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-eight patents protecting this drug.

This drug has six hundred and seventy-seven 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-one 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:	677
US Patents:	28
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	163
Clinical Trials:	1
Patent Applications:	4,170
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.	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-eight 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		RX	Yes	No	10,441,194		Y
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-004	Nov 13, 2017		RX	Yes	No	9,941,931		Y
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-002	Nov 13, 2017		RX	Yes	Yes	9,320,455		Y
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-002	Nov 13, 2017		RX	Yes	Yes	9,268,909		Y
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-006	Nov 13, 2017		RX	Yes	No	10,441,194		Y
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-006	Nov 13, 2017		RX	Yes	No	8,545,402		Y
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-004	Nov 13, 2017		RX	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	207202-002	Nov 13, 2017	9,089,567
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-003	Nov 13, 2017	8,017,615
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-001	Nov 13, 2017	9,387,182
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-005	Nov 13, 2017	7,053,092
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-005	Nov 13, 2017	8,017,615
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-003	Nov 13, 2017	9,089,567
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-005	Nov 13, 2017	8,642,760

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/003803 Aripiprazole 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/000471 Abilify 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/002755 Maintenance 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/004021 Aripiprazole 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/003899 Aripiprazole 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/004008 Aripiprazole 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 MYCITE KIT

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

Country	Patent Number	Title	Estimated Expiration
China	101423492
Taiwan	201735896	Method of manufacturing miniature ingestible devices
Hong Kong	1201717	與藥物製品整合的可攝入的事件標記系統 (INTEGRATED INGESTIBLE EVENT MARKER SYSTEM WITH PHARMACEUTICAL PRODUCT)
Taiwan	I596968
South Korea	100490222
European Patent Office	2392258	Systeme pharma-informatique (Pharma-informatics system)
Taiwan	I503101

Supplementary Protection Certificates for ABILIFY MYCITE KIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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

ABILIFY MYCITE KIT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ABILIFY MYCITE

Introduction to ABILIFY MYCITE

ABILIFY MYCITE, a groundbreaking drug-device combination, is the first FDA-approved digital medicine system. It consists of aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor, designed to track drug ingestion. This system is indicated for the treatment of adults with schizophrenia, as well as for the acute treatment of manic and mixed episodes associated with bipolar I disorder, and as an add-on treatment for depression in adults[4][5].

Mechanism of Action and Clinical Development

ABILIFY MYCITE works by incorporating an IEM sensor into aripiprazole tablets. When the tablet comes into contact with stomach fluid, the sensor activates and communicates with a wearable patch, which then sends the data to a smartphone app. This system provides real-time information on medication adherence, which can be crucial for managing serious mental illnesses[5].

Clinical development of ABILIFY MYCITE involved extensive human factor studies and clinical trials to ensure the system's usability and effectiveness. Despite these efforts, the European Medicines Agency (EMA) raised concerns about the system's reliability and safety, leading to the withdrawal of the marketing authorization application in Europe[2].

Regulatory Milestones

The FDA approved ABILIFY MYCITE in November 2017, marking a significant milestone in the integration of digital technology into pharmaceuticals. However, the EMA's evaluation highlighted several unresolved issues, including concerns about the system's ability to reliably measure medication intake and potential skin reactions from the wearable patch[2][5].

Market Outlook

The market for schizophrenia treatments is expected to evolve significantly due to increasing research and healthcare spending globally. Here are some key points regarding the market outlook for ABILIFY MYCITE:

Market Size and Forecast

The market size for ABILIFY MYCITE in the seven major markets (7MM), including the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, is forecasted to grow from 2023 to 2032. Detailed market size analyses for each country are provided, indicating a potential expansion in market size driven by incremental healthcare spending and the development of novel therapies[1][4].

Competitive Landscape

The competitive landscape for schizophrenia treatments is dynamic, with several emerging therapies expected to challenge ABILIFY MYCITE's market position. Late-stage emerging therapies will significantly impact the market, forcing companies to innovate and adapt to maintain market share[1][4].

Financial Trajectory

Sales Forecast

The sales forecast for ABILIFY MYCITE from 2023 to 2032 is a critical component of its financial trajectory. The report provides in-depth analysis of forecasted sales data, which will help clients in decision-making regarding their therapeutic portfolios. The sales data are broken down by country, providing a comprehensive view of the market's potential[1][4].

Revenue Impact

The revenue generated by ABILIFY MYCITE will be influenced by several factors, including market competition, regulatory approvals, and the adoption rate of the digital medicine system. Despite the initial limited launch, Otsuka aims to expand the system's use based on feedback from early adopters, which could positively impact revenue[5].

Challenges and Opportunities

Technical and Safety Concerns

The EMA's concerns about the system's reliability and safety pose significant challenges. The risk of patients taking too many doses due to the system's potential failure and skin reactions from the wearable patch are critical issues that need to be addressed[2].

Market Penetration

The limited launch strategy allows Otsuka to gather feedback and enhance the system before a broader rollout. This approach can help in addressing technical and safety concerns, thereby improving market penetration and acceptance[5].

SWOT Analysis

Strengths

• First FDA-approved digital medicine system, offering a unique approach to medication adherence.
• Comprehensive data collection on medication intake and patient activity.
• Potential for improved patient outcomes through better adherence tracking[5].

Weaknesses

• Technical and safety concerns raised by regulatory bodies.
• Limited initial launch, which may slow down market penetration.
• Dependence on digital technology, which can be a barrier for some patients[2][5].

Opportunities

• Growing market for schizophrenia treatments due to increased healthcare spending.
• Potential for expansion into other mental health conditions.
• Collaboration with health plans and providers to enhance the system's adoption[1][4].

Threats

• Emerging therapies that could offer alternative treatments.
• Regulatory hurdles in different regions.
• Competition from other digital health solutions[1][4].

Country-Wise Market Analysis

The market analysis for ABILIFY MYCITE is detailed for each of the 7MM countries. Here are some highlights:

United States

The US market is expected to be a significant contributor to the overall revenue of ABILIFY MYCITE. The FDA approval in 2017 marked the beginning of its commercial journey in the US, with a focus on limited launch and feedback-driven expansion[5].

EU4 and the United Kingdom

Despite the withdrawal of the marketing authorization application in Europe, there is potential for future re-submission and approval. The market sizes in Germany, France, Italy, Spain, and the UK are forecasted, indicating potential growth if regulatory hurdles are overcome[1][2].

Japan

The Japanese market also presents opportunities for growth, with detailed market size forecasts available. The approval and adoption process in Japan will be crucial for the overall financial trajectory of ABILIFY MYCITE[1].

Key Takeaways

• ABILIFY MYCITE is a pioneering digital medicine system with the potential to transform medication adherence in schizophrenia and other mental health conditions.
• The market outlook is influenced by regulatory approvals, technical and safety concerns, and the emergence of new therapies.
• A detailed SWOT analysis highlights the strengths, weaknesses, opportunities, and threats that will shape the financial trajectory of ABILIFY MYCITE.
• Country-wise market analyses provide insights into the potential revenue streams and growth opportunities.

FAQs

Q: What is ABILIFY MYCITE, and how does it work? A: ABILIFY MYCITE is a drug-device combination that includes aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor. The sensor tracks medication ingestion and communicates with a wearable patch and a smartphone app.

Q: What are the regulatory milestones for ABILIFY MYCITE? A: ABILIFY MYCITE was approved by the FDA in November 2017 but faced regulatory challenges in Europe, leading to the withdrawal of its marketing authorization application.

Q: What are the potential market challenges for ABILIFY MYCITE? A: Technical and safety concerns, competition from emerging therapies, and regulatory hurdles are significant challenges for ABILIFY MYCITE.

Q: How does the limited launch strategy impact the market penetration of ABILIFY MYCITE? A: The limited launch allows for feedback-driven improvement and addresses initial technical and safety concerns, which can enhance market penetration and acceptance.

Q: What is the forecasted market size for ABILIFY MYCITE from 2023 to 2032? A: The market size for ABILIFY MYCITE in the 7MM is forecasted to grow, with detailed analyses provided for each country, reflecting potential growth driven by healthcare spending and novel therapies.

Cited Sources

1. Research and Markets, "ABILIFY MYCITE Drug Insight and Market Forecast - 2032"
2. European Medicines Agency, "Abilify MyCite | European Medicines Agency (EMA) - Europa.eu"
3. Pharmaceutical Executive, "Specialty Product Launch Insights"
4. PR Newswire, "ABILIFY MYCITE: A Drug-device Combination Comprised of Aripiprazole Tablets Embedded with an IEM----Drug Insights and Market Forecasts 2019-2022--2023-2032"
5. Otsuka Pharmaceutical Co., Ltd., "ABILIFY MYCITE® (aripiprazole tablets with sensor) | Discover Otsuka"