLINEETHANOL
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 09005909
Patent: SAL FUMARATO DE (ALFA S, BETA R)-6-BROMO-ALFA-[2-(DIMETILAMINO)ETI L]-2-METOXI-ALFA-1-NAFTALENIL-BETA-FENIL-3-QUINOLINAETANOL. (FUMARATE SALT OF (ALPHA S, BETA R)-6-BROMO-ALPHA-[2-(DIMETHYLAMIN O)ETHYL]-2-METHOXY-ALPHA-1-NAPHTHALENYL-BETA-PHENYL-3-QUINOLINEE THANOL.)
Estimated Expiration: ⤷ Sign Up
Montenegro
Patent: 456
Patent: FUMARATNA SO (ALFA S, BETA R)-6-BROMO-ALFA-[2-(DIMETILAMINO)ETIL]-2-METOKSI-ALFA-1-NAFTALENIL-BETA-FENIL-3-KINOLINETANOLA (FUMARATE SALT OF (ALPHA S, BETA R)-6-BROMO-ALPHA-[2-(DIMETHYLAMINO)ETHYL]-2-METHOXY-ALPHA-1-NAPHTHALENYL-BETA-PHENYL-3-QUINOLINEETHANOL)
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 6485
Patent: FUMARATE SALT OF (ALPHA S, BETA R)-6-BROMO-ALPHA-[2-(DIMETHYLAMINO)ETHYL]-2-METHOXY-ALPHA-1-NAPHTHALENYL-BETA-PHENYL-3-QUINOLINEETHANOL
Estimated Expiration: ⤷ Sign Up
Norway
Patent: 2773
Estimated Expiration: ⤷ Sign Up
Patent: 092535
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 081350
Patent: SAL FUMARATO DE (ALFAS S, BETA R)-6-BROMO-ALFA-[2(DIMETILAMINO)ETIL]-2-METOXI-ALFA-1-NAFTALENIL-BETA-FENIL-3-QUINOLINAETANOL
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 86940
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 86940
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 408
Patent: FUMARATNA SO (ALFA S, BETA R)-6-BROMO-ALFA-[2-(DIMETILAMINO)ETIL]-2-METOKSI-ALFA-1-NAFTALENIL-BETA-FENIL-3-KINOLINETANOLA (FUMARATE SALT OF (ALPHA S, BETA R)-6-BROMO-ALPHA-[2-(DIMETHYLAMINO)ETHYL]-2¬METHOXY-ALPHA-1-NAPHTHALENYL-BETA-PHENYL-3-QUlNOLINEETHANOL)
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 86940
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 0903907
Patent: FUMARATE SALT OF (ALPHA S,BETA R)-6-BROMO-ALPHA-[2-(DIMETHYLAMINO)ETHYL]-2-METHOXY-ALPHA-1-NAPHTHALENYL-BETA-PHENYL-3-QUINOLINEETHANOL
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1514700
Estimated Expiration: ⤷ Sign Up
Patent: 090087020
Patent: FUMARATE SALT OF (ALPHA S, BETA R)-6-BROMO-ALPHA-[2-(DIMETHYLAMINO)ETHYL]-2-METHOXY-ALPHA-1-NAPHTHALENYL-BETA-PHENYL-3-QUINOLINEETHANOL
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 87923
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 17098
Estimated Expiration: ⤷ Sign Up
Patent: 0838527
Patent: Fumarate salt of (alpha S, beta R)-6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-1-naphthalenyl-beta-phenyl-3-quinolineethanol
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 813
Patent: ФУМАРАТНАЯ СОЛЬ (АЛЬФА S, БЕТА R)-6-БРОМ-АЛЬФА-[2-(ДИМЕТИЛАМИНО)ЭТИЛ]-2-МЕТОКСИ-АЛЬФА-1-НАФТАЛЕНИЛ-БЕТА-ФЕНИЛ-3-ХИНОЛИНЭТАНОЛА;ФУМАРАТНА СІЛЬ (АЛЬФА S, БЕТА R)-6-БРОМ-АЛЬФА-[2-(ДИМЕТИЛАМІНО)ЕТИЛ]-2-МЕТОКСІ-АЛЬФА-1-НАФТАЛЕНІЛ-БЕТА-ФЕНІЛ-3-ХІНОЛІНЕТАНОЛУ (FUMARATE SALT OF (ALPHA S, BETA R)-6-BROMO-ALPHA-[2-(DIMETHYLAMINO)ETHYL]-2-METHOXY-ALPHA-1-NAPHTHALENYL-BETA-PHENYL-3-QUINOLINEETHANOL)
Estimated Expiration: ⤷ Sign Up
Uruguay
Patent: 762
Patent: SAL FUMARATO DE (ALFA S, BETA R)-6-BROMO-ALFA-[2(DIMETILAMINO) ETIL]-2-METOXI-ALFA-1-NAFTALENIL-BETA-FENIL-3-QUINOLINAETANOL
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| European Patent Office | 2086940 | SEL DE FUMARATE DE (ALPHA S, BÊTA R)-6-BROMO-ALPHA-[2-(DIMÉTHYLAMINO)ÉTHYL]-2-MÉTHOXY-ALPHA-1-NAPHTALÉNYL-BÊTA-PHÉNYL-3-QUINOLÉINEÉTHANOL (FUMARATE SALT OF (ALPHA S, BETA R)-6-BROMO-ALPHA-[2-(DIMETHYLAMINO)ETHYL]-2-METHOXY-ALPHA-1-NAPHTHALENYL-BETA-PHENYL-3-QUINOLINEETHANOL) | ⤷ Sign Up |
| Croatia | P20120639 | ⤷ Sign Up | |
| China | 101547904 | Fumarate salt of (alpha s, beta r)-6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-1-naphthalenyl-beta-phenyl-3-quinolineethanol | ⤷ Sign Up |
| Serbia | 52408 | FUMARATNA SO (ALFA S, BETA R)-6-BROMO-ALFA-[2-(DIMETILAMINO)ETIL]-2-METOKSI-ALFA-1-NAFTALENIL-BETA-FENIL-3-KINOLINETANOLA (FUMARATE SALT OF (ALPHA S, BETA R)-6-BROMO-ALPHA-[2-(DIMETHYLAMINO)ETHYL]-2¬METHOXY-ALPHA-1-NAPHTHALENYL-BETA-PHENYL-3-QUlNOLINEETHANOL) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SIRTURO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1527050 | 2014/045 | 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 |
| 1527050 | 132014902288493 | Italy | ⤷ Sign Up | PRODUCT NAME: BEDAQUILINA O UN SUO SALE DI ADDIZIONE DI ACIDO O BASE FARMACEUTICAMENTE ACCETTABILE INCLUSO BEDAQUILINA FUMARATO(SIRTURO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/901, 20140305 |
| 1527050 | SPC/GB14/057 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: BEDAQUILINE, OR A PHARMACEUTICALLY ACCEPTABLE ACID OR BASE ADDITION SALT THEREOF, INCLUDING BEDAQUILINE FUMARATE; REGISTERED: UK EU/1/13/901 20140307 |
| 1527050 | C20140026 00112 | Estonia | ⤷ Sign Up | PRODUCT NAME: BEDAKVILIIN;REG NO/DATE: K(2014)1616 (LOPLIK) 07.03.2014 |
| >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.
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