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-one patents protecting this drug and three Paragraph IV challenges.

This drug has one hundred and thirty-one patent family members in thirty-seven 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:	131
US Patents:	4
Applicants:	2
NDAs:	7
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	159
Patent Applications:	4,526
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
Otsuka Pharmaceutical Development & Commercialization, Inc.	NA
P&C Labs, Egypt	Phase 1
Genuine Research Center, Egypt	Phase 1

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 three 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	207202-005	Nov 13, 2017		DISCN	Yes	No			Y
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-004	Sep 29, 2014		RX	Yes	Yes
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-005	Nov 13, 2017		DISCN	Yes	No			Y

Expired US Patents for ABILIFY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-004	Nov 15, 2002
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-006	Nov 15, 2002
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-005	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/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

International Patents for ABILIFY

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

Country	Patent Number	Title	Estimated Expiration
Turkey	200001810
Israel	188455
European Patent Office	1441698	FORME DE DOSAGE ORALE TRÈS FONDANTE (FLASHMELT ORAL DOSAGE FORMULATION)

Supplementary Protection Certificates for ABILIFY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0367141	300161	Netherlands		300161, 20091027, EXPIRES: 20141026
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
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

Market Dynamics and Financial Trajectory for ABILIFY (Aripiprazole)

Last updated: December 9, 2025

Summary

ABILIFY (Aripiprazole), a versatile atypical antipsychotic developed by Otsuka Pharmaceutical and marketed by Bristol-Myers Squibb (and later by other firms such as Otsuka alone), has experienced significant market evolution since its debut. It is prescribed primarily for schizophrenia, bipolar disorder, and major depressive disorder, among other indications. This analysis provides a comprehensive overview of ABILIFY’s market environment, competitive landscape, revenue trajectory, regulatory considerations, and future growth prospects.

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What Are the Core Market Dynamics Driving ABILIFY’s Position?

1. Pharmacological Profile and Therapeutic Expansion

Unique Mechanism of Action:
Aripiprazole functions as a partial agonist at dopamine D2 receptors and serotonin 5-HT1A receptors, with antagonist activity at 5-HT2A receptors, offering a differentiated pharmacological profile. This mechanism underpins its favorable side effect profile relative to first-generation antipsychotics.

Indication Expansion:
Initially approved in 2002 for schizophrenia (FDA, 2002), subsequent approvals expanded ABILIFY's use to bipolar disorder (2003), irritability associated with autism (2009), adjunctive treatment for major depressive disorder (2007), and Tourette’s syndrome (2017).

Impact:
Therapeutic versatility enhances market penetration and sustains revenue streams amid competition.

2. Market Penetration and Prescribing Trends

Global Prescriptions Context:
As of 2022, ABILIFY was among the top-selling antipsychotics with estimated global sales surpassing $4.5 billion (IQVIA). The drug maintains a broad data-driven prescriber base across psychiatry and neurology, with prescription volumes growing in emerging markets.

Adoption Challenges:
Clinicians may switch to newer agents offering improved efficacy or safety, such as brexpiprazole and cariprazine, which are structurally similar but marketed with specific advantages.

3. Competitive Landscape

Key Competitors	Therapeutic Class	Notable Features	Market Share (2022)	Price Positioning
Risperdal (Risperidone)	Atypical antipsychotic	Similar efficacy, more side effects	~25%	Lower, generic options available
Seroquel (Quetiapine)	Atypical antipsychotic	Sedative effects, broader use in depression	~20%	Competitive with ABILIFY
Latuda (Lurasidone)	Atypical antipsychotic	Weight-neutral profile, fewer metabolic side effects	~10%	Slight premium pricing
Brexpiprazole, Cariprazine	Partial agonists	Emerging, targeted indications	<10%	Premium, niche markets

Implication:
ABILIFY retains a leading position but faces pressure from newer agents with improved safety profiles or specific target indications.

4. Regulatory and Patent Considerations

Patent Landscape:
Its primary patent protection expired in the U.S. in 2017, leading to generic entry. Despite this, the originator company utilized patent litigations and formulation patents to sustain exclusivity until 2021.

Regulatory Approvals and Off-Label Use:
Broad FDA approval and off-label prescribing contribute significantly to sales. Ongoing patent litigations and regulatory modifications influence market exclusivity and pricing strategies.

5. Pricing Strategies and Reimbursement Policies

Pricing Trends:
Post-generic entry, ABILIFY’s price declined considerably—estimates suggest reductions of 40-60%—prompting shifts toward volume-based revenue strategies.

Insurance and Reimbursement:
Reimbursement levels in key markets (U.S., EU, Japan) impact prescription volume. Payers increasingly favor generics, exerting downward pressure on profits.

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What Is ABILIFY’s Financial Trajectory?

1. Revenue and Sales Trends

Year	Estimated Global Sales	Key Factors
2012	~$7.3 billion	Patent protection, extended indications
2017	~$4.8 billion	Patent expiry, generics enter
2020	~$3.4 billion	Market saturation, competition intensifies
2022	~$4.5 billion	Recovery driven by emerging markets

Analysis:
The initial peak in sales (2012) was driven by widespread patent exclusivity, but subsequent declines followed patent expiration. The resurgence in 2022 correlates with increased penetration in Asia-Pacific and Latin America, along with expanded indications and formulations.

2. Impact of Patent Expiry and Generics

Patent Expiration:
US patent expired in 2017; EU followed suit in 2018. Consequent generic entry caused an immediate 60-70% reduction in the drug's wholesale price.

Generic Competition:
Supply chain dynamics and aggressive price erosion have underscored the importance of volume sales and pipeline expansion.

3. Strategic Responses and Reformulations

Extended-Release and Depot Variants:
Otsuka and partners launched long-acting injectable forms (e.g., ABILIFY MAINTENA in 2013). These formulations support persistent revenue despite generics.

Biosimilars & Future Innovation:
While biosimilars are less relevant for small molecules like aripiprazole, pipeline development centers on novel delivery mechanisms and expanded indications.

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How Do Regulatory and Policy Environments Influence ABILIFY’s Trajectory?

Jurisdiction	Policies Impacting ABILIFY	Key Developments
United States	Patent laws, Medicare pricing, Medicaid rebates	Patent expirations, price controls
European Union	Price and reimbursement negotiations, NICE guidelines	Off-label restrictions, generics
Japan	Reimbursement caps, regulatory approval processes	Therapeutic guidelines, cost-effectiveness

Regulatory pathways in emerging markets (e.g., India, China) increasingly favor generics and biosimilars, impacting ABILIFY’s pricing and market share.

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How Do Market Trends Inform Future Growth?

1. Pharmacoeconomic & Value-Based Changes

Shift toward value-based care incentivizes the development of formulations with improved safety, adherence, and long-term outcomes.

2. Demographic and Epidemiological Drivers

Global schizophrenia prevalence (~1%) and rising mental health awareness sustain demand. Aging populations in developed markets further influence prescriptions.

3. Innovation and Pipeline Prospects

Focus Area	Candidate Drugs / Technologies	Expected Impact
Long-acting injectables	ABILIFY MAINTENA, newer depot formulations	Enhance adherence, expand patient base
Digital health solutions	Digital adherence tools	Improve treatment management, reduce relapse rates
Pharmacogenomics	Precision medicine approaches	Personalized therapy optimizing outcomes

4. Emerging Markets and Access

Growing healthcare infrastructure and awareness levels in Asia-Pacific, Africa, and Latin America represent significant growth opportunities.

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Comparison Table: ABILIFY vs. Leading Competitors

Feature	ABILIFY (Aripiprazole)	Risperdal (Risperidone)	Seroquel (Quetiapine)	Latuda (Lurasidone)
Approved Indications	Schizophrenia, Bipolar, MDD, Autism	Schizophrenia, Bipolar	Schizophrenia, MDD	Schizophrenia, Depression
Mechanism	Partial D2/5-HT1A agonist	D2, 5-HT2A antagonist	D2, 5-HT2A antagonist	5-HT2A antagonism
Patent Status	Expired (2017 US)	Expired (2013 US)	Patent expired (~2017)	Patented in 2013
Price (USD, 2022)	~$10 per 10mg (brand), generic ~$2	~$15 per 1mg	~$20 per 25mg	~$25 per 20mg
Side Effect Profile	Less weight gain, metabolic issues	Higher risk of weight gain	Sedation, metabolic risk	Metabolic neutrality

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Conclusion and Market Outlook

Key Takeaways

• Market Position: ABILIFY remains a key player, with annual revenues exceeding $4.5 billion globally, despite patent expirations and intensifying competition.

• Growth Drivers: Expanding indications (autism, depression), long-acting formulations, and emerging markets offer avenues for growth.

• Challenges: Patent cliffs, generic competition, downward price pressures, and evolving reimbursement policies require strategic adaptation.

• Investment Perspective: Sustained revenue relies on innovation in formulations, pipeline development, and capturing value in emerging markets.

• Regulatory and Policy Shifts: Active management of patent exclusivity strategies and compliance are critical for maintaining market share.

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FAQs

1. How has patent expiration affected ABILIFY’s market revenues?
Patent expiration in 2017 led to the entry of generics, causing a significant drop—up to 60-70%—in wholesale prices and affecting branded sales, which declined from a peak of over $7 billion in 2012 to below $4 billion in recent years.

2. What strategies are Otsuka/Bristol-Myers Squibb employing to sustain ABILIFY’s revenues?
Strategies include expanding authorized indications, launching extended-release formulations like ABILIFY MAINTENA, exploring digital adherence tools, and targeting emerging markets.

3. How significant are generics for ABILIFY's future?
Generics dominate the market post-patent expiry, limiting branded sales. However, innovating in formulations and indications can help sustain premium pricing segments.

4. What role does regulatory policy play in ABILIFY’s commercialization?
Regulations influence patent prolongation, approval of new formulations, pricing, and reimbursement. Active patent litigation and policy shifts in key markets impact long-term profitability.

5. What are the future prospects for ABILIFY in the context of competing therapies?
While facing competition from newer agents with improved safety and efficacy profiles, ABILIFY’s long-acting formulations and broader indications support sustained relevance, especially when combined with digital health strategies.

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References

[1] IQVIA. "Global Psychiatry Market Data," 2022.

[2] FDA. "Approval of Abilify (Aripiprazole)," 2002.

[3] European Medicines Agency. "Marketing Authorization for Abilify," 2003.

[4] Otsuka Pharmaceutical. "ABILIFY Development and Launch," 2020.

[5] Marketwatch. "Top-Selling Antipsychotics 2012-2022," 2022.

[6] Congressional Budget Office. "Impact of Patent Litigation on Pharmaceutical Innovation," 2018.

[7] NICE. "Guidance on Antipsychotic Use," 2015.