Question 1

Is there a generic for Avatrombopag maleate?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Avatrombopag maleate. It is available as 2 brand (NDA) applications.

Question 2

What is the reference-listed drug for Avatrombopag maleate?

Accepted Answer

DOPTELET SPRINKLE (NDA 219696, AKARX INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Avatrombopag maleate?

Accepted Answer

The Orange Book lists 1 patent against Avatrombopag maleate products, with the earliest listed expiry in 2027. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Avatrombopag maleate have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 5 marketing-exclusivity periods for Avatrombopag maleate. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Avatrombopag maleate are approved?

Accepted Answer

Avatrombopag maleate is approved in the following dosage forms: granule, tablet.

Product	Applicant	Application	TE	Approved
DOPTELET SPRINKLERLD	AKARX INC	NDA 219696	—	Jul 24, 2025
DOPTELETRLD	AKARX INC	NDA 210238	—	May 21, 2018

Avatrombopag maleate

Brand (NDA) products · granule, tablet

Marketing exclusivity (5)

Listed patents (1)

Avatrombopag maleate — frequently asked questions

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