See the DrugPatentWatch profile for aristada
What is Aristada?
Aristada (aripiprazole lauroxil) is an injectable antipsychotic medication used to treat schizophrenia in adults. It belongs to the class of atypical antipsychotics and works by modulating dopamine and serotonin activity in the brain to reduce symptoms like hallucinations, delusions, and disorganized thinking.[1]
How is Aristada administered?
Aristada comes as a long-acting intramuscular injection, given in the arm or buttocks by a healthcare provider. Doses range from 441 mg to 1064 mg, with options for every 4, 6, or 8 weeks depending on patient needs. A separate injection of aripiprazole (Abilify) is often required on day one to start therapy quickly.[1][2]
How does Aristada differ from other antipsychotics like Abilify Maintena?
Aristada is a prodrug of aripiprazole, converting to the active form in the body after injection, which provides sustained release over weeks. Abilify Maintena is extended-release aripiprazole itself. Both treat schizophrenia but Aristada's prodrug design may offer more consistent absorption. Aristada Initio provides a one-time 675 mg dose as a faster starter option.[1][3]
Who makes Aristada and what is its patent status?
Alkermes plc manufactures Aristada. Key U.S. patents cover the formulation and delivery, with the primary composition-of-matter patent (U.S. Patent 8,338,472) expiring in 2025. Additional method-of-use patents extend protection into the 2030s, though challenges from generics could shorten exclusivity. Check DrugPatentWatch.com for latest expiration dates and litigation updates: DrugPatentWatch.com - Aristada Patents.[4][5]
What side effects do patients report?
Common side effects include akathisia (restlessness), injection-site pain, weight gain, and headache. Serious risks involve tardive dyskinesia, neuroleptic malignant syndrome, and increased mortality in elderly dementia patients. Monitoring for metabolic changes like high blood sugar is required.[1][2]
When did Aristada get FDA approval and what is its pricing?
The FDA approved Aristada in October 2015. Monthly costs range from $2,500 to $3,500 without insurance, varying by dose and pharmacy. Patient assistance programs from Alkermes can lower out-of-pocket expenses for eligible users.[1][6]
1. Aristada Prescribing Information (FDA)
2. Drugs.com - Aristada
3. Abilify Maintena Prescribing Information (FDA)
4. DrugPatentWatch.com - Aristada
5. U.S. Patent 8,338,472 (Google Patents)
6. GoodRx - Aristada Pricing