FDA Orange Book
Is there a generic for Fyarro?
Fyarro 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 Fyarro (sirolimus). The Orange Book shows its last listed patent expires October 28, 2040 and its last listed exclusivity ends November 22, 2028.
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Fyarro products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | 100MG/VIAL | Marketed (Rx) | None | 0 | None |
NDA 213312, held by AADI BIOSCIENCES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Fyarro patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8911786 | February 14, 2029 | Drug product | U-3259 | 213312 |
| 10206887 | April 15, 2030 | Drug product | None | 213312 |
| 12061183 | March 5, 2036 | Drug product | None | 213312 |
| 10705070 | March 5, 2036 | Drug product | None | 213312 |
| 12133844 | June 29, 2036 | Method of use | U-4040 | 213312 |
| 12133844 | June 29, 2036 | Method of use | U-4041 | 213312 |
| 12133844 | June 29, 2036 | Method of use | U-4042 | 213312 |
| 10973806 | June 29, 2036 | Method of use | U-3258 | 213312 |
| 11497737 | October 28, 2040 | Drug product | None | 213312 |
Fyarro exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-386 | Orphan drug exclusivity | November 22, 2028 | 213312 |
Fyarro NDC codes
Questions
Is there a generic for Fyarro?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Fyarro (sirolimus). The Orange Book shows its last listed patent expires October 28, 2040 and its last listed exclusivity ends November 22, 2028.
What is the generic name for Fyarro?
The active ingredient in Fyarro is sirolimus, per the FDA Orange Book.
When does the Fyarro patent expire?
The last patent listed for Fyarro in the Orange Book expires October 28, 2040. 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.