ARIPIPRAZOLE - Generic Drug Details

What are the generic drug sources for aripiprazole and what is the scope of freedom to operate?

Aripiprazole is the generic ingredient in eight branded drugs marketed by Xiamen Lp Pharm Co, Otsuka Pharm Co Ltd, Mylan, Otsuka, Amneal Pharms, Apotex, Aurobindo Pharma Ltd, Chartwell Rx, Hetero Labs Ltd Iii, Lannett Co Inc, Rubicon, Vistapharm Llc, Alembic, Orbion Pharms, Sciegen Pharms Inc, Square Pharms, Accord Hlthcare, Aiping Pharm Inc, Ajanta Pharma Ltd, Alkem Labs Ltd, Aurobindo Pharma, Hetero Labs Ltd V, Lupin, Macleods Pharms Ltd, Norvium Bioscience, Prinston Inc, Sunshine, Teva Pharms Usa, Torrent, Unichem, Zydus Pharms, and Alkermes Inc, and is included in forty-five NDAs. There are sixty patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Aripiprazole has eight hundred and sixty-four patent family members in forty-seven countries.

There are forty-nine drug master file entries for aripiprazole. Forty-seven suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for ARIPIPRAZOLE

International Patents:	864
US Patents:	60
Tradenames:	8
Applicants:	32
NDAs:	45
Drug Master File Entries:	49
Finished Product Suppliers / Packagers:	47
Raw Ingredient (Bulk) Api Vendors:	161
Clinical Trials:	385
Patent Applications:	7,025
Drug Prices:	Drug price trends for ARIPIPRAZOLE
Drug Sales Revenues:	Drug sales revenues for ARIPIPRAZOLE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ARIPIPRAZOLE
What excipients (inactive ingredients) are in ARIPIPRAZOLE?	ARIPIPRAZOLE excipients list
DailyMed Link:	ARIPIPRAZOLE at DailyMed

See drug prices for ARIPIPRAZOLE

See drug sales revenues for ARIPIPRAZOLE

Recent Clinical Trials for ARIPIPRAZOLE

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

Sponsor	Phase
Instituto de Salud Carlos III	Phase 4
Consorcio Centro de Investigación Biomédica en Red (CIBER)	Phase 4
First Affiliated Hospital Xi'an Jiaotong University	N/A

See all ARIPIPRAZOLE clinical trials

Generic filers with tentative approvals for ARIPIPRAZOLE

Applicant	Application No.	Strength	Dosage Form
		20MG	TABLET, ORALLY DISINTEGRATING; ORAL
		15MG	TABLET, ORALLY DISINTEGRATING; ORAL
		10MG	TABLET, ORALLY DISINTEGRATING; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ARIPIPRAZOLE

Drug Class

Atypical Antipsychotic

Medical Subject Heading (MeSH) Categories for ARIPIPRAZOLE

Antipsychotic Agents

Anatomical Therapeutic Chemical (ATC) Classes for ARIPIPRAZOLE

N05AX	Other antipsychotics
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for ARIPIPRAZOLE

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
ABILIFY	Oral Solution	aripiprazole	1 mg/mL	021713	1	2007-12-20
ABILIFY	Tablets	aripiprazole	2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg	021436	8	2006-11-15
ABILIFY	Orally Disintegrating Tablets	aripiprazole	10 mg, 15 mg, 20 mg and 30 mg	021729	1	2006-11-15

US Patents and Regulatory Information for ARIPIPRAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Torrent	ARIPIPRAZOLE	aripiprazole	TABLET;ORAL	201519-001	Apr 28, 2015	AB	RX	No	No
Alkermes Inc	ARISTADA	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207533-003	Oct 5, 2015		RX	Yes	Yes	10,238,651
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-005	Nov 13, 2017		DISCN	Yes	No	8,718,193		Y
Prinston Inc	ARIPIPRAZOLE	aripiprazole	TABLET;ORAL	205363-004	Dec 4, 2017	AB	RX	No	No
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-004	Nov 13, 2017		DISCN	Yes	No	9,320,455		Y
Alkem Labs Ltd	ARIPIPRAZOLE	aripiprazole	TABLET;ORAL	207105-004	Feb 21, 2019	AB	RX	No	No
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-003	Nov 13, 2017		DISCN	Yes	No	11,464,423		Y

Expired US Patents for ARIPIPRAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-001	Nov 15, 2002	9,089,567
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-006	Nov 15, 2002	9,089,567
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-003	Nov 15, 2002	8,017,615*PED
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-004	Nov 13, 2017	8,017,615
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-004	Nov 13, 2017	7,053,092
Otsuka	ABILIFY	aripiprazole	TABLET, ORALLY DISINTEGRATING;ORAL	021729-005	Jun 7, 2006	8,642,600*PED
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-001	Feb 28, 2013	8,338,428

EU/EMA Drug Approvals for ARIPIPRAZOLE

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 ARIPIPRAZOLE

Country	Patent Number	Title	Estimated Expiration
Singapore	10201600202U	MEDICAL DEVICE CONTAINING A CAKE COMPOSITION COMPRISING ARIPIPRAZOLE AS AN ACTIVE INGREDIENT, AND A CAKE COMPOSITION COMPRISING ARIPIPRAZOLE AS AN ACTIVE INGREDIENT
Israel	186898	PHARMA-INFORMATICS SYSTEM
South Korea	20030060871
Taiwan	I332839
Malaysia	154613	SYSTEM FOR SUPPLY CHAIN MANAGEMENT
China	111991373	一种阿立哌唑口溶膜及其制备方法 (Aripiprazole orally-soluble film and preparation method thereof)
South Africa	201305199	MEDICAL DEVICE CONTAINING A CAKE COMPOSITION COMPRISING ARIPIPRAZOLE AS AN ACTIVE INGREDIENT, AND A CAKE COMPOSITION ARIPIPRAZOLE AS AN ACTIVE INGREDIENT

Supplementary Protection Certificates for ARIPIPRAZOLE

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	2014C/029	Belgium		PRODUCT NAME: ARIPIPRAZOLE; AUTHORISATION NUMBER AND DATE: EU/1/13/882 20131119
1675573	92427	Luxembourg		PRODUCT NAME: ARIPIPRAZOLE
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	C300669	Netherlands		PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115

Market Dynamics and Financial Trajectory for Aripiprazole

Introduction

Aripiprazole, a widely used antipsychotic medication, is experiencing significant market dynamics and financial shifts. This article delves into the current market size, growth projections, key drivers, and challenges facing the aripiprazole market.

Current Market Size and Growth Projections

The global aripiprazole market was valued at US$ 121 million in 2023 and is expected to reach US$ 167.1 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 5.1% during the forecast period of 2024-2030[1].

Another analysis suggests that the market will grow at a CAGR of 4.60% from 2022 to 2029, driven by increasing prevalence of mental health disorders such as depression, schizophrenia, and bipolar mania[3].

Key Drivers of Market Growth

Several factors are driving the growth of the aripiprazole market:

Increasing Prevalence of Mental Health Disorders

The rise in the prevalence of depression, schizophrenia, and bipolar mania globally is a major driver for the expansion of the aripiprazole market. As mental health awareness increases, so does the demand for effective treatments like aripiprazole[3].

Geriatric Population and Healthcare Expenditure

The increasing geriatric population and rising healthcare expenditure are also significant drivers. Older adults are more likely to suffer from mental health disorders, and increased healthcare spending supports the development and use of antipsychotic medications[3].

Research and Development Activities

Emerging new markets and the rise in research and development activities are providing beneficial opportunities for the aripiprazole market. New formulations and delivery methods, such as long-acting injectable solutions, are enhancing treatment options and patient compliance[3][5].

Market Segmentation

The aripiprazole market is segmented based on several criteria:

By Drug Class

Aripiprazole falls under the categories of antipsychotics and antimanic agents[3].

By Application

The drug is used to treat major depressive disorders, schizophrenia, bipolar mania, and other mental health conditions[3].

By Demographic

The market is segmented into adult and pediatric patients, with each demographic having different treatment needs and market dynamics[3].

By Dosage Form

Aripiprazole is available in various forms, including tablets, orally disintegrating tablets, oral solution, and injections. The long-acting injectable (LAI) solutions are particularly noteworthy for their convenience and compliance benefits[3][5].

Geographical Distribution

North America currently dominates the aripiprazole market due to the presence of major key players, high disposable income, and well-developed healthcare infrastructure. However, the Asia-Pacific region is expected to grow significantly during the forecast period due to increasing research and development activities and growing government support[3].

Financial Trajectory and Challenges

Revenue Growth

The financial performance of the aripiprazole market is robust, with revenue expected to grow steadily over the forecast period. Companies like Otsuka Pharmaceutical, Teva, and others are driving this growth through their strategic brands and new product launches[1][5].

Patent Expiry and Competition

The dual patent expiry of Abilify Maintena, a key product of Otsuka Pharmaceutical, poses a significant risk. This expiry is expected to lead to a 12% reduction in sales from 2024 to 2025 and could plummet further by the end of 2029. However, Otsuka is proactively developing new formulations, such as Abilify Asimtufii, to offset these losses and maintain market share[5].

Strategic Initiatives by Key Players

Companies are adopting several strategies to maintain and grow their market share:

New Formulations

Otsuka Pharmaceutical's launch of Abilify Asimtufii, a once-every-two-month LAI solution, is a significant example. This new formulation is expected to enhance patient compliance and provide a competitive edge despite the patent expiry of Abilify Maintena[5].

Global Rollout

The global rollout of new products, such as Vyepti by Lundbeck, and the expansion of existing products into new markets are also key strategies. These initiatives help in maintaining revenue growth and market dominance[2].

Impact on Patient Accessibility

The patent expiry of Abilify Maintena, while challenging for Otsuka, can translate into a positive outcome for the wider market. Increased competition and lower prices can make the drug more accessible to a larger patient population, which is a beneficial outcome for public health[5].

Regulatory and Market Trends

Regulatory Approvals

Recent regulatory approvals, such as the FDA approval of Abilify Asimtufii and the favorable FDA AdCom votes for brexpiprazole, indicate a supportive regulatory environment for new psychiatric treatments[2].

Market Competition

The market is competitive, with several key players including Otsuka Pharmaceutical, Teva, APOTEX, and others. The competition is expected to increase with the entry of generic versions post-patent expiry, which will drive innovation and cost-effectiveness[1].

Patient Epidemiology Analysis

The patient epidemiology analysis highlights the growing need for effective treatments. Factors such as disease epidemiology, country demographics, and import-export tariffs are crucial in forecasting the market scenario for individual countries[3].

Key Takeaways

• The global aripiprazole market is expected to grow at a CAGR of 5.1% from 2024 to 2030.
• Key drivers include the increasing prevalence of mental health disorders, rising geriatric population, and growing healthcare expenditure.
• New formulations and delivery methods, such as LAI solutions, are enhancing treatment options.
• North America dominates the market, but the Asia-Pacific region is expected to grow significantly.
• Patent expiry of key products poses challenges, but companies are developing new formulations to maintain market share.
• Increased competition post-patent expiry can make the drug more accessible to a larger patient population.

Frequently Asked Questions (FAQs)

Q: What is the expected growth rate of the global aripiprazole market from 2024 to 2030? A: The global aripiprazole market is expected to grow at a CAGR of 5.1% from 2024 to 2030[1].

Q: Which regions dominate the aripiprazole market? A: North America currently dominates the market, but the Asia-Pacific region is expected to grow significantly during the forecast period[3].

Q: What are the main drivers of the aripiprazole market growth? A: The main drivers include the increasing prevalence of mental health disorders, rising geriatric population, and growing healthcare expenditure[3].

Q: How will the patent expiry of Abilify Maintena impact Otsuka Pharmaceutical? A: The patent expiry is expected to lead to a 12% reduction in sales from 2024 to 2025, but Otsuka is developing new formulations to offset these losses[5].

Q: What are the new formulations being developed by key players? A: Otsuka Pharmaceutical has launched Abilify Asimtufii, a once-every-two-month LAI solution, to enhance patient compliance and maintain market share[5].

Cited Sources:

1. Global Aripiprazole Drug Market Research Report 2024 - Valuates Reports
2. Financial results and business update - Lundbeck - Lundbeck
3. Global Aripiprazole Market - Industry Trends and Forecast to 2029 - Data Bridge Market Research
4. Global Aripiprazole Market Size, Trends and Projections - Market Research Intellect
5. Otsuka's new formulations to offset Abilify Maintena dual patent expiry impact - Financial Express