FDA Orange Book
Is there a generic for Kygevvi?
Kygevvi contains doxecitine and doxribtimine. 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 Kygevvi (doxecitine and doxribtimine). The Orange Book shows its last listed patent expires August 19, 2040 and its last listed exclusivity ends November 3, 2030.
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Kygevvi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for solution, oral | 2GM/PACKET;2GM/PACKET | Marketed (Rx) | None | 0 | None |
NDA 219792, held by UCB INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Kygevvi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10471087 | August 7, 2036 | Method of use | U-4358 | 219792 |
| 11649259 | August 19, 2040 | Drug product | U-4358 | 219792 |
Kygevvi exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | November 3, 2030 | 219792 |
Kygevvi NDC codes
Questions
Is there a generic for Kygevvi?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Kygevvi (doxecitine and doxribtimine). The Orange Book shows its last listed patent expires August 19, 2040 and its last listed exclusivity ends November 3, 2030.
What is the generic name for Kygevvi?
The active ingredient in Kygevvi is doxecitine and doxribtimine, per the FDA Orange Book.
When does the Kygevvi patent expire?
The last patent listed for Kygevvi in the Orange Book expires August 19, 2040. 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.