FDA Orange Book
Is there a generic for Lynavoy?
Lynavoy contains linerixibat. 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 Lynavoy (linerixibat). The Orange Book shows its last listed patent expires September 6, 2031 and its last listed exclusivity ends March 17, 2033.
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Lynavoy products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 40MG | Marketed (Rx) | None | 0 | None |
NDA 220295, held by INTERCEPT PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Lynavoy patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9040518 | September 6, 2031 | Drug substance, Drug product | None | 220295 |
Lynavoy exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | March 17, 2031 | 220295 |
| ODE-517 | Orphan drug exclusivity | March 17, 2033 | 220295 |
Lynavoy NDC codes
Questions
Is there a generic for Lynavoy?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Lynavoy (linerixibat). The Orange Book shows its last listed patent expires September 6, 2031 and its last listed exclusivity ends March 17, 2033.
What is the generic name for Lynavoy?
The active ingredient in Lynavoy is linerixibat, per the FDA Orange Book.
When does the Lynavoy patent expire?
The last patent listed for Lynavoy in the Orange Book expires September 6, 2031. 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.