RISPERDAL CONSTA Drug Patent Profile

When do Risperdal Consta patents expire, and when can generic versions of Risperdal Consta launch?

Risperdal Consta is a drug marketed by Janssen Pharms and is included in one NDA.

The generic ingredient in RISPERDAL CONSTA is risperidone. There are thirty drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the risperidone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Risperdal Consta

A generic version of RISPERDAL CONSTA was approved as risperidone by APOTEX INC on September 15^th, 2008.

Summary for RISPERDAL CONSTA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	143
Clinical Trials:	45
Patent Applications:	4,060
Drug Prices:	Drug price information for RISPERDAL CONSTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RISPERDAL CONSTA
What excipients (inactive ingredients) are in RISPERDAL CONSTA?	RISPERDAL CONSTA excipients list
DailyMed Link:	RISPERDAL CONSTA at DailyMed

See drug prices for RISPERDAL CONSTA

Recent Clinical Trials for RISPERDAL CONSTA

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

Sponsor	Phase
Otsuka America Pharmaceutical	Phase 4
Gazda, Thomas D., M.D., PC	Phase 4
Zogenix, Inc.	Phase 1

See all RISPERDAL CONSTA clinical trials

US Patents and Regulatory Information for RISPERDAL CONSTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharms	RISPERDAL CONSTA	risperidone	INJECTABLE;INTRAMUSCULAR	021346-004	Apr 12, 2007	AB	RX	Yes	No
Janssen Pharms	RISPERDAL CONSTA	risperidone	INJECTABLE;INTRAMUSCULAR	021346-003	Oct 29, 2003	AB	RX	Yes	No
Janssen Pharms	RISPERDAL CONSTA	risperidone	INJECTABLE;INTRAMUSCULAR	021346-001	Oct 29, 2003	AB	RX	Yes	Yes
Janssen Pharms	RISPERDAL CONSTA	risperidone	INJECTABLE;INTRAMUSCULAR	021346-002	Oct 29, 2003	AB	RX	Yes	No

Expired US Patents for RISPERDAL CONSTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	RISPERDAL CONSTA	risperidone	INJECTABLE;INTRAMUSCULAR	021346-002	Oct 29, 2003	6,368,632*PED
Janssen Pharms	RISPERDAL CONSTA	risperidone	INJECTABLE;INTRAMUSCULAR	021346-001	Oct 29, 2003	6,194,006*PED
Janssen Pharms	RISPERDAL CONSTA	risperidone	INJECTABLE;INTRAMUSCULAR	021346-002	Oct 29, 2003	6,264,987*PED
Janssen Pharms	RISPERDAL CONSTA	risperidone	INJECTABLE;INTRAMUSCULAR	021346-002	Oct 29, 2003	6,379,703*PED

EU/EMA Drug Approvals for RISPERDAL CONSTA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Laboratorios Farmacéuticos Rovi, S.A.	Okedi	risperidone	EMEA/H/C/005406 Treatment of schizophrenia in adults for whom tolerability and effectiveness has been established with oral risperidone.	Authorised	no	no	no	2022-02-14

International Patents for RISPERDAL CONSTA

See the table below for patents covering RISPERDAL CONSTA around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2003534366
China	100453067
Spain	2183172
Denmark	168537

Supplementary Protection Certificates for RISPERDAL CONSTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0196132	SPC/GB93/036	United Kingdom		SPC/GB93/036:, EXPIRES: 20071207
0196132	94C0008	Belgium		PRODUCT NAME: RISPERIDONE; NAT REG.: 2 S 414 F 3 19940527; FIRST REG.: GB 0242/0186 19921208

RISPERDAL CONSTA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for RISPERDAL CONSTA

Introduction

RISPERDAL CONSTA, a long-acting injectable form of the antipsychotic medication risperidone, has been a significant player in the treatment of schizophrenia and bipolar I disorder. Developed through a collaboration between Janssen Pharmaceutica and Alkermes Inc., this drug has seen various market and financial trends over the years.

Therapeutic Indications and Approval

RISPERDAL CONSTA was initially approved in 2003 for the treatment of schizophrenia and later received approval for the maintenance treatment of bipolar I disorder as both a monotherapy and adjunctive therapy to lithium or valproate[4].

Market Performance

Revenue Trends

The revenue generated by RISPERDAL CONSTA has experienced fluctuations over recent years. In 2020, the drug reported revenues of $642 million, which decreased by 7% from the previous year. This decline continued, with revenues dropping to $592 million in 2021 and further to $485 million in 2022, representing an 18% decline from 2021[1].

Manufacturing and Royalty Revenues

Alkermes, the company responsible for manufacturing RISPERDAL CONSTA, reported significant revenues from this product. In the first quarter of 2022, manufacturing and royalty revenues from RISPERDAL CONSTA were $17.4 million, an increase from $14.2 million in the same period of the prior year[2].

Licensing and Partnership Dynamics

The financial performance of RISPERDAL CONSTA has been influenced by licensing agreements. In 2022, Janssen Pharmaceutica partially terminated its license agreement for the long-acting INVEGA products in the U.S., which affected Alkermes' revenue. This led to a decrease in royalty payments and prompted Alkermes to initiate binding arbitration proceedings[2].

Clinical and Market Impact

Treatment Efficacy

RISPERDAL CONSTA has been shown to be effective in clinical trials for both schizophrenia and bipolar I disorder. It delays the time to relapse of mood episodes when used as a monotherapy or adjunctive therapy[4].

Patient Compliance

The long-acting nature of RISPERDAL CONSTA, administered via intramuscular injection every two weeks, enhances patient compliance by ensuring consistent medication delivery. This is particularly beneficial for patients with mental health conditions who may struggle with adherence to daily medication regimens[4].

Financial Highlights

Revenue Projections and Actuals

In fiscal 2011, RISPERDAL CONSTA generated record manufacturing and royalty revenues of $154.3 million, driven by worldwide sales exceeding $1.5 billion by Janssen. However, more recent years have seen a decline in revenues. For instance, Alkermes projected manufacturing revenues for RISPERDAL CONSTA to range from $120 to $125 million in subsequent years, but actual figures have been lower due to various market and licensing factors[3].

Cash and Debt Position

As of March 31, 2022, Alkermes had a strong cash position with $758.7 million in cash, cash equivalents, and total investments, but also carried a total debt of $295.2 million[2].

Expenses and Profitability

Operating Expenses

Alkermes' financial reports show significant expenses related to the production and marketing of RISPERDAL CONSTA. In the first quarter of 2022, the company incurred costs of goods manufactured and sold amounting to $55.1 million, along with substantial research and development and selling, general, and administrative expenses[2].

Net Loss and Non-GAAP Earnings

Despite the revenue generated, Alkermes reported a GAAP net loss of $35.9 million in the first quarter of 2022. However, on a non-GAAP basis, the company reported a net income of $19.6 million, reflecting adjustments for share-based compensation, depreciation, and other items[2].

Competitive Landscape

Market Competition

The market for long-acting antipsychotic therapies is competitive, with other products like INVEGA TRINZA and INVEGA HAFYERA also vying for market share. The partial termination of the license agreement for these products by Janssen has impacted Alkermes' revenue and highlights the dynamic nature of the market[2].

Regulatory and Legal Considerations

Arbitration Proceedings

The partial termination of the license agreement by Janssen led Alkermes to commence binding arbitration proceedings. This legal action is aimed at resolving disputes related to Janssen's royalty and other obligations under the agreement[2].

Adverse Reactions and Safety Profile

Common Adverse Reactions

Clinical trials have identified several common adverse reactions associated with RISPERDAL CONSTA, including headache, muscle stiffness, dizziness, and weight increase. For patients with bipolar disorder, tremor and parkinsonism are also notable adverse reactions[4].

Future Outlook

Market Potential

Despite the recent decline in revenues, RISPERDAL CONSTA remains a significant treatment option for schizophrenia and bipolar I disorder. Its unique delivery mechanism and efficacy profile continue to make it a valuable asset in the mental health treatment landscape.

Financial Projections

Alkermes' financial projections for RISPERDAL CONSTA are cautious, reflecting the impact of licensing agreements and market dynamics. However, the company's strong cash position and ongoing legal efforts to resolve licensing disputes suggest a potential for stabilization and growth in the future.

Key Takeaways

• Revenue Decline: RISPERDAL CONSTA has seen a decline in revenues from 2020 to 2022, influenced by licensing agreements and market dynamics.
• Licensing Agreements: The partial termination of the license agreement by Janssen has significantly impacted Alkermes' revenue.
• Clinical Efficacy: RISPERDAL CONSTA is effective in treating schizophrenia and bipolar I disorder, enhancing patient compliance.
• Financial Position: Alkermes maintains a strong cash position but carries significant debt.
• Regulatory and Legal: Ongoing arbitration proceedings aim to resolve disputes related to licensing agreements.

FAQs

What is RISPERDAL CONSTA used for?

RISPERDAL CONSTA is used for the treatment of schizophrenia and the maintenance treatment of bipolar I disorder as both a monotherapy and adjunctive therapy to lithium or valproate[4].

How is RISPERDAL CONSTA administered?

RISPERDAL CONSTA is administered via intramuscular injection every two weeks, utilizing Alkermes’ proprietary Medisorb drug-delivery technology[4].

Why has RISPERDAL CONSTA's revenue declined?

The revenue decline is primarily due to the partial termination of the license agreement by Janssen and other market dynamics[1][2].

What are the common adverse reactions associated with RISPERDAL CONSTA?

Common adverse reactions include headache, muscle stiffness, dizziness, weight increase, and for bipolar disorder, tremor and parkinsonism[4].

What is the current financial position of Alkermes regarding RISPERDAL CONSTA?

Alkermes has a strong cash position but reported a GAAP net loss in the first quarter of 2022. On a non-GAAP basis, the company reported a net income[2].

Sources

1. PharmaCompass: Risperdal Consta | Annual Sales Report.
2. PR Newswire: Alkermes plc Reports First Quarter 2022 Financial Results.
3. Alkermes Investor Relations: Alkermes Reports Financial Results for Fiscal 2011 and Provides Guidance.
4. Alkermes Investor Relations: FDA Grants Approval for Use of RISPERDAL(R) CONSTA(R) as Monotherapy and Adjunctive Therapy for Bipolar I Disorder.