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Last Updated: July 12, 2020

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DOPTELET Drug 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 are three patents protecting this drug.

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

The generic ingredient in DOPTELET is avatrombopag maleate. Additional details are available on the avatrombopag maleate profile page.

US ANDA Litigation and Generic Entry Outlook for Doptelet

Doptelet will be eligible for patent challenges on May 21, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 26, 2026. 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:3
Applicants:1
NDAs:1
Bulk Api Vendors: 29
Clinical Trials: 1
Patent Applications: 31
Drug Prices: Drug price information for DOPTELET
DailyMed Link:DOPTELET at DailyMed
Drug patent expirations by year for DOPTELET
Drug Prices for DOPTELET

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Generic Entry Opportunity Date for DOPTELET
Generic Entry Date for DOPTELET*:
Constraining patent/regulatory exclusivity:
TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT
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
National Cancer Institute (NCI)Phase 2
Ohio State University Comprehensive Cancer CenterPhase 2

See all DOPTELET clinical trials

US Patents and Regulatory Information for DOPTELET

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
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

Supplementary Protection Certificates for DOPTELET

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1466912 2019C/547 Belgium   Start Trial PRODUCT NAME: AVATROMBOPAG ET SES SELS, TELS QUE L'AVATROMBOPAG MALEATE; AUTHORISATION NUMBER AND DATE: EU/1/19/1373 20190624
1466912 122019000107 Germany   Start Trial PRODUCT NAME: AVATROMBOPAG ODER PHARMAZEUTISCH AKZEPTABLE SALZE DAVON, INSBESONDERE AVATROMBOPAG MALEAT; REGISTRATION NO/DATE: EU/1 /19/1373 20190620
1466912 CA 2019 00057 Denmark   Start Trial PRODUCT NAME: AVATROMBOPAG MALEAT; REG. 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 LUC00137 Luxembourg   Start Trial PRODUCT NAME: MALEATE D'AVATROMBOPAG; AUTHORISATION NUMBER AND DATE: EU/1/19/1373 20190624
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Harvard Business School
Merck
Dow
Moodys
Colorcon

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.