ARISTADA Drug Patent Profile

When do Aristada patents expire, and what generic alternatives are available?

Aristada is a drug marketed by Alkermes Inc and is included in two NDAs. There are twenty patents protecting this drug.

This drug has one hundred and forty-seven patent family members in twenty-eight countries.

The generic ingredient in ARISTADA is aripiprazole lauroxil. There are forty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the aripiprazole lauroxil profile page.

DrugPatentWatch^® Generic Entry Outlook for Aristada

Aristada was eligible for patent challenges on October 5, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 19, 2035. This may change due to patent challenges or generic licensing.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for ARISTADA

International Patents:	147
US Patents:	16
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	58
Clinical Trials:	4
Patent Applications:	350
Drug Prices:	Drug price information for ARISTADA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ARISTADA
What excipients (inactive ingredients) are in ARISTADA?	ARISTADA excipients list
DailyMed Link:	ARISTADA at DailyMed

See drug prices for ARISTADA

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

Constraining patent/regulatory exclusivity:

9,526,726

NDA:

207533

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 ARISTADA

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

Sponsor	Phase
University of California, Los Angeles	Phase 4
Alkermes, Inc.	Phase 4
Alkermes, Inc.	Phase 3

See all ARISTADA clinical trials

Pharmacology for ARISTADA

Drug Class

Atypical Antipsychotic

US Patents and Regulatory Information for ARISTADA

ARISTADA is protected by seventeen US patents.

This potential generic entry date is based on patent 9,526,726.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	207533-003	Oct 5, 2015		RX	Yes	Yes	10,238,651
Alkermes Inc	ARISTADA	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207533-003	Oct 5, 2015		RX	Yes	Yes	9,452,131
Alkermes Inc	ARISTADA	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207533-004	Jun 5, 2017		RX	Yes	No	9,193,685		Y
Alkermes Inc	ARISTADA	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207533-004	Jun 5, 2017		RX	Yes	No	9,034,867		Y
Alkermes Inc	ARISTADA	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207533-003	Oct 5, 2015		RX	Yes	Yes	8,431,576			Y

International Patents for ARISTADA

When does loss-of-exclusivity occur for ARISTADA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

European Patent Office

Israel

Japan

Mexico

Morocco

New Zealand

Russian Federation

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ARISTADA around the world.

Country	Patent Number	Title	Estimated Expiration
New Zealand	615513	Pharmaceutical compositions comprising sorbitan esters
Taiwan	I483935
Slovenia	2445502
Japan	6093341
New Zealand	723869	Aripiprazole formulations having increased injection speeds

Supplementary Protection Certificates for ARISTADA

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
1675573	92427	Luxembourg		PRODUCT NAME: ARIPIPRAZOLE
1675573	300669	Netherlands		PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115

Market Dynamics and Financial Trajectory for ARISTADA

Last updated: November 16, 2025

Introduction

ARISTADA (aripiprazole lauroxil), a long-acting injectable antipsychotic manufactured by Alkermes, addresses the chronic management of schizophrenia in adult patients. Since its FDA approval in October 2015, ARISTADA has positioned itself within a competitive landscape of antipsychotic therapies, driven by evolving market dynamics. Understanding its market penetration, competitive positioning, valuation trajectory, and key financial drivers is essential for stakeholders, including investors, healthcare providers, and industry analysts.

Market Overview of Schizophrenia Treatment

Schizophrenia affects over 20 million individuals globally, with a significant proportion requiring lifelong antipsychotic therapy. The global antipsychotic drugs market was valued at approximately USD 16 billion in 2021 and is projected to grow at a CAGR of 3-5% through 2026, fueled by increasing prevalence, improved treatment adherence strategies, and innovation in drug formulations [1].

Long-acting injectable (LAI) antipsychotics, including ARISTADA, are increasingly favored for their advantages in medication compliance and relapse prevention, especially among patients with poor adherence to oral medication. The LAI segment has seen a CAGR of roughly 6% over the past five years, reflecting rising adoption rates.

Market Dynamics Influencing ARISTADA

1. Competitive Landscape

ARISTADA operates in a refined market segment with key competitors like Risperdal Consta, Invega Sustenna, and Perseris. While generics dominate the broader antipsychotic market, LAIs are characterized by patent protections and unique delivery mechanisms, enabling premium pricing strategies.

Key competitors:

• Risperdal Consta (risperidone): A long-established LAI with broad clinician familiarity.
• Invega Sustenna (paliperidone): Offers similar administration and efficacy profiles.
• Perseris (risperidone microspheres): Recently approved, with a different dosing profile.

ARISTADA differentiates itself with flexible dosing options (monthly or every six weeks), potentially improving adherence and patient convenience.

2. Patent Protection and Regulatory Environment

Patent exclusivity, especially the related patents protecting ARISTADA’s delivery system and formulation, provides a near-term market monopoly. Alkermes has extended patent protection until at least 2030, supporting revenue generation and discouraging early generic competition.

Regulatory developments, including potential approvals of biosimilars or similar formulations, could threaten ARISTADA's market share beyond patent expiry.

3. Adoption and Prescriber Behavior

Physician prescribing patterns are influenced by several factors:

• Efficacy and Safety Profile: ARISTADA demonstrates comparable efficacy to oral formulations with a favorable safety profile.
• Patient Preference: The extended dosing interval appeals to patients seeking convenience.
• Pharmacist and Payer Incentives: Reimbursement policies and formulary placements determine accessibility.

Despite clinical advantages, prescriber inertia and preference for established treatments can impede rapid adoption.

4. Reimbursement and Pricing Strategies

ARISTADA commands premium pricing (~USD 1,200 per injection), justified by its convenience and adherence benefits. Contract negotiations with payers and inclusion in formularies heavily influence market penetration.

Payers increasingly favor cost-effective therapies, pressing pharmaceutical companies to demonstrate economic value through health outcome data.

5. Market Penetration and Growth Drivers

As of 2022, ARISTADA’s domestic (U.S.) market share remains modest, estimated around 10-15% within the LAI segment for schizophrenia, reflecting early-stage adoption. Growth drivers include:

• Expanded indications and patient access programs.
• Increased awareness of long-term adherence benefits.
• Clinical data supporting efficacy and safety.

International expansion prospects depend on regulatory pathways and local market dynamics, potentially augmenting growth over the next decade.

Financial Trajectory and Revenue Outlook

1. Revenue Trends and Historical Performance

Since launch, ARISTADA’s revenues have shown steady, albeit incremental, growth. Alkermes' fiscal reports indicate:

• 2018: USD 245 million.
• 2020: USD 310 million.
• 2022: Approximately USD 390 million.

Year-over-year growth primarily stems from increased prescription volume rather than average price increases, due to competitive pressures and payer negotiations.

2. Revenue Drivers

• Prescription Volume Growth: Institutional and outpatient settings see rising utilization.
• Pricing Management: Maintaining premium pricing amid competitive threats.
• Market Expansion: Increasing prescriber awareness and insurance coverage.

3. Profitability and Cost Analysis

ARISTADA’s gross margins align with Alkermes' overall product portfolio (~60-65%), supported by high-value specialty formulations. Operating expenses, including R&D and sales, influence net profitability. Continued investments in clinical trials and innovation are expected to offset margins temporarily but support long-term revenue stability.

4. Future Revenue Projections

Analysts project ARISTADA’s revenues to reach USD 500-600 million by mid-decade, contingent upon:

• Market share expansion within existing and new geographic regions.
• Further differentiation through clinical data demonstrating superiority or unique benefits.
• Strategic reimbursement negotiations, enhancing patient access.

Potential market expansion into neuropsychiatric indications beyond schizophrenia (e.g., bipolar disorder) could further diversify revenue streams, although such indications are currently at exploratory phases.

Risks and Challenges

• Patent Expiry and Generics: Erosion of market share post-patent expiry could drastically reduce revenues, unless brand loyalty persists or new indications are developed.
• Competitive Innovation: Emergence of oral or depot formulations with enhanced efficacy or shorter dosing intervals.
• Regulatory and Reimbursement Hurdles: Stringent approval processes or unfavorable coverage decisions may hinder growth.
• Market Penetration Barriers: Slow prescriber adoption due to clinical inertia or safety concerns.

Strategic Outlook

Alkermes’ focus on differentiating ARISTADA through dosing flexibility, coupled with ongoing clinical research, aims to reinforce its market position. Innovative delivery systems and combination therapies may open additional revenue channels. However, a cautious approach considers patent cliffs and competitive threats, emphasizing the importance of lifecycle management and pipeline diversification.

Key Takeaways

• ARISTADA is well-positioned in the growing LAI segment for schizophrenia, capitalizing on adherence advantages and patient preferences.
• Patent exclusivity remains a critical driver of revenue, with protections until approximately 2030, providing a window for growth.
• Market expansion depends on prescriber acceptance, insurance coverage, and competitive positioning; the drug’s premium pricing is justified by its convenience.
• Revenue growth is expected to stabilize around USD 500-600 million annually by the mid-2020s, contingent on market share gains and international expansion.
• Risks include patent expiration, competitive innovation, and regulatory hurdles, requiring strategic planning and pipeline investment.

FAQs

1. When does ARISTADA’s patent protection expire, and how does this impact its market exclusivity?
Patent protections for ARISTADA are expected to last until at least 2030, providing Alkermes with market exclusivity during this period. Post-expiry, generic competition could erode market share unless new formulations or indications are developed.

2. How does ARISTADA compare to oral antipsychotics in terms of adherence and outcomes?
ARISTADA’s long-acting injection reduces daily medication burden, improving adherence and reducing relapse risk. Clinical studies show comparable efficacy to oral formulations with better compliance in certain patient populations.

3. What factors influence the adoption of ARISTADA in clinical practice?
Key drivers include prescriber familiarity, perceived efficacy and safety, patient preference for less frequent dosing, insurance formulary placement, and reimbursement policies.

4. What are the prospects for international expansion of ARISTADA?
Limited by regulatory approval pathways, international markets are cautiously opening. Future growth depends on approvals in Europe, Asia, and other regions, along with localized reimbursement strategies.

5. What strategies can Alkermes employ to extend ARISTADA’s lifecycle?
Potential strategies include developing new formulations (e.g., shorter dosing intervals), exploring additional therapeutic indications, biosimilar diversification, and leveraging digital health tools to improve adherence and monitoring.

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Sources:

[1] Market research reports on antipsychotic drugs, 2021 data.