Aripiprazole lauroxil - Generic Drug Details

What are the generic drug sources for aripiprazole lauroxil and what is the scope of freedom to operate?

Aripiprazole lauroxil is the generic ingredient in two branded drugs marketed by Alkermes Inc and is included in two NDAs. There are seventeen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Aripiprazole lauroxil has one hundred and eighty-six patent family members in twenty-nine countries.

There are three drug master file entries for aripiprazole lauroxil. One supplier is listed for this compound.

Summary for aripiprazole lauroxil

International Patents:	186
US Patents:	17
Tradenames:	2
Applicants:	1
NDAs:	2
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	7
Patent Applications:	235
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for aripiprazole lauroxil
What excipients (inactive ingredients) are in aripiprazole lauroxil?	aripiprazole lauroxil excipients list
DailyMed Link:	aripiprazole lauroxil at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for aripiprazole lauroxil

Dosage:

SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

Dosage:

SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for aripiprazole lauroxil

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Miami	Phase 4
University of California, Los Angeles	Phase 4
Alkermes, Inc.	Phase 4

See all aripiprazole lauroxil clinical trials

Pharmacology for aripiprazole lauroxil

Drug Class

Atypical Antipsychotic

Anatomical Therapeutic Chemical (ATC) Classes for aripiprazole lauroxil

N05AX	Other antipsychotics
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for aripiprazole lauroxil

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alkermes Inc	ARISTADA	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207533-002	Oct 5, 2015		RX	Yes	No			Y
Alkermes Inc	ARISTADA	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207533-002	Oct 5, 2015		RX	Yes	No			Y
Alkermes Inc	ARISTADA	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207533-001	Oct 5, 2015		RX	Yes	No
Alkermes Inc	ARISTADA	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207533-002	Oct 5, 2015		RX	Yes	No
Alkermes Inc	ARISTADA	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207533-002	Oct 5, 2015		RX	Yes	No
Alkermes Inc	ARISTADA	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207533-004	Jun 5, 2017		RX	Yes	No

International Patents for aripiprazole lauroxil

Country	Patent Number	Title	Estimated Expiration
New Zealand	762767	Aripiprazole formulations having increased injection speeds
Australia	2017204486	Pharmaceutical compositions comprising sorbitan esters
New Zealand	615513	Pharmaceutical compositions comprising sorbitan esters
European Patent Office	3182958	COMPOSITION DE PROMÉDICAMENT D'ARIPIPRAZOLE (ARIPIPRAZOLE PRODRUG COMPOSITIONS)
Israel	292079
Russian Federation	2019134055

Supplementary Protection Certificates for aripiprazole lauroxil

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1675573	300669	Netherlands		PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
1675573	2014C/029	Belgium		PRODUCT NAME: ARIPIPRAZOLE; AUTHORISATION NUMBER AND DATE: EU/1/13/882 20131119
1675573	C300669	Netherlands		PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
0367141	SPC/GB04/039	United Kingdom		PRODUCT NAME: ARIPIPRAZOLE OR A SALT THEREOF; REGISTERED: UK EU/1/04/276/001 20040604; UK EU/1/04/276/002 20040604; UK EU/1/04/276/003 20040604; UK EU/1/04/276/004 20040604; UK EU/1/04/276/005 20040604; UK EU/1/04/276/006 20040604; UK EU/1/04/276/007 20040604; UK EU/1/04/276/008 20040604; UK EU/1/04/276/009 20040604; UK EU/1/04/276/010 20040604; UK EU/1/04/276/011 20040604; UK EU/1/04/276/012 20040604; UK EU/1/04/276/013 20040604; UK EU/1/04/276/014 20040604; UK EU/1/04/276/015 20040604; UK EU/1/04/276/016 20040604; UK EU/1/04/276/017 20040604; UK EU/1/04/276/018 20040604; UK EU/1/04/276/019 20040604; UK EU/1/04/276/020 20040604
1675573	92427	Luxembourg		PRODUCT NAME: ARIPIPRAZOLE

Aripiprazole lauroxil Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Aripiprazole Lauroxil

Introduction

Aripiprazole lauroxil, marketed under the brand name Aristada, is a long-acting injectable antipsychotic approved by the FDA for the treatment of schizophrenia. Since its approval in October 2015, the drug has undergone significant developments in its dosing regimens, clinical trials, and market positioning.

Approval and Initial Market Entry

Aripiprazole lauroxil was initially approved by the FDA in October 2015 for the treatment of schizophrenia, with dosing schedules of 441 mg, 662 mg, and 882 mg administered via intramuscular injection every four or six weeks[3][5].

Expansion of Dosing Regimens

The FDA approved additional dosing schedules for aripiprazole lauroxil, including a 1064 mg dose administered every eight weeks, in June 2017. This expansion allowed for more flexible treatment options, enhancing patient compliance and clinical outcomes[5].

Clinical Trials and Efficacy

Several clinical trials have demonstrated the efficacy and safety of aripiprazole lauroxil. The ALPINE study, for example, evaluated the efficacy and safety of the Aristada Initio regimen and the 2-month dose of Aristada (1064 mg), showing significant reductions in Positive and Negative Syndrome Scale (PANSS) total scores from baseline to Week 4 and beyond[1].

Long-Term Outcomes

Long-term studies have also shown sustained therapeutic benefits. A phase 3, 52-week open-label extension study found high retention rates and significant improvements in clinical symptoms, with remission rates of 73.8% and 68.1% for the 441 mg and 882 mg groups, respectively[4].

Market Positioning

Aripiprazole lauroxil has positioned itself as a valuable option in the treatment of schizophrenia due to its long-acting nature, which improves patient adherence compared to oral antipsychotics. The drug's ability to be administered monthly, every six weeks, or every two months aligns with the need for convenient and reliable treatment regimens[2][4].

Financial Trajectory

Initial Revenue Growth

Following its approval, Aristada saw steady revenue growth as it gained traction in the market. The drug's unique dosing regimens and the introduction of Aristada Initio, which allows for immediate initiation without the need for oral aripiprazole supplementation for several weeks, have contributed to its financial success[3][5].

Competitive Landscape

Aripiprazole lauroxil competes in a market dominated by other long-acting injectable antipsychotics such as paliperidone palmitate. However, its flexible dosing options and favorable pharmacokinetic profile have helped it carve out a significant market share. The ALPINE study, although not a head-to-head comparison, provided valuable clinical data that supports its efficacy and safety, further solidifying its market position[1].

Revenue Projections

Given the drug's established efficacy, safety profile, and the expanding treatment options, revenue projections for aripiprazole lauroxil are positive. The drug's ability to reduce dosing frequency and improve patient adherence is expected to continue driving its market growth.

Patient and Provider Acceptance

Patient Compliance

The long-acting nature of aripiprazole lauroxil has been a key factor in improving patient compliance. Studies have shown high retention rates, indicating that patients are more likely to adhere to their treatment regimens when using this medication[4].

Provider Preference

Healthcare providers have increasingly adopted aripiprazole lauroxil due to its ease of administration and the flexibility it offers in terms of dosing intervals. This preference is reflected in the growing number of prescriptions and the drug's integration into treatment guidelines for schizophrenia[2].

Challenges and Opportunities

Side Effects and Safety Profile

While aripiprazole lauroxil has a generally favorable safety profile, it is not without side effects. Common adverse events include weight gain, akathisia, and injection-site pain. Managing these side effects is crucial for maintaining patient compliance and overall treatment success[4].

Market Expansion

There is potential for further market expansion through increased awareness and education among healthcare providers and patients. Additionally, ongoing research and clinical trials could lead to new indications or dosing regimens, further enhancing the drug's market position.

Key Takeaways

• Approval and Expansion: Aripiprazole lauroxil was approved in 2015 with initial dosing regimens and has since seen the approval of additional dosing schedules.
• Clinical Efficacy: The drug has demonstrated significant efficacy in reducing symptoms of schizophrenia in both short-term and long-term studies.
• Market Positioning: It offers flexible dosing options, improving patient compliance and adherence.
• Financial Trajectory: The drug has seen steady revenue growth and is projected to continue growing due to its favorable pharmacokinetic profile and market acceptance.
• Patient and Provider Acceptance: High retention rates and provider preference indicate strong acceptance of the drug.

FAQs

Q: What is aripiprazole lauroxil used for?

A: Aripiprazole lauroxil is used for the treatment of schizophrenia in adults.

Q: How is aripiprazole lauroxil administered?

A: It is administered via intramuscular injection, with dosing intervals of every four weeks, six weeks, or two months.

Q: What are the common side effects of aripiprazole lauroxil?

A: Common side effects include weight gain, akathisia, neuroleptic malignant syndrome, tardive dyskinesia, and injection-site pain.

Q: How does aripiprazole lauroxil improve patient compliance?

A: Its long-acting nature reduces the frequency of dosing, making it easier for patients to adhere to their treatment regimens.

Q: What is the significance of the Aristada Initio regimen?

A: The Aristada Initio regimen allows for immediate initiation of treatment with a single injection of aripiprazole lauroxil combined with a single oral dose of aripiprazole, eliminating the need for several weeks of oral supplementation.

Sources

1. ALPINE Study of ARISTADA® (aripiprazole lauroxil) | HCP. Aristadahcp.com.
2. Aripiprazole Lauroxil Dosing Regimens: Understanding Dosage Strengths and Injection Intervals. Cambridge.org.
3. Aripiprazole lauroxil: Uses, Interactions, Mechanism of Action. Drugbank.com.
4. Aripiprazole Lauroxil, a Novel Injectable Long-Acting Antipsychotic. MDPI.com.
5. Clinical Review(s) - accessdata.fda.gov. Accessdata.fda.gov.