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. Forty 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 RISING on October 8^th, 2008.

Summary for RISPERDAL CONSTA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	121
Clinical Trials:	45
Patent Applications:	4,330
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
Gazda, Thomas D., M.D., PC	Phase 4
Otsuka America Pharmaceutical	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	021346-001	Oct 29, 2003	5,792,477*PED
Janssen Pharms	RISPERDAL CONSTA	risperidone	INJECTABLE;INTRAMUSCULAR	021346-001	Oct 29, 2003	5,688,801*PED
Janssen Pharms	RISPERDAL CONSTA	risperidone	INJECTABLE;INTRAMUSCULAR	021346-003	Oct 29, 2003	6,264,987*PED
Janssen Pharms	RISPERDAL CONSTA	risperidone	INJECTABLE;INTRAMUSCULAR	021346-004	Apr 12, 2007	6,110,503*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/005406Treatment 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
Denmark	2269577
Cyprus	1117734
Brazil	PI0111060	composição adequada para injeção através de uma agulha em um hospedeiro e métodos para sua preparação
Spain	8705881

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

Market Dynamics and Financial Trajectory for RISPERDAL CONSTA

Last updated: November 20, 2025

Introduction

Risperdal Consta (risperidone long-acting injectable) stands as a significant asset within antipsychotic treatments, specifically targeting schizophrenia and bipolar disorder. Its sustained-release formulation offers improved medication adherence, a crucial factor in managing chronic psychiatric conditions. Analyzing its market dynamics and financial pathway provides insights into its long-term commercial prospects amid evolving healthcare landscapes and competitive pressures.

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Market Overview

Global Market Size and Growth Drivers

The global antipsychotic drugs market, valued at approximately USD 15 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of around 3.5% through 2028. Risperdal Consta, as a flagship long-acting injectable (LAI), constitutes a notable share of this market, driven by the increasing prevalence of schizophrenia (approximately 20 million globally) and bipolar disorder, which collectively propel demand for long-term therapeutic options.

Prescription Trends and Adoption Patterns

American and European markets see rising adoption of LAIs, attributed to evidence linking their use to improved adherence and reduced hospitalization rates. Data indicates nearly 50% of schizophrenia patients are prescribed LAIs, with Risperdal Consta accounting for a sizable portion. The shift toward injectables over oral antipsychotics—due to lower non-adherence—favors sustained demand for Risperdal Consta, particularly in institutional care settings.

Competitive Landscape

The competitive environment includes both first-generation LAIs like haloperidol decanoate and newer formulations such as long-acting paliperidone products (e.g., Invega Sustenna) and aripiprazole (Abilify Maintena). Notably, generics and biosimilars threaten the market share of brand-name drugs over time, pressing manufacturers for continuous innovation and marketing strategies.

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Development Pipeline and Regulatory Factors

Pipeline Products and Formulation Innovations

While Risperdal Consta remains a micture in the LAI segment, ongoing developments aim to enhance its formulation—such as extended duration dosing—potentially reducing injection frequency to improve patient convenience. Additionally, cumulative data supporting efficacy and safety influence regulatory status, with FDA and EMA approvals reinforcing market confidence.

Regulatory Environment

Stringent regulatory policies, especially around biosimilar approval, influence market penetration of generic risperidone formulations. Patent expirations and patent litigations shape the landscape, with a typical patent life of 10-12 years post-launch, after which biosimilars or generics can diminish revenues.

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Market Challenges and Opportunities

Pricing and Reimbursement Policies

Pricing strategies and reimbursement frameworks heavily impact revenue streams. In markets like the US, insurance coverage and formulary placements determine patient access. Pricing pressures from payers and government bodies impact profitability, especially amid rising healthcare costs.

Adherence and Patient Acceptance

The efficacy of Risperdal Consta hinges on adherence—long-acting formulations reduce missed doses but require injection site management and patient acceptance. Education campaigns and clinician prescribing habits influence uptake rates.

Emerging Therapies and Innovation

Innovations such as digital therapeutics, depot formulations with longer durations, and targeted delivery systems promise to expand market share. Additionally, personalized medicine approaches could refine patient selection, optimizing outcomes and reducing wastage.

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Financial Trajectory and Revenue Forecasts

Historical Financial Performance

Johnson & Johnson (J&J), the primary marketer of Risperdal Consta in the US, reported that the antipsychotic portfolio generated approximately USD 2 billion annually pre-patent expiry. Risperdal's revenues have declined over recent years due to generic competition but remain significant owing to its entrenched market position.

Projection for the Next 5-10 Years

Forecasts indicate a gradual decline in Risperdal Consta revenues post-2024, aligning with patent cliffs and biosimilar entries. However, strategic measures like line extensions, dosing innovations, and expanded indications (e.g., autism-associated irritability) are expected to mitigate sharp declines.

Assuming sustained market share retention of approximately 25% within the LAI segment, revenues could stabilize around USD 1 billion by 2030. The incorporation of biosimilars, if they capture approximately 40-50% of the market, will significantly influence profitability margins.

Impact of Biosimilars and Patent Expirations

Biosimilar risperidone products are entering markets globally, especially in Europe and Asia, exerting downward pricing pressure. In the U.S., patent litigations have deferred biosimilar entry until at least 2024. Post-patent expiration, anticipated price reductions—up to 30-50%—will impact gross margins and overall sales.

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Strategic Outlook and Business Implications

Market Penetration and Expansion Strategies

Active efforts include targeting emerging markets where healthcare infrastructure is rapidly developing and LAIs are gaining favor. Collaborations with healthcare providers to improve injection delivery and patient monitoring can enhance penetration.

Innovation and Lifecycle Management

Investments in long-acting formulations with extended dosing intervals (e.g., monthly to trimestral injections) will sustain relevance. Moreover, developing formulations for broader indications like dementia psychosis could unlock additional revenues.

Pricing, Reimbursement, and Access Policies

Proactive engagement with payers to secure favorable formulary status is vital. Cost-effective generic options, alongside branded formulations with clinical advantages, can balance market competitiveness. Monitoring policy developments will be crucial for strategic planning.

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Conclusion

Risperdal Consta exemplifies the resilience and challenges inherent in blockbuster psychiatric drugs. While approaching patent cliffs threaten near-term revenues, strategic innovation, geographic expansion, and formulation enhancements provide pathways for sustained profitability. The evolving landscape of biosimilars, reimbursement policies, and technological advancements underscores the need for agility in market approaches.

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Key Takeaways

• The global LAI antipsychotic market is expanding, with Risperdal Consta maintaining a strong presence due to its efficacy and adherence benefits.
• Patent expirations and biosimilar entries pose significant long-term revenue challenges, prompting investments in formulation innovations and new indications.
• Market growth is driven by increasing prevalence of schizophrenia and bipolar disorder, alongside rising acceptance of LAIs over oral medications.
• Strategic alliances, regulatory compliance, and patient-centric approaches are critical for maintaining market share amid intensifying competition.
• Financial sustainability hinges on balancing pricing strategies, expanding into emerging markets, and leveraging pipeline advancements.

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FAQs

Q1: When is Risperdal Consta’s patent expiration expected, and how will it impact the market?

A1: In the U.S., patent expiration for Risperdal Consta is anticipated around 2024. Post-expiry, biosimilar risperidone products are expected to enter the market, potentially reducing revenues by 30-50%. Manufacturers are preparing by developing extended formulations and new indications to mitigate revenue loss.

Q2: What are the primary competitive advantages of Risperdal Consta over oral risperidone?

A2: Risperdal Consta offers sustained medication levels, improving adherence and reducing relapse rates. It requires less frequent injections (typically every two weeks to four weeks), leading to better compliance, fewer hospitalizations, and overall improved treatment outcomes.

Q3: How does the emergence of biosimilars influence pricing strategies for Risperdal Consta?

A3: Biosimilar entries lead to increased price competition, forcing manufacturers to adopt aggressive pricing, offer rebates, and develop differentiation strategies, such as improved formulations or expanded clinical indications, to preserve profitability.

Q4: Are there ongoing innovations that could extend Risperdal Consta’s market relevance?

A4: Yes. Ongoing developments include longer-acting formulations with dosing intervals of three to six months, as well as new delivery mechanisms and expanded indications like behavioral disorders in autism, which could prolong the drug’s lifecycle.

Q5: Which regions present the most growth opportunities for Risperdal Consta?

A5: Emerging markets in Asia, Latin America, and parts of Africa offer significant growth potential due to increasing healthcare access, rising prevalence of psychiatric conditions, and evolving attitudes toward injectable antipsychotics. Tailored pricing and partnerships in these regions are critical.

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References

1. MarketsandMarkets. Antipsychotic Drugs Market, 2022.
2. IQVIA. Global Psychiatry Market Trends, 2022.
3. Johnson & Johnson Annual Reports, 2022.
4. FDA Patent and Exclusivity Data.
5. Novartis/Biogen Biosimilar Risperdal Entry Analysis.