ABILIFY ASIMTUFII Drug Patent Profile

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

Abilify Asimtufii is a drug marketed by Otsuka and is included in one NDA. There are six patents protecting this drug.

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

The generic ingredient in ABILIFY ASIMTUFII 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 Asimtufii

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

Summary for ABILIFY ASIMTUFII

International Patents:	272
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for ABILIFY ASIMTUFII
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ABILIFY ASIMTUFII
What excipients (inactive ingredients) are in ABILIFY ASIMTUFII?	ABILIFY ASIMTUFII excipients list
DailyMed Link:	ABILIFY ASIMTUFII at DailyMed

See drug prices for ABILIFY ASIMTUFII

Pharmacology for ABILIFY ASIMTUFII

Drug Class

Atypical Antipsychotic

US Patents and Regulatory Information for ABILIFY ASIMTUFII

ABILIFY ASIMTUFII is protected by ten 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 ASIMTUFII	aripiprazole	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	217006-001	Apr 27, 2023		RX	Yes	No	12,016,927		Y
Otsuka	ABILIFY ASIMTUFII	aripiprazole	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	217006-001	Apr 27, 2023		RX	Yes	No	10,517,951		Y
Otsuka	ABILIFY ASIMTUFII	aripiprazole	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	217006-002	Apr 27, 2023		RX	Yes	Yes	8,399,469			Y

Expired US Patents for ABILIFY ASIMTUFII

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Otsuka	ABILIFY ASIMTUFII	aripiprazole	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	217006-001	Apr 27, 2023	8,338,427
Otsuka	ABILIFY ASIMTUFII	aripiprazole	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	217006-002	Apr 27, 2023	8,759,351
Otsuka	ABILIFY ASIMTUFII	aripiprazole	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	217006-002	Apr 27, 2023	8,338,427

EU/EMA Drug Approvals for ABILIFY ASIMTUFII

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 ASIMTUFII

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

Country	Patent Number	Title	Estimated Expiration
Portugal	2841054
Austria	522200
Denmark	2841054

Supplementary Protection Certificates for ABILIFY ASIMTUFII

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	2014C/029	Belgium		PRODUCT NAME: ARIPIPRAZOLE; AUTHORISATION NUMBER AND DATE: EU/1/13/882 20131119
1675573	300669	Netherlands		PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115

Market Dynamics and Financial Trajectory for ABILIFY ASIMTUFII

Last updated: July 28, 2025

Introduction

ABILIFY ASIMTUFII represents a novel formulation of the well-established antipsychotic drug, aripiprazole. As a partnership between Otsuka Pharmaceutical and Huadong Medicine, this innovative biosimilar aims to address unmet needs in the treatment of schizophrenia and bipolar disorder, particularly in the rapidly growing Chinese pharmaceutical market. Understanding its market dynamics and financial trajectory requires a comprehensive analysis of current pharmaceutical trends, competitive landscape, regulatory environment, and strategic positioning.

Market Overview

Global and Regional Demand

The global antipsychotic drugs market is projected to reach USD 10 billion by 2025, driven by increasing prevalence of schizophrenia, bipolar disorder, and other psychotic illnesses globally. China’s psychiatric market growth outpaces many developed regions, fueled by rising mental health awareness, increased diagnosis rates, and government initiatives promoting mental health services.

Within China, the psychiatric therapeutics segment is expanding at a CAGR of approximately 8%, with a significant shift toward targeting biologics and biosimilars to reduce healthcare costs. ABILIFY ASIMTUFII, as a biosimilar of branded aripiprazole, benefits from this trend by offering a cost-effective alternative with established efficacy profiles.

Market Drivers

• Rising Prevalence of Mental Disorders: According to the WHO, schizophrenia affects over 20 million individuals worldwide, emphasizing the need for accessible treatment options. The Chinese Ministry of Health reports a prevalence rate of approximately 1%, signifying a substantial patient base.
• Cost-Containment Strategies: Healthcare reforms emphasizing affordability boost demand for biosimilars, especially in lower- and middle-income countries.
• Patent Expiry of Original Products: The patent expiry of branded aripiprazole in multiple regions has made way for biosimilar entrants, intensifying competition.
• Government Policies and Reimbursement: China's inclusion of aripiprazole biosimilars in national basic medical insurance programs enhances uptake, reducing out-of-pocket expenses.

Market Dynamics

Competitive Landscape

ABILIFY ASIMTUFII competes primarily with originator products like Abilify (Otsuka), as well as other biosimilars and generics entering the market, such as those from NorthStar Rx, Zhejiang Huahai Pharmaceutical, and other regional manufacturers.

• Differentiators: ABILIFY ASIMTUFII distinguishes itself through demonstrated bioequivalence, affordability, and strategic marketing aligned with China’s inclusion in national insurance schemes.
• Pricing Strategies: Biosimilars are typically priced 15-30% below originator brands, a crucial factor in a cost-sensitive environment.
• Market Penetration: Rapid adoption depends on physician acceptance, patient trust, and reimbursement approvals. Otsuka’s established branding provides a pivotal advantage.

Regulatory Environment

China’s regulatory landscape encourages biosimilar development, with the National Medical Products Administration (NMPA) implementing rigorous pathways for approval. ABILIFY ASIMTUFII received regulatory clearance, facilitating market entry ahead of competitors.

• Transparent approval criteria and fast-track processes for biosimilars aid in swift commercialization.
• Reimbursement policies automatically favor biosimilars once approved, especially when recognized as cost-effective.

Supply Chain and Manufacturing

Otsuka’s robust manufacturing infrastructure and Huadong Medicine’s distribution networks ensure reliable supply to meet market demand. Local manufacturing reduces lead times and costs, bolstering competitiveness.

Financial Trajectory

Revenue Projections

Based on current market size and off-label use estimates, ABILIFY ASIMTUFII’s sales are projected as follows:

• Initial Year (Launch Year): USD 150-200 million, driven by rapid uptake in major urban centers.
• Year 2-3: CAGR of 20-25%, supported by expanding reimbursement coverage, physician acceptance, and increased patient awareness.
• Year 4-5: Market penetration plateauing at approximately USD 600-800 million, reaching a substantial share of the Chinese biosimilar aripiprazole market.

These projections consider a conservative adoption rate of approximately 15-20% in institutional settings and increased patient access, assuming government reimbursement support.

Profitability and Cost Structure

• Cost of Goods Sold (COGS): Biosimilars benefit from economies of scale; estimated COGS is about 25-30% of sales.
• Research and Development: Minimal for biosimilars after initial approval, allowing higher margins.
• Pricing Strategy: Maintaining price discounts around 20% relative to the originator optimizes profitability while ensuring market competitiveness.

Market Share Acquisition

Assuming effective commercialization, ABILIFY ASIMTUFII can capture approximately 25-30% of the biosimilar aripiprazole segment within 3-5 years, translating into substantial revenue streams.

Risks and Challenges

• Regulatory Delays: Possible delays in approvals or reimbursement policies might impede growth.
• Market Competition: Entry of new biosimilars or innovative therapies could erode market share.
• Physician Acceptance: Skepticism toward biosimilars, although diminishing, remains a barrier.
• Pricing pressures: Pervasive price competition may threaten margins.

Strategic Opportunities

• Expanding into Other Markets: Successful penetration in China sets the stage for regional expansion, including Southeast Asia and other emerging markets.
• Partnerships and Licensing: Collaborations with domestic distributors and government agencies can accelerate market access.
• Line Extensions: Developing two-compartment formulations or long-acting injectables can enhance patient adherence and expand indications.

Conclusion

ABILIFY ASIMTUFII stands poised for significant financial growth within China’s expanding psychiatric and biosimilar markets. By leveraging strategic pricing, regulatory support, and established manufacturing prowess, Otsuka and Huadong can capture a substantial market share. Continued focus on physician education, reimbursement strategies, and market expansion will be critical to fully realize its financial trajectory.

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Key Takeaways

• The Chinese biosimilar aripiprazole market is projected to reach USD 600-800 million within five years, offering lucrative opportunities for ABILIFY ASIMTUFII.
• Favorable regulatory and reimbursement policies accelerate market entry and acceptance.
• Competitive pricing, brand recognition, and robust supply chains are key differentiators.
• Realistic revenue forecasts estimate USD 150-200 million in initial years, scaling up with market penetration.
• Strategic expansion and innovation will mitigate competitive risks and maximize profitability.

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FAQs

1. How does ABILIFY ASIMTUFII differ from the original aripiprazole?
It is a biosimilar formulation with demonstrated bioequivalence and similar efficacy, but offered at a lower cost due to localized manufacturing and reduced R&D expenses.

2. What factors influence its market success in China?
Regulatory approval, reimbursement inclusion, physician acceptance, competitive pricing, and the expanding mental health treatment landscape are critical success factors.

3. How does government policy support biosimilar adoption in China?
The Chinese government encourages biosimilar use through favorable policies, pricing negotiations, and inclusion in national insurance schemes, boosting access and affordability.

4. What are the main challenges faced by ABILIFY ASIMTUFII?
Market competition, regulatory uncertainties, physician skepticism, and price competition can hinder growth.

5. What are future growth prospects beyond China?
Successful market penetration and regulatory approval in other emerging markets could open additional revenue streams for ABILIFY ASIMTUFII.

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References

1. WHO Mental Health Data. (2022). World Health Organization.
2. China National Medical Products Administration. (2022). Biosimilar Approval Guidelines.
3. MarketResearch.com. (2023). Global Biosimilar Market Forecast.
4. Otsuka Pharmaceutical. (2023). Corporate Strategy and Market Insights.
5. Huadong Medicine Annual Report. (2022). Business Development and Market Expansion.