Question 1

Is there a generic for Crisaborole?

Accepted Answer

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

Question 2

What is the reference-listed drug for Crisaborole?

Accepted Answer

EUCRISA (NDA 207695, ANACOR PHARMS 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 Crisaborole?

Accepted Answer

The Orange Book lists 8 patents against Crisaborole 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 Crisaborole have FDA marketing exclusivity?

Accepted Answer

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

Accepted Answer

Crisaborole is approved in the following dosage form: ointment.

Patent	Expires	In	Type
8501712	Feb 16, 2027	in 8 mo	U-1932
9682092	Feb 16, 2027	in 8 mo	U-1932
8501712*PED	Aug 16, 2027	in 1 yr 2 mo
9682092*PED	Aug 16, 2027	in 1 yr 2 mo
8039451	Jun 29, 2029	in 3 yr 1 mo	SubstanceProduct
8039451*PED	Dec 29, 2029	in 3 yr 7 mo
8168614	Jan 20, 2030	in 3 yr 8 mo	U-1932
8168614*PED	Jul 20, 2030	in 4 yr 2 mo

Crisaborole

Brand (NDA) products · ointment

Marketing exclusivity (1)

Listed patents (8)

Crisaborole — frequently asked questions

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