FDA Orange Book
Is there a generic for Palsonify?
Palsonify contains paltusotine. 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 Palsonify (paltusotine). The Orange Book shows its last listed patent expires March 25, 2044 and its last listed exclusivity ends September 25, 2032.
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Palsonify products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 20MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 30MG BASE | Marketed (Rx) | None | 0 | None |
NDA 219070, held by CRINETICS PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Palsonify patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11414397 | July 12, 2037 | Drug substance, Drug product | U-4283 | 219070 |
| 10875839 | July 12, 2037 | Method of use | U-4283 | 219070 |
| 10597377 | July 12, 2037 | Drug substance, Drug product | U-4283 | 219070 |
| 10351547 | July 12, 2037 | Drug substance, Drug product | U-4283 | 219070 |
| 9896432 | July 12, 2037 | Drug substance, Drug product | U-4283 | 219070 |
| 10464918 | January 16, 2039 | Drug substance | None | 219070 |
| 11957674 | September 7, 2041 | Method of use | U-4283 | 219070 |
| 11266641 | September 7, 2041 | Drug product | U-4283 | 219070 |
| 12208092 | March 25, 2044 | Method of use | U-4282 | 219070 |
Palsonify exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | September 25, 2030 | 219070 |
| ODE-537 | Orphan drug exclusivity | September 25, 2032 | 219070 |
Palsonify NDC codes
Questions
Is there a generic for Palsonify?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Palsonify (paltusotine). The Orange Book shows its last listed patent expires March 25, 2044 and its last listed exclusivity ends September 25, 2032.
What is the generic name for Palsonify?
The active ingredient in Palsonify is paltusotine, per the FDA Orange Book.
When does the Palsonify patent expire?
The last patent listed for Palsonify in the Orange Book expires March 25, 2044. 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.