ARISTADA Drug Patent Profile

When do Aristada patents expire, and what generic alternatives are available?

Aristada is a drug marketed by Alkermes Inc and is included in two NDAs. There are seventeen patents protecting this drug.

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

The generic ingredient in ARISTADA 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

Aristada 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 March 19, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ARISTADA

International Patents:	141
US Patents:	13
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	4
Patent Applications:	131
Drug Prices:	Drug price information for ARISTADA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ARISTADA
What excipients (inactive ingredients) are in ARISTADA?	ARISTADA excipients list
DailyMed Link:	ARISTADA at DailyMed

See drug prices for ARISTADA

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

NDA:

207533

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

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

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

See all ARISTADA clinical trials

Pharmacology for ARISTADA

Drug Class

Atypical Antipsychotic

US Patents and Regulatory Information for ARISTADA

ARISTADA is protected by fourteen 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	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207533-004	Jun 5, 2017		RX	Yes	No
Alkermes Inc	ARISTADA	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207533-003	Oct 5, 2015		RX	Yes	Yes
Alkermes Inc	ARISTADA	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207533-004	Jun 5, 2017		RX	Yes	No			Y
Alkermes Inc	ARISTADA	aripiprazole lauroxil	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207533-004	Jun 5, 2017		RX	Yes	No			Y

International Patents for ARISTADA

When does loss-of-exclusivity occur for ARISTADA?

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

Australia

Brazil

Canada

China

European Patent Office

Israel

Japan

Mexico

Morocco

New Zealand

Russian Federation

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 around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3761983	STRATÉGIE DE DOSAGE D'ARIPIPRAZOLE (ARIPIPRAZOLE DOSING STRATEGY)
China	110368360
Saudi Arabia	110310539
Australia	2017204486	Pharmaceutical compositions comprising sorbitan esters

Supplementary Protection Certificates for ARISTADA

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	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

Market Dynamics and Financial Trajectory for ARISTADA

Overview of ARISTADA

ARISTADA, developed by Alkermes plc, is a long-acting injectable (LAI) antipsychotic medication, specifically aripiprazole lauroxil, used in the treatment of schizophrenia. It is notable for its flexibility in dosing options and administration routes, offering both deltoid and gluteal injections, which sets it apart from other LAIs like Abilify Maintena[1].

Market Growth and Trends

The global market for schizophrenia drugs, including LAIs like ARISTADA, is experiencing significant growth. The schizophrenia drugs market was valued at USD 7.90 billion in 2023 and is projected to grow at a CAGR of 5.3% from 2024 to 2030. This growth is driven by the increasing prevalence of schizophrenia, improved diagnosis rates, and the preference for third-generation antipsychotics due to their superior clinical benefits and lower risk of severe side effects[4].

Increasing Demand for LAIs

The demand for LAIs is on the rise due to several factors:

• Improved Patient Outcomes: LAIs have been shown to improve stability and adherence to treatment, even after discontinuation of the medication[1].
• Health Economics: The widening body of health economics outcome data supports the benefits of LAIs, leading to broader penetration and sustained growth[1].
• Physician Experience: Enhanced physician experience and increased marketing efforts by multiple entrants are driving the adoption of LAIs[1].

Financial Performance of ARISTADA

Revenue Growth

ARISTADA has demonstrated consistent revenue growth:

• In the fourth quarter of 2022, net sales of ARISTADA were $79.2 million, representing a 1% increase from the prior year[2].
• For the full year 2022, net sales of ARISTADA reached $302.1 million, a 10% increase from the previous year[2].
• This trend continues, with total revenues for Alkermes plc, including ARISTADA, showing an 18% year-over-year increase in proprietary product sales[5].

Market Share and Competition

ARISTADA competes in the schizophrenia drugs market, which is dominated by several key players:

• Second-Generation Antipsychotics: Drugs like Risperdal (Risperidone), Invega (Paliperidone), and Zyprexa (Olanzapine) are prominent, but ARISTADA stands out due to its long-acting formulation and multiple dosing options[4].
• Third-Generation Antipsychotics: This segment, which includes ARISTADA, is expected to grow at the fastest CAGR of 6.1% due to superior clinical benefits and a lower risk of severe side effects[4].

Distribution and Access

Distribution Channels

ARISTADA is available through various distribution channels:

• Hospital Pharmacies: A significant portion of schizophrenia medications, including ARISTADA, are dispensed through hospital pharmacies[4].
• Retail Pharmacies: Retail pharmacies also play a crucial role in the distribution of ARISTADA, making it accessible to a broader patient population[4].

Patient Support Programs

Alkermes offers several support programs to enhance patient access and adherence:

• Co-pay Savings Program: Eligible patients can benefit from co-pay savings, reducing the financial burden of treatment[3].
• ARISTADA Care Support: This program provides assistance in finding healthcare providers and offers additional support resources for patients and caregivers[3].

Clinical and Therapeutic Advantages

Flexibility in Administration

ARISTADA offers pre-filled syringes with multiple maintenance strengths and can be administered via both deltoid and gluteal routes, providing flexibility that other LAIs lack[1].

Therapeutic Efficacy

Clinical data supports the efficacy of ARISTADA:

• Rapid Achievement of Therapeutic Levels: Patients achieve therapeutic levels quickly, typically within 2-8 hours, and sustain these levels throughout the dosing period[1].
• Reduced Need for Oral Supplementation: Unlike some other antipsychotics, ARISTADA does not require oral supplementation, enhancing patient convenience and adherence[1].

Future Outlook

Market Projections

The schizophrenia drugs market, including the segment for LAIs like ARISTADA, is expected to continue growing driven by increasing awareness, improved diagnosis, and the preference for third-generation antipsychotics. The North American market, in particular, holds a significant share due to high awareness and diagnosis rates, as well as advancements in medical research[4].

Competitive Landscape

As the market evolves, new entrants and improved formulations are expected to emerge. For example, Rovi Pharma is developing an improved LAI version of Risperdal Consta, which could potentially compete with ARISTADA in the future[1].

Key Takeaways

• ARISTADA is a long-acting injectable antipsychotic with multiple dosing options and administration routes.
• The drug has shown consistent revenue growth, driven by its therapeutic advantages and market demand.
• The schizophrenia drugs market is projected to grow at a CAGR of 5.3% from 2024 to 2030.
• ARISTADA benefits from patient support programs and a strong distribution network.
• The drug's flexibility and efficacy make it a preferred choice for long-term schizophrenia treatment.

FAQs

What is ARISTADA used for?

ARISTADA is used for the treatment of schizophrenia. It is a long-acting injectable antipsychotic medication.

How is ARISTADA administered?

ARISTADA can be administered via both deltoid and gluteal injections, offering flexibility in dosing options.

What are the key advantages of ARISTADA over other LAIs?

ARISTADA offers multiple maintenance strengths, pre-filled syringes, and does not require oral supplementation, making it more convenient and effective.

How has ARISTADA performed financially?

ARISTADA has shown consistent revenue growth, with a 10% increase in net sales from 2021 to 2022, reaching $302.1 million.

What support programs are available for ARISTADA patients?

Alkermes offers co-pay savings programs, patient assistance programs, and ARISTADA Care Support to help patients access and adhere to the treatment.

What is the projected growth rate for the schizophrenia drugs market?

The schizophrenia drugs market is projected to grow at a CAGR of 5.3% from 2024 to 2030.

Sources

1. Grand View Research: Long-acting injectable (LAIs) antipsychotics market report.
2. Alkermes plc: Financial results for the fourth quarter and year 2022.
3. ARISTADA Resources: Support programs and prescribing information.
4. Grand View Research: Schizophrenia drugs market size and share report.
5. Alkermes plc: Financial results for the fourth quarter and year 2023.