FDA Orange Book
Is there a generic for Jascayd?
Jascayd contains nerandomilast. 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 Jascayd (nerandomilast). The Orange Book shows its last listed patent expires October 22, 2038 and its last listed exclusivity ends October 7, 2032.
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Jascayd products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 18MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 9MG | Marketed (Rx) | None | 0 | None |
NDA 218764, held by BOEHRINGER INGELHEIM PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Jascayd patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8754073 | November 26, 2029 | Drug substance, Drug product | U-4298 | 218764 |
| 8609670 | August 23, 2032 | Drug substance | None | 218764 |
| 9802954 | February 19, 2034 | Method of use | U-4298 | 218764 |
| 11813266 | October 22, 2038 | Method of use | U-4372 | 218764 |
| 11406638 | October 22, 2038 | Method of use | U-4373 | 218764 |
| 11813266 | October 22, 2038 | Method of use | U-4292 | 218764 |
| 11406638 | October 22, 2038 | Method of use | U-4297 | 218764 |
Jascayd exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-979 | New indication | December 19, 2028 | 218764 |
| NCE | New chemical entity | October 7, 2030 | 218764 |
| ODE-546 | Orphan drug exclusivity | October 7, 2032 | 218764 |
Jascayd NDC codes
Questions
Is there a generic for Jascayd?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Jascayd (nerandomilast). The Orange Book shows its last listed patent expires October 22, 2038 and its last listed exclusivity ends October 7, 2032.
What is the generic name for Jascayd?
The active ingredient in Jascayd is nerandomilast, per the FDA Orange Book.
When does the Jascayd patent expire?
The last patent listed for Jascayd in the Orange Book expires October 22, 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.