FDA Orange Book

Generic for Eucrisa

Eucrisa contains crisaborole. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Eucrisa is crisaborole. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Eucrisa products in the Orange Book

Eucrisa products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
ointment, topical2%Marketed (Rx)AB1AB

NDA 207695, held by ANACOR PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic crisaborole

Approved generic versions of Eucrisa
CompanyANDATE codeApprovedStrengths
MACLEODS PHARMACEUTICALS LTD216242AB (A-rated, therapeutically equivalent)September 24, 20262%

Eucrisa patents

Patents listed for Eucrisa
PatentExpiresCoversUse codeNDA
8501712February 16, 2027Method of useU-1932207695
9682092February 16, 2027Method of useU-1932207695
8501712*PEDAugust 16, 2027Method of useNone207695
9682092*PEDAugust 16, 2027Method of useNone207695
8039451June 29, 2029Drug substance, Drug productNone207695
8039451*PEDDecember 29, 2029Method of useNone207695
8168614January 20, 2030Method of useU-1932207695
8168614*PEDJuly 20, 2030Method of useNone207695

Eucrisa exclusivity

Exclusivity listed for Eucrisa
CodeMeaningExpiresNDA
D-191New dosing scheduleApril 3, 2026207695

Eucrisa NDC codes

Questions

Is there a generic for Eucrisa?

Yes. The generic name for Eucrisa is crisaborole. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Eucrisa?

The active ingredient in Eucrisa is crisaborole, per the FDA Orange Book.

When does the Eucrisa patent expire?

The last patent listed for Eucrisa in the Orange Book expires July 20, 2030. A listed patent expiry date is not a generic launch date.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.

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