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Avatrombopag maleate - Generic Drug Details
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What are the generic drug sources for avatrombopag maleate and what is the scope of freedom to operate?
Avatrombopag maleate
is the generic ingredient in one branded drug marketed by Akarx Inc and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Avatrombopag maleate has twenty-one patent family members in fourteen countries.
Summary for avatrombopag maleate
International Patents: | 21 |
US Patents: | 3 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Bulk Api Vendors: | 4 |
Clinical Trials: | 2 |
DailyMed Link: | avatrombopag maleate at DailyMed |
Recent Clinical Trials for avatrombopag maleate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Eisai Inc. | Phase 3 |
US Patents and Regulatory Information for avatrombopag maleate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Akarx Inc | DOPTELET | avatrombopag maleate | TABLET;ORAL | 210238-001 | May 21, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Akarx Inc | DOPTELET | avatrombopag maleate | TABLET;ORAL | 210238-001 | May 21, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Akarx Inc | DOPTELET | avatrombopag maleate | TABLET;ORAL | 210238-001 | May 21, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
Akarx Inc | DOPTELET | avatrombopag maleate | TABLET;ORAL | 210238-001 | May 21, 2018 | RX | Yes | Yes | Start Trial | Start Trial | 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 avatrombopag maleate
Country | Patent Number | Estimated Expiration |
---|---|---|
Japan | WO2003062233 | Start Trial |
Japan | 4844574 | Start Trial |
Japan | 4120586 | Start Trial |
Japan | 2008111001 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for avatrombopag maleate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1466912 | 341 50024-2019 | Slovakia | Start Trial | PRODUCT NAME: AVATROMBOPAG VO VSETKYCH FORMACH CHRANENYCH ZA- KLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/19/1373 20190624 |
1466912 | 1990057-0 | Sweden | Start Trial | PRODUCT NAME: AVATROMBOPAG, AND PHYSIOLOGICAL SALTS THEREOF, INCLUDING AVATROMBOPAG MALEATE; REG. NO/DATE: EU/1/19/1373 20190624 |
1466912 | 301020 | Netherlands | Start Trial | PRODUCT NAME: AVATROMBOPAG, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER AVATROMBOPAG-MALEAAT; REGISTRATION NO/DATE: EU/1/19/1373 20190624 |
1466912 | 2019/058 | Ireland | Start Trial | PRODUCT NAME: AVATROMBOPAG OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR AVATROMBOPAG MALEATE; REGISTRATION NO/DATE: EU/1/19/1373 20190624 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |