Question 1

Is there a generic for Difamilast?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Difamilast. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Difamilast?

Accepted Answer

ADQUEY (NDA 219474, ACROTECH BIOPHARMA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Difamilast?

Accepted Answer

The Orange Book lists 2 patents against Difamilast products, with the earliest listed expiry in 2028. 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 Difamilast have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Difamilast. 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 Difamilast are approved?

Accepted Answer

Difamilast is approved in the following dosage form: ointment.

Patent	Expires	In	Type
RE46792	Mar 01, 2028	in 1 yr 9 mo	SubstanceProductU-4445
10588893	Dec 31, 2036	in 10 yr 8 mo	SubstanceProduct

Difamilast

Brand (NDA) products · ointment

Marketing exclusivity (1)

Listed patents (2)

Difamilast — frequently asked questions

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