FDA Orange Book
Is there a generic for Modeyso?
Modeyso contains dordaviprone. 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 Modeyso (dordaviprone). The Orange Book shows its last listed patent expires January 30, 2037 and its last listed exclusivity ends August 6, 2032.
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Modeyso products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 125MG BASE | Marketed (Rx) | None | 0 | None |
NDA 219876, held by CHIMERIX INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Modeyso patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9629842 | April 30, 2032 | Method of use | U-4254 | 219876 |
| RE46290 | August 30, 2032 | Method of use | U-4254 | 219876 |
| 9265765 | July 26, 2034 | Drug product | None | 219876 |
| 11976068 | March 1, 2036 | Drug product | None | 219876 |
| 12102639 | January 30, 2037 | Method of use | U-4254 | 219876 |
| 10369154 | January 30, 2037 | Method of use | U-4254 | 219876 |
| 10172862 | January 30, 2037 | Method of use | U-4254 | 219876 |
Modeyso exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | August 6, 2030 | 219876 |
| ODE-547 | Orphan drug exclusivity | August 6, 2032 | 219876 |
Modeyso NDC codes
Questions
Is there a generic for Modeyso?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Modeyso (dordaviprone). The Orange Book shows its last listed patent expires January 30, 2037 and its last listed exclusivity ends August 6, 2032.
What is the generic name for Modeyso?
The active ingredient in Modeyso is dordaviprone, per the FDA Orange Book.
When does the Modeyso patent expire?
The last patent listed for Modeyso in the Orange Book expires January 30, 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.