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Last Updated: November 22, 2024

Avatrombopag maleate - Generic Drug Details


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What are the generic sources for avatrombopag maleate and what is the scope of patent protection?

Avatrombopag maleate is the generic ingredient in one branded drug marketed by Akarx Inc and is included in one NDA. There is one patent 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:1
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:
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

Anatomical Therapeutic Chemical (ATC) Classes for avatrombopag maleate

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Akarx Inc DOPTELET avatrombopag maleate TABLET;ORAL 210238-001 May 21, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for avatrombopag maleate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1466912 CR 2019 00057 Denmark ⤷  Sign Up PRODUCT NAME: AVATROMBOPAG ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF, I SAERDELESHED AVATROMBOPAG MALEAT; REG. NO/DATE: EU/1/19/1373 20190624
1466912 LUC00137 Luxembourg ⤷  Sign Up PRODUCT NAME: AVATROMBOPAG OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER LE MALEATE D'AVATROMBOPAG; AUTHORISATION NUMBER AND DATE: EU/1/19/1373 20190624
1466912 58/2019 Austria ⤷  Sign Up PRODUCT NAME: AVATROMBOPAG ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON, INSBESONDERE AVATROMBOPAGMALEAT; REGISTRATION NO/DATE: EU/1/19/1373 (MITTEILUNG) 20190624
1466912 C20190040 00310 Estonia ⤷  Sign Up PRODUCT NAME: AVATROMBOPAAG;REG NO/DATE: EU/1/19/1373 24.06.2019
1466912 341 50024-2019 Slovakia ⤷  Sign Up PRODUCT NAME: AVATROMBOPAG VO VSETKYCH FORMACH CHRANENYCH ZA- KLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/19/1373 20190624
1466912 SPC/GB19/071 United Kingdom ⤷  Sign Up PRODUCT NAME: AVATROMBOPAG MALEATE; REGISTERED: UK EU/1/19/1373/001-002 20190624; UK EXTRA MA'S ON IPSUM 20190624
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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