FDA Orange Book
Is there a generic for Itovebi?
Itovebi contains inavolisib. 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 Itovebi (inavolisib). The Orange Book shows its last listed patent expires June 14, 2038 and its last listed exclusivity ends October 10, 2029.
Run it in Rivvi
Map Itovebi and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Itovebi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 3MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 9MG | Marketed (Rx) | None | 0 | None |
NDA 219249, held by GENENTECH INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Itovebi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8343955 | September 27, 2030 | Method of use | U-4024 | 219249 |
| 8242104 | September 27, 2030 | Drug substance, Drug product | None | 219249 |
| 11760753 | July 1, 2036 | Method of use | U-4024 | 219249 |
| 9650393 | July 1, 2036 | Drug substance, Drug product | U-4024 | 219249 |
| 10851091 | July 1, 2036 | Drug substance, Drug product | None | 219249 |
| 11028100 | April 26, 2038 | Drug substance, Drug product | None | 219249 |
| 12410189 | June 14, 2038 | Method of use | U-4024 | 219249 |
Itovebi exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | October 10, 2029 | 219249 |
Itovebi NDC codes
Questions
Is there a generic for Itovebi?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Itovebi (inavolisib). The Orange Book shows its last listed patent expires June 14, 2038 and its last listed exclusivity ends October 10, 2029.
What is the generic name for Itovebi?
The active ingredient in Itovebi is inavolisib, per the FDA Orange Book.
When does the Itovebi patent expire?
The last patent listed for Itovebi in the Orange Book expires June 14, 2038. 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.