FDA Orange Book
Is there a generic for Raldesy?
Raldesy contains trazodone. 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 Raldesy (trazodone). The Orange Book shows its last listed patent expires March 13, 2029.
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Raldesy products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | 10MG/ML | Marketed (Rx) | None | 0 | None |
NDA 218637, held by KAMAT PHARMATECH LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Raldesy patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8133893 | March 13, 2029 | Drug substance, Drug product | None | 218637 |
Raldesy NDC codes
Questions
Is there a generic for Raldesy?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Raldesy (trazodone). The Orange Book shows its last listed patent expires March 13, 2029.
What is the generic name for Raldesy?
The active ingredient in Raldesy is trazodone, per the FDA Orange Book.
When does the Raldesy patent expire?
The last patent listed for Raldesy in the Orange Book expires March 13, 2029. 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.