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Generated: September 21, 2017
What are the generic sources for bedaquiline fumarate and what is the scope of bedaquiline fumarate 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.| Tradenames: | 1 |
| Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 1 |
| Clinical Trials: see list | 553 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | bedaquiline fumarate at DailyMed |
| Ingredient-type | Diarylquinolines |
| Drug Class | Diarylquinoline Antimycobacterial |
| 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 | 204384-001 | Dec 28, 2012 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | Y | ► Subscribe | ||||||||||||||||
Janssen Therap | SIRTURO | bedaquiline fumarate | TABLET;ORAL | 204384-001 | Dec 28, 2012 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
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 | 204384-001 | Dec 28, 2012 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Serbia | 52408 | ► Subscribe | |||||||||||||||||||||||||||
| Brazil | PI0719693 | ► Subscribe | |||||||||||||||||||||||||||
| Mexico | 2009005909 | ► Subscribe | |||||||||||||||||||||||||||
| Germany | 60332023 | ► Subscribe | |||||||||||||||||||||||||||
| Iceland | 7620 | ► Subscribe | |||||||||||||||||||||||||||
| South Africa | 200500680 | ► Subscribe | |||||||||||||||||||||||||||
| Norway | 20050476 | ► Subscribe | |||||||||||||||||||||||||||
| Ukraine | 82198 | ► Subscribe | |||||||||||||||||||||||||||
| Mexico | PA05001052 | ► Subscribe | |||||||||||||||||||||||||||
| Austria | 463482 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0140026 00112 | Estonia | ► Subscribe | PRODUCT NAME: BEDAKVILIIN;REG NO/DATE: K(2014)1616 (LOPLIK) 07.03.2014 | ||||||||||||||||||||||||||
| 14/045 | Ireland | ► Subscribe | PRODUCT NAME: BEDAQUILINE, OR A PHARMACEUTICALLY ACCEPTABLE ACID OR BASE ADDITION SALT THEREOF, INCLUDING BEDAQUILINE FUMARATE; REGISTRATION NO/DATE: EU/1/13/901 20140305 | ||||||||||||||||||||||||||
| C0060 | France | ► Subscribe | PRODUCT NAME: BEDAQUILINE OU UN DE SES SELS D'ADDITION D'ACIDE OU DE BASE PHARMACEUTIQUEMENT ACCEPTABLE, Y COMPRIS LE FUMARATE DE BEDAQUILINE; REGISTRATION NO/DATE: EU/1/13/901 20140307 | ||||||||||||||||||||||||||
| 2014032,C1527050 | Lithuania | ► Subscribe | PRODUCT NAME: BEDAQUILINUM; REGISTRATION NO/DATE: EU/1/13/901 20140305 | ||||||||||||||||||||||||||
| 2014032 | Lithuania | ► Subscribe | PRODUCT NAME: BEDAQUILINUM; REGISTRATION NO/DATE: EU/1/13/901 20140305 | ||||||||||||||||||||||||||
| 90050-0 | Sweden | ► Subscribe | PRODUCT NAME: BEDAQUILINE, OR A PHARMACEUTICALLY ACCEPTABLE ACID OR BASE ADDITION SALT THEREOF, INCLUDING BEDAQUILINE FUMARATE; REG. NO/DATE: EU/1/13/901 20140305 | ||||||||||||||||||||||||||
| 520 | Luxembourg | ► Subscribe | PRODUCT NAME: BEDAQUILINE, OU SON SEL D ADDITION D ACIDE OU DE BASE PHARMACEUTIQUEMENT ACCEPTABLE, Y COMPRIS LE FUMARATE DE BEDAQUILINE. FIRST REGISTRATION: 20140307 | ||||||||||||||||||||||||||
| 8 5021-2014 | Slovakia | ► Subscribe | PRODUCT NAME: BEDACHILIN FUMARAT; REGISTRATION NO/DATE: EU/1/13/901 20140305 | ||||||||||||||||||||||||||
| 0684 | Netherlands | ► Subscribe | PRODUCT NAME: BEDAQUILINE, OF EEN FARMACEUTISCH AANVAARDBAAR ZUUR- OF BASE-ADDITIEZOUT DAARVAN, WAARONDER BEDAQUILINEFUMARAAT; REGISTRATION NO/DATE: EU/1/13/901 20140307 | ||||||||||||||||||||||||||
| 00684 | Netherlands | ► Subscribe | PRODUCT NAME: BEDAQUILINE, OF EEN FARMACEUTISCH AANVAARDBAAR ZUUR- OF BASE-ADDITIEZOUT DAARVAN, WAARONDER BEDAQUILINEFUMARAAT; REGISTRATION NO/DATE: EU/1/13/901 20140307 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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 verifification 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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