ABILIFY ASIMTUFII Drug Patent Profile

When do Abilify Asimtufii patents expire, 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 sixty-eight 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. Forty-nine 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:	268
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			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

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
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

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/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 ASIMTUFII

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

Country	Patent Number	Title	Estimated Expiration
Israel	234770
Norway	20081631
Chile	2010000405
Mexico	2014012811

Supplementary Protection Certificates for ABILIFY ASIMTUFII

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1675573	92427	Luxembourg		PRODUCT NAME: ARIPIPRAZOLE
1675573	C300669	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	300669	Netherlands		PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115

Market Dynamics and Financial Trajectory for ABILIFY ASIMTUFII

Introduction to ABILIFY ASIMTUFII

ABILIFY ASIMTUFII, developed by Otsuka Pharmaceuticals in partnership with Lundbeck, is a significant advancement in the treatment of schizophrenia and bipolar I disorder. This longer-acting injectable formulation of aripiprazole has been approved by the FDA as of April 2023 and is set to play a crucial role in Otsuka's strategy to mitigate the impact of the impending patent expiry of its predecessor, ABILIFY MAINTENA.

The Impact of Patent Expiry on ABILIFY MAINTENA

ABILIFY MAINTENA, a once-monthly intramuscular injection for schizophrenia, is scheduled to lose its market exclusivity in the U.S. and Europe in October 2024. This loss of exclusivity is expected to lead to a significant decline in sales, with GlobalData estimating a 12% drop from 2024 to 2025 and a continued plummet to around $459 million by 2029[1][5].

The Role of ABILIFY ASIMTUFII in Mitigating Sales Decline

To counteract the anticipated decline in ABILIFY MAINTENA sales, Otsuka has developed ABILIFY ASIMTUFII. This new formulation is administered once every two months, offering a more convenient treatment option for patients. The FDA approval of ABILIFY ASIMTUFII was supported by the pivotal 031-201-00181 study, which demonstrated that the 960-mg dose of ABILIFY ASIMTUFII achieved similar plasma levels of aripiprazole as ABILIFY MAINTENA, with a similar safety profile[1].

Market Positioning and Competitive Advantage

ABILIFY ASIMTUFII is positioned to maintain Otsuka's market presence in the antipsychotic sector. The longer-acting formulation provides a competitive edge over generic versions of ABILIFY MAINTENA that will enter the market post-patent expiry. This strategic move by Otsuka aims to ensure sustained growth in mental health solutions despite the challenges posed by patent expirations[1].

Financial Implications

The financial trajectory for ABILIFY ASIMTUFII is closely tied to its ability to offset the declining revenues from ABILIFY MAINTENA. With ABILIFY MAINTENA's annual revenues expected to drop below $1 billion by 2027 or 2028 and further to around $700,000 by 2029, ABILIFY ASIMTUFII is crucial for stabilizing Otsuka's revenue streams[1].

Revenue Projections

• Short-Term Impact: The immediate financial impact will be observed as ABILIFY ASIMTUFII starts to generate revenue, potentially softening the blow of ABILIFY MAINTENA's patent expiry.
• Long-Term Growth: Over the long term, ABILIFY ASIMTUFII is expected to contribute significantly to Otsuka's revenue, especially as it gains market acceptance and preference due to its convenience and efficacy.

Cost and Insurance Considerations

For patients, the cost of ABILIFY ASIMTUFII is a critical factor. Eligible patients may benefit from savings programs that reduce the cost to as little as $5 per fill, with an annual maximum benefit of $8,000 and a monthly maximum benefit tied to the wholesale acquisition cost plus dispensing fees[2].

Strategic Partnerships and Portfolio Diversification

Otsuka's partnership with Lundbeck extends beyond ABILIFY ASIMTUFII. Another key asset, Rexulti (brexpiprazole), approved for major depressive disorder, schizophrenia, and agitation associated with dementia in Alzheimer’s disease patients, also plays a role in diversifying Otsuka's revenue streams. Although Otsuka's investigational two-drug combo, AVP-786, failed its Phase III trial, the company remains committed to exploring new therapeutic options[1].

Market Transformation and Accessibility

The introduction of generics following the patent expiry of ABILIFY MAINTENA will transform the injectable antipsychotic market. While this will lead to increased competition and lower prices, it also means greater accessibility of the drug to a larger patient population. ABILIFY ASIMTUFII, with its longer-acting formulation, will continue to offer a premium option within this market[5].

Industry Expert Insights

Eleni Tokali, a pharma analyst at GlobalData, highlighted Otsuka's adaptability in the face of patent expirations and the robust pathway for sustained growth in mental health solutions through new formulations like ABILIFY ASIMTUFII[1].

Financial Performance of Otsuka and Lundbeck

In the first nine months of 2023, Lundbeck reported a significant increase in revenue, driven by strong performance across strategic brands, including ABILIFY MAINTENA and ASIMTUFII. The revenue from these products grew by 10% compared to the same period in 2022[3].

Key Financial Metrics

• Revenue Growth: The combined revenue from ABILIFY MAINTENA and ASIMTUFII showed a 10% increase in the first nine months of 2023.
• Gross Profit: Lundbeck's gross profit increased by 8% during the same period, reflecting the positive impact of these strategic brands.

Conclusion

The market dynamics and financial trajectory for ABILIFY ASIMTUFII are intricately linked to the patent expiry of ABILIFY MAINTENA and Otsuka's strategic efforts to maintain its market position. With its longer-acting formulation and strategic partnerships, ABILIFY ASIMTUFII is poised to play a critical role in sustaining Otsuka's revenue streams and ensuring continued growth in the mental health sector.

Key Takeaways

• Patent Expiry Impact: ABILIFY MAINTENA's patent expiry in October 2024 will lead to a significant decline in sales.
• ABILIFY ASIMTUFII's Role: The new formulation will help mitigate this decline and maintain Otsuka's market presence.
• Financial Projections: ABILIFY ASIMTUFII is expected to contribute significantly to Otsuka's revenue, offsetting the decline from ABILIFY MAINTENA.
• Market Transformation: The introduction of generics and ABILIFY ASIMTUFII will transform the injectable antipsychotic market, enhancing accessibility and competition.
• Strategic Partnerships: Otsuka's partnership with Lundbeck and other assets like Rexulti will diversify revenue streams.

FAQs

Q: What is the expected impact of ABILIFY MAINTENA's patent expiry on Otsuka's sales? A: The patent expiry is expected to lead to a 12% decline in sales from 2024 to 2025, with sales plummeting further to around $459 million by 2029[1][5].

Q: How does ABILIFY ASIMTUFII differ from ABILIFY MAINTENA? A: ABILIFY ASIMTUFII is a longer-acting injectable formulation, administered once every two months, compared to the once-monthly administration of ABILIFY MAINTENA[1].

Q: What are the cost and insurance considerations for ABILIFY ASIMTUFII? A: Eligible patients may pay as little as $5 per fill, with an annual maximum benefit of $8,000 and a monthly maximum benefit tied to the wholesale acquisition cost plus dispensing fees[2].

Q: How is Otsuka diversifying its revenue streams beyond ABILIFY ASIMTUFII? A: Otsuka is diversifying its revenue streams through other assets like Rexulti (brexpiprazole) and exploring new therapeutic options despite the failure of AVP-786 in its Phase III trial[1].

Q: What is the expected impact of generics on the market for injectable antipsychotics? A: The introduction of generics will increase competition and lower prices, making the drug more accessible to a larger patient population, while ABILIFY ASIMTUFII will offer a premium option with its longer-acting formulation[5].

Sources

1. Biospace: Otsuka's Longer-Acting Schizophrenia Injection to Offset Abilify Maintena’s Loss of Exclusivity[1].
2. Otsuka Pharmaceuticals: Cost & Insurance | ABILIFY ASIMTUFII® (aripiprazole)[2].
3. Lundbeck: Q3 2023 Corporate Release[3].
4. Minnesota Department of Human Services: Aristada / Minnesota Department of Human Services[4].
5. Pharmaceutical Technology: Otsuka's Abilify Maintena: dual drug expiry signals sales decline[5].