FDA Orange Book
Is there a generic for Jaypirca?
Jaypirca contains pirtobrutinib. 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 Jaypirca (pirtobrutinib). The Orange Book shows its last listed patent expires September 14, 2041 and its last listed exclusivity ends December 3, 2032.
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Jaypirca products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 50MG | Marketed (Rx) | None | 0 | None |
NDA 216059, held by LOXO ONCOLOGY INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Jaypirca patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10918622 | December 16, 2036 | Method of use | U-3518 | 216059 |
| 10695323 | December 16, 2036 | Drug substance, Drug product | U-3518 | 216059 |
| 10464905 | December 16, 2036 | Method of use | U-3518 | 216059 |
| 12220401 | December 16, 2036 | Drug substance, Drug product | U-3518 | 216059 |
| 10464905 | December 16, 2036 | Method of use | U-4362 | 216059 |
| 10918622 | December 16, 2036 | Method of use | U-4362 | 216059 |
| 10695323 | December 16, 2036 | Drug substance, Drug product | U-4362 | 216059 |
| 12220401 | December 16, 2036 | Drug substance, Drug product | U-4362 | 216059 |
| 10342780 | December 16, 2036 | Drug substance, Drug product | None | 216059 |
| 12268666 | July 29, 2039 | Drug product | None | 216059 |
| 12109193 | September 14, 2041 | Drug product | None | 216059 |
Jaypirca exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | January 27, 2028 | 216059 |
| I-981 | New indication | December 2, 2028 | 216059 |
| ODE-424 | Orphan drug exclusivity | January 27, 2030 | 216059 |
| ODE-451 | Orphan drug exclusivity | December 1, 2030 | 216059 |
| ODE-518 | Orphan drug exclusivity | December 3, 2032 | 216059 |
Jaypirca NDC codes
Questions
Is there a generic for Jaypirca?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Jaypirca (pirtobrutinib). The Orange Book shows its last listed patent expires September 14, 2041 and its last listed exclusivity ends December 3, 2032.
What is the generic name for Jaypirca?
The active ingredient in Jaypirca is pirtobrutinib, per the FDA Orange Book.
When does the Jaypirca patent expire?
The last patent listed for Jaypirca in the Orange Book expires September 14, 2041. 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.