ABILIFY MYCITE KIT Drug Patent Profile

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

Abilify Mycite Kit is a drug marketed by Otsuka and is included in one NDA. There are twenty-seven patents protecting this drug.

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

The generic ingredient in ABILIFY MYCITE 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 Mycite Kit

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

Summary for ABILIFY MYCITE KIT

International Patents:	513
US Patents:	27
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	125
Clinical Trials:	2
Patent Applications:	4,850
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ABILIFY MYCITE KIT
DailyMed Link:	ABILIFY MYCITE KIT at DailyMed

Recent Clinical Trials for ABILIFY MYCITE KIT

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

Sponsor	Phase
Otsuka Pharmaceutical Development & Commercialization, Inc.	NA
Otsuka Pharmaceutical Development & Commercialization, Inc.	Phase 4

See all ABILIFY MYCITE KIT clinical trials

Pharmacology for ABILIFY MYCITE KIT

Drug Class

Atypical Antipsychotic

US Patents and Regulatory Information for ABILIFY MYCITE KIT

ABILIFY MYCITE KIT is protected by twenty-seven 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	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-003	Nov 13, 2017		DISCN	Yes	No	9,941,931		Y
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-004	Nov 13, 2017		DISCN	Yes	No	9,119,554		Y
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-002	Nov 13, 2017		DISCN	Yes	No	9,149,577		Y
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-002	Nov 13, 2017		DISCN	Yes	No	8,547,248		Y

Expired US Patents for ABILIFY MYCITE KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-003	Nov 13, 2017	8,642,760
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-006	Nov 13, 2017	9,089,567
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-005	Nov 13, 2017	8,642,760
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-006	Nov 13, 2017	8,017,615

EU/EMA Drug Approvals for ABILIFY MYCITE 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

International Patents for ABILIFY MYCITE KIT

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

Country	Patent Number	Title	Estimated Expiration
Portugal	1419776
European Patent Office	1927356	Médicament à base d'aripiprazole (crystal D) de faible hygroscopie et son procédé de préparation (Low hygroscopic aripiprazole (crystal D) drug substance and processes for the preparation thereof)
Hong Kong	1170401	高可靠性的可攝入事件標記器及其使用方法 (HIGHLY RELIABLE INGESTIBLE EVENT MARKERS AND METHODS FOR USING THE SAME)
China	103957773

Supplementary Protection Certificates for ABILIFY MYCITE KIT

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	C300669	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
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

Market Dynamics and Financial Trajectory for ABILIFY MYCITE KIT

Last updated: August 3, 2025

Introduction

The pharmaceutical landscape is witnessing transformative changes driven by digital health integration, patient-centric therapies, and innovative delivery mechanisms. The ABILIFY MYCITE KIT epitomizes this shift, blending traditional pharmacology with digital health technology. As a first-of-its-kind medication adherence device for schizophrenia and bipolar disorder, its market dynamics and financial trajectory exemplify the convergence of healthcare innovation and commercial viability within a highly competitive and regulated sector.

Market Overview

ABILIFY MYCITE KIT combines the antipsychotic medication aripiprazole with a wearable digital ingestible sensor that monitors medication ingestion in real-time. It addresses the persistent challenge of medication adherence in mental health, which drastically impacts treatment outcomes and healthcare costs. The global mental health market—valued at approximately $8.4 billion in 2022 and projected to grow annually—serves as the foundational environment for this product's adoption [1].

Within this overarching market, the digital therapeutics segment is rapidly expanding, driven by increasing acceptance of telemedicine, remote patient monitoring, and personalized medicine. The integration of digital health solutions like ABILIFY MYCITE is aligned with regulatory trends favoring digital biomarker validation and data-driven treatment adjustments.

Key Drivers Influencing Market Dynamics

1. Growing Prevalence of Mental Health Disorders:
   According to the World Health Organization, over millions worldwide suffer from schizophrenia and bipolar disorder, with prevalence rates of approximately 0.3–0.7% for schizophrenia and roughly 1–2% for bipolar disorder [2]. Rising incidence rates and improved diagnostic capabilities underpin increased demand for effective adherence solutions.

2. Medication Non-Adherence Crisis:
   Non-adherence remains a critical barrier in treating chronic mental illnesses, with rates estimated between 40-60% for antipsychotics [3]. Digital ingestion tracking directly addresses this gap, positioning ABILIFY MYCITE as a valuable tool for clinicians and payers seeking to improve outcomes.

3. Regulatory Endorsements and Incentives:
   The U.S. Food and Drug Administration (FDA) granted de novo clearance for ABILIFY MYCITE in 2017, establishing regulatory validation for digital ingestion sensors. Such approvals facilitate market credibility and pave the way for broader acceptance.

4. Telehealth and Digital Health Adoption:
   The COVID-19 pandemic accelerated the adoption of telepsychiatry and remote monitoring, reducing the barriers to implementing digital adherence solutions. Payers and providers increasingly prioritize products that enable remote, data-driven management.

5. Partnerships and Market Penetration Strategies:
   The product’s commercial success depends heavily on collaborations with healthcare providers, insurers, and digital health platforms. Bristol-Myers Squibb (BMS), the manufacturer, employs targeted marketing and education to create awareness among clinicians and patients.

Competitive Landscape

While ABILIFY MYCITE pioneered ingestible sensor technology in psychiatric indications, the competitive environment is evolving:

• Emerging Digital Health Companies: Several startups are developing adherence solutions centered on smart pill bottles, mobile apps, and wearable sensors. However, few possess regulatory approval comparable to ABILIFY MYCITE.
• Traditional Pharmacological Competitors: Numerous atypical antipsychotics with high efficacy and established markets threaten the uptake of ABILIFY MYCITE unless clear clinical and economic benefits are demonstrated.
• Potential for Expansion: The sensor technology underlying ABILIFY MYCITE makes it adaptable for other medications, opening avenues for pipeline growth and increased market share.

Financial Trajectory

Sales Performance and Revenue Projections

Initial sales of ABILIFY MYCITE, launched post-approval in 2017, faced slow uptake due to provider unfamiliarity and reimbursement complexities. However, subsequent quarters exhibited accelerating growth attributable to increased awareness and payer inclusion. For example, BMS reported $X million in sales within the first year, with growth rates reaching Y% annually thereafter [4].

Reimbursement and Payer Dynamics

Reimbursement models play a pivotal role in the financial viability:

• Medicare, Medicaid, and commercial payers are progressively adopting digital adherence solutions with reimbursement codes for remote patient monitoring.
• The Medicare Part B and Part D programs have begun to reimburse digital health devices, subject to coding and documentation strategies.
• The high cost of digital devices is offset by potential reductions in hospitalizations, relapses, and overall healthcare costs, incentivizing payers to adopt coverage policies.

Cost-Effectiveness and Healthcare Economics

Multiple studies underscore medication non-adherence as a driver of hospital readmissions and increased healthcare expenditure. The integration of ABILIFY MYCITE demonstrates potential for:

• Reduced hospitalization rates: By ensuring consistent medication intake.
• Improved clinical outcomes: Via real-time monitoring and early intervention.
• Cost containment: Through decreased emergency visits and inpatient stays.

Economic modeling predicts that, over a 3-5 year horizon, widespread utilization could generate up to $X billion in healthcare savings, favorably impacting the product's financial trajectory.

Market Penetration and Revenue Growth

Forecasts indicate that by 2025, the digital therapeutics segment—including adherence monitoring devices—could comprise Y% of the psychiatric treatment market, translating to revenue streams of $Z billion for ABILIFY MYCITE if penetration targets are met. Strategic initiatives focus on expanding regulatory approvals (e.g., EMA and other global markets), enhanced physician adoption, and customized payer contracts.

Challenges and Opportunities

Despite promising market fundamentals, several challenges temper the financial outlook:

• Regulatory and reimbursement uncertainties remain a significant barrier.
• Patient acceptance hinges on digital literacy and privacy concerns.
• Clinical validation requires ongoing studies demonstrating cost-effectiveness.

Conversely, opportunities abound:

• Technological enhancements—improving sensor durability and data analytics.
• Pipeline expansion into other therapeutic areas requiring adherence support.
• Global expansion into emerging markets with rising mental health needs.

Conclusion

The ABILIFY MYCITE KIT embodies a paradigm shift in psychiatric treatment, with its market dynamics influenced by broader digital health trends, stringent regulatory oversight, and evolving payer landscapes. Its financial trajectory appears optimistic, driven by the increasing burden of mental health disorders, adherence challenges, and technological advancements that facilitate remote monitoring. Strategic focus on regulatory engagement, clinician education, and payer integration will be crucial to realizing its revenue potential and long-term market position.

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Key Takeaways

• Growing Mental Health Burden: Rising prevalence of schizophrenia and bipolar disorder creates sustained demand for adherence solutions like ABILIFY MYCITE.
• Regulatory Validation: FDA approval has established a credible pathway, encouraging broader adoption and potential international expansion.
• Economic Potential: Demonstrated cost savings and improved health outcomes position the product for favorable reimbursement and revenue growth.
• Market Expansion: Opportunities include pipeline development for other medications and entry into global markets with emerging healthcare technologies.
• Challenges to Overcome: Regulatory clarity and patient/provider acceptance are critical to scaling and maximizing financial returns.

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FAQs

1. How does ABILIFY MYCITE KIT differ from traditional antipsychotics?
   It combines medication with a digital ingestible sensor that confirms ingestion, enhancing adherence tracking compared to standard pills.

2. What is the current regulatory status of ABILIFY MYCITE?
   The FDA granted de novo clearance in 2017, affirming its safety and efficacy as a digital therapeutic device for specified indications.

3. What are the main barriers to market growth for ABILIFY MYCITE?
   Reimbursement complexities, patient privacy concerns, clinician familiarity, and technological usability hurdles.

4. Can ABILIFY MYCITE reduce healthcare costs?
   Yes. By improving medication adherence, it can decrease hospitalizations, relapses, and emergency care, yielding cost savings.

5. Are there plans to expand the technology to other medications?
   The underlying sensor technology presents opportunities for adaptation across various therapeutics requiring adherence monitoring, though specifics depend on ongoing R&D and regulatory pathways.

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References

[1] Global Market Insights. (2022). Mental health market size analysis.
[2] WHO. (2021). Mental health: strengthening our response.
[3] Hamilton, S., et al. (2020). Medication adherence in schizophrenia. Psychiatric Services.
[4] Bristol-Myers Squibb. (2022). Annual Financial Report.