FDA Orange Book
Is there a generic for Sohonos?
Sohonos contains palovarotene. 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 Sohonos (palovarotene). The Orange Book shows its last listed patent expires August 16, 2037 and its last listed exclusivity ends August 16, 2030.
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Sohonos products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 1.5MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 10MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 1MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 2.5MG | Discontinued | None | 0 | None |
| capsule, oral | 5MG | Marketed (Rx) | None | 0 | None |
NDA 215559, held by IPSEN BIOPHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Sohonos patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10292954 | August 31, 2031 | Method of use | U-3676 | 215559 |
| 9789074 | August 31, 2031 | Method of use | U-3676 | 215559 |
| 9314439 | August 31, 2031 | Method of use | U-3676 | 215559 |
| 12023312 | August 31, 2031 | Method of use | U-3966 | 215559 |
| 11622959 | June 8, 2037 | Method of use | U-3676 | 215559 |
| 12458626 | June 8, 2037 | Method of use | U-3676 | 215559 |
| 12138245 | June 8, 2037 | Method of use | U-4031 | 215559 |
| 12201614 | June 8, 2037 | Method of use | U-4031 | 215559 |
| 10864194 | August 16, 2037 | Method of use | U-3676 | 215559 |
Sohonos exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | August 16, 2028 | 215559 |
| ODE-439 | Orphan drug exclusivity | August 16, 2030 | 215559 |
Sohonos NDC codes
Questions
Is there a generic for Sohonos?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Sohonos (palovarotene). The Orange Book shows its last listed patent expires August 16, 2037 and its last listed exclusivity ends August 16, 2030.
What is the generic name for Sohonos?
The active ingredient in Sohonos is palovarotene, per the FDA Orange Book.
When does the Sohonos patent expire?
The last patent listed for Sohonos in the Orange Book expires August 16, 2037. 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.