ABILIFY MAINTENA KIT Drug Patent Profile

Which patents cover Abilify Maintena Kit, and when can generic versions of Abilify Maintena Kit launch?

Abilify Maintena Kit is a drug marketed by Otsuka Pharm Co Ltd and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and forty-three patent family members in forty countries.

The generic ingredient in ABILIFY MAINTENA KIT is aripiprazole. There are forty-nine drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Abilify Maintena Kit

A generic version of ABILIFY MAINTENA KIT was approved as aripiprazole by ALEMBIC on April 28^th, 2015.

Summary for ABILIFY MAINTENA KIT

International Patents:	243
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	125
Clinical Trials:	9
Patent Applications:	4,536
Drug Prices:	Drug price information for ABILIFY MAINTENA KIT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ABILIFY MAINTENA KIT
DailyMed Link:	ABILIFY MAINTENA KIT at DailyMed

See drug prices for ABILIFY MAINTENA KIT

Recent Clinical Trials for ABILIFY MAINTENA KIT

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

Sponsor	Phase
Otsuka Beijing Research Institute	Phase 1
Chonbuk National University Hospital	Phase 4
Otsuka Pharmaceutical Co., Ltd.	Phase 4

See all ABILIFY MAINTENA KIT clinical trials

Paragraph IV (Patent) Challenges for ABILIFY MAINTENA KIT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ABILIFY MAINTENA KIT	Extended-release Injectable Suspension	aripiprazole	300 mg/vial and 400 mg/vial	202971	1	2021-12-20

US Patents and Regulatory Information for ABILIFY MAINTENA KIT

ABILIFY MAINTENA KIT is protected by eighteen US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-004	Sep 29, 2014		RX	Yes	Yes	8,399,469			Y
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-002	Feb 28, 2013		RX	Yes	Yes	11,344,547
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-003	Sep 29, 2014		RX	Yes	No	11,154,553

Expired US Patents for ABILIFY MAINTENA KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-003	Sep 29, 2014	7,807,680
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-004	Sep 29, 2014	8,338,428
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-002	Feb 28, 2013	9,089,567

EU/EMA Drug Approvals for ABILIFY MAINTENA KIT

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Mylan Pharmaceuticals Limited	Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen)	aripiprazole	EMEA/H/C/003803Aripiprazole Mylan Pharma is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.Aripiprazole Mylan Pharma is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.Aripiprazole Mylan Pharma is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.	Authorised	yes	no	no	2015-06-30
Otsuka Pharmaceutical Netherlands B.V.	Abilify	aripiprazole	EMEA/H/C/000471Abilify is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.Abilify is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.Abilify is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.	Authorised	no	no	no	2004-06-04
Otsuka Pharmaceutical Netherlands B.V.	Abilify Maintena	aripiprazole	EMEA/H/C/002755Maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole.	Authorised	no	no	no	2013-11-14

International Patents for ABILIFY MAINTENA KIT

See the table below for patents covering ABILIFY MAINTENA KIT around the world.

Country	Patent Number	Title	Estimated Expiration
Norway	20081627
Canada	2543242	FORMULATION D'ARIPIPRAZOLE INJECTABLE STERILE A LIBERATION CONTROLEE ET PROCEDE (CONTROLLED RELEASE STERILE INJECTABLE ARIPIPRAZOLE FORMULATION AND METHOD)
Luxembourg	92427

Supplementary Protection Certificates for ABILIFY MAINTENA KIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1675573	PA2014020	Lithuania		PRODUCT NAME: ARIPIPRAZOLUM; REGISTRATION NO/DATE: EU/1/13/882 20131115
1675573	239 5013-2014	Slovakia		PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882/001 - EU/1/13/882/004 20131119
1675573	CA 2014 00026	Denmark		PRODUCT NAME: ARIPIPRAZOL; REG. NO/DATE: EU/1/13/882/001-004 20131119

Market Dynamics and Financial Trajectory for the ABILIFY MAINTENA KIT

Last updated: July 27, 2025

Introduction

The ABILIFY MAINTENA KIT, a long-acting injectable formulation of aripiprazole, stands as a pivotal treatment in managing schizophrenia and bipolar I disorder. Developed by Otsuka Pharmaceutical and marketed in collaboration with Bristol-Myers Squibb, ABILIFY MAINTENA exemplifies the growing segment of depot antipsychotics designed for adherence enhancement. This analysis critically examines the market dynamics underpinning ABILIFY MAINTENA’s trajectory and projects its financial outlook within the evolving pharmaceutical landscape.

Overview of ABILIFY MAINTENA

Product Profile:
ABILIFY MAINTENA (aripiprazole extended-release injectable) offers monthly dosing, addressing adherence challenges inherent in oral antipsychotics. Its unique pharmacokinetics enable sustained therapeutic plasma levels over four weeks, reducing relapse rates among schizophrenic and bipolar patients. The product received FDA approval in 2013, followed by subsequent approvals for bipolar I disorder maintenance.

Manufacturers and Approvals:
Otsuka Pharmaceutical, partnering with BMS, manufactures and markets ABILIFY MAINTENA across multiple regions. Subsequent approvals in Europe, Japan, and emerging markets expand its footprint, contingent upon regional regulatory landscapes.

Market Dynamics

Market Size and Growth Drivers

Schizophrenia and Bipolar Disorder Epidemiology:
The global schizophrenia market was valued at approximately USD 5 billion in 2022, with projections indicating a compound annual growth rate (CAGR) of 4-6% over the next five years, driven by increasing prevalence and shifts toward long-acting injectables (LAIs). Similarly, bipolar disorder affects an estimated 1-2% globally, with robust growth in treatment adoption, especially in developed economies.

Adherence and Healthcare Outcomes:
Non-adherence to oral antipsychotics remains a critical challenge, contributing to high relapse rates, hospitalization, and increased healthcare costs. LAIs like ABILIFY MAINTENA address these issues effectively, incentivizing prescriber adoption and increasing market penetration in psychiatric practice.

Competitive Landscape:
ABILIFY MAINTENA faces competition from other depot antipsychotics, including Risperdal Consta, Invega Sustenna, and upcoming biosimilars or novel formulations. However, its favorable side effect profile and once-monthly dosing confer a competitive edge.

Regulatory and Reimbursement Factors

Regulatory Approvals:
Continued approvals and label expansions bolster market access. Recent data supporting efficacy and safety enhance physician confidence.

Reimbursement Policies:
Insurance coverage and formulary inclusion significantly influence utilization. Countries with high healthcare expenditure and proactive reimbursement strategies favor ABILIFY MAINTENA's penetration, especially given its potential to reduce overall costs by preventing relapses.

Market Challenges

Pricing Pressures:
Healthcare payers increasingly scrutinize high-cost injectables relative to oral alternatives, pressuring manufacturers to justify premium pricing through improved outcomes.

Patient and Physician Acceptance:
Acceptance hinges on perceived efficacy, side-effect management, and administration convenience. Resistance may stem from injection apprehension or lack of awareness.

Future Market Opportunities

Expanding Indications:
Research into predicting and expanding ABILIFY MAINTENA's indications, including treatment-resistant mood disorders or adjunctive uses, could diversify revenue streams.

Geographical Expansion:
Emerging markets present substantial growth potential due to rising mental health awareness, urbanization, and improved healthcare infrastructure.

Digital and Support Services:
Integration of digital adherence tools and patient support programs can enhance compliance and foster brand loyalty.

Financial Trajectory

Revenue Generation and Growth Projections

Historical Revenue Trends:
Otsuka and BMS reported sustained growth for ABILIFY MAINTENA post-launch, with market penetration reaching over 15% in developed markets by 2022. In 2021, global sales approximated USD 2.2 billion, with North America accounting for the lion’s share.

Forecasted Growth:
Projected CAGR of 5-7% over the next five years relies on expanding indications, better reimbursement, and market acceptance. Market analysts anticipate revenues crossing USD 3 billion by 2027 if current trends hold.

Cost Structure and Profitability

Manufacturing and Marketing:
High manufacturing costs associated with biopharmaceutical formulations are offset by premium pricing. Effective marketing strategies targeting psychiatrists and mental health clinics drive volume.

Pricing Strategies:
Tiered pricing in emerging markets and value-based pricing models in developed economies are employed to optimize margins.

Risks and Investment Outlook

Patent Expiry and Biosimilar Competition:
Longest-term profitability depends on patent protections. The looming patent cliff threatens generic and biosimilar entrants post-2028, potentially eroding market share.

Regulatory and Market Access Risks:
Delays or restrictions in key markets could dampen revenues. Nonetheless, strong clinical data and proven efficacy support sustained growth.

Strategic Initiatives Driving Financial Success

• Research and Development:
  Investment in novel formulations, such as monthly and quarterly variants, enhances patient convenience and market share.

• Partnerships and Licensing:
  Strategic collaborations bolster geographic expansion, especially in Asian and Latin American markets.

• Digital Engagement:
  Adoption of telepsychiatry and adherence monitoring tools enhances patient retention and therapy adherence.

Conclusion

The ABILIFY MAINTENA KIT occupies a strategic position within the psychiatric pharmacotherapy landscape. Its market is buoyed by the ongoing shift toward long-acting injectables, driven by adherence benefits and evolving clinical guidelines. While challenges persist—particularly patent cliffs, pricing pressures, and market penetration barriers—the product's strong clinical profile and expanding indications underpin a positive financial trajectory. Market players focusing on innovation, regional expansion, and value-based care models position themselves to capitalize on the sustained demand for effective mental health treatments.

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Key Takeaways

• Growing Market Demand: The global markets for schizophrenia and bipolar disorder treatments are expanding, underpinning increased adoption of long-acting injectables like ABILIFY MAINTENA.
• Efficacy and Adherence: The product’s pharmacokinetics and dosing convenience support its preferred status among clinicians and patients, fostering sustained revenue growth.
• Regulatory and Reimbursement Landscape: Regulatory approvals and favorable reimbursement policies are vital for market expansion, especially in emerging economies.
• Patent and Competition Risks: Patent expiry and biosimilar entry pose long-term threats; continuous innovation and strategic partnerships are crucial.
• Financial Outlook: Projected steady growth, with revenues exceeding USD 3 billion by 2027, hinge upon market expansion, indication updates, and optimizing cost structures.

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FAQs

1. What factors influence the market share of ABILIFY MAINTENA?
Market share is influenced by clinicians’ familiarity with the product, reimbursement policies, patient acceptance, competitive drugs, and regulatory approvals. Efficacy, safety profile, and dosing convenience also drive adoption.

2. How do patent timelines affect ABILIFY MAINTENA’s financial outlook?
Patent protections delay generic and biosimilar competition, safeguarding revenue streams. Once patents expire (anticipated around 2028), revenue may decline unless accompanied by new formulations or indications.

3. What are the primary challenges in expanding ABILIFY MAINTENA’s global footprint?
Regulatory hurdles, reimbursement disparities, cultural perceptions of injections, and infrastructure limitations in emerging markets challenge broader access.

4. How does ABILIFY MAINTENA compare cost-wise with oral antipsychotics?
While initial costs are higher due to formulation and administration expenses, long-term savings accrue from reduced relapse rates, hospitalization, and improved adherence, offsetting higher upfront costs.

5. What future developments could shape ABILIFY MAINTENA’s market trajectory?
Innovations in extended-release formulations, digital adherence tools, new clinical indications, and strategic partnerships in non-traditional markets will influence growth prospects.

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Sources:
[1] IQVIA. "Global Pharmaceutical Market Data." 2022.
[2] Otsuka Pharmaceutical. "Product Label and Clinical Data." 2023.
[3] Market Research Future. "Long-acting Injectable Antipsychotics Market Analysis." 2023.
[4] FDA. "Approval and Labeling Information for ABILIFY MAINTENA." 2013.
[5] Global Data. "Schizophrenia and Bipolar Market Outlook." 2023.