Prescription medicine
Olanzapine and samidorphan l-malate Brand names: Lybalvi
Olanzapine and samidorphan l-malate (Lybalvi) is a prescription medicine with an FDA approval on record since 2021. No generic is listed; pharmacies paid $55.10 per Lybalvi 10-10 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the olanzapine and samidorphan l-malate FDA label on DailyMed (effective January 31, 2026, Alkermes, Inc.); the NDA 213378 record on Drugs@FDA; every olanzapine and samidorphan l-malate label on DailyMed.
Highlights of the record
FDA label of January 31, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS.
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. LYBALVI is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions ( 5.1 )]. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. LYBALVI is not approved for the treatment of patients with dementia-related psychosis.
Used for
From the label: indications and usageLYBALVI is indicated for the treatment of: Schizophrenia in adults Bipolar I disorder in adults Acute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate Maintenance monotherapy treatment LYBALVI is a combination of olanzapine, an atypical antipsychotic, and samidorphan, an opioid antagonist, indicated for the treatment of: Schizophrenia in adults ( 1 ) Bipolar I disorder in adu
Forms and strengths
- 5 mg / 10 mg
- 10 mg / 10 mg
- 15 mg / 10 mg
- 20 mg / 10 mg
Film-coated tablet.
On the market
- Earliest approval on file
- May 28, 2021 Lybalvi, Alkermes Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- November 12, 2041 Lybalvi tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $55.10 per tablet Lybalvi 10-10 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,582 through July 30, 2026
What is olanzapine and samidorphan l-malate used for?
From the label: indications and usageLYBALVI is indicated for the treatment of: Schizophrenia in adults Bipolar I disorder in adults Acute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate Maintenance monotherapy treatment LYBALVI is a combination of olanzapine, an atypical antipsychotic, and samidorphan, an opioid antagonist, indicated for the treatment of: Schizophrenia in adults ( 1 ) Bipolar I disorder in adults ( 1 ) Acute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate Maintenance monotherapy treatment
FDA pharmacologic class: Atypical Antipsychotic and Opioid Antagonist.
Source: FDA drug label (LYBALVI), Alkermes, Inc., effective January 31, 2026 (SPL set 32ffddd1-4e2b-45d9-9b36-bb730167ec80), via openFDA; the full label on DailyMed
What does the patient leaflet for olanzapine and samidorphan l-malate say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about LYBALVI?LYBALVI may cause serious side effects, including: Increased risk of death in elderly people with dementia related psychosis. LYBALVI increases the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). LYBALVI is not approved for the treatment of people with dementia-related psychosis.
From the patient leaflet: What should I avoid while taking LYBALVI?Do not drive a car, operate machinery, or do other dangerous activities until you know how LYBALVI affects you. LYBALVI may make you feel drowsy. Avoid drinking alcohol during treatment with LYBALVI. Avoid getting over-heated or dehydrated. Do not exercise too much. In hot weather, stay inside in a cool place if possible. Stay out of the sun. Do not wear too much clothing or heavy clothing. Drink plenty of water.
From the patient leaflet: How should I store LYBALVI?Store LYBALVI at room temperature between 68°F to 77°F (20°C to 25°C). Keep tightly closed, in a dry place, and away from moisture. Keep LYBALVI and all medicines out of the reach of children.
Source: FDA drug label (LYBALVI), Alkermes, Inc., effective January 31, 2026 (SPL set 32ffddd1-4e2b-45d9-9b36-bb730167ec80), via openFDA; the full label on DailyMed
Is there a generic for olanzapine and samidorphan l-malate (Lybalvi)?
No generic olanzapine and samidorphan l-malate is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 14 patents for Lybalvi tablets: the compound patent runs to August 30, 2031, and the last listed entry to November 12, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2021 earliest approval on file
- 2041 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for olanzapine and samidorphan l-malate (Lybalvi)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $55.10 per Lybalvi 10-10 mg tablet, up 5% from $52.51 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Lybalvi 20-10 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Lybalvi 10-10 mg tablet | Brand | $55.10 per tablet | $1,652.91 | +5% |
| Lybalvi 15-10 mg tablet | Brand | $55.12 per tablet | $1,653.58 | +5% |
| Lybalvi 20-10 mg tablet | Brand | $54.98 per tablet | $1,649.45 | +5% |
| Lybalvi 5-10 mg tablet | Brand | $55.21 per tablet | $1,656.41 | +5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the olanzapine and samidorphan l-malate label say about other medicines?
The olanzapine and samidorphan l-malate label names 3 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Diazepam | drug interactions | Diazepam, Alcohol, and Other CNS Acting Drugs Clinical Implication: Concomitant use of diazepam, alcohol, or other CNS acting drugs with LYBALVI may potentiate the orthostatic hypotension observed with olanzapine [see Warnings and Precautions ()]. … |
| Levodopa | drug interactions | Monitor blood pressure. ( 7.2 ) Levodopa and Dopamine Agonists: Not recommended. |
| Lithium | contraindications | If LYBALVI is administered with lithium or valproate, refer to the lithium or valproate Prescribing Information for the contraindications for these products [see Warnings and Precautions ( 5.18 )]. |
Check olanzapine and samidorphan l-malate against other medicines
Source: FDA drug label (LYBALVI), Alkermes, Inc., effective January 31, 2026 (SPL set 32ffddd1-4e2b-45d9-9b36-bb730167ec80), via openFDA; the full label on DailyMed
What do FAERS reports show for olanzapine and samidorphan l-malate?
The FDA Adverse Event Reporting System holds 1,582 reports that list olanzapine and samidorphan l-malate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 16 are coded as a death and 169 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other atypical antipsychotics
- the pharmacologic class, with prices and generics
- Olanzapine and samidorphan l-malate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other