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Last Updated: February 28, 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 nineteen patent family members in twelve 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.

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
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.

Synonyms for DOPTELET
1-(3-chloro-5-((4-(4-chlorothiophen-2-yl)-5-(4-cyclohexylpiperazin-1-yl)thiazol-2-yl)carbamoyl)pyridin-2-yl)piperidine-4-carboxylic acid
1-[3-chloro-5-[[[4-(4-chloro-2-thienyl)-5-(4-cyclohexyl-1-piperazinyl)-2-thiazolyl]amino]carbonyl]-2-pyridinyl]-4-piperidinecarboxylic acid
1-[3-Chloro-5-[[4-(4-chloro-2-thienyl)-5-(4-cyclohexylpiperazino)-2-thiazolyl]carbamoyl]-2-pyridyl]piperidine-4-carboxylic acid
1-[3-chloro-5-[[4-(4-chlorothiophen-2-yl)-5-(4-cyclohexylpiperazin-1-yl)-1,3-thiazol-2-yl]carbamoyl]pyridin-2-yl]piperidine-4-carboxylic acid
3H8GSZ4SQL
4-Piperidinecarboxylic acid, 1-(3-chloro-5-(((4-(4-chloro-2-thienyl)-5-(4-cyclohexyl-1-piperazinyl)-2-thiazolyl)amino)carbonyl)-2-pyridinyl)-
570406-98-3
A14087
AKR 501
AKR-501
AKR-501;E5501;AS1670542
AS 1670542
AVATROMBOPAG
Avatrombopag (USAN/INN)
Avatrombopag [USAN:INN]
BCP28031
CHEMBL2103883
CS-3397
D10306
DB11995
DTXSID30205667
E 5501
E5501
FT-0728753
GTPL9953
HY-13463
SB16846
SCHEMBL289354
UNII-3H8GSZ4SQL
YM 477
YM477
ZINC72190218

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
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 LUC00137 Luxembourg   Start Trial PRODUCT NAME: MALEATE D'AVATROMBOPAG; AUTHORISATION NUMBER AND DATE: EU/1/19/1373 20190624
1466912 CA 2019 00057 Denmark   Start Trial PRODUCT NAME: AVATROMBOPAG MALEAT; REG. NO/DATE: EU/1/19/1373 20190624
1466912 301020 Netherlands   Start Trial PRODUCT NAME: AVATROMBOPAG, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER AVATROMBOPAG-MALEAAT; REGISTRATION NO/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:

Boehringer Ingelheim
Dow
Express Scripts
Harvard Business School
Merck
Colorcon

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