LYBALVI — FDA application NDA213378
Listed sponsor: ALKERMES INC · ALKS company profile · 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 |
Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.
Orange Book patent and exclusivity listings
| Listing | Product | Descriptive date | Flags/code |
|---|---|---|---|
| Patent 10716785 | 001 | listed patent expiry date: 2031-08-23 | U-3136 |
| Patent 10716785 | 001 | listed patent expiry date: 2031-08-23 | U-3137 |
| Patent 10716785 | 002 | listed patent expiry date: 2031-08-23 | U-3137 |
| Patent 10716785 | 002 | listed patent expiry date: 2031-08-23 | U-3136 |
| Patent 10716785 | 003 | listed patent expiry date: 2031-08-23 | U-3137 |
| Patent 10716785 | 003 | listed patent expiry date: 2031-08-23 | U-3136 |
| Patent 10716785 | 004 | listed patent expiry date: 2031-08-23 | U-3137 |
| Patent 10716785 | 004 | listed patent expiry date: 2031-08-23 | U-3136 |
| Patent 11185541 | 001 | listed patent expiry date: 2031-08-23 | U-3140 |
| Patent 11185541 | 002 | listed patent expiry date: 2031-08-23 | U-3140 |
| Patent 11185541 | 003 | listed patent expiry date: 2031-08-23 | U-3140 |
| Patent 11185541 | 004 | listed patent expiry date: 2031-08-23 | U-3140 |
| Patent 11241425 | 001 | listed patent expiry date: 2031-08-23 | U-3137 |
| Patent 11241425 | 002 | listed patent expiry date: 2031-08-23 | U-3137 |
| Patent 11241425 | 003 | listed patent expiry date: 2031-08-23 | U-3137 |
| Patent 11241425 | 004 | listed patent expiry date: 2031-08-23 | U-3137 |
| Patent 11351166 | 001 | listed patent expiry date: 2031-08-23 | U-3140 |
| Patent 11351166 | 001 | listed patent expiry date: 2031-08-23 | U-3141 |
| Patent 11351166 | 002 | listed patent expiry date: 2031-08-23 | U-3140 |
| Patent 11351166 | 002 | listed patent expiry date: 2031-08-23 | U-3141 |
| Patent 11351166 | 003 | listed patent expiry date: 2031-08-23 | U-3140 |
| Patent 11351166 | 003 | listed patent expiry date: 2031-08-23 | U-3141 |
| Patent 11351166 | 004 | listed patent expiry date: 2031-08-23 | U-3140 |
| Patent 11351166 | 004 | listed patent expiry date: 2031-08-23 | U-3141 |
| Patent 11793805 | 001 | listed patent expiry date: 2031-08-23 | U-3734 |
| Patent 11793805 | 002 | listed patent expiry date: 2031-08-23 | U-3734 |
| Patent 11793805 | 003 | listed patent expiry date: 2031-08-23 | U-3734 |
| Patent 11793805 | 004 | listed patent expiry date: 2031-08-23 | U-3734 |
| Patent 12194035 | 001 | listed patent expiry date: 2031-08-23 | U-3141 |
| Patent 12194035 | 002 | listed patent expiry date: 2031-08-23 | U-3141 |
| Patent 12194035 | 003 | listed patent expiry date: 2031-08-23 | U-3141 |
| Patent 12194035 | 004 | listed patent expiry date: 2031-08-23 | U-3141 |
| Patent 9126977 | 001 | listed patent expiry date: 2031-08-23 | drug product, U-3136 |
| Patent 9126977 | 001 | listed patent expiry date: 2031-08-23 | drug product, U-3137 |
| Patent 9126977 | 002 | listed patent expiry date: 2031-08-23 | drug product, U-3137 |
| Patent 9126977 | 002 | listed patent expiry date: 2031-08-23 | drug product, U-3136 |
| Patent 9126977 | 003 | listed patent expiry date: 2031-08-23 | drug product, U-3136 |
| Patent 9126977 | 003 | listed patent expiry date: 2031-08-23 | drug product, U-3137 |
| Patent 9126977 | 004 | listed patent expiry date: 2031-08-23 | drug product, U-3137 |
| Patent 9126977 | 004 | listed patent expiry date: 2031-08-23 | drug product, U-3136 |
| Patent 9517235 | 001 | listed patent expiry date: 2031-08-23 | U-3139 |
| Patent 9517235 | 001 | listed patent expiry date: 2031-08-23 | U-3138 |
| Patent 9517235 | 002 | listed patent expiry date: 2031-08-23 | U-3138 |
| Patent 9517235 | 002 | listed patent expiry date: 2031-08-23 | U-3139 |
| Patent 9517235 | 003 | listed patent expiry date: 2031-08-23 | U-3139 |
| Patent 9517235 | 003 | listed patent expiry date: 2031-08-23 | U-3138 |
| Patent 9517235 | 004 | listed patent expiry date: 2031-08-23 | U-3139 |
| Patent 9517235 | 004 | listed patent expiry date: 2031-08-23 | U-3138 |
| Patent 9119848 | 001 | listed patent expiry date: 2031-08-30 | drug substance |
| Patent 9119848 | 002 | listed patent expiry date: 2031-08-30 | drug substance |
| Patent 9119848 | 003 | listed patent expiry date: 2031-08-30 | drug substance |
| Patent 9119848 | 004 | listed patent expiry date: 2031-08-30 | drug substance |
| Patent 8778960 | 001 | listed patent expiry date: 2032-02-13 | U-3136 |
| Patent 8778960 | 001 | listed patent expiry date: 2032-02-13 | U-3137 |
| Patent 8778960 | 002 | listed patent expiry date: 2032-02-13 | U-3136 |
| Patent 8778960 | 002 | listed patent expiry date: 2032-02-13 | U-3137 |
| Patent 8778960 | 003 | listed patent expiry date: 2032-02-13 | U-3136 |
| Patent 8778960 | 003 | listed patent expiry date: 2032-02-13 | U-3137 |
| Patent 8778960 | 004 | listed patent expiry date: 2032-02-13 | U-3137 |
| Patent 8778960 | 004 | listed patent expiry date: 2032-02-13 | U-3136 |
| Patent 10300054 | 001 | listed patent expiry date: 2033-05-31 | drug product, U-3140 |
| Patent 10300054 | 001 | listed patent expiry date: 2033-05-31 | drug product, U-3141 |
| Patent 10300054 | 002 | listed patent expiry date: 2033-05-31 | drug product, U-3141 |
| Patent 10300054 | 002 | listed patent expiry date: 2033-05-31 | drug product, U-3140 |
| Patent 10300054 | 003 | listed patent expiry date: 2033-05-31 | drug product, U-3140 |
| Patent 10300054 | 003 | listed patent expiry date: 2033-05-31 | drug product, U-3141 |
| Patent 10300054 | 004 | listed patent expiry date: 2033-05-31 | drug product, U-3140 |
| Patent 10300054 | 004 | listed patent expiry date: 2033-05-31 | drug product, U-3141 |
| Patent 11707466 | 001 | listed patent expiry date: 2041-11-12 | drug product |
| Patent 11707466 | 002 | listed patent expiry date: 2041-11-12 | drug product |
| Patent 11707466 | 003 | listed patent expiry date: 2041-11-12 | drug product |
| Patent 11707466 | 004 | listed patent expiry date: 2041-11-12 | drug product |
| Patent 11951111 | 001 | listed patent expiry date: 2041-11-12 | U-3886 |
| Patent 11951111 | 001 | listed patent expiry date: 2041-11-12 | U-3887 |
| Patent 11951111 | 002 | listed patent expiry date: 2041-11-12 | U-3886 |
| Patent 11951111 | 002 | listed patent expiry date: 2041-11-12 | U-3887 |
| Patent 11951111 | 003 | listed patent expiry date: 2041-11-12 | U-3886 |
| Patent 11951111 | 003 | listed patent expiry date: 2041-11-12 | U-3887 |
| Patent 11951111 | 004 | listed patent expiry date: 2041-11-12 | U-3886 |
| Patent 11951111 | 004 | listed patent expiry date: 2041-11-12 | U-3887 |
| Patent 12390474 | 001 | listed patent expiry date: 2041-11-12 | drug product |
| Patent 12390474 | 002 | listed patent expiry date: 2041-11-12 | drug product |
| Patent 12390474 | 003 | listed patent expiry date: 2041-11-12 | drug product |
| Patent 12390474 | 004 | listed patent expiry date: 2041-11-12 | drug product |
| Exclusivity NCE | 001 | listed exclusivity date: 2026-05-28 | FDA code as listed |
| Exclusivity NCE | 002 | listed exclusivity date: 2026-05-28 | FDA code as listed |
| Exclusivity NCE | 003 | listed exclusivity date: 2026-05-28 | FDA code as listed |
| Exclusivity NCE | 004 | listed exclusivity date: 2026-05-28 | FDA code as listed |
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 · CHEMBL715
- SAMIDORPHAN L-MALATE · UNII 0AJQ5N56E0 · lmmol compound RARHXUAUPNYAJF-QSYGGRRVSA-N · CHEMBL2105749
Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.
Related pages
Sponsor company · FDA-approved application index
Peer clusters: No published peer-cluster link for this sponsor.
Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.
Regulatory listing data as published by FDA; not medical or investment advice.