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 | 204384-001 | Dec 28, 2012 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
Janssen Therap | SIRTURO | bedaquiline fumarate | TABLET;ORAL | 204384-002 | May 27, 2020 | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
Janssen Therap | SIRTURO | bedaquiline fumarate | TABLET;ORAL | 204384-002 | May 27, 2020 | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Janssen Therap | SIRTURO | bedaquiline fumarate | TABLET;ORAL | 204384-002 | May 27, 2020 | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
>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 |
---|---|---|---|
Spain | 2387923 | ⤷ Subscribe | |
South Korea | 20090087020 | FUMARATE SALT OF (ALPHA S, BETA R)-6-BROMO-ALPHA-[2-(DIMETHYLAMINO)ETHYL]-2-METHOXY-ALPHA-1-NAPHTHALENYL-BETA-PHENYL-3-QUINOLINEETHANOL | ⤷ Subscribe |
Brazil | 0312927 | Derivados de quinolina e seu uso como inibidores micobacterias | ⤷ Subscribe |
Slovenia | 2086940 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BEDAQUILINE FUMARATE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1527050 | 178 5021-2014 | Slovakia | ⤷ Subscribe | PRODUCT NAME: BEDACHILIN FUMARAT; REGISTRATION NO/DATE: EU/1/13/901 20140305 |
1527050 | 50/2014 | Austria | ⤷ Subscribe | PRODUCT NAME: BEDAQUILIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SAEURE- ODER BASENADDITIONSSALZ DAVON, EINSCHLIESSLICH BEDAQUILINFUMARAT; REGISTRATION NO/DATE: EU/1/13/901 20140307 |
1527050 | 122014000083 | Germany | ⤷ Subscribe | PRODUCT NAME: BEDAQUILIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SAEURE- ODER BASENADDITIONSSALZ DAVON; REGISTRATION NO/DATE: EU/1/13/901 20140305 |
1527050 | PA2014032 | Lithuania | ⤷ Subscribe | PRODUCT NAME: BEDAQUILINUM; REGISTRATION NO/DATE: EU/1/13/901 20140305 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
BEDAQUILINE FUMARATE Market Analysis and Financial Projection Experimental
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