FDA Orange Book
Is there a generic for Lybalvi?
Lybalvi contains olanzapine and samidorphan l-malate. 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 Lybalvi (olanzapine and samidorphan l-malate). The Orange Book shows its last listed patent expires November 12, 2041 and its last listed exclusivity ends May 28, 2026.
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Lybalvi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG;EQ 10MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | 15MG;EQ 10MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | 20MG;EQ 10MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | 5MG;EQ 10MG BASE | Marketed (Rx) | None | 0 | None |
NDA 213378, held by ALKERMES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Lybalvi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11241425 | August 23, 2031 | Method of use | U-3137 | 213378 |
| 12194035 | August 23, 2031 | Method of use | U-3141 | 213378 |
| 11185541 | August 23, 2031 | Method of use | U-3140 | 213378 |
| 11793805 | August 23, 2031 | Method of use | U-3734 | 213378 |
| 11351166 | August 23, 2031 | Method of use | U-3140 | 213378 |
| 11351166 | August 23, 2031 | Method of use | U-3141 | 213378 |
| 9126977 | August 23, 2031 | Drug product | U-3136 | 213378 |
| 9126977 | August 23, 2031 | Drug product | U-3137 | 213378 |
| 9517235 | August 23, 2031 | Method of use | U-3139 | 213378 |
| 9517235 | August 23, 2031 | Method of use | U-3138 | 213378 |
| 10716785 | August 23, 2031 | Method of use | U-3136 | 213378 |
| 10716785 | August 23, 2031 | Method of use | U-3137 | 213378 |
| 9119848 | August 30, 2031 | Drug substance | None | 213378 |
| 8778960 | February 13, 2032 | Method of use | U-3136 | 213378 |
| 8778960 | February 13, 2032 | Method of use | U-3137 | 213378 |
| 10300054 | May 31, 2033 | Drug product | U-3140 | 213378 |
| 10300054 | May 31, 2033 | Drug product | U-3141 | 213378 |
| 11951111 | November 12, 2041 | Method of use | U-3886 | 213378 |
| 11951111 | November 12, 2041 | Method of use | U-3887 | 213378 |
| 11707466 | November 12, 2041 | Drug product | None | 213378 |
| 12390474 | November 12, 2041 | Drug product | None | 213378 |
Lybalvi exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | May 28, 2026 | 213378 |
Lybalvi NDC codes
Questions
Is there a generic for Lybalvi?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Lybalvi (olanzapine and samidorphan l-malate). The Orange Book shows its last listed patent expires November 12, 2041 and its last listed exclusivity ends May 28, 2026.
What is the generic name for Lybalvi?
The active ingredient in Lybalvi is olanzapine and samidorphan l-malate, per the FDA Orange Book.
When does the Lybalvi patent expire?
The last patent listed for Lybalvi in the Orange Book expires November 12, 2041. 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.