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Bedaquiline fumarate - Generic Drug Details
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What are the generic 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-six 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: | 96 |
| US Patents: | 2 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 23 |
| Patent Applications: | 1 |
| DailyMed Link: | bedaquiline fumarate at DailyMed |
Pharmacology for bedaquiline fumarate
| Drug Class | Diarylquinoline Antimycobacterial |
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 | Start Trial | Start Trial | Start Trial | ||||
| Janssen Therap | SIRTURO | bedaquiline fumarate | TABLET;ORAL | 204384-002 | May 27, 2020 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Janssen Therap | SIRTURO | bedaquiline fumarate | TABLET;ORAL | 204384-001 | Dec 28, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Janssen Therap | SIRTURO | bedaquiline fumarate | TABLET;ORAL | 204384-002 | May 27, 2020 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start 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 bedaquiline fumarate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Norway | 20050476 | Start Trial |
| Spain | 2395237 | Start Trial |
| Brazil | 0312927 | Start Trial |
| New Zealand | 576485 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for bedaquiline fumarate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1527050 | 178 5021-2014 | Slovakia | Start Trial | PRODUCT NAME: BEDACHILIN FUMARAT; REGISTRATION NO/DATE: EU/1/13/901 20140305 |
| 1527050 | C 2014 034 | Romania | Start Trial | PRODUCT NAME: BEDAQUILINA SAU O SARE DE ADITIE A UNUI ACID SAU A UNEI BAZEACCEPTABILA FARMACEUTIC A ACESTEIA, INCLUSIV FUMARAT DE BEDAQUILINA - FUMARAT DE BEDAQUILINA (1R,2S)-1-(6-BROMO-2-METOXIQUINOLIN-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 |
| 1527050 | C300684 | Netherlands | Start Trial | PRODUCT NAME: BEDAQUILINE, OF EEN FARMACEUTISCH AANVAARDBAAR ZUUR- OF BASE-ADDITIEZOUT DAARVAN, WAARONDER BEDAQUILINEFUMARAAT; REGISTRATION NO/DATE: EU/1/13/901 20140307 |
| 1527050 | 122014000083 | Germany | Start Trial | PRODUCT NAME: BEDAQUILIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SAEURE- ODER BASENADDITIONSSALZ DAVON; 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.
ISSN: 2162-2639
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