FDA Orange Book
Is there a generic for Ontralfy?
Ontralfy contains tizanidine. 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 Ontralfy (tizanidine). The Orange Book shows its last listed patent expires May 7, 2042.
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Ontralfy products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | EQ 2MG BASE/5ML | Marketed (Rx) | None | 0 | None |
NDA 216190, held by FIDELITY BIOPHARMA CO USA. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Ontralfy patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12263158 | May 7, 2042 | Drug product | U-2779 | 216190 |
| 12042484 | May 7, 2042 | Drug product | U-2779 | 216190 |
Ontralfy NDC codes
Questions
Is there a generic for Ontralfy?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Ontralfy (tizanidine). The Orange Book shows its last listed patent expires May 7, 2042.
What is the generic name for Ontralfy?
The active ingredient in Ontralfy is tizanidine, per the FDA Orange Book.
When does the Ontralfy patent expire?
The last patent listed for Ontralfy in the Orange Book expires May 7, 2042. 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.