ABILIFY Drug Patent Profile

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

Abilify is a drug marketed by Otsuka and Otsuka Pharm Co Ltd and is included in seven NDAs. There are forty-six patents protecting this drug and three Paragraph IV challenges.

This drug has three hundred and one patent family members in thirty-nine countries.

The generic ingredient in ABILIFY 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

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

Summary for ABILIFY

International Patents:	301
US Patents:	5
Applicants:	2
NDAs:	7
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	163
Clinical Trials:	158
Patent Applications:	4,170
Drug Prices:	Drug price information for ABILIFY
Drug Sales Revenues:	Drug sales revenues for ABILIFY
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ABILIFY
What excipients (inactive ingredients) are in ABILIFY?	ABILIFY excipients list
DailyMed Link:	ABILIFY at DailyMed

See drug prices for ABILIFY

See drug sales revenues for ABILIFY

Recent Clinical Trials for ABILIFY

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

Sponsor	Phase
P&C Labs, Egypt	Phase 1
Genuine Research Center, Egypt	Phase 1
University of Chicago	Phase 2

See all ABILIFY clinical trials

Pharmacology for ABILIFY

Drug Class

Atypical Antipsychotic

Paragraph IV (Patent) Challenges for ABILIFY

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
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 ABILIFY

ABILIFY is protected by four 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	202971-003	Sep 29, 2014		RX	Yes	No
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-006	Nov 13, 2017		RX	Yes	No			Y
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-004	Nov 13, 2017		RX	Yes	No			Y
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-002	Feb 28, 2013		RX	Yes	Yes

Expired US Patents for ABILIFY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-005	Nov 15, 2002
Otsuka	ABILIFY	aripiprazole	TABLET, ORALLY DISINTEGRATING;ORAL	021729-004	Jun 7, 2006
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-001	Nov 15, 2002
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-006	Nov 15, 2002

EU/EMA Drug Approvals for ABILIFY

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

International Patents for ABILIFY

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

Country	Patent Number	Title	Estimated Expiration
Hungary	0600141
Germany	68925405
Poland	393603
Taiwan	I342776

Supplementary Protection Certificates for ABILIFY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0367141	C300161	Netherlands		PRODUCT NAME: ARIPIPRAZOLUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/04/276/001-005;006-010;011-015;016-020 20040604
1675573	92427	Luxembourg		PRODUCT NAME: ARIPIPRAZOLE
0367141	300161	Netherlands		300161, 20091027, EXPIRES: 20141026
1675573	C300669	Netherlands		PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115

ABILIFY Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ABILIFY

Overview of ABILIFY

ABILIFY, also known as aripiprazole, is a widely used atypical antipsychotic medication primarily prescribed for treating schizophrenia, bipolar I disorder, and other psychotic disorders. Here’s a detailed look at the market dynamics and financial trajectory of this drug.

Market Size and Growth

The global antipsychotic drugs market, which includes ABILIFY, was valued at USD 16.88 billion in 2023 and is projected to grow at a CAGR of 6.1% from 2024 to 2030. This growth is driven by an increase in the prevalence of mental health disorders, advancements in drug development, and growing awareness about mental health issues[1].

Key Drivers

Increasing Prevalence of Mental Health Disorders

The rising prevalence of mental health disorders such as schizophrenia, bipolar disorder, and major depressive disorders is a significant driver for the market. For instance, the COVID-19 pandemic led to an estimated increase of 26% and 28% in anxiety and major depressive disorders, respectively, which has boosted the demand for antipsychotic drugs like ABILIFY[1].

Advancements in Drug Development

Advancements in drug development, particularly the introduction of third-generation antipsychotics, have significantly impacted the market. ABILIFY, being a third-generation antipsychotic, has seen increased adoption due to its efficacy and the development of new formulations such as extended-release injectable suspensions[1].

Product Formulations and Approvals

ABILIFY Maintena and ABILIFY Asimtufii

ABILIFY Maintena, a long-acting injectable (LAI) formulation of aripiprazole, has been a pivotal product for Otsuka Pharmaceutical. However, the dual patent expiry of ABILIFY Maintena in Europe and the US in October 2024 is expected to impact sales, with a projected 12% reduction from 2024 to 2025[3].

To offset this impact, Otsuka has introduced ABILIFY Asimtufii, a once-every-two-month LAI formulation for the treatment of schizophrenia and bipolar I disorder. This new formulation, launched in the US in April 2023, is expected to sustain growth in mental health solutions for the company[3].

Financial Performance

Revenue and Sales

ABILIFY has been a significant contributor to Otsuka’s financial success, particularly in the US, which accounts for 49% of the drug’s total revenue from 2013 to 2023. According to Lundbeck's financial reports, the sales of ABILIFY Maintena and related products have shown steady growth. For example, in the first nine months of 2023, the revenue from strategic brands, including ABILIFY, increased by 14% compared to the same period in 2022[2].

Impact of Patent Expiry

The upcoming patent expiry of ABILIFY Maintena is expected to lead to increased competition and lower prices, which could negatively impact Otsuka’s sales. However, this could also translate to a positive outcome for the wider market by making the drug more accessible to a larger patient population[3].

Regional Market Dynamics

North America

North America, particularly the US, dominates the antipsychotic drugs market, including ABILIFY, with a revenue share of 37.67% in 2023. The strong prevalence of psychiatric illnesses and the presence of prominent biopharmaceutical companies in the region are key factors driving this dominance[1].

Asia Pacific

The Asia Pacific region is expected to witness significant growth due to a large population experiencing chronic and mental illnesses, increasing healthcare spending, and growing investments in healthcare infrastructure. China, in particular, is expected to grow rapidly due to high prevalence rates and government initiatives to improve mental health awareness and access to treatments[1].

Competitive Landscape

Market Share and Competitors

Aripiprazole, the active ingredient in ABILIFY, accounted for the largest market revenue share in 2023. The sales of this segment are expected to continue growing with the adoption of third-generation products. Other competitors in the market include brexpiprazole, lurasidone, and cariprazine, which are also third-generation antipsychotics[1].

Future Outlook

Growth Projections

The third-generation antipsychotics, including ABILIFY, are expected to register the fastest CAGR of 10.1% during the forecast period. This growth is driven by increasing advancements in drug development methods, such as the development of molecules that act as partial agonists and dopaminergic receptors in the treatment of psychosis[1].

New Formulations and Innovations

Otsuka’s proactive approach in expanding its LAI portfolio with new formulations like ABILIFY Asimtufii reflects the company’s focus on advancing psychiatric care solutions. These innovations are expected to drive market growth and maintain the company’s competitive edge despite the challenges posed by patent expiries[3].

Key Takeaways

• Market Growth: The global antipsychotic drugs market, including ABILIFY, is projected to grow at a CAGR of 6.1% from 2024 to 2030.
• Drivers: Increasing prevalence of mental health disorders, advancements in drug development, and growing awareness about mental health issues.
• Product Formulations: ABILIFY Maintena and ABILIFY Asimtufii are key formulations, with the latter expected to offset the impact of patent expiry.
• Financial Performance: ABILIFY has been a significant revenue generator for Otsuka, but faces challenges from patent expiry.
• Regional Dynamics: North America dominates the market, while the Asia Pacific region is expected to witness significant growth.
• Competitive Landscape: Aripiprazole holds a significant market share, with other third-generation antipsychotics also contributing to market growth.

FAQs

What is the current market size of the global antipsychotic drugs market?

The global antipsychotic drugs market was valued at USD 16.88 billion in 2023[1].

How is the market expected to grow?

The market is projected to grow at a CAGR of 6.1% from 2024 to 2030[1].

What are the key drivers for the growth of ABILIFY?

Key drivers include the increasing prevalence of mental health disorders, advancements in drug development, and growing awareness about mental health issues[1].

What impact will the patent expiry of ABILIFY Maintena have on Otsuka’s sales?

The patent expiry is expected to lead to a 12% reduction in sales from 2024 to 2025, but new formulations like ABILIFY Asimtufii are expected to offset this impact[3].

Which region dominates the antipsychotic drugs market?

North America, particularly the US, dominates the market with a revenue share of 37.67% in 2023[1].

What are the future growth projections for third-generation antipsychotics like ABILIFY?

Third-generation antipsychotics are expected to register the fastest CAGR of 10.1% during the forecast period[1].

Sources

1. Grand View Research: Antipsychotic Drugs Market Size And Share Report, 2030
2. Lundbeck: Lundbeck's revenue in the first nine months of 2023
3. GlobalData: Otsuka's new formulations to offset Abilify Maintena dual patent expiry impact
4. Data Bridge Market Research: Global Aripiprazole Market - Industry Trends and Forecast to 2029
5. Bristol Myers Squibb: Bristol-Myers Squibb Announces Extension of U.S. Agreement for ABILIFY and Establishment of an Oncology Collaboration with Otsuka