# LYBALVI — FDA application NDA213378

Informational only - not investment advice.

Application NDA213378 · type NDA · FDA status: approved · original approval 2021-05-28

Listed sponsor: ALKERMES INC · [ALKS company profile](/company/ALKS/) · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

## FDA application facts

| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 001 | LYBALVI | OLANZAPINE; SAMIDORPHAN L-MALATE | TABLET | ORAL | 5MG;EQ 10MG BASE | Prescription | not listed | Yes |
| 002 | LYBALVI | OLANZAPINE; SAMIDORPHAN L-MALATE | TABLET | ORAL | 10MG;EQ 10MG BASE | Prescription | not listed | Yes |
| 003 | LYBALVI | OLANZAPINE; SAMIDORPHAN L-MALATE | TABLET | ORAL | 15MG;EQ 10MG BASE | Prescription | not listed | Yes |
| 004 | LYBALVI | OLANZAPINE; SAMIDORPHAN L-MALATE | TABLET | ORAL | 20MG;EQ 10MG BASE | Prescription | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent 10716785, product 001; listed patent expiry date: 2031-08-23.
- Patent 10716785, product 001; listed patent expiry date: 2031-08-23.
- Patent 10716785, product 002; listed patent expiry date: 2031-08-23.
- Patent 10716785, product 002; listed patent expiry date: 2031-08-23.
- Patent 10716785, product 003; listed patent expiry date: 2031-08-23.
- Patent 10716785, product 003; listed patent expiry date: 2031-08-23.
- Patent 10716785, product 004; listed patent expiry date: 2031-08-23.
- Patent 10716785, product 004; listed patent expiry date: 2031-08-23.
- Patent 11185541, product 001; listed patent expiry date: 2031-08-23.
- Patent 11185541, product 002; listed patent expiry date: 2031-08-23.
- Patent 11185541, product 003; listed patent expiry date: 2031-08-23.
- Patent 11185541, product 004; listed patent expiry date: 2031-08-23.
- Patent 11241425, product 001; listed patent expiry date: 2031-08-23.
- Patent 11241425, product 002; listed patent expiry date: 2031-08-23.
- Patent 11241425, product 003; listed patent expiry date: 2031-08-23.
- Patent 11241425, product 004; listed patent expiry date: 2031-08-23.
- Patent 11351166, product 001; listed patent expiry date: 2031-08-23.
- Patent 11351166, product 001; listed patent expiry date: 2031-08-23.
- Patent 11351166, product 002; listed patent expiry date: 2031-08-23.
- Patent 11351166, product 002; listed patent expiry date: 2031-08-23.
- Patent 11351166, product 003; listed patent expiry date: 2031-08-23.
- Patent 11351166, product 003; listed patent expiry date: 2031-08-23.
- Patent 11351166, product 004; listed patent expiry date: 2031-08-23.
- Patent 11351166, product 004; listed patent expiry date: 2031-08-23.
- Patent 11793805, product 001; listed patent expiry date: 2031-08-23.
- Patent 11793805, product 002; listed patent expiry date: 2031-08-23.
- Patent 11793805, product 003; listed patent expiry date: 2031-08-23.
- Patent 11793805, product 004; listed patent expiry date: 2031-08-23.
- Patent 12194035, product 001; listed patent expiry date: 2031-08-23.
- Patent 12194035, product 002; listed patent expiry date: 2031-08-23.
- Patent 12194035, product 003; listed patent expiry date: 2031-08-23.
- Patent 12194035, product 004; listed patent expiry date: 2031-08-23.
- Patent 9126977, product 001; listed patent expiry date: 2031-08-23.
- Patent 9126977, product 001; listed patent expiry date: 2031-08-23.
- Patent 9126977, product 002; listed patent expiry date: 2031-08-23.
- Patent 9126977, product 002; listed patent expiry date: 2031-08-23.
- Patent 9126977, product 003; listed patent expiry date: 2031-08-23.
- Patent 9126977, product 003; listed patent expiry date: 2031-08-23.
- Patent 9126977, product 004; listed patent expiry date: 2031-08-23.
- Patent 9126977, product 004; listed patent expiry date: 2031-08-23.
- Patent 9517235, product 001; listed patent expiry date: 2031-08-23.
- Patent 9517235, product 001; listed patent expiry date: 2031-08-23.
- Patent 9517235, product 002; listed patent expiry date: 2031-08-23.
- Patent 9517235, product 002; listed patent expiry date: 2031-08-23.
- Patent 9517235, product 003; listed patent expiry date: 2031-08-23.
- Patent 9517235, product 003; listed patent expiry date: 2031-08-23.
- Patent 9517235, product 004; listed patent expiry date: 2031-08-23.
- Patent 9517235, product 004; listed patent expiry date: 2031-08-23.
- Patent 9119848, product 001; listed patent expiry date: 2031-08-30.
- Patent 9119848, product 002; listed patent expiry date: 2031-08-30.
- Patent 9119848, product 003; listed patent expiry date: 2031-08-30.
- Patent 9119848, product 004; listed patent expiry date: 2031-08-30.
- Patent 8778960, product 001; listed patent expiry date: 2032-02-13.
- Patent 8778960, product 001; listed patent expiry date: 2032-02-13.
- Patent 8778960, product 002; listed patent expiry date: 2032-02-13.
- Patent 8778960, product 002; listed patent expiry date: 2032-02-13.
- Patent 8778960, product 003; listed patent expiry date: 2032-02-13.
- Patent 8778960, product 003; listed patent expiry date: 2032-02-13.
- Patent 8778960, product 004; listed patent expiry date: 2032-02-13.
- Patent 8778960, product 004; listed patent expiry date: 2032-02-13.
- Patent 10300054, product 001; listed patent expiry date: 2033-05-31.
- Patent 10300054, product 001; listed patent expiry date: 2033-05-31.
- Patent 10300054, product 002; listed patent expiry date: 2033-05-31.
- Patent 10300054, product 002; listed patent expiry date: 2033-05-31.
- Patent 10300054, product 003; listed patent expiry date: 2033-05-31.
- Patent 10300054, product 003; listed patent expiry date: 2033-05-31.
- Patent 10300054, product 004; listed patent expiry date: 2033-05-31.
- Patent 10300054, product 004; listed patent expiry date: 2033-05-31.
- Patent 11707466, product 001; listed patent expiry date: 2041-11-12.
- Patent 11707466, product 002; listed patent expiry date: 2041-11-12.
- Patent 11707466, product 003; listed patent expiry date: 2041-11-12.
- Patent 11707466, product 004; listed patent expiry date: 2041-11-12.
- Patent 11951111, product 001; listed patent expiry date: 2041-11-12.
- Patent 11951111, product 001; listed patent expiry date: 2041-11-12.
- Patent 11951111, product 002; listed patent expiry date: 2041-11-12.
- Patent 11951111, product 002; listed patent expiry date: 2041-11-12.
- Patent 11951111, product 003; listed patent expiry date: 2041-11-12.
- Patent 11951111, product 003; listed patent expiry date: 2041-11-12.
- Patent 11951111, product 004; listed patent expiry date: 2041-11-12.
- Patent 11951111, product 004; listed patent expiry date: 2041-11-12.
- Patent 12390474, product 001; listed patent expiry date: 2041-11-12.
- Patent 12390474, product 002; listed patent expiry date: 2041-11-12.
- Patent 12390474, product 003; listed patent expiry date: 2041-11-12.
- Patent 12390474, product 004; listed patent expiry date: 2041-11-12.
- Exclusivity NCE, product 001; listed exclusivity date: 2026-05-28.
- Exclusivity NCE, product 002; listed exclusivity date: 2026-05-28.
- Exclusivity NCE, product 003; listed exclusivity date: 2026-05-28.
- Exclusivity NCE, product 004; listed exclusivity date: 2026-05-28.

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

## Compound cross-links

- OLANZAPINE · UNII N7U69T4SZR · [lmmol compound KVWDHTXUZHCGIO-UHFFFAOYSA-N](https://lmmol.com/compound/KVWDHTXUZHCGIO-UHFFFAOYSA-N)
- SAMIDORPHAN L-MALATE · UNII 0AJQ5N56E0 · [lmmol compound RARHXUAUPNYAJF-QSYGGRRVSA-N](https://lmmol.com/compound/RARHXUAUPNYAJF-QSYGGRRVSA-N)

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

## Related pages

- [Sponsor company](/company/ALKS/)
- [FDA-approved application index](/drug/)

Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA213378. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.