FDA Orange Book
Is there a generic for Flyrcado?
Flyrcado contains flurpiridaz f-18. 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 Flyrcado (flurpiridaz f-18). The Orange Book shows its last listed patent expires May 13, 2042 and its last listed exclusivity ends September 27, 2029.
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Flyrcado products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 5-55mCi/ML | Marketed (Rx) | None | 0 | None |
NDA 215168, held by GE HEALTHCARE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Flyrcado patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9161997 | February 4, 2026 | Drug substance, Drug product | U-4011 | 215168 |
| 7344702 | May 26, 2026 | Drug substance | None | 215168 |
| 8226929 | June 21, 2028 | Method of use | U-4011 | 215168 |
| 9603951 | May 2, 2031 | Method of use | U-4011 | 215168 |
| 8936777 | June 30, 2031 | Method of use | U-4011 | 215168 |
| 9687571 | November 1, 2032 | Drug product | U-4011 | 215168 |
| 12527884 | May 13, 2042 | Drug product | U-4406 | 215168 |
Flyrcado exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | September 27, 2029 | 215168 |
Flyrcado NDC codes
Questions
Is there a generic for Flyrcado?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Flyrcado (flurpiridaz f-18). The Orange Book shows its last listed patent expires May 13, 2042 and its last listed exclusivity ends September 27, 2029.
What is the generic name for Flyrcado?
The active ingredient in Flyrcado is flurpiridaz f-18, per the FDA Orange Book.
When does the Flyrcado patent expire?
The last patent listed for Flyrcado in the Orange Book expires May 13, 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.