ARISTADA INITIO KIT Drug Patent Profile

Which patents cover Aristada Initio Kit, and what generic alternatives are available?

Aristada Initio Kit is a drug marketed by Alkermes Inc and is included in one NDA. There are eight patents protecting this drug.

This drug has one hundred patent family members in twenty-eight countries.

The generic ingredient in ARISTADA INITIO KIT is aripiprazole lauroxil. There are forty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the aripiprazole lauroxil profile page.

DrugPatentWatch^® Generic Entry Outlook for Aristada Initio Kit

Aristada Initio Kit was eligible for patent challenges on October 5, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 8, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ARISTADA INITIO KIT

International Patents:	100
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
DailyMed Link:	ARISTADA INITIO KIT at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ARISTADA INITIO KIT

NDA:

209830

Dosage:

SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ARISTADA INITIO KIT

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

Sponsor	Phase
Alkermes, Inc.	Phase 4
University of California, Los Angeles	Phase 4
Alkermes, Inc.	Phase 3

See all ARISTADA INITIO KIT clinical trials

Pharmacology for ARISTADA INITIO KIT

Drug Class

Atypical Antipsychotic

US Patents and Regulatory Information for ARISTADA INITIO KIT

ARISTADA INITIO KIT is protected by eight US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alkermes Inc	ARISTADA INITIO KIT	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	209830-001	Jun 29, 2018		RX	Yes	Yes
Alkermes Inc	ARISTADA INITIO KIT	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	209830-001	Jun 29, 2018		RX	Yes	Yes			Y
Alkermes Inc	ARISTADA INITIO KIT	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	209830-001	Jun 29, 2018		RX	Yes	Yes
Alkermes Inc	ARISTADA INITIO KIT	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	209830-001	Jun 29, 2018		RX	Yes	Yes			Y
Alkermes Inc	ARISTADA INITIO KIT	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	209830-001	Jun 29, 2018		RX	Yes	Yes				Y

International Patents for ARISTADA INITIO KIT

When does loss-of-exclusivity occur for ARISTADA INITIO KIT?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

Hungary

Israel

Japan

Lithuania

Mexico

New Zealand

Poland

Portugal

Russian Federation

Serbia

Slovenia

Spain

Turkey

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ARISTADA INITIO KIT around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	077239
Argentina	109699	PRODROGAS DE COMPUESTOS CON NH ÁCIDOS
Japan	2020007316
Japan	7042239
China	112641785

Supplementary Protection Certificates for ARISTADA INITIO KIT

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

Introduction

ARISTADA INITIO, a long-acting injectable atypical antipsychotic, has been a significant addition to the treatment paradigm for schizophrenia. Developed by Alkermes plc, this medication has carved out a niche in the market due to its unique initiation regimen and pharmacokinetic profile. Here, we delve into the market dynamics and financial trajectory of ARISTADA INITIO KIT.

Approval and Launch

The FDA approved ARISTADA INITIO in July 2018, marking a pivotal moment in the treatment of schizophrenia. This approval allowed for the initiation of ARISTADA on day one, providing a rapid and effective treatment option for patients[4].

Pharmacokinetic Profile

ARISTADA INITIO leverages Alkermes' proprietary NanoCrystal technology, enabling faster dissolution and achieving relevant levels of aripiprazole within four days of initiation. This is crucial for ensuring that patients have adequate medication levels from the outset, enhancing the continuity of care[4].

Market Positioning

ARISTADA INITIO is part of a broader portfolio of schizophrenia treatments offered by Alkermes. Its ability to be initiated on the same day as the first ARISTADA dose, or up to 10 days thereafter, offers flexibility and convenience for healthcare providers. This flexibility is particularly valuable in hospital settings, where more than one-third of patients initiate long-acting therapies[4].

Financial Performance

Quarterly and Annual Sales

The financial performance of ARISTADA has been robust. In the fourth quarter of 2022, net sales of ARISTADA were $79.2 million, representing a slight increase from the previous year. For the full year 2022, net sales of ARISTADA reached $302.1 million, a 10% increase from the prior year[2].

In 2023, the net sales of ARISTADA continued to grow, reaching $327.7 million, which is an 8.5% increase from 2022. This growth indicates a strong market presence and increasing adoption of the medication[5].

Revenue Projections

For 2024, Alkermes has projected net sales of ARISTADA to be between $340 million and $360 million, reflecting continued confidence in the product's market performance[5].

Market Growth Drivers

Increasing Adoption

The approval of ARISTADA INITIO has significantly enhanced the adoption of ARISTADA. The ability to initiate treatment on day one has been particularly appealing in hospital settings, where timely and effective treatment is critical[4].

Competitive Advantage

ARISTADA INITIO is the first and only long-acting atypical antipsychotic that can be initiated on day one, providing a unique competitive advantage. This differentiation has helped Alkermes to expand its market share in the schizophrenia treatment segment[4].

Clinical Efficacy

The ALPINE post-marketing study demonstrated the efficacy and safety of the ARISTADA INITIO regimen and the 2-month dose of ARISTADA. The study showed significant reductions in PANSS (Positive and Negative Syndrome Scale) total scores, indicating improved clinical outcomes for patients[1].

Challenges and Opportunities

Regulatory Environment

While the FDA approval of ARISTADA INITIO was a significant milestone, ongoing regulatory scrutiny and potential changes in healthcare policies can impact market dynamics. However, Alkermes' commitment to innovation and addressing real-world needs of patients has helped navigate these challenges[4].

Market Competition

The schizophrenia treatment market is competitive, with several other long-acting injectable antipsychotics available. However, ARISTADA INITIO's unique initiation regimen and pharmacokinetic profile have helped it stand out in this crowded market[4].

Financial Impact on Alkermes

Revenue Contribution

ARISTADA, including ARISTADA INITIO, has become a significant contributor to Alkermes' revenue. The growth in ARISTADA sales has helped drive overall revenue increases for the company, contributing to its financial stability and growth[5].

Operating Expenses

While the revenue from ARISTADA has been increasing, Alkermes has also managed its operating expenses effectively. The company has seen a balance between research and development expenses, selling and general administrative costs, and other operational expenditures, ensuring sustainable financial performance[5].

Key Takeaways

• Approval and Launch: ARISTADA INITIO was approved by the FDA in July 2018, allowing for day-one initiation of ARISTADA.
• Pharmacokinetic Profile: The medication achieves relevant levels of aripiprazole within four days using NanoCrystal technology.
• Financial Performance: Net sales of ARISTADA have shown consistent growth, with $327.7 million in 2023 and projected sales between $340 million and $360 million for 2024.
• Market Growth Drivers: Increasing adoption, competitive advantage, and clinical efficacy have driven market growth.
• Challenges and Opportunities: Regulatory environment and market competition are key factors, but ARISTADA INITIO's unique features have helped it maintain a strong market position.

FAQs

Q: What is ARISTADA INITIO, and how does it differ from ARISTADA?

A: ARISTADA INITIO is a long-acting injectable atypical antipsychotic designed for the initiation of ARISTADA. It differs from ARISTADA in its pharmacokinetic profile, allowing for faster achievement of relevant aripiprazole levels within four days[4].

Q: What was the primary objective of the ALPINE post-marketing study?

A: The primary objective was to evaluate the efficacy of the ARISTADA INITIO regimen and the 2-month dose of ARISTADA during the first 4 weeks of treatment in adult patients hospitalized for an acute exacerbation of schizophrenia[1].

Q: How has the approval of ARISTADA INITIO impacted the treatment paradigm for schizophrenia?

A: The approval has provided an alternative regimen that allows for day-one initiation of ARISTADA, enhancing continuity of care and offering flexibility in dosing options for healthcare providers[4].

Q: What are the projected net sales of ARISTADA for 2024?

A: Alkermes has projected net sales of ARISTADA to be between $340 million and $360 million for 2024[5].

Q: How does ARISTADA INITIO contribute to Alkermes' financial performance?

A: ARISTADA, including ARISTADA INITIO, is a significant contributor to Alkermes' revenue, driving overall revenue increases and contributing to the company's financial stability and growth[5].

Sources

1. ALPINE Study of ARISTADA® (aripiprazole lauroxil) | HCP. Aristadahcp.com.
2. Alkermes plc Reports Financial Results for the Fourth Quarter and Year Ended Dec. 31, 2022. Investor.Alkermes.com.
3. Pharmacokinetics of ARISTADA® (aripiprazole lauroxil) | HCP. Aristadahcp.com.
4. FDA Approves ARISTADA INITIO™ for the Initiation of ARISTADA for Schizophrenia. PR Newswire.
5. Alkermes plc Reports Financial Results for the Fourth Quarter and Year Ended Dec. 31, 2023, and Provides Financial Expectations for 2024. PR Newswire.