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Last Updated: July 16, 2024

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DOPTELET Drug Patent Profile


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When do Doptelet patents expire, and when can generic versions of Doptelet launch?

Doptelet is a drug marketed by Akarx Inc and is included in one NDA. There is one patent protecting this drug.

This drug has twenty-one patent family members in fourteen countries.

The generic ingredient in DOPTELET is avatrombopag maleate. One supplier is listed for this compound. Additional details are available on the avatrombopag maleate profile page.

DrugPatentWatch® Generic Entry Outlook for Doptelet

Doptelet was eligible for patent challenges on May 21, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 28, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for DOPTELET
International Patents:21
US Patents:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 51
Clinical Trials: 7
Patent Applications: 67
Drug Prices: Drug price information for DOPTELET
What excipients (inactive ingredients) are in DOPTELET?DOPTELET excipients list
DailyMed Link:DOPTELET at DailyMed
Drug patent expirations by year for DOPTELET
Drug Prices for DOPTELET

See drug prices for DOPTELET

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DOPTELET
Generic Entry Date for DOPTELET*:
Constraining patent/regulatory exclusivity:
NDA:
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 DOPTELET

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Sobi, Inc.Phase 3
The First Affiliated Hospital of Soochow UniversityPhase 2/Phase 3
Chinese PLA General HospitalPhase 4

See all DOPTELET clinical trials

US Patents and Regulatory Information for DOPTELET

DOPTELET is protected by one US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of DOPTELET is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting DOPTELET

2-Acylaminothiazole derivative or salt thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting DOPTELET

TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT
Exclusivity Expiration: ⤷  Sign Up

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 Y Y ⤷  Sign Up
Akarx Inc DOPTELET avatrombopag maleate TABLET;ORAL 210238-001 May 21, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 DOPTELET

See the table below for patents covering DOPTELET around the world.

Country Patent Number Title Estimated Expiration
Japan WO2003062233 2−アシルアミノチアゾール誘導体又はその塩 ⤷  Sign Up
European Patent Office 1466912 DERIVE DE 2-ACYLAMINOTHIAZOLE ET SON SEL (2-ACYLAMINOTHIAZOLE DERIVATIVE OR SALT THEREOF) ⤷  Sign Up
Cyprus 1114169 ⤷  Sign Up
South Korea 101010905 ⤷  Sign Up
Portugal 1466912 ⤷  Sign Up
Denmark 1466912 ⤷  Sign Up
Canada 2472711 DERIVE DE 2-ACYLAMINOTHIAZOLE ET SON SEL (2-ACYLAMINOTHIAZOLE DERIVATIVE OR SALT THEREOF) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DOPTELET

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1466912 2019C/547 Belgium ⤷  Sign Up PRODUCT NAME: AVATROMBOPAG ET SES SELS, TELS QUE L'AVATROMBOPAG MALEATE; AUTHORISATION NUMBER AND DATE: EU/1/19/1373 20190624
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 132019000000157 Italy ⤷  Sign Up PRODUCT NAME: AVATROMBOPAG O SUOI SALI FARMACEUTICAMENTE ACCETTABILI, IN PARTICOLARE AVATROMBOPAG MALEATO(DOPTELET); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1373, 20190624
1466912 122019000107 Germany ⤷  Sign Up PRODUCT NAME: AVATROMBOPAG ODER PHARMAZEUTISCH AKZEPTABLE SALZE DAVON, INSBESONDERE AVATROMBOPAG MALEAT; REGISTRATION NO/DATE: EU/1 /19/1373 20190620
1466912 1990057-0 Sweden ⤷  Sign Up PRODUCT NAME: AVATROMBOPAG, AND PHYSIOLOGICAL SALTS THEREOF, INCLUDING AVATROMBOPAG MALEATE; REG. NO/DATE: EU/1/19/1373 20190624
1466912 CA 2019 00057 Denmark ⤷  Sign Up PRODUCT NAME: AVATROMBOPAG MALEAT; REG. NO/DATE: EU/1/19/1373 20190624
1466912 638 Finland ⤷  Sign Up
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.