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-two patent family members in thirty-six countries.

The generic ingredient in RISVAN 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 Risvan

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

Summary for RISVAN

International Patents:	182
US Patents:	14
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	2,495
What excipients (inactive ingredients) are in RISVAN?	RISVAN excipients list
DailyMed Link:	RISVAN at DailyMed

Pharmacology for RISVAN

Drug Class

Atypical Antipsychotic

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	11,752,093		Y
Labs Farms Rovi Sa	RISVAN	risperidone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	214835-002	Mar 29, 2024		DISCN	Yes	No	10,335,366		Y
Labs Farms Rovi Sa	RISVAN	risperidone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	214835-001	Mar 29, 2024		DISCN	Yes	No	11,752,092
Labs Farms Rovi Sa	RISVAN	risperidone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	214835-002	Mar 29, 2024		DISCN	Yes	No	11,173,110
Labs Farms Rovi Sa	RISVAN	risperidone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	214835-002	Mar 29, 2024		DISCN	Yes	No	10,881,605		Y
Labs Farms Rovi Sa	RISVAN	risperidone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	214835-001	Mar 29, 2024		DISCN	Yes	No	11,759,416
Labs Farms Rovi Sa	RISVAN	risperidone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	214835-001	Mar 29, 2024		DISCN	Yes	No	11,007,139

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/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 RISVAN

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

Country	Patent Number	Title	Estimated Expiration
South Africa	201501426	INJECTABLE COMPOSITIONS COMPRISING LETROZOLE OR ANASTROZOLE
South Korea	20150015020	Paliperidone implant formulation
Portugal	2394663
Brazil	112014029209	formulação para implante de risperidona ou paliperidona
Morocco	37870	Compositions injectables comprenant du létrozole ou de l'anastrozole
Hungary	E058322
Croatia	P20140158

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

RISVAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Risvan®

Introduction

Risvan®, the brand name for Risperidone ISM® in the United States, Canada, and Australia, is a significant product in the pharmaceutical portfolio of Laboratorios Farmaceuticos ROVI. This long-acting injectable is designed for the treatment of schizophrenia in adults, and its market dynamics and financial trajectory are shaped by several key factors.

Regulatory Approvals

A crucial milestone for Risvan® was the approval by the U.S. Food and Drug Administration (FDA) in March 2024. This approval marked a significant step in ROVI's international expansion strategy, as it also received approvals in Canada and Australia in the same period[4].

Market Launch and Expansion

Risvan® was initially launched in several European countries, including Germany, the United Kingdom, Spain, Portugal, Italy, Austria, Greece, and Serbia. The product's launch in the U.S., Canada, and Australia in 2024 is expected to significantly boost its global presence and sales[4].

Sales Performance

In 2023, the sales of Okedi® (the European brand name for Risperidone ISM®) were 14.4 million euros, with a notable 42% increase in the fourth quarter compared to the third quarter of the year. This growth indicates strong market acceptance and potential for further expansion[1][4].

Global Sales Projections

ROVI forecasts that Risvan® could achieve potential sales of between 200 and 300 million euros globally in the upcoming years. This projection is based on the product's differential characteristics and its positioning in the market for long-acting injectables to treat schizophrenia[4].

Competitive Landscape

The market for schizophrenia treatments is competitive, but Risvan®'s unique delivery technology and long-acting formulation provide it with a competitive edge. The product's approval and launch in key markets will help it to capture a significant share of the global schizophrenia treatment market[4].

Pricing and Revenue Strategies

The pricing strategy for Risvan® will be influenced by various market dynamics, including the impact of the Inflation Reduction Act (IRA) in the U.S. market. Manufacturers are adjusting to new economic realities, which may involve higher list prices at launch to account for inevitable net price declines over the product's lifecycle[3].

Clinical and Regulatory Requirements

As part of the FDA approval, ROVI is required to conduct a postmarketing pharmacokinetic study to evaluate exposure to Risvan® similar to the daily administration of 6mg of oral risperidone. This study, while not affecting the approval or marketing of Risvan®, is a standard regulatory requirement and will be completed by July 2026[4].

Financial Impact on ROVI

The approval and launch of Risvan® are expected to positively impact ROVI's financial performance. The company's operating revenue and specialty pharmaceutical business sales have shown stability and growth, with the specialty pharmaceutical business increasing by 1% in 2023 compared to 2022. The addition of Risvan® to the global market is anticipated to contribute significantly to ROVI's revenue growth in the coming years[1][4].

Industrial Expansion

ROVI's industrial presence is also expanding, with the approval of its new sodium heparin plant in Escúzar, Granada, in June 2024. This expansion positions ROVI as one of the largest pharmaceutical industrial groups in Spain, with eight fully-integrated plants and a ninth under construction. This infrastructure will support the production and supply of Risvan® and other products[4].

Market Access Trends

The U.S. market access trends for 2024, as outlined by IQVIA, highlight the importance of evidence generation, including Health Economic Outcomes Research (HEOR), Real World Evidence (RWE), and Patient Reported Outcomes (PRO). These trends suggest that manufacturers like ROVI will need to focus on demonstrating the value of their products through robust evidence to navigate the complex U.S. market[3].

Conclusion

Risvan® is poised to become a significant player in the global market for schizophrenia treatments. With its recent FDA approval, international expansion, and strong sales performance, the product is expected to drive substantial revenue growth for ROVI. The company's commitment to clinical studies, regulatory compliance, and industrial expansion further solidifies its position in the pharmaceutical industry.

Key Takeaways

• FDA Approval: Risvan® received FDA approval in March 2024, marking a significant milestone in its global expansion.
• Sales Projections: ROVI forecasts potential sales of between 200 and 300 million euros globally for Risvan®.
• Market Expansion: The product has been launched in several European countries and recently in the U.S., Canada, and Australia.
• Competitive Edge: Risvan®'s unique delivery technology provides a competitive edge in the schizophrenia treatment market.
• Regulatory Requirements: A postmarketing pharmacokinetic study is required by the FDA, to be completed by July 2026.
• Financial Impact: The launch of Risvan® is expected to positively impact ROVI's financial performance.

FAQs

Q: What is Risvan®, and how is it used? A: Risvan® is a long-acting injectable formulation of risperidone, used for the treatment of schizophrenia in adults.

Q: When did Risvan® receive FDA approval? A: Risvan® received FDA approval in March 2024.

Q: What are the projected global sales for Risvan®? A: ROVI forecasts potential sales of between 200 and 300 million euros globally for Risvan® in the upcoming years.

Q: In which countries has Risvan® been launched? A: Risvan® has been launched in several European countries, including Germany, the UK, Spain, and others, and recently in the U.S., Canada, and Australia.

Q: What additional regulatory requirements must ROVI fulfill for Risvan®? A: ROVI must conduct a postmarketing pharmacokinetic study to evaluate exposure to Risvan® similar to the daily administration of 6mg of oral risperidone, with the final report to be submitted before July 2026.

Sources

1. Laboratorios Farmaceuticos ROVI - Results_Press Release[1]
2. Servier - Newsroom: Servier confirms its 2025 trajectory to achieve its 2030 ambition[2]
3. IQVIA - Top 10 U.S. Market Access Trends for 2024[3]
4. Laboratorios Farmaceuticos ROVI - ROVI forecasts potential Risperidone ISM® sales of between 200 and 300 million euros globally[4]
5. Laboratorios Farmaceuticos ROVI - Results_Press Release[5]