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Last Updated: December 9, 2023

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

SponsorPhase
Chinese PLA General HospitalPhase 4
Eisai Inc.Phase 3
Eisai Inc.Phase 2

See all avatrombopag maleate clinical trials

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

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Colorcon
Mallinckrodt
McKinsey
Boehringer Ingelheim
Dow

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.