Rexulti generic availability, cost & more

Brexpiprazole is the active ingredient in Rexulti, but it isn’t yet available as a generic alternative

By Karen Berger, Pharm.D. | Apr. 17, 2024

Key takeaways

Rexulti is a brand-name second-generation antipsychotic that contains the active ingredient brexpiprazole.
Rexulti is currently only available under its brand name. There is not a generic formulation available at this time.
Consult your healthcare provider for more information about Rexulti or other alternatives that may work for you.

Rexulti is a prescription medication that contains the active ingredient brexpiprazole. The brand-name drug is a member of a drug class called atypical antipsychotic drugs, or second-generation antipsychotics. Made by Otsuka America Pharmaceutical, Inc., Rexulti is approved by the Food & Drug Administration (FDA) for the following uses:

Adjunctive therapy (an add-on medication) to antidepressant medication for the treatment of major depressive disorder (depression) in adults
Treatment of schizophrenia in adults and pediatric patients ages 13 and older
Treatment of agitation associated with dementia due to Alzheimer’s disease

Brand-name drugs can be costly. For people who pay out of pocket with no insurance coverage or discounts, a one-month supply of Rexulti costs about $1,924. That’s over $23,000 per year. Because of these high prices, patients who take Rexulti may want to know if a lower-cost generic is available.

Is generic Rexulti available?

Generic Rexulti is not yet available in pharmacies. Several generic formulations of brexpiprazole have received tentative approval from the FDA. A tentative approval means that the generic formulation is ready to be approved, but the brand name product still has patents that have not yet expired. These patents allow only the manufacturer to make and market the drug until the patents expire. The FDA does not give final approval until all patent or exclusivity issues are resolved. Companies with tentative approval cannot sell the generic drug yet. So, if you see generic brexpiprazole advertised or in the news, know that these are tentative approvals, and the generic formulations are not yet available in pharmacies.

Although you cannot get generic Rexulti at the moment, you may want to know more about generics in general—are they as good as their brand-name counterparts? This general information applies to all prescription and over-the-counter (OTC) drugs (but not dietary supplements, which are not as strictly regulated). Here are some key facts about generics:

Although a generic drug may look different from a brand-name drug, it contains the same active ingredient and works the same way. However, there is usually a significant difference in cost, as generics can cost up to 80% less than their brand-name counterparts.
Because brand-name and generic medications contain the same active ingredient and have the same FDA-approved uses, they are the same in terms of safety and efficacy. Since generics offer the benefit of significant cost savings, many patients choose generics when available.
The FDA requires generics to be bioequivalent to the brand. This means that the generic drug results in the same blood levels in the body over the same period of time as the brand.
According to the FDA, 91% of all prescriptions in the United States are filled as generics instead of their brand-name versions.

Rexulti: Important information

The following table summarizes information about Rexulti, such as its uses, side effects, and warnings.

Rexulti (brexpiprazole): Key information
Uses	Add-on therapy, in addition to an antidepressant, to treat depression in adults Treatment of schizophrenia in adults and children ages 13 and older Treatment of agitation associated with dementia due to Alzheimer’s disease
Standard dosage	Rexulti is taken once daily, with or without food, as an oral tablet available in the following strengths: 0.25 milligrams (mg), 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg. For depression use in adults, the starting dose is 0.5 or 1 mg, the recommended target dosage is 2 mg, and the maximum dosage is 3 mg. For schizophrenia in adults, the starting dose is 1 mg, the recommended target dose is 2–4 mg, and the maximum dosage is 4 mg. For schizophrenia in pediatric patients ages 13–17, the starting dose is 0.5 mg, the recommended target dose is 2–4 mg, and the maximum dosage is 4 mg. For agitation associated with dementia due to Alzheimer’s disease, the starting dose is 0.5 mg, the recommended target dose is 2 mg, and the maximum dosage is 3 mg.
Common side effects	Headache Stomach problems like constipation, diarrhea, and heartburn Increased appetite Fatigue Uncontrollable shaking of a body part Dizziness, unsteadiness, and balance problems
Contraindications	People who are allergic to brexpiprazole or any ingredient in Rexulti should not take this medication. Rexulti should not be used as an as-needed treatment for agitation associated with dementia due to Alzheimer’s disease. Tell your healthcare provider about your medical conditions before taking Rexulti, including whether you are pregnant, planning to become pregnant, or breastfeeding. Also, tell your healthcare provider about all the medications you take, including prescription and OTC drugs, vitamins, and supplements—so your healthcare provider can screen for drug interactions.
Other considerations	Older adult patients with dementia-related psychosis who take antipsychotic medication are at increased risk of death. People who have dementia-related psychosis without agitation associated with dementia due to Alzheimer’s disease should not take Rexulti. In clinical trials, antidepressants increased the risk of suicidal thoughts and behaviors in children, adolescents, and young adults. People of any age should be closely monitored for mood and behavior changes while taking Rexulti. Serious side effects may occur, such as neuroleptic malignant syndrome (a serious condition that can lead to death; symptoms include high fever, muscle stiffness, confusion, sweating, and changes in pulse, heart rate, blood pressure, and breathing), tardive dyskinesia (uncontrolled body movements), weight gain, high blood sugar, high cholesterol, compulsive behaviors, low blood cell counts, orthostatic hypotension (a drop in blood pressure when standing up), fainting, seizures, and others.

Rexulti alternatives

If you are interested in switching to a different medication, the best way to do so is to consult your healthcare provider for medical advice. Only your healthcare provider can decide which medication is appropriate for you based on individual factors such as the condition being treated, your medical history, and other medicines you take. Some examples of Rexulti alternatives include:

Abilify (aripiprazole)
Geodon (ziprasidone)
Invega (paliperidone)
Latuda (lurasidone)
Risperdal (risperidone)
Seroquel (quetiapine)
Vraylar (cariprazine)

Bottom line

Until generic Rexulti is available, there are ways to save on this brand-name drug if cost is a concern:

Use a SingleCare prescription discount card. The average out-of-pocket cost for a one-month supply of 1 mg Rexulti is $1,930, but you can pay as low as $1,370 per month with a Rexulti SingleCare coupon, depending on the pharmacy you choose to fill your prescription. That’s a savings of $560 per month and $6,720 per year.
Look into the manufacturer’s copay card. Eligible patients with commercial insurance may sign up for the Rexulti Savings Card and pay $0 for the first two months of Rexulti and $5 for each refill, including a 90-day supply. Check with the manufacturer for more information and eligibility requirements.
Find out if you are eligible for the Otsuka patient assistance program. The Otsuka Patient Assistance Foundation, Inc. (OPAF) is a nonprofit organization that provides free medication (prescribed by a healthcare provider and made by Otsuka) to eligible uninsured or underinsured patients.