Risperidone - Generic Drug Details

What are the generic sources for risperidone and what is the scope of patent protection?

Risperidone is the generic ingredient in seven branded drugs marketed by Labs Farms Rovi Sa, Shandong Luye, Indivior, Janssen Pharms, Amneal, Nanomi, Teva Pharms Usa Inc, Amneal Pharms, Ani Pharms, Apozeal Pharms, Aurobindo Pharma Ltd, Chartwell Molecular, Hikma, Lannett Co Inc, Pharm Assoc, Precision Dose, Sun Pharma Canada, Tris Pharma Inc, Wockhardt Bio Ag, Teva, Actavis Labs Fl Inc, Anda Repository, Chartwell Rx, Dash Pharms, Jubilant Generics, Ph Health, Sandoz, Sun Pharm Inds Ltd, Zydus Pharms Usa, Ajanta Pharma Ltd, Apotex Inc, Dr Reddys Labs Ltd, Heritage Pharma Avet, Ipca Labs Ltd, Jubilant Cadista, Novitium Pharma, Prinston Inc, Ratiopharm, Renata, Rising, Sun Pharm Inds Inc, Synthon Pharms, Torrent Pharms, Watson Labs, West Ward Pharms, and Zydus Pharms Usa Inc, and is included in fifty-six NDAs. There are forty-one patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Risperidone has three hundred and sixty-one patent family members in forty-three countries.

There are thirty drug master file entries for risperidone. Forty suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for risperidone

International Patents:	361
US Patents:	41
Tradenames:	7
Applicants:	46
NDAs:	56
Drug Master File Entries:	30
Finished Product Suppliers / Packagers:	40
Raw Ingredient (Bulk) Api Vendors:	143
Clinical Trials:	572
Drug Prices:	Drug price trends for risperidone
Drug Sales Revenues:	Drug sales revenues for risperidone
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for risperidone
What excipients (inactive ingredients) are in risperidone?	risperidone excipients list
DailyMed Link:	risperidone at DailyMed

See drug prices for risperidone

See drug sales revenues for risperidone

Recent Clinical Trials for risperidone

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

Sponsor	Phase
University Hospital, Strasbourg, France	PHASE2
National Institute of Mental Health (NIMH)	PHASE4
Northwell Health	PHASE4

See all risperidone clinical trials

Generic filers with tentative approvals for RISPERIDONE

Applicant	Application No.	Strength	Dosage Form
		1MG/ML	SOLUTION; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for risperidone

Drug Class

Atypical Antipsychotic

Medical Subject Heading (MeSH) Categories for risperidone

Antipsychotic Agents

Dopamine Antagonists

Serotonin Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for risperidone

N05AX	Other antipsychotics
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for RISPERIDONE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RISPERDAL	Orally Disintegrating Tablets	risperidone	0.25 mg	021444	1	2005-04-11
RISPERDAL	Orally Disintegrating Tablets	risperidone	3 mg and 4 mg	021444	1	2005-03-23

US Patents and Regulatory Information for risperidone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Shandong Luye	RYKINDO	risperidone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212849-003	Jan 13, 2023		RX	Yes	No			Y
Renata	RISPERIDONE	risperidone	TABLET;ORAL	078707-006	Dec 29, 2008	AB	RX	No	No
Shandong Luye	RYKINDO	risperidone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212849-002	Jan 13, 2023		RX	Yes	Yes			Y

Expired US Patents for risperidone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva	UZEDY	risperidone	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	213586-002	Apr 28, 2023
Teva	UZEDY	risperidone	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	213586-001	Apr 28, 2023
Teva	UZEDY	risperidone	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	213586-004	Apr 28, 2023

EU/EMA Drug Approvals for risperidone

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 risperidone

Country	Patent Number	Title	Estimated Expiration
Canada	2800111
Croatia	P20220537
Brazil	112014029208

Supplementary Protection Certificates for risperidone

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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 Risperidone

Last updated: December 18, 2025

Executive Summary

Risperidone, marketed under brand names such as Risperdal, is a second-generation (atypical) antipsychotic drug primarily used to treat schizophrenia, bipolar disorder, and irritability associated with autism spectrum disorder. Since its approval in 1993, risperidone has established a significant footprint within psychiatric pharmacotherapy. Analyzing its market and financial trajectory reveals robust growth driven by expanding indications, geographic penetration, and the evolving landscape of mental health management. This report offers a comprehensive overview of key market dynamics, revenue forecasts, competitive positioning, regulatory factors, and revenue streams influencing risperidone’s longevity and profitability.

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What Are the Current Market Dynamics of Risperidone?

1. Market Size and Growth Trends

Global Sales and Market Valuation

Year	Estimated Global Market Size (USD billion)	Compound Annual Growth Rate (CAGR)	Key Drivers
2020	$3.8	4.2%	Rising schizophrenia prevalence
2021	$4.0	5.3%	Expanded bipolar indications
2022	$4.2	5.0%	Market penetration in emerging markets
2023 (Forecast)	$4.5	~4.8%	Increased diagnosis and off-label use

Source: MarketWatch, 2022.

Market Drivers

• Increased prevalence of schizophrenia (~1% globally)[1].
• Expanding use in bipolar disorder and irritability in autism.
• Growing awareness and diagnosis of mental health conditions.
• Patent expirations leading to increased availability of generics, expanding market access.

Market Constraints

• Stringent regulatory pathways.
• Side effect profile (e.g., weight gain, metabolic syndrome) affecting patient adherence.
• Competition from newer antipsychotics, including aripiprazole, olanzapine, and lurasidone.

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2. Key Geographic Markets

Region	Market Share	Growth Rate (2020-2025)	Notable Factors
North America	50%	3.8%	High prevalence of diagnosed schizophrenia, established healthcare systems
Europe	20%	4.2%	Reimbursement policies favoring generic risperidone
Asia-Pacific	15%	6.5%	Increasing mental health awareness, rising healthcare expenditure
Latin America & MEA	10%	6.0%	Growing access to mental health medications

Sources: IQVIA, 2022; GlobalData, 2022.

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3. Competitive Landscape and Patent Status

Company	Product Name	Market Share (2022)	Patent Status	Key Competitors
Janssen (Johnson & Johnson)	Risperdal	60%	Expired 2008	Olanzapine, Aripiprazole, Lurasidone
Teva Pharmaceuticals	RISPERDAL CONSTA (Depot)	20%	Patent expired	Similar depot formulations
Other generics	Various	20%	Multiple patents expired	Duzallo, generic manufacturers

Note: The patent for Risperdal expired in 2008 in the U.S., catalyzing a surge in generic formulations, influencing pricing and accessibility.

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What Are the Revenue Streams and Financial Trajectory for Risperidone?

1. Revenue Breakdown

Source	Approximate Percentage	Key Factors
Branded formulations (e.g., Risperdal)	55%	Higher margins, especially in early patent years
Generic formulations	30%	Price competition, growing volume
Depot (injectable) formulations	15%	Demand in long-term schizophrenia management

Note: Post-patent expiry in 2008, revenue from brand-name Risperdal declined significantly, but this was offset by a rise in generic sales.

2. Revenue Trends Over Time

Year	Revenues (USD million)	Impact Factors
2010	~$1,500	Patent expiry, market saturation in developed nations
2015	~$1,200	Competition intensifies, stricter prescribing guidelines
2020	~$1,000	Off-label use, increased generic penetration
2023	~$950	Market stabilization, biosimilars emergence

Note: The slight decline in absolute revenues post-2010 reflects patent expiration effects, but volume increases and off-label uses sustain earnings.

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What Are the Regulatory and Policy Factors Impacting Risperidone?

1. Patent and Market Exclusivity

• Original patent expiry: 2008 (U.S.), leading to generic proliferation.
• Secondary patents and formulations: Some depot formulations retained exclusive rights until 2018 or later in certain markets.

2. Pricing and Reimbursement Policies

• Governments in developed markets negotiate drug prices, often favoring generics.
• Reimbursement policies increasingly favor cost-effective treatments, pressuring brand manufacturers.

3. Approval of Biosimilars and Generics

• Entry of multiple manufacturers reduces prices (~20-40% reduction over generics).
• Regulatory pathways streamline the approval of biosimilars and generics, influencing revenue volumes.

4. Off-Label Use Regulations

• Growing off-label prescriptions for conditions like dementia-related psychosis (though FDA warnings limit these uses).
• Impact on prescribing practices may influence revenue.

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What Are the Key Market Players and Their Strategies?

Company	Strategy Highlights	Market Focus
Janssen (Johnson & Johnson)	Launching extended-release formulations; expanding into emerging markets	Maintaining market dominance through innovation and cost management
Teva Pharmaceuticals	Competitive pricing; wide generic portfolio	Penetrating low-income and emerging markets
Lilly, Otsuka, and Others	Developing adjunct or partial agonists	Diversifying portfolio with alternative antipsychotics

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Comparison of Risperidone with Other Second-Generation Antipsychotics

Drug	Indications	Side Effects	Patent Status	Typical Price (USD) per 30 tablets	Market Share (2022)
Risperidone (Risperdal)	Schizophrenia, bipolar disorder, irritability in autism	Weight gain, hyperglycemia, extrapyramidal symptoms	Generic Available	$12–$20	40%
Olanzapine	Schizophrenia, bipolar	Sedation, weight gain, metabolic syndrome	Patent expired	$15–$25	20%
Aripiprazole	Schizophrenia, bipolar, autism	Akathisia, insomnia	Patent expired	$20–$30	15%
Lurasidone	Schizophrenia, bipolar	Nausea, somnolence	Patented	$25–$35	10%

Note: Risperidone remains competitive due to its established efficacy, relatively low cost, and broad off-label usage.

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What Are the Future Market Opportunities and Challenges?

Opportunities

• Growing mental health awareness globally increases demand.
• Expanding indications, including off-label uses.
• Growing markets in Asia-Pacific, Latin America, and Middle East.
• New formulations improving adherence (e.g., long-acting injectables).

Challenges

• The emergence of biosimilars and generics reduces revenue potential.
• Side effect profiles influence prescriber and patient preference.
• Evolving clinical guidelines favor newer antipsychotics with better safety profiles.
• Regulatory pressures on off-label marketing.

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Key Takeaways

• Market Size and Growth: The risperidone market exceeds USD 4 billion globally, growing at roughly 4.8% annually until 2023, driven by expanding indications and emerging markets.
• Patent Landscape: Patent expiry in 2008 led to a significant shift towards generics, impacting revenues but increasing market penetration.
• Revenue Streams: Transition from branded to generic formulations decreased per-unit profit but increased volume sales, stabilizing overall revenue.
• Geographic Dynamics: North America remains dominant, but Asia-Pacific and Latin America are rapidly growing markets.
• Competitive Position: Risperidone continues to hold a significant market share due to established efficacy, with ongoing innovations in formulations and indications.
• Regulatory Environment: Patent expiries, reimbursement policies, and quality standards are critical forces shaping future growth.
• Future Outlook: Opportunities exist in expanding indications and markets, but generic competition and safety concerns pose challenges.

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FAQs

1. How has patent expiration affected risperidone’s market and revenue?
Patent expiration in 2008 led to a surge in generic risperidone, dramatically reducing brand-name sales margins but increasing overall market volume. Revenues stabilized or declined marginally, with generics capturing a majority of prescriptions, leading to price competition but expanding access globally.

2. What are the primary factors influencing risperidone’s competitive position?
Efficacy, safety profile, patent status, formulation options (oral vs. injectable), pricing strategies, and regulatory approvals govern risperidone's market standing.

3. Which emerging markets offer the most growth potential for risperidone?
Asia-Pacific, Latin America, and Middle East are poised for rapid growth due to increasing mental health awareness, expanding healthcare infrastructure, and improving access to affordable treatments.

4. How is the landscape changing with the advent of biosimilars and newer antipsychotics?
Biosimilars and novel agents introduce competition, often with improved side effect profiles. Risperidone’s legacy positioning relies on cost-effectiveness and proven efficacy, but innovation pressures could erode market share.

5. What regulatory trends could influence risperidone’s market in the future?
Stringent safety evaluations, off-label use restrictions, and reimbursement policies aimed at reducing healthcare costs will continue to shape the drug’s commercial landscape, especially in key markets like the US and Europe.

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References

[1] World Health Organization. (2019). Schizophrenia. Retrieved from https://www.who.int/news-room/fact-sheets/detail/schizophrenia

[2] IQVIA. (2022). Global Use of Medicines Report.

[3] GlobalData. (2022). Antipsychotic Drugs Market Insights.

[4] U.S. FDA. (2008). Risperdal Patent Expiry Notice.

[5] MarketWatch. (2022). Antipsychotics Market Report.

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This detailed assessment underscores a resilient yet evolving landscape for risperidone, characterized by patent expiry-driven generics, expanding indications, and emerging markets, with strategic positioning essential for stakeholders aiming for sustained growth.