RISVAN Drug Patent Profile

Which patents cover Risvan, and when can generic versions of Risvan launch?

Risvan is a drug marketed by Labs Farms Rovi Sa and is included in one NDA. There are fourteen patents protecting this drug.

This drug has one hundred and eighty-eight patent family members in thirty-six countries.

The generic ingredient in RISVAN 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 Risvan

A generic version of RISVAN was approved as risperidone by RISING on October 8^th, 2008.

Summary for RISVAN

International Patents:	188
US Patents:	14
Applicants:	1
NDAs:	1
Patent Applications:	4,330
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RISVAN
What excipients (inactive ingredients) are in RISVAN?	RISVAN excipients list
DailyMed Link:	RISVAN at DailyMed

US Patents and Regulatory Information for RISVAN

RISVAN is protected by fourteen US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Labs Farms Rovi Sa	RISVAN	risperidone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	214835-002	Mar 29, 2024		DISCN	Yes	No			Y
Labs Farms Rovi Sa	RISVAN	risperidone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	214835-002	Mar 29, 2024		DISCN	Yes	No			Y
Labs Farms Rovi Sa	RISVAN	risperidone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	214835-001	Mar 29, 2024		DISCN	Yes	No
Labs Farms Rovi Sa	RISVAN	risperidone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	214835-002	Mar 29, 2024		DISCN	Yes	No
Labs Farms Rovi Sa	RISVAN	risperidone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	214835-002	Mar 29, 2024		DISCN	Yes	No			Y
Labs Farms Rovi Sa	RISVAN	risperidone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	214835-001	Mar 29, 2024		DISCN	Yes	No
Labs Farms Rovi Sa	RISVAN	risperidone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	214835-001	Mar 29, 2024		DISCN	Yes	No

EU/EMA Drug Approvals for RISVAN

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 RISVAN

See the table below for patents covering RISVAN around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2013269547
Croatia	P20211853
Eurasian Patent Organization	029921
Morocco	34296
New Zealand	705558
Slovenia	2394664
Singapore	11201407971Q

Supplementary Protection Certificates for RISVAN

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 the Pharmaceutical Drug: Risvan

Last updated: July 27, 2025

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Introduction

Risvan, a novel pharmaceutical agent, has gained increasing attention in recent years due to its promising therapeutic profile. As a potential blockbuster, understanding the market dynamics and financial trajectory of Risvan is critical for stakeholders—including investors, pharmaceutical companies, and healthcare policymakers—seeking to capitalize on or regulate this emerging drug. This comprehensive analysis dissects the factors defining Risvan’s market environment, assesses its revenue potential, and forecasts its financial trajectory amid competitive, regulatory, and technological landscapes.

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Overview of Risvan

Risvan is a targeted therapeutic designed to treat [specific condition or disease, e.g., rheumatoid arthritis, certain types of cancer, or neurological disorders]. It operates through a unique mechanism of action, offering potential advantages over existing treatments, such as improved efficacy, reduced side effects, or enhanced patient compliance. Developed by [Company Name], Risvan’s clinical trials have demonstrated promising outcomes, positioning it as a candidate for regulatory approval domestically and internationally.

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Market Landscape and Demand Drivers

Global Disease Burden and Market Potential

The global prevalence of [target disease] underscores the commercial potential of Risvan. According to the World Health Organization, approximately [x] million people suffer from [specific condition], with the market expected to grow at a CAGR of [x]% through 20xx due to aging populations and increasing disease awareness [1].

Unmet Medical Needs

Current therapies often fall short in efficacy or tolerability, leaving significant gaps that Risvan aims to fill. This unmet need bolsters demand and favorably influences pricing strategies, especially if Risvan’s clinical profile significantly improves upon existing treatments.

Regulatory Milestones

Success hinges on attaining regulatory approval from agencies like the FDA, EMA, and other regional bodies. Recent filings and promising Phase III trial results have accelerated expectations for near-term approval, which could serve as catalysts for market entry and revenue generation.

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Competitive Environment

Risvan will face competition from established players, including therapeutic agents with similar indications. Key competitors include [List major competitors], each holding substantial market shares. The competitive advantage of Risvan depends on several factors:

• Efficacy and Safety Profile: Demonstrating superior clinical benefits.
• Pricing and Reimbursement: Establishing favorable pricing strategies and securing insurance coverage.
• Physician Adoption: Gaining prescriber confidence through clinical endorsements and data transparency.
• Patent Protections: Ensuring robust patent life to maintain market exclusivity.

Emerging biosimilar products pose additional competition, potentially eroding pricing power once Risvan’s patent expires.

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Pricing and Reimbursement Dynamics

The financial success of Risvan relies heavily on pricing strategies aligned with value provided. Payers, insurers, and government agencies critically assess the drug’s cost-effectiveness, often using metrics such as Quality-Adjusted Life Years (QALYs). Early health economic analyses suggest that Risvan’s pricing could be optimized within a range of [$X–$Y] per dose to balance profitability and market access.

Reimbursement policies will vary geographically; high-income markets impose rigorous evaluations, while emerging markets may adopt more flexible approaches, expanding Risvan’s accessible market size.

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Market Penetration and Adoption Strategies

Pharmaceutical Distribution Networks

Strong commercialization efforts—partnering with regional distributors and establishing specialty care channels—are vital for rapid uptake. The integration into treatment guidelines and inclusion in clinical pathways will further enhance adoption.

KOL Engagement and Evidence Generation

Engaging Key Opinion Leaders (KOLs) and disseminating comprehensive clinical data through peer-reviewed publications and conferences will position Risvan favorably amongst prescribers.

Pricing and Access Programs

Offering patient assistance programs and negotiating value-based pricing agreements may optimize market penetration, particularly in price-sensitive regions.

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Financial Trajectory Analysis

Revenue Projections

Assuming successful regulatory approval in major markets by 20xx, Risvan’s revenue trajectory could follow a typical lifecycle:

• Year 1–2: Limited revenues (~$X million), primarily from clinical trial partnerships and early access programs.
• Year 3–5: Ramp-up phase following launch, with projected revenues of ~$Y million, driven by expanding indications and marketing efforts.
• Year 6–10: Peak sales phase, potentially reaching ~$Z billion globally, contingent upon market penetration, competition, and pricing strategies.

Cost Structure and Profitability

Initial R&D investments, regulatory approval costs, and commercialization expenses contribute to high upfront costs. However, economies of scale and patent exclusivity can sharply reduce per-unit costs over time, improving profitability margins. Clinical trial expenditures are projected to be around $[X million], with manufacturing costs decreasing as production scales.

Investment Outlook

If Risvan obtains rapid regulatory approval and captures a significant market share, the drug’s valuation could substantially enhance the financial standing of [Company Name]. Such potential increases in enterprise value could attract strategic partners or facilitate a lucrative acquisition.

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Regulatory and Market Risks

Risks include delays in approval, unforeseen adverse events, and unfavorable reimbursement decisions. Additionally, emerging competitors and biosimilars could curtail Risvan’s market share and erode long-term revenues. Market access challenges due to pricing pressures or policy shifts are also notable risks.

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Future Outlook and Strategic Implications

Risvan’s success pivots on several factors:

• Accelerated path to approval and commercial readiness.
• Effective positioning against existing therapies.
• Strategic partnerships to expand geographic reach.
• Continuous evidence generation to reinforce clinical and economic value.

In the evolving landscape of targeted therapies, Risvan’s financial trajectory will hinge on its ability to navigate these complexities while establishing a sustainable, competitive advantage.

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Key Takeaways

• Risvan operates in a growing global market driven by unmet medical needs and increasing disease prevalence.
• Competitive differentiation depends on superior efficacy, safety, and strategic pricing aligned with payer expectations.
• Early approval prospects and successful market entry could rapidly elevate revenue streams, with peak sales potentially reaching billions.
• Costs during development and commercialization are high, but economies of scale and patent protection promise long-term profitability.
• Ongoing regulatory, competitive, and market access risks necessitate vigilant strategic planning.

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FAQs

1. What are the primary factors influencing Risvan’s market launch success?
Regulatory approval speed, clinical efficacy, safety profile, strategic pricing, reimbursement negotiations, and prescriber adoption are pivotal.

2. How does Risvan compare to existing therapies in its class?
Preliminary clinical data suggest Risvan offers improved efficacy and tolerability; however, comprehensive comparative studies are essential for definitive positioning.

3. What barriers could impede Risvan’s financial growth?
Regulatory delays, adverse safety findings, aggressive biosimilar competition, pricing disagreements, and restricted reimbursement can hinder revenue growth.

4. What is the projected timeline for Risvan to reach peak revenue?
Assuming rapid approval and market penetration, peak revenues could be realized within 6 to 10 years post-launch.

5. How can stakeholders mitigate risks associated with Risvan?
By investing in robust clinical development, maintaining strategic pricing, securing intellectual property, and engaging early with healthcare policymakers, stakeholders can mitigate potential risks.

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References

[1] World Health Organization. (2022). Global Disease Burden Data.
Note: Actual source references should be verified and cited accordingly.