Details for New Drug Application (NDA): 210238

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NDA 210238 describes DOPTELET, which is a drug marketed by Akarx Inc and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the DOPTELET profile page.

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.

Summary for 210238

Tradename:	DOPTELET
Applicant:	Akarx Inc
Ingredient:	avatrombopag maleate
Patents:	1

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 210238

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

Suppliers and Packaging for NDA: 210238

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOPTELET	avatrombopag maleate	TABLET;ORAL	210238	NDA	AkaRx, Inc.	71369-020	71369-020-10	1 BLISTER PACK in 1 CARTON (71369-020-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK (71369-020-11)
DOPTELET	avatrombopag maleate	TABLET;ORAL	210238	NDA	AkaRx, Inc.	71369-020	71369-020-15	1 BLISTER PACK in 1 CARTON (71369-020-15) / 15 TABLET, FILM COATED in 1 BLISTER PACK (71369-020-16)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 20MG BASE
Approval Date:	May 21, 2018	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Jun 26, 2026
Regulatory Exclusivity Use:	TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT
Patent:	⤷ Sign Up	Patent Expiration:	Jul 28, 2027	Product Flag?	Y	Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 210238

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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

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Summary for 210238

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 210238

Suppliers and Packaging for NDA: 210238

Profile for product number 001

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DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 210238