FDA Orange Book
Is there a generic for Pylarify?
Pylarify contains piflufolastat 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 Pylarify (piflufolastat f-18). The Orange Book shows its last listed patent expires June 9, 2037 and its last listed exclusivity ends May 26, 2026.
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Pylarify products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 50ML (1-80mCi/ML) | Marketed (Rx) | None | 0 | None |
NDA 214793, held by PROGENICS PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Pylarify patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8487129 | November 7, 2027 | Drug substance, Drug product | None | 214793 |
| 9861713 | July 31, 2029 | Drug substance, Drug product | U-3130 | 214793 |
| 12070513 | July 31, 2029 | Drug substance, Drug product | U-3130 | 214793 |
| 8778305 | September 21, 2030 | Drug substance, Drug product | U-3130 | 214793 |
| 10947197 | June 9, 2037 | Drug substance, Drug product | U-3130 | 214793 |
| 11851407 | June 9, 2037 | Drug substance, Drug product | U-3130 | 214793 |
Pylarify exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | May 26, 2026 | 214793 |
Pylarify NDC codes
Questions
Is there a generic for Pylarify?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Pylarify (piflufolastat f-18). The Orange Book shows its last listed patent expires June 9, 2037 and its last listed exclusivity ends May 26, 2026.
What is the generic name for Pylarify?
The active ingredient in Pylarify is piflufolastat f-18, per the FDA Orange Book.
When does the Pylarify patent expire?
The last patent listed for Pylarify in the Orange Book expires June 9, 2037. 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.