About aripiprazole lauroxil
Aripiprazole lauroxil manufacturers are currently limited to the originator, Alkermes, which sells it in the US as Aristada and Aristada Initio. Aripiprazole lauroxil is a long-acting injectable prodrug of the antipsychotic aripiprazole, given every one to two months for schizophrenia. No generic is approved. Pharmaceutical companies interested in aripiprazole lauroxil can explore future generic development as patents expire, or partner on long-acting injectable technology.
Aripiprazole lauroxil key facts
|
Property |
Aripiprazole lauroxil |
|---|---|
|
INN |
Aripiprazole lauroxil |
|
Chemical description |
N-lauroyloxymethyl prodrug of aripiprazole |
|
Drug class |
Atypical antipsychotic; long-acting injectable (LAI) |
|
Brand names |
Aristada; Aristada Initio (US) |
|
Originator |
Alkermes (US) |
|
Dosage forms and strengths |
Extended-release injectable suspension in prefilled syringes: 441, 662, 882 and 1,064 mg (Aristada); 675 mg nanocrystal suspension (Aristada Initio) |
|
Aripiprazole equivalent |
441, 662, 882 and 1,064 mg correspond to 300, 450, 600 and 724 mg aripiprazole |
|
Dosing interval |
Monthly (441, 662, 882 mg); every 6 weeks (882 mg); every 2 months (1,064 mg) |
|
Indication |
Schizophrenia in adults |
|
First approval |
US FDA, 5 October 2015 |
|
Other approvals |
2-month 1,064 mg dose (June 2017); Aristada Initio (29 June 2018) |
|
Generic status |
No generic approved |
|
Patent status |
US patents and exclusivities estimated to run to 2039 |
|
EU status |
Not approved |
Aripiprazole lauroxil manufacturers and licensing history
Alkermes developed aripiprazole lauroxil using its long-acting injectable technology. The FDA approved Aristada on 5 October 2015 for schizophrenia, with monthly and 6-weekly dosing. A 2-month 1,064 mg dose followed in June 2017.
On 29 June 2018, the FDA approved Aristada Initio, a 675 mg nanocrystal formulation. With a single 30 mg oral dose of aripiprazole, it allows patients to start Aristada on day one, instead of taking oral aripiprazole for 21 days.
Aristada is protected by 17 US patents and has no generic competition. Opposition proceedings in Europe have been brought against some related patents. Developers interested in future generics should assess patent expiry, LAI manufacturing capability and particle size control.
Aripiprazole lauroxil dosage forms and dossier types
Aripiprazole lauroxil is approved as extended-release injectable suspensions in prefilled syringes. Any future generic would need to match the formulation and release profile.
|
Form |
Strengths |
Typical dossier |
Notes |
|---|---|---|---|
|
Aripiprazole lauroxil extended-release injectable suspension |
441, 662, 882, 1,064 mg |
US NDA (originator); future US ANDA |
Reference Aristada |
|
Aripiprazole lauroxil nanocrystal suspension |
675 mg |
US NDA (originator) |
Reference Aristada Initio; initiation only |
|
Aripiprazole lauroxil API |
Bulk |
US DMF |
Particle size is critical |
|
Target market |
Dossier format |
Key requirement |
|---|---|---|
|
United States |
NDA / future ANDA |
Patents and exclusivities to about 2039 |
|
European Union |
Not applicable |
Not approved |
|
Other markets |
National dossier |
Reference to US approval; LAI development |
Aripiprazole lauroxil regulatory and patent status
The FDA approved Aristada on 5 October 2015 and Aristada Initio on 29 June 2018. Aripiprazole lauroxil is not approved in the EU. Its US patents and exclusivities are estimated to run to about 2039, and no generic is approved. Like all antipsychotics, it carries a boxed warning about increased mortality in elderly patients with dementia-related psychosis.
Aripiprazole lauroxil mechanism of action and therapeutic use
Aripiprazole lauroxil is slowly converted in the body to aripiprazole, which partially activates dopamine D2 and serotonin 5-HT1A receptors and blocks serotonin 5-HT2A receptors. The slow release allows injections every one to two months. It is used for schizophrenia in adults, to improve adherence compared with daily tablets.
Aripiprazole lauroxil licensing and sourcing
Aripiprazole lauroxil is currently available only from Alkermes. Companies interested in this molecule usually explore future generic development, LAI technology partnerships or regional licensing. Current offers and supplier contacts are listed among the aripiprazole lauroxil manufacturers on Pipelinepharma.
Frequently asked questions about aripiprazole lauroxil
Who manufactures aripiprazole lauroxil? Alkermes is the only manufacturer and sells aripiprazole lauroxil as Aristada and Aristada Initio in the US.
Is there a generic version of aripiprazole lauroxil? No. No generic is approved, and US patents and exclusivities are estimated to run to about 2039.
What is the difference between Aristada and Aristada Initio? Aristada is the maintenance injection given every one to two months. Aristada Initio is a one-time 675 mg starting injection that allows treatment to begin on day one.
What forms and strengths of aripiprazole lauroxil are available? Aristada is available in 441, 662, 882 and 1,064 mg prefilled syringes, and Aristada Initio as a 675 mg prefilled syringe.
Is aripiprazole lauroxil approved in the EU? No. Aripiprazole lauroxil is approved in the US but not in the EU.
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