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
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: | 15 |
Patent Applications: | 69 |
Formulation / Manufacturing: | see details |
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
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
Sponsor | Phase |
---|---|
Centers for Disease Control and Prevention | Phase 2/Phase 3 |
Tuberculosis Trials Consortium | Phase 2/Phase 3 |
Beijing Chest Hospital | Phase 4 |
Pharmacology for SIRTURO
Drug Class | Diarylquinoline Antimycobacterial |
Anatomical Therapeutic Chemical (ATC) Classes 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 |
---|---|---|---|
Taiwan | 200838527 | Fumarate salt of (alpha S, beta R)-6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-1-naphthalenyl-beta-phenyl-3-quinolineethanol | ⤷ Try a Trial |
Austria | 463482 | ⤷ Try a Trial | |
Malaysia | 143564 | QUINOLINE DERIVATIVES AND THEIR USE AS MYCOBACTERIAL INHIBITORS | ⤷ Try a Trial |
Australia | 2003262529 | QUINOLINE DERIVATIVES AND THEIR USE AS MYCOBACTERIAL INHIBITORS | ⤷ Try a Trial |
Denmark | 1527050 | ⤷ 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 | CA 2014 00044 | Denmark | ⤷ Try a Trial | PRODUCT NAME: BEDAKILIN ELLER ET FARMACEUTISK ACCEPTABELT SYRE-ELLER BASEADDITIONSSALT DERAF, HERUNDER BEDAKILINFUMARAT; REG. NO/DATE: EU/1/13/901 20140305 |
1527050 | C20140026 00112 | Estonia | ⤷ Try a Trial | PRODUCT NAME: BEDAKVILIIN;REG NO/DATE: K(2014)1616 (LOPLIK) 07.03.2014 |
1527050 | SPC/GB14/057 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: BEDAQUILINE, OR A PHARMACEUTICALLY ACCEPTABLE ACID OR BASE ADDITION SALT THEREOF, INCLUDING BEDAQUILINE FUMARATE; REGISTERED: UK EU/1/13/901 20140307 |
1527050 | 1490050-0 | Sweden | ⤷ Try a Trial | PRODUCT NAME: BEDAQUILINE, OR A PHARMACEUTICALLY ACCEPTABLE ACID OR BASE ADDITION SALT THEREOF, INCLUDING BEDAQUILINE FUMARATE; REG. NO/DATE: EU/1/13/901 20140305 |
1527050 | C300684 | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |