Bedaquiline fumarate - Generic Drug Details
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What are the generic drug sources for bedaquiline fumarate and what is the scope of patent protection?
Bedaquiline fumarate
is the generic ingredient in one branded drug marketed by Janssen Therap and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Bedaquiline fumarate has ninety-seven patent family members in thirty-nine countries.
There is one drug master file entry for bedaquiline fumarate. One supplier is listed for this compound.
Summary for bedaquiline fumarate
International Patents: | 97 |
US Patents: | 2 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 37 |
Patent Applications: | 157 |
What excipients (inactive ingredients) are in bedaquiline fumarate? | bedaquiline fumarate excipients list |
DailyMed Link: | bedaquiline fumarate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for bedaquiline fumarate
Generic Entry Date for bedaquiline fumarate*:
Constraining patent/regulatory exclusivity:
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.
Pharmacology for bedaquiline fumarate
Drug Class | Diarylquinoline Antimycobacterial |
Anatomical Therapeutic Chemical (ATC) Classes for bedaquiline fumarate
US Patents and Regulatory Information for bedaquiline fumarate
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 | 204384-002 | 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 | Y | Y | ⤷ 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 bedaquiline fumarate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Denmark | 2086940 | ⤷ Sign Up | |
Brazil | PI0719693 | SAL FUMARATO DE (ALFA S, BETA R)-6-BROMO-ALFA-[2- (DEMETILAMINO)ETIL]-2-METÓXI-ALFA-1-NAFTALENIL-BETA- FENIL-3-QUINOLINAETANOL | ⤷ Sign Up |
European Patent Office | 1527050 | DERIVES DE QUINOLEINE ET LEUR UTILISATION EN TANT QU'INHIBITEURS MYCOBACTERIENS (QUINOLINE DERIVATIVES AND THEIR USE AS MYCOBACTERIAL INHIBITORS) | ⤷ Sign Up |
Argentina | 040673 | INHIBIDORES MICOBACTERIANOS, COMPOSICION FARMACEUTICA Y PROCESO DE PREPARACION DEL COMPUESTO | ⤷ Sign Up |
Serbia | 20050058 | DERIVATI HINOLINA I NJIHOVA UPOTREBA KAO MIKOBAKTERIJSKIH INHIBITORA (QUINOLINE DERIVATIVES AND THEIR USE AS MYCOBACTERIAL INHIBITORS) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for bedaquiline fumarate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1527050 | PA2014032 | Lithuania | ⤷ Sign Up | PRODUCT NAME: BEDAQUILINUM; REGISTRATION NO/DATE: EU/1/13/901 20140305 |
1527050 | CA 2014 00044 | Denmark | ⤷ Sign Up | PRODUCT NAME: BEDAKILIN ELLER ET FARMACEUTISK ACCEPTABELT SYRE-ELLER BASEADDITIONSSALT DERAF, HERUNDER BEDAKILINFUMARAT; REG. NO/DATE: EU/1/13/901 20140305 |
1527050 | 122014000083 | Germany | ⤷ Sign Up | PRODUCT NAME: BEDAQUILIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SAEURE- ODER BASENADDITIONSSALZ DAVON; REGISTRATION NO/DATE: EU/1/13/901 20140305 |
1527050 | 178 5021-2014 | Slovakia | ⤷ Sign Up | PRODUCT NAME: BEDACHILIN FUMARAT; REGISTRATION NO/DATE: EU/1/13/901 20140305 |
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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