FDA Orange Book

Is there a generic for Tascenso ODT?

Tascenso ODT contains fingolimod lauryl. 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 Tascenso ODT (fingolimod lauryl). The Orange Book shows its last listed patent expires January 19, 2036.

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Tascenso ODT products in the Orange Book

Tascenso ODT products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
tablet, orally disintegrating, oralEQ 0.25MG BASEMarketed (Rx)None0None
tablet, orally disintegrating, oralEQ 0.5MG BASEMarketed (Rx)None0None

NDA 214962, held by CYCLE PHARMACEUTICALS LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Tascenso ODT patents

Patents listed for Tascenso ODT
PatentExpiresCoversUse codeNDA
10555902January 19, 2036Method of useU-3268214962
9925138January 19, 2036Drug productNone214962
10925829January 19, 2036Drug productNone214962
10555902January 19, 2036Method of useU-3493214962

Tascenso ODT NDC codes

Questions

Is there a generic for Tascenso ODT?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Tascenso ODT (fingolimod lauryl). The Orange Book shows its last listed patent expires January 19, 2036.

What is the generic name for Tascenso ODT?

The active ingredient in Tascenso ODT is fingolimod lauryl, per the FDA Orange Book.

When does the Tascenso ODT patent expire?

The last patent listed for Tascenso ODT in the Orange Book expires January 19, 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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