FDA Orange Book
Is there a generic for Nereus?
Nereus contains tradipitant. 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 Nereus (tradipitant). The Orange Book shows its last listed patent expires August 9, 2036 and its last listed exclusivity ends December 30, 2030.
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Nereus products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 85MG | Marketed (Rx) | None | 0 | None |
NDA 220152, held by VANDA PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Nereus patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11324735 | March 4, 2036 | Method of use | U-4396 | 220152 |
| 10821099 | March 4, 2036 | Method of use | U-4396 | 220152 |
| 10772880 | March 4, 2036 | Method of use | U-4396 | 220152 |
| 12318375 | August 9, 2036 | Method of use | U-4396 | 220152 |
Nereus exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | December 30, 2030 | 220152 |
Nereus NDC codes
Questions
Is there a generic for Nereus?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Nereus (tradipitant). The Orange Book shows its last listed patent expires August 9, 2036 and its last listed exclusivity ends December 30, 2030.
What is the generic name for Nereus?
The active ingredient in Nereus is tradipitant, per the FDA Orange Book.
When does the Nereus patent expire?
The last patent listed for Nereus in the Orange Book expires August 9, 2036. 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.