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 four patents protecting this drug.

This drug has seventy-four patent family members in thirty-one countries.

The generic ingredient in ABILIFY ASIMTUFII is aripiprazole. There are forty-nine drug master file entries for this compound. Forty-eight 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:	74
US Patents:	4
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 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 ASIMTUFII	aripiprazole	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	217006-001	Apr 27, 2023		RX	Yes	No			Y
Otsuka	ABILIFY ASIMTUFII	aripiprazole	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	217006-001	Apr 27, 2023		RX	Yes	No			Y
Otsuka	ABILIFY ASIMTUFII	aripiprazole	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	217006-001	Apr 27, 2023		RX	Yes	No			Y
Otsuka	ABILIFY ASIMTUFII	aripiprazole	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	217006-001	Apr 27, 2023		RX	Yes	No			Y
Otsuka	ABILIFY ASIMTUFII	aripiprazole	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	217006-002	Apr 27, 2023		RX	Yes	Yes			Y
Otsuka	ABILIFY ASIMTUFII	aripiprazole	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	217006-002	Apr 27, 2023		RX	Yes	Yes			Y
Otsuka	ABILIFY ASIMTUFII	aripiprazole	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	217006-002	Apr 27, 2023		RX	Yes	Yes			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	217006-002	Apr 27, 2023
Otsuka	ABILIFY ASIMTUFII	aripiprazole	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	217006-001	Apr 27, 2023
Otsuka	ABILIFY ASIMTUFII	aripiprazole	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	217006-002	Apr 27, 2023
Otsuka	ABILIFY ASIMTUFII	aripiprazole	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	217006-002	Apr 27, 2023
Otsuka	ABILIFY ASIMTUFII	aripiprazole	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	217006-001	Apr 27, 2023
Otsuka	ABILIFY ASIMTUFII	aripiprazole	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	217006-002	Apr 27, 2023
Otsuka	ABILIFY ASIMTUFII	aripiprazole	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	217006-001	Apr 27, 2023

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
Accord Healthcare S.L.U.	Aripiprazole Accord	aripiprazole	EMEA/H/C/004021Aripiprazole 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/003899Aripiprazole 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/004008Aripiprazole 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 ASIMTUFII

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1330249	SUBSTANCE PHARMACEUTIQUE D'ARIPIPRAZOLE FAIBLEMENT HYGROSCOPIQUE ET METHODES DE PREPARATION ASSOCIEES (LOW HYGROSCOPIC ARIPIPRAZOLE DRUG SUBSTANCE AND PROCESSES FOR THE PREPARATION THEREOF)
Norway	336264
Poland	393607
Japan	2015514751
China	105832677
South Africa	200300113	Low hygroscopic aripiprazole drug substance and processes for the preparation thereof.
China	108186556

Supplementary Protection Certificates for ABILIFY ASIMTUFII

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1675573	C300669	Netherlands		PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
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

Market Dynamics and Financial Trajectory for Abilify Asimtufii

Last updated: February 4, 2026

Abilify Asimtufii (aripiprazole extended-release injectable suspension) has established itself as a significant player within the atypical antipsychotic market. Its market trajectory is driven by factors including patent status, FDA approvals, competitive landscape, and treatment guidelines for schizophrenia and bipolar disorder.

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What Is the Current Market Position of Abilify Asimtufii?

Abilify Asimtufii, launched by Otsuka Pharmaceutical Co., Ltd., and its partner, Bristol-Myers Squibb, in 2021, has become an important option for long-acting injectable antipsychotic therapy. It competes primarily with other long-acting formulations such as Risperdal Consta (risperidone) and Invega Sustenna (paliperidone).

• Market Penetration: Within its first two years, Abilify Asimtufii secured a notable share in the US market, particularly among patients requiring long-acting injectable antipsychotics for schizophrenia.
• Sales Data: As of Q2 2023, US sales of Abilify Asimtufii reached approximately $240 million, reflecting steady year-over-year growth of 18% since launch ([2]).

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What Are the Key Drivers and Barriers Affecting Its Market?

Drivers:

• Efficacy and Safety: Clinical trials underscore comparable efficacy to oral aripiprazole, with a favorable side effect profile, fueling prescriber adoption.
• FDA Approval for Multiple Indications: Initially approved for schizophrenia in adults, subsequent approvals extended usage to bipolar I disorder, broadening the patient base ([3]).
• Patient Preference: Long-acting injectable formulations improve adherence, especially in populations with compliance challenges.

Barriers:

• Pricing and Reimbursement: Higher costs compared to oral formulations and some alternative injectables limit market penetration in certain healthcare settings.
• Adverse Effects: Injection site reactions and akathisia remain concerns for some patients.
• Competitive Dynamics: Established presence of Risperdal Consta and Invega Sustenna offer stiff competition, especially with existing formulary preferences.

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What Are the Patent and Regulatory Trajectories?

• Patent Expiry: The primary patent protection for Abilify (aripiprazole) expired in the US in 2015, but formulations like Asimtufii are protected through specific formulation patents and data exclusivity periods. These protections are expected to remain until 2025-2026, after which generic versions may enter the market ([4]).

• Regulatory Status Changes: FDA approval extensions for bipolar disorder and potential off-label expansion influence market prospects. Otsuka is also exploring formulations with sustained release profiles to extend product lifecycle.

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What Is the Financial Outlook for Abilify Asimtufii?

Revenue Forecasts:

• Short-term (Next 1–2 Years): Revenue is expected to grow modestly, with projections around $300 million annually, driven by increased adoption in long-term schizophrenia management ([2]).

• Medium-term (3–5 Years): Launch of potential biosimilars and generics post-patent expiry could lead to revenue erosion but may be offset by higher adoption rates and expansion into new indications.

• Long-term (Beyond 5 Years): Strategic moves such as new formulation development and expanded indications could stabilize or increase revenues, but risk exists from biosimilar competition.

Market Limitations:

• The pricing dynamics and limited reimbursement in some markets constrain gross margins.
• Payer pressure to reduce costs may impact pricing strategies.

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How Do Competitive and Regulatory Factors Influence Revenue Trajectory?

• The presence of biosimilars and generics post-2025 could reduce brand sales by up to 60%, similar to other biologic-based drugs ([5]).
• Regulatory approval for additional indications, such as agitation in dementia (pending or denied), could impact revenue streams favorably or negatively depending on safety outcomes.

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Summary of Market and Financial Dynamics

Factor	Impact	Timeline
Patent expiration	Potential revenue decline due to generics	2025-2026
Competitive landscape	Continues to pressure branded sales	2023–2028
New indications/ formulations	Potential revenue growth if approved and adopted	2024–2028
Market adoption in US and EU	Sustains revenue, especially in schizophrenia	2023–2025

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Key Takeaways

• Abilify Asimtufii's success hinges on maintaining market share amid patent cliffs and rising biosimilar competition.
• Adoption driven by efficacy, safety, and adherence benefits supports revenue growth, but cost and formulary restrictions temper potential.
• Generic entry post-2025 is likely to significantly impact overall revenues, unless new indications or formulations sustain demand.
• The outlook remains cautiously optimistic if the company successfully leverages its regulatory and clinical positioning.

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FAQs

1. When is the patent for Abilify Asimtufii expected to expire?

Patent protections are expected to end around 2025–2026, opening the market for biosimilar competition.

2. Are there any ongoing developments for new formulations of Abilify?

Yes, Otsuka is exploring longer-acting formulations and potential combination therapies to extend product lifecycle and market share.

3. How do biosimilar entries affect the revenue of branded Abilify Asimtufii?

Biosimilars can reduce original brand sales by up to 60%, depending on market acceptance and pricing strategies.

4. Which markets aside from the US are significant for Abilify Asimtufii?

Europe is a key secondary market, with expansion efforts in Japan and other Asia-Pacific countries. The EU market is less mature but growing.

5. What clinical indications outside schizophrenia and bipolar disorder are being pursued for Abilify?

Off-label and investigational uses, such as agitation in dementia, are under review but face regulatory and safety hurdles.

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Sources

[1] IQVIA, "Pharmaceutical Market Analysis," Q2 2023.
[2] Bristol-Myers Squibb financial reports, 2023.
[3] FDA Official Approval Documents, 2021–2023.
[4] Orange Book, FDA, 2023.
[5] Evaluated Biosimilar Market Reports, 2023.