Details for New Drug Application (NDA): 219696

NDA 219696 describes DOPTELET SPRINKLE, 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 SPRINKLE profile page.

The generic ingredient in DOPTELET SPRINKLE is avatrombopag maleate. One supplier is listed for this compound. Additional details are available on the avatrombopag maleate profile page.

Summary for 219696

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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 219696

Constraining patent/regulatory exclusivity:

NEW PRODUCT

Dosage:

GRANULE;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: 219696

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DOPTELET SPRINKLE	avatrombopag maleate	GRANULE;ORAL	219696	NDA	AkaRx, Inc.	71369-010	71369-010-30	1 BOTTLE in 1 CARTON (71369-010-30) / 30 GRANULE in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GRANULE;ORAL			Strength	EQ 10MG BASE
Approval Date:	Jul 24, 2025	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Jul 24, 2028
Regulatory Exclusivity Use:	NEW PRODUCT
Patent:		Patent Expiration:	Jul 28, 2027	Product Flag?	Y	Substance Flag?	Y	Delist Request?

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