FDA Orange Book
Is there a generic for Hyftor?
Hyftor contains sirolimus. 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 Hyftor (sirolimus). The Orange Book shows its last listed patent expires April 11, 2045 and its last listed exclusivity ends March 22, 2029.
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Hyftor products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| gel, topical | 0.2% | Marketed (Rx) | None | 0 | None |
NDA 213478, held by NOBELPHARMA CO LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Hyftor patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12740970 | April 11, 2045 | Drug product | None | 213478 |
Hyftor exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-391 | Orphan drug exclusivity | March 22, 2029 | 213478 |
Hyftor NDC codes
Questions
Is there a generic for Hyftor?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Hyftor (sirolimus). The Orange Book shows its last listed patent expires April 11, 2045 and its last listed exclusivity ends March 22, 2029.
What is the generic name for Hyftor?
The active ingredient in Hyftor is sirolimus, per the FDA Orange Book.
When does the Hyftor patent expire?
The last patent listed for Hyftor in the Orange Book expires April 11, 2045. 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.