ABILIFY MAINTENA KIT Drug Patent Profile

When do Abilify Maintena Kit patents expire, and when can generic versions of Abilify Maintena Kit launch?

Abilify Maintena Kit is a drug marketed by Otsuka Pharm Co Ltd and is included in one NDA. There are eleven patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and eighty-six patent family members in forty-one countries.

The generic ingredient in ABILIFY MAINTENA KIT 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 Maintena Kit

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

Summary for ABILIFY MAINTENA KIT

International Patents:	286
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	163
Clinical Trials:	9
Patent Applications:	4,170
Drug Prices:	Drug price information for ABILIFY MAINTENA KIT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ABILIFY MAINTENA KIT
DailyMed Link:	ABILIFY MAINTENA KIT at DailyMed

See drug prices for ABILIFY MAINTENA KIT

Recent Clinical Trials for ABILIFY MAINTENA KIT

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

Sponsor	Phase
Otsuka Beijing Research Institute	Phase 1
Otsuka Pharmaceutical Co., Ltd.	Phase 4
Chonbuk National University Hospital	Phase 4

See all ABILIFY MAINTENA KIT clinical trials

Paragraph IV (Patent) Challenges for ABILIFY MAINTENA KIT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ABILIFY MAINTENA KIT	Extended-release Injectable Suspension	aripiprazole	300 mg/vial and 400 mg/vial	202971	1	2021-12-20

US Patents and Regulatory Information for ABILIFY MAINTENA KIT

ABILIFY MAINTENA KIT is protected by twenty-two 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	202971-004	Sep 29, 2014		RX	Yes	No	8,338,427		Y
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-003	Sep 29, 2014		RX	Yes	No	8,722,679		Y
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-004	Sep 29, 2014		RX	Yes	No	8,722,679		Y
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-002	Feb 28, 2013		RX	Yes	Yes	11,154,553
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-002	Feb 28, 2013		RX	Yes	Yes	8,030,313
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-004	Sep 29, 2014		RX	Yes	No	11,648,347		Y
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-001	Feb 28, 2013		RX	Yes	No	8,030,313

Expired US Patents for ABILIFY MAINTENA KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-003	Sep 29, 2014	8,759,351
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-002	Feb 28, 2013	8,759,351
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-003	Sep 29, 2014	8,030,313
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-003	Sep 29, 2014	9,089,567
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-004	Sep 29, 2014	8,993,761
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-002	Feb 28, 2013	8,338,428
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-004	Sep 29, 2014	8,030,313

EU/EMA Drug Approvals for ABILIFY MAINTENA KIT

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
Zentiva, k.s.	Aripiprazole Zentiva	aripiprazole	EMEA/H/C/003899 Aripiprazole 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/004008 Aripiprazole 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 MAINTENA KIT

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

Country	Patent Number	Title	Estimated Expiration
Israel	225902
China	105832677
Slovenia	1927355
Hong Kong	1203059
Canada	2713466	SUBSTANCE PHARMACEUTIQUE D'ARIPIPRAZOLE FAIBLEMENT HYGROSCOPIQUE ET METHODES DE PREPARATION ASSOCIEES (LOW HYGROSCOPIC ARIPIPRAZOLE DRUG SUBSTANCE AND PROCESSES FOR THE PREPARATION THEREOF)
China	102579446
China	101423493

Supplementary Protection Certificates for ABILIFY MAINTENA KIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1675573	C20140014 00322	Estonia		PRODUCT NAME: ARIPIPRASOOL;REG NO/DATE: K(2013)8163 (LOPLIK) 19.11.2013
1675573	2014C/029	Belgium		PRODUCT NAME: ARIPIPRAZOLE; AUTHORISATION NUMBER AND DATE: EU/1/13/882 20131119
1675573	PA2014020	Lithuania		PRODUCT NAME: ARIPIPRAZOLUM; REGISTRATION NO/DATE: EU/1/13/882 20131115
1675573	122014000057	Germany		PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882 20131115
0367141	300161	Netherlands		300161, 20091027, EXPIRES: 20141026
1675573	CA 2014 00026	Denmark		PRODUCT NAME: ARIPIPRAZOL; REG. NO/DATE: EU/1/13/882/001-004 20131119
0367141	C00367141/01	Switzerland		FORMER REPRESENTATIVE: BOHEST AG, CH

ABILIFY MAINTENA KIT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Abilify Maintena Kit

Introduction

Abilify Maintena, an atypical antipsychotic medication developed by Otsuka Pharmaceutical, has been a cornerstone in the treatment of schizophrenia and bipolar I disorder since its approval in 2013. However, the drug is on the cusp of a significant market shift due to the impending loss of its market exclusivity.

Market Exclusivity and Patent Expiry

The dual patent expiry of Abilify Maintena in the US and Europe, set to occur in October 2024, marks a critical juncture for Otsuka Pharmaceutical. This event is expected to have a profound impact on the drug's sales trajectory and the company's overall financial performance[1][4][5].

Impact on Sales

GlobalData estimates that the loss of market exclusivity will result in a 12% reduction in Abilify Maintena's sales from 2024 to 2025. This decline is projected to continue, with sales expected to plummet through 2029. By 2027 or 2028, the annual revenues for Abilify Maintena are likely to drop below $1 billion, and by 2029, they may dip to around $700,000[1][4][5].

Compound Annual Growth Rate (CAGR)

The compound annual growth rate (CAGR) for Abilify Maintena's global sales is projected to be a negative 21% from 2024 to 2029. This significant decline underscores the challenges Otsuka will face in maintaining its revenue streams from this drug[5].

Regional Impact

The US market, which has historically contributed 49% of Abilify Maintena's total revenue from 2013 to 2023, will be particularly affected by the patent expiry. The loss of exclusivity in this key market will lead to increased competition and lower prices, further exacerbating the sales decline[4][5].

New Formulations as a Mitigation Strategy

To offset the expected decline in sales, Otsuka has developed new formulations of its schizophrenia therapy. The most notable is Abilify Asimtufii, a longer-acting injectable that only needs to be administered once every two months. Approved by the FDA in April 2023, Abilify Asimtufii is expected to help buttress Otsuka's revenues[1][4].

Abilify Asimtufii: A Longer-Acting Alternative

Abilify Asimtufii, developed in partnership with Lundbeck, offers several advantages over Abilify Maintena. It achieves similar plasma levels of aripiprazole with a less frequent dosing regimen, which could enhance patient compliance and convenience. The safety profiles of both formulations are largely similar, with Abilify Asimtufii being well-tolerated even at multiple doses[1][4].

Financial Performance and Revenue Streams

Despite the challenges posed by the patent expiry, Otsuka's financial performance remains robust. The company's revenue from Abilify Maintena and Abilify Asimtufii combined showed a growth of 8% in 2023, driven by higher sales. However, the long-term financial trajectory will depend on how effectively Otsuka can transition patients to the new formulation and maintain market share[2].

Diversification of Revenue Streams

Otsuka is also diversifying its revenue streams through other products, such as Rexulti (brexpiprazole), which is approved for major depressive disorder, schizophrenia, and agitation associated with dementia in Alzheimer’s disease patients. Although the company faced a setback with the failure of its investigational two-drug combo AVP-786 in a Phase III trial, it continues to explore new avenues for growth[1].

Market Innovation and Patient Care

Otsuka's strategic initiatives, particularly in the development of new formulations like Abilify Asimtufii, reflect the company's commitment to market innovation and patient care. These efforts are designed to ensure sustained growth in mental health solutions despite the challenges posed by patent expirations.

Accessibility and Market Impact

While the patent expiry of Abilify Maintena is expected to negatively impact Otsuka's sales, it can also translate to a positive outcome for the wider market. Increased competition and lower prices will make the drug more accessible to a larger patient population, which is a significant benefit in the context of mental health care[4].

Challenges in Lifecycle Management

The pharmaceutical industry is inherently subject to lifecycle management challenges, particularly when patents expire. Otsuka's adaptability in developing new formulations highlights the company's readiness to face these challenges and ensure continued growth.

Expert Insights

Eleni Tokali, a pharma analyst at GlobalData, noted: "The upcoming patent expiry of Abilify Maintena is a critical moment for Otsuka, highlighting the challenges inherent in the pharmaceutical industry’s lifecycle management. The company’s adaptability in the face of patent expirations with new formulations showcases a robust pathway for sustained growth in mental health solutions."[1][4]

Safety and Efficacy of Abilify Maintena

Abilify Maintena has a well-documented safety profile, with common adverse reactions including increased weight, akathisia, injection site pain, and sedation. The safety data from clinical trials indicate that these reactions are generally manageable and do not significantly differ from those observed with the new formulation, Abilify Asimtufii[3].

Conclusion

The loss of market exclusivity for Abilify Maintena in October 2024 marks a significant turning point for Otsuka Pharmaceutical. While this event is expected to lead to a decline in sales, the company's proactive development of new formulations, such as Abilify Asimtufii, positions it well for sustained growth in the mental health sector.

Key Takeaways

• Patent Expiry Impact: Abilify Maintena's sales are expected to decline by 12% from 2024 to 2025 and continue to plummet through 2029.
• New Formulations: Abilify Asimtufii, a longer-acting injectable, is set to mitigate the sales decline.
• Market Accessibility: The patent expiry will make the drug more accessible to a larger patient population due to increased competition and lower prices.
• Financial Performance: Otsuka's revenue streams are diversifying, with growth seen in 2023 despite the impending patent expiry.
• Lifecycle Management: Otsuka's adaptability in developing new formulations showcases its readiness to face lifecycle management challenges.

FAQs

Q: What is the expected impact of the patent expiry on Abilify Maintena's sales?

A: The patent expiry is expected to result in a 12% reduction in sales from 2024 to 2025, with sales projected to continue declining through 2029.

Q: How is Otsuka mitigating the impact of the patent expiry?

A: Otsuka has developed a new formulation, Abilify Asimtufii, which is a longer-acting injectable administered once every two months.

Q: What are the common adverse reactions associated with Abilify Maintena?

A: Common adverse reactions include increased weight, akathisia, injection site pain, and sedation.

Q: How does Abilify Asimtufii compare to Abilify Maintena in terms of safety and efficacy?

A: Abilify Asimtufii has a similar safety profile to Abilify Maintena and achieves similar plasma levels of aripiprazole with less frequent dosing.

Q: What is the significance of the US market for Abilify Maintena?

A: The US market has historically contributed 49% of Abilify Maintena's total revenue from 2013 to 2023, making it a crucial market for the drug.

Sources

1. Biospace: Otsuka's Longer-Acting Schizophrenia Injection to Offset Abilify Maintena’s Loss of Exclusivity[1].
2. Lundbeck: Q4 2023 Corporate Release[2].
3. FDA: ABILIFY MAINTENA (aripiprazole) for extended-release injectable suspension[3].
4. GlobalData: Otsuka's new formulations to offset Abilify Maintena dual patent expiry impact[4].
5. Pharmaceutical Technology: Otsuka's Abilify Maintena: dual drug expiry signals sales decline[5].