FDA Orange Book
Is there a generic for Revtorpyk?
Revtorpyk contains gedatolisib. 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 Revtorpyk (gedatolisib). The Orange Book shows its last listed exclusivity ends July 14, 2031.
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Revtorpyk products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | 180MG/VIAL | Marketed (Rx) | None | 0 | None |
NDA 219908, held by CELCUITY INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Revtorpyk exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | July 14, 2031 | 219908 |
Revtorpyk NDC codes
Questions
Is there a generic for Revtorpyk?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Revtorpyk (gedatolisib). The Orange Book shows its last listed exclusivity ends July 14, 2031.
What is the generic name for Revtorpyk?
The active ingredient in Revtorpyk is gedatolisib, per the FDA Orange Book.
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.