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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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DOPTELET

Generic Entry Date for DOPTELET^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 210238 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

Sponsor	Phase
Sobi, Inc.	Phase 3
The First Affiliated Hospital of Soochow University	Phase 2/Phase 3
Chinese PLA General Hospital	Phase 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

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Glossary

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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

Expired US Patents for DOPTELET

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Akarx Inc	DOPTELET	avatrombopag maleate	TABLET;ORAL	210238-001	May 21, 2018	⤷ Sign Up	⤷ Sign Up
Akarx Inc	DOPTELET	avatrombopag maleate	TABLET;ORAL	210238-001	May 21, 2018	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for DOPTELET

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

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	03062233		⤷ Sign Up
Japan	4844574		⤷ Sign Up
Japan	WO2003062233	２−アシルアミノチアゾール誘導体又はその塩	⤷ Sign Up
China	1639157		⤷ Sign Up
Japan	4120586		⤷ Sign Up
Spain	2610611		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for DOPTELET

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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