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Last Updated: June 29, 2022

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 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.

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 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
Raw Ingredient (Bulk) Api Vendors: 39
Clinical Trials: 7
Patent Applications: 81
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 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
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 four US patents and three FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of DOPTELET is See Plans and Pricing.

This potential generic entry date is based on TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

2-acylaminothiazole derivative or salt thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF THROMBOCYTOPENIA IN AN ADULT PATIENT WITH CHRONIC IMMUNE THROMBOCYTOPENIA WHO HAS HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT

2-acylaminothiazole derivative or salt thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF THROMBOCYTOPENIA IN AN ADULT PATIENT WITH CHRONIC LIVER DISEASE WHO IS SCHEDULED TO UNDERGO A PROCEDURE USING DOPTELET

2-acylaminothiazole derivative or salt thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF THROMBOCYTOPENIA IN AN ADULT PATIENT WITH CHRONIC LIVER DISEASE WHO IS SCHEDULED TO UNDERGO A PROCEDURE

FDA Regulatory Exclusivity protecting DOPTELET

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Akarx Inc DOPTELET avatrombopag maleate TABLET;ORAL 210238-001 May 21, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Akarx Inc DOPTELET avatrombopag maleate TABLET;ORAL 210238-001 May 21, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Akarx Inc DOPTELET avatrombopag maleate TABLET;ORAL 210238-001 May 21, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 C20190040 00310 Estonia See Plans and Pricing PRODUCT NAME: AVATROMBOPAAG;REG NO/DATE: EU/1/19/1373 24.06.2019
1466912 CR 2019 00057 Denmark See Plans and Pricing PRODUCT NAME: AVATROMBOPAG ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF, I SAERDELESHED AVATROMBOPAG MALEAT; REG. NO/DATE: EU/1/19/1373 20190624
1466912 2019C/547 Belgium See Plans and Pricing PRODUCT NAME: AVATROMBOPAG ET SES SELS, TELS QUE L'AVATROMBOPAG MALEATE; AUTHORISATION NUMBER AND DATE: EU/1/19/1373 20190624
1466912 132019000000157 Italy See Plans and Pricing PRODUCT NAME: AVATROMBOPAG O SUOI SALI FARMACEUTICAMENTE ACCETTABILI, IN PARTICOLARE AVATROMBOPAG MALEATO(DOPTELET); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1373, 20190624
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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