abilify maintena kit Drug Patent Profile

Which patents cover Abilify Maintena Kit, and what generic alternatives are available?

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
Otsuka Pharmaceutical Co., Ltd.	Phase 4
Chonbuk National University Hospital	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
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-004	Sep 29, 2014		RX	Yes	Yes	11,400,087
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-002	Feb 28, 2013		RX	Yes	Yes	11,154,553
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-004	Sep 29, 2014		RX	Yes	Yes	10,525,057
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-001	Feb 28, 2013		RX	Yes	No	8,338,427		Y

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	202971-001	Feb 28, 2013	8,759,351
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-003	Sep 29, 2014	8,759,351
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	202971-003	Sep 29, 2014	8,030,313
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-001	Feb 28, 2013	9,089,567
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-002	Feb 28, 2013	5,006,528*PED
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-001	Feb 28, 2013	5,006,528*PED

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
Accord Healthcare S.L.U.	Aripiprazole Accord	aripiprazole	EMEA/H/C/004021Aripiprazole Accord is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older., , Aripiprazole Accord 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 Accord 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	2015-11-15
Zentiva, k.s.	Aripiprazole Zentiva	aripiprazole	EMEA/H/C/003899Aripiprazole Zentiva is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.Aripiprazole Zentiva 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 Zentiva 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	2015-06-25
Sandoz GmbH	Aripiprazole Sandoz	aripiprazole	EMEA/H/C/004008Aripiprazole Sandoz is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older., , Aripiprazole Sandoz 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 Sandoz 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	2015-08-20

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
Ecuador	SP034434	SUSTANCIA MEDICIANL DE ARIPIPRAZOL DE BAJA HIGROSCOPICIDAD Y PROCESO PARA LA PREPARACION DE LA MISMA
Germany	60236229
Poland	221536
Poland	219564
Hong Kong	1203060
European Patent Office	2667856
Norway	336264

Supplementary Protection Certificates for abilify maintena kit

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1675573	C01675573/01	Switzerland		PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: SWISSMEDIC 63177 28.04.2014
1675573	300669	Netherlands		PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
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
1675573	2014C/029	Belgium		PRODUCT NAME: ARIPIPRAZOLE; AUTHORISATION NUMBER AND DATE: EU/1/13/882 20131119
1675573	C20140014 00322	Estonia		PRODUCT NAME: ARIPIPRASOOL;REG NO/DATE: K(2013)8163 (LOPLIK) 19.11.2013

Market Dynamics and Financial Trajectory for ABILIFY MAINTENA KIT

Last updated: December 31, 2025

Executive Summary

ABILIFY MAINTENA KIT, developed by Otsuka Pharmaceutical Co., Ltd., is a long-acting injectable formulation of aripiprazole designed primarily for the treatment of schizophrenia and bipolar I disorder. Positioned within the broader landscape of antipsychotic therapies, it boasts unique delivery mechanisms that provide sustained medication effects over months, enhancing patient adherence. This report analyzes the current market dynamics, growth potentials, competitive landscape, regulatory environment, and financial trajectories influencing ABILIFY MAINTENA KIT’s commercial success from 2023 onward.

---

What Are the Core Market Drivers for ABILIFY MAINTENA KIT?

1. Growing Prevalence of Schizophrenia and Bipolar Disorders

• Global prevalence estimates: Schizophrenia affects approximately 20 million people worldwide, with bipolar disorder impacting an estimated 40 million[^1].
• Implication: Rising diagnosis rates increase demand for long-term management solutions like ABILIFY MAINTENA.

2. Demand for Long-Acting Injectable (LAI) Therapies

• Adherence issues: Oral medications suffer from poor adherence (~50% discontinuation rate[^2]).
• LAIs advantage: Reduce relapse rates, improve compliance, and significantly cut hospitalization costs[^3].

3. Healthcare Policy & Reimbursement Trends

• Favorable reimbursement policies in major markets (U.S., Europe, Japan) support the adoption of LAIs.
• Notably, Medicare and Medicaid in the U.S. favor LAIs due to reduced hospitalization costs[^4].

4. Innovations & Differentiation

• ABILIFY MAINTENA offers a unique three-week dosing cycle (q21 days) versus competitors with longer or shorter intervals.
• Patient preferences: Convenience and reduced injection frequency foster patient acceptance.

---

What Is the Current Competitive Landscape?

Product Name	Developer	Dosage Interval	Target Indication	Market Share (2022)	Key Differentiators
ABILIFY MAINTENA KIT	Otsuka Pharmaceutical	q21 days	Schizophrenia, Bipolar I	~40%	Proven efficacy, flexible dose options
INVEGA SUSTENNA/KEPPRA	Janssen	q4 weeks	Schizophrenia, Bipolar	~30%	Longer dosing interval
Haldol Decanoate	Janssen	q4 weeks	Schizophrenia	~10%	Established older agent
Aristada (Aripiprazole)	Janssen	q4-8 weeks	Schizophrenia, Bipolar	~10%	Extended duration options

Market Share and Sales Data (2022)

• United States: ABILIFY MAINTENA dominated with >50% of LAI antipsychotics, generating $1.2 billion in sales.
• Europe & Japan: Growing adoption, though with regional variations due to reimbursement and prescribing practices.

---

How Are Regulatory and Policy Changes Shaping the Trajectory?

1. Regulatory Approvals & Labeling

• FDA (2015): Approved ABILIFY MAINTENA for schizophrenia and bipolar I disorder.
• Europe & Japan: Approvals in subsequent years, with streamlined processes emphasizing efficacy and safety.

2. Reimbursement & Pricing Landscape

• In the U.S., Medicare Part D and Medicaid favor LAIs due to cost-effectiveness.
• Pricing: Average wholesale price (AWP) ranges from $750–$950 per injection, depending on dosing.

3. Patent & Exclusivity

• The original patent expired in 2028, opening opportunities for biosimilars and generics, potentially impacting sales.

---

What Are the Financial Projections and Growth Opportunities?

Year	Global Sales (USD billions)	CAGR (Compound Annual Growth Rate)	Major Drivers	Risks
2023	$1.7	—	Continued adoption, new markets	Patent expiry, biosimilar entry
2024	$2.0	15%	Expanded indications, new reg.	Pricing pressures
2025	$2.4	15%	Increasing awareness	Competitive innovation
2026+	$3.0+	20% (post-patent expiry)	Biosimilar competition	Market saturation

Growth Factors

• Market Penetration: Expanding into emerging markets (Asia, Latin America).
• Indication Expansion: Potential uses in agitation in dementia or other neuropsychiatric disorders.
• Combination Therapies: Opportunities for co-administration with other psychotropics.

Key Risks

• Patent expiration in 2028 may precipitate generic entry.
• Competition from longer-acting formulations (e.g., Haldol Decanoate, Risperdal Consta).
• Regulatory hurdles for new indications or formulations.

---

How Do Patent Expiry and Biosimilar Entry Impact Revenue Outlook?

Patent Timeline

Patent Type	Expiry Date	Implication
Composition Patent	2028	Biosimilar competition likely to intensify
Manufacturing Patent	2030	Reduced barriers to biosimilar entry

Biosimilar Landscape

• First biosimilars expected by 2028–2030.
• Impact on pricing: Potential 20–30% price erosion.
• Market reaction: Shift towards value-based pricing and formulary negotiations.

---

What Are the Strategic Opportunities Moving Forward?

1. Geographic Expansion

• Tap into markets with low current penetration such as China and India.
• Partner with regional distributors for faster adoption.

2. Indication Expansion

• Pursue regulatory approval for adjunctive or off-label uses such as agitation control.
• Conduct clinical trials to support additional indications.

3. Formulation & Delivery Innovation

• Develop extended-release formulations with longer dosing intervals.
• Explore implantable options for improved adherence.

4. Pricing & Reimbursement Strategies

• Demonstrate cost-effectiveness through health economic studies.
• Collaborate with payers to establish favorable formulary placements.

---

Summary Table of Key Market and Financial Indicators

Indicator	Details
Market Size (2023)	~$1.7 billion globally, predominantly U.S.
Main Competitors	INVEGA SUSTENNA, Haldol Decanoate, Aristada
Pricing Range (per injection)	$750–$950
Growth Projections (2024–2026)	15–20% CAGR, driven by expansion and indication growth
Patent Expiry	2028
Potential Biosimilar Entry	2028–2030

---

Key Takeaways

• Market Outlook: ABILIFY MAINTENA KIT is poised for sustained growth driven by increasing prevalence of schizophrenia, bipolar disorder, and preference for LAI therapies.
• Competitive Positioning: It holds a strong market share, but faces imminent biosimilar threats post-2028.
• Regulatory and Reimbursement Environment: Favors long-acting formulations, particularly in developed markets.
• Growth Opportunities: Geographic expansion, indication diversification, and formulation innovations offer avenues for continued revenue enhancement.
• Challenges: Patent expiration, pricing pressures, and emerging biosimilars risk eroding market share if not strategically managed.

---

FAQs

Q1: What distinguishes ABILIFY MAINTENA from other long-acting antipsychotics?
A1: ABILIFY MAINTENA offers a three-week dosing cycle with proven efficacy in schizophrenia and bipolar disorder, and flexibility in dosing, providing increased adherence benefits over longer-acting agents that require q4-week or longer intervals.

Q2: How will patent expiration affect ABILIFY MAINTENA’s revenues?
A2: The patent expiry in 2028 exposes the drug to biosimilar competition, likely leading to a decline in pricing and market share unless Otsuka implements strategic pricing, licensing, or formulary negotiations.

Q3: What are the main barriers to entry for competitors in this market?
A3: Regulatory approval processes, manufacturing complexity, and establishing reimbursement agreements pose significant barriers, though biosimilar entry post-2028 could challenge established brands.

Q4: Which regions hold the greatest growth potential for ABILIFY MAINTENA?
A4: Emerging markets such as China, India, and Latin America offer substantial growth opportunities due to rising awareness, expanding healthcare infrastructure, and unmet needs.

Q5: How does ABILIFY MAINTENA compare cost-wise to oral aripiprazole?
A5: Although higher upfront per-injection costs (~$750–$950) are associated with ABILIFY MAINTENA, savings accrue over time through reduced hospitalization and improved adherence, making it cost-effective in chronic management.

---

References

[^1]: World Health Organization. Mental Health Atlas 2017.
[^2]: Olfson M, et al. “Treatment adherence for schizophrenia in a nationwide sample.” J Clin Psychiatry, 2015.
[^3]: Nasrallah HA. “Adherence to treatment in schizophrenia.” World Psychiatry, 2014.
[^4]: Ingram M, et al. “Injection-based antipsychotic strategies reduce hospitalization costs.” Psychiatr Serv., 2018.

---

This comprehensive analysis aims to inform pharmaceutical stakeholders, investors, and clinicians about the intricate dynamics shaping ABILIFY MAINTENA KIT’s market and financial landscape, emphasizing strategic opportunities and potential risks.