FDA Orange Book

Is there a generic for Velsipity?

Velsipity contains etrasimod. 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

No. The Orange Book lists no active FDA-approved generic (ANDA) for Velsipity (etrasimod). The Orange Book shows its last listed patent expires June 21, 2036 and its last listed exclusivity ends October 12, 2028.

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Velsipity products in the Orange Book

Velsipity products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
tablet, oralEQ 2MG BASEMarketed (Rx)None0None

NDA 216956, held by PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Velsipity patents

Patents listed for Velsipity
PatentExpiresCoversUse codeNDA
9126932July 22, 2029Method of useU-3732216956
8580841March 5, 2030Drug substance, Drug productNone216956
12377071January 6, 2036Method of useU-4255216956
11007175January 6, 2036Method of useU-3730216956
12156866January 6, 2036Method of useU-4047216956
11884626June 21, 2036Method of useU-3731216956
10676435June 21, 2036Method of useU-3731216956
11091435June 21, 2036Drug substance, Drug productNone216956
10301262June 21, 2036Drug substance, Drug productNone216956

Velsipity exclusivity

Exclusivity listed for Velsipity
CodeMeaningExpiresNDA
NCENew chemical entityOctober 12, 2028216956

Velsipity NDC codes

Questions

Is there a generic for Velsipity?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Velsipity (etrasimod). The Orange Book shows its last listed patent expires June 21, 2036 and its last listed exclusivity ends October 12, 2028.

What is the generic name for Velsipity?

The active ingredient in Velsipity is etrasimod, per the FDA Orange Book.

When does the Velsipity patent expire?

The last patent listed for Velsipity in the Orange Book expires June 21, 2036. 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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