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.
One supplier is listed for this compound.
Summary for avatrombopag maleate
| International Patents: | 21 |
| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 16 |
| Clinical Trials: | 4 |
| Patent Applications: | 8 |
| What excipients (inactive ingredients) are in avatrombopag maleate? | avatrombopag maleate excipients list |
| DailyMed Link: | avatrombopag maleate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for avatrombopag maleate
Generic Entry Date for avatrombopag maleate*:
Constraining patent/regulatory exclusivity:
TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT 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.
Recent Clinical Trials for avatrombopag maleate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Chinese PLA General Hospital | Phase 4 |
| Eisai Inc. | Phase 3 |
| Eisai Inc. | Phase 2 |
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Akarx Inc | DOPTELET | avatrombopag maleate | TABLET;ORAL | 210238-001 | May 21, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Akarx Inc | DOPTELET | avatrombopag maleate | TABLET;ORAL | 210238-001 | May 21, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Akarx Inc | DOPTELET | avatrombopag maleate | TABLET;ORAL | 210238-001 | May 21, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Akarx Inc | DOPTELET | avatrombopag maleate | TABLET;ORAL | 210238-001 | May 21, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for avatrombopag maleate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Akarx Inc | DOPTELET | avatrombopag maleate | TABLET;ORAL | 210238-001 | May 21, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
| Akarx Inc | DOPTELET | avatrombopag maleate | TABLET;ORAL | 210238-001 | May 21, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for avatrombopag maleate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 2314586 | Dérivé 2-acylaminothiazole ou sel de celui-ci (2-Acylaminothiazole derivative or salt thereof) | ⤷ Try a Trial |
| Luxembourg | C00137 | ⤷ Try a Trial | |
| Denmark | 1466912 | ⤷ Try a Trial | |
| China | 1639157 | ⤷ Try a Trial | |
| Portugal | 1466912 | ⤷ Try a Trial | |
| Hungary | S1900052 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for avatrombopag maleate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1466912 | 2019/058 | Ireland | ⤷ Try a Trial | PRODUCT NAME: AVATROMBOPAG OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR AVATROMBOPAG MALEATE; REGISTRATION NO/DATE: EU/1/19/1373 20190624 |
| 1466912 | C201930073 | Spain | ⤷ Try a Trial | PRODUCT NAME: AVATROMBOPAG O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, EN PARTICULAR MALEATO DE AVATROMBOPAG; NATIONAL AUTHORISATION NUMBER: EU/1/19/1373; DATE OF AUTHORISATION: 20190620; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1373; DATE OF FIRST AUTHORISATION IN EEA: 20190620 |
| 1466912 | 1990057-0 | Sweden | ⤷ Try a Trial | PRODUCT NAME: AVATROMBOPAG, AND PHYSIOLOGICAL SALTS THEREOF, INCLUDING AVATROMBOPAG MALEATE; REG. NO/DATE: EU/1/19/1373 20190624 |
| 1466912 | 2019C/547 | Belgium | ⤷ Try a Trial | PRODUCT NAME: AVATROMBOPAG ET SES SELS, TELS QUE L'AVATROMBOPAG MALEATE; AUTHORISATION NUMBER AND DATE: EU/1/19/1373 20190624 |
| 1466912 | LUC00137 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: AVATROMBOPAG OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER LE MALEATE D'AVATROMBOPAG; AUTHORISATION NUMBER AND DATE: EU/1/19/1373 20190624 |
| 1466912 | 638 | Finland | ⤷ Try a Trial | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
