FDA Orange Book
Is there a generic for Krazati?
Krazati contains adagrasib. 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 Krazati (adagrasib). The Orange Book shows its last listed patent expires August 21, 2043 and its last listed exclusivity ends December 12, 2029.
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Krazati products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 200MG | Marketed (Rx) | None | 0 | None |
NDA 216340, held by BRISTOL MYERS SQUIBB CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Krazati patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10689377 | May 17, 2037 | Drug substance, Drug product | U-3490 | 216340 |
| 10689377 | May 17, 2037 | Drug substance, Drug product | U-3953 | 216340 |
| 12336995 | February 5, 2041 | Method of use | U-3953 | 216340 |
| 12281113 | September 10, 2041 | Drug substance, Drug product | None | 216340 |
| 12653789 | August 21, 2043 | Drug product | None | 216340 |
| 12383503 | August 21, 2043 | Drug product | None | 216340 |
Krazati exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | December 12, 2027 | 216340 |
| ODE-352 | Orphan drug exclusivity | December 12, 2029 | 216340 |
Krazati NDC codes
Questions
Is there a generic for Krazati?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Krazati (adagrasib). The Orange Book shows its last listed patent expires August 21, 2043 and its last listed exclusivity ends December 12, 2029.
What is the generic name for Krazati?
The active ingredient in Krazati is adagrasib, per the FDA Orange Book.
When does the Krazati patent expire?
The last patent listed for Krazati in the Orange Book expires August 21, 2043. 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.