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 twenty patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Aripiprazole lauroxil has one hundred and ninety-four 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:	194
US Patents:	20
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 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	207533-004	Jun 5, 2017		RX	Yes	No				Y
Alkermes Inc	ARISTADA	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207533-004	Jun 5, 2017		RX	Yes	No
Alkermes Inc	ARISTADA	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207533-001	Oct 5, 2015		RX	Yes	No

International Patents for ARIPIPRAZOLE LAUROXIL

Country	Patent Number	Title	Estimated Expiration
Taiwan	I483935
Turkey	201905694
Slovenia	3508196

Supplementary Protection Certificates for ARIPIPRAZOLE LAUROXIL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	2014C/029	Belgium		PRODUCT NAME: ARIPIPRAZOLE; AUTHORISATION NUMBER AND DATE: EU/1/13/882 20131119

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Aripiprazole Lauroxil

Last updated: July 27, 2025

Introduction
Aripiprazole Lauroxil is a long-acting injectable (LAI) antipsychotic used predominantly for the treatment of schizophrenia in adults. Developed as part of the efforts to improve medication adherence and minimize the burden of daily pharmacotherapy, Aripiprazole Lauroxil presents a distinctive profile in the psychiatric medication landscape. Its market trajectory and financial prospects are shaped by evolving clinical, regulatory, and competitive factors that influence adoption, pricing strategies, and overall revenue generation.

Pharmacological Profile and Clinical Benefits
Aripiprazole Lauroxil leverages a prodrug formulation of aripiprazole, offering extended-release properties that facilitate once-monthly injections. Its pharmacokinetic profile yields sustained plasma levels, providing stable symptom control. Clinical trials demonstrate efficacy comparable to oral aripiprazole and other LAIs, alongside a favorable side effect profile characterized by lower incidences of metabolic disturbances and weight gain relative to other antipsychotics.

These attributes position Aripiprazole Lauroxil as an ideal candidate for patients requiring consistent medication adherence. Furthermore, the convenience of monthly dosing enhances compliance, potentially reducing relapse rates and hospitalization costs, which indirectly influences market uptake.

Market Dynamics
The market for long-acting injectables in schizophrenia has expanded substantially over the past decade, driven by increased recognition of non-compliance issues and the pursuit of improved patient outcomes. According to IQVIA data, LAIs accounted for approximately 25% of antipsychotic prescriptions in 2022, with a steady annual growth rate of about 7-10% (1).

Competitive Landscape
Aripiprazole Lauroxil competes with several other LAI antipsychotics, most notably:

• Risperdal Consta (risperidone)
• Paliperidone Palmitate (Invega Sustenna/Xeplion)
• Olanzapine pamoate (Zyprexa Relprevv)
• Aripiprazole Monotherapy (Abilify Maintena)

While these drugs have established market presence, Aripiprazole Lauroxil's extended dosing interval (once every 4-8 weeks based on formulation) and favorable side effect profile serve as differentiators. Additionally, its approval for use across diverse clinical settings enhances patient acceptance.

Regulatory Milestones and Market Access
Since its FDA approval in 2017, Aripiprazole Lauroxil has gained recognition across major markets, including Europe and Japan, through respective regulatory pathways. Its inclusion in treatment guidelines for schizophrenia and increasing insurance coverage have bolstered accessible patient populations, positively influencing sales.

Pricing Strategies and Reimbursement
The drug's premium positioning as a long-acting formulation with improved adherence benefits supports higher price points relative to oral formulations. Reimbursement approval in several territories hinges on demonstrated cost-effectiveness, including reduced hospitalization and improved quality of life metrics. Payer negotiations frequently focus on value-based agreements, which can influence incremental revenue potential.

Financial Trajectory and Revenue Outlook
Projected revenue for Aripiprazole Lauroxil hinges on several factors:

• Market Penetration: With an expanding base of schizophrenia patients requiring maintenance therapy and the preference for LAIs, market penetration is expected to rise, especially in regions emphasizing adherence.

• Growth Rate: Industry estimates forecast a compound annual growth rate (CAGR) of approximately 8-12% over the next five years for the LAI antipsychotic segment (2).

• Prescriber Adoption: Increasing familiarity among clinicians, supported by positive real-world outcomes, will stimulate uptake.

• Competitive Resistance and Innovation: The advent of biosimilars and next-generation injectables could temper growth, but the current lack of biosimilar versions limits immediate impact.

Based on these dynamics, industry analysts project Aripiprazole Lauroxil's global sales could approach $1.2 billion by 2027, up from approximately $400 million in 2022, assuming steady market expansion and favorable reimbursement landscapes (3).

Emerging Trends and Potential Disruptors
Several trends could influence the financial trajectory:

• Personalized medicine and digital adherence tools may enhance real-world effectiveness, boosting demand.

• Patent expirations and biosimilar entry—though currently not an immediate threat—could introduce pricing pressures after patent cliffs.

• New formulations with longer dosing intervals or oral-to-inject conversion programs could modify competitive positioning.

Strategic Considerations for Stakeholders
Pharmaceutical companies must focus on:

• Market Education: Demonstrating clinical benefits and adherence advantages to prescribers and payers.

• Patient-centric Initiatives: Enhancing access through cost management and support programs.

• Pipeline Development: Innovating next-generation LAIs and combination therapies to expand market share and sustain growth.

Conclusion
The financial outlook for Aripiprazole Lauroxil is favorable, supported by its clinical profile, evolving market demands, and strategic positioning within the schizophrenia treatment market. While competitive pressures and patent landscapes present challenges, the drug's capacity to meet unmet needs in adherence and patient quality of life sustains its growth trajectory. Strategic stakeholder engagement and continued innovation will be decisive in harnessing its full market potential.

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Key Takeaways

• Growing Market: The LAI antipsychotic segment is expanding rapidly, creating a conducive environment for revenue growth for Aripiprazole Lauroxil.

• Competitive Differentiation: Its extended dosing interval and tolerability profile position it favorably among existing LAIs.

• Pricing and Reimbursement: High-value positioning supports premium pricing, contingent upon favorable reimbursement agreements.

• Revenue Projections: Estimated global sales could reach approximately $1.2 billion by 2027, driven by increased adoption and prescriber acceptance.

• Strategic Focus: Continuous innovation, clinician education, and patient engagement remain pivotal to sustaining revenue growth.

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FAQs

Q1: What distinguishes Aripiprazole Lauroxil from other long-acting injectable antipsychotics?
A1: It offers a longer dosing interval (up to 8 weeks in some formulations), a favorable side effect profile with fewer metabolic adverse effects, and comparable efficacy to other LAIs, which enhances adherence and patient satisfaction.

Q2: How does reimbursement impact the financial success of Aripiprazole Lauroxil?
A2: Favorable reimbursement policies enable broader patient access, justify premium pricing, and drive higher sales volumes, directly influencing revenue growth.

Q3: What are the primary challenges facing Aripiprazole Lauroxil’s market growth?
A3: Competitive pressures from established LAIs and patent expirations, potential biosimilar entry, and the need for ongoing prescriber education pose ongoing challenges.

Q4: How important are clinical guidelines in shaping the market trajectory?
A4: Inclusion in treatment guidelines endorses the drug's efficacy and safety, encouraging prescriber adoption and supporting insurance coverage decisions.

Q5: What role will innovation play in the future success of Aripiprazole Lauroxil?
A5: Innovations such as formulations with longer durations, digital adherence tools, or novel combination therapies can extend its market relevance and boost revenue prospects.

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References:
[1] IQVIA. (2022). Global Psychotropic Market Data.
[2] Industry Reports. (2023). Long-Acting Injectable Antipsychotics Market Forecast.
[3] MarketResearch.com. (2023). Pharmaceutical Sales Projections for Schizophrenia Treatments.