FDA Orange Book
Is there a generic for Truqap?
Truqap contains capivasertib. 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 Truqap (capivasertib). The Orange Book shows its last listed patent expires April 16, 2033 and its last listed exclusivity ends June 12, 2029.
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Truqap products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 160MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 200MG | Marketed (Rx) | None | 0 | None |
NDA 218197, held by ASTRAZENECA PHARMACEUTICALS LP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Truqap patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11760760 | October 10, 2028 | Method of use | U-3762 | 218197 |
| 10654855 | October 10, 2028 | Method of use | U-3762 | 218197 |
| 12252495 | October 10, 2028 | Method of use | U-3762 | 218197 |
| 11236095 | October 10, 2028 | Method of use | U-4559 | 218197 |
| 9492453 | October 10, 2028 | Method of use | U-4559 | 218197 |
| 10059714 | October 10, 2028 | Drug substance, Drug product | None | 218197 |
| 8101623 | March 10, 2030 | Drug substance, Drug product | U-3762 | 218197 |
| 10039766 | April 16, 2033 | Method of use | U-3762 | 218197 |
| 10039766 | April 16, 2033 | Method of use | U-4559 | 218197 |
| 9487525 | April 16, 2033 | Drug substance, Drug product | None | 218197 |
Truqap exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | November 16, 2028 | 218197 |
| I-991 | New indication | June 12, 2029 | 218197 |
Truqap NDC codes
Questions
Is there a generic for Truqap?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Truqap (capivasertib). The Orange Book shows its last listed patent expires April 16, 2033 and its last listed exclusivity ends June 12, 2029.
What is the generic name for Truqap?
The active ingredient in Truqap is capivasertib, per the FDA Orange Book.
When does the Truqap patent expire?
The last patent listed for Truqap in the Orange Book expires April 16, 2033. 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.