LUVOX CR Drug Patent Profile

When do Luvox Cr patents expire, and when can generic versions of Luvox Cr launch?

Luvox Cr is a drug marketed by Jazz Pharms and is included in one NDA.

The generic ingredient in LUVOX CR is fluvoxamine maleate. There are eleven drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the fluvoxamine maleate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Luvox Cr

A generic version of LUVOX CR was approved as fluvoxamine maleate by UPSHER SMITH LABS on November 29^th, 2000.

Summary for LUVOX CR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	73
Patent Applications:	1,100
DailyMed Link:	LUVOX CR at DailyMed

Paragraph IV (Patent) Challenges for LUVOX CR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LUVOX CR	Extended-release Capsules	fluvoxamine maleate	100 mg	022033	1	2009-04-20
LUVOX CR	Extended-release Capsules	fluvoxamine maleate	150 mg	022033	1	2009-04-13

US Patents and Regulatory Information for LUVOX CR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Jazz Pharms	LUVOX CR	fluvoxamine maleate	CAPSULE, EXTENDED RELEASE;ORAL	022033-001	Feb 28, 2008		DISCN	Yes	No
Jazz Pharms	LUVOX CR	fluvoxamine maleate	CAPSULE, EXTENDED RELEASE;ORAL	022033-002	Feb 28, 2008		DISCN	Yes	No

Expired US Patents for LUVOX CR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Jazz Pharms	LUVOX CR	fluvoxamine maleate	CAPSULE, EXTENDED RELEASE;ORAL	022033-001	Feb 28, 2008
Jazz Pharms	LUVOX CR	fluvoxamine maleate	CAPSULE, EXTENDED RELEASE;ORAL	022033-002	Feb 28, 2008

International Patents for LUVOX CR

See the table below for patents covering LUVOX CR around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1178780	PREPARATIONS D'INHIBITEURS SPECIFIQUES DU RECAPTAGE DE LA SEROTONINE A LIBERATION MULTIPARTICULAIRE REGULEE (MULTIPARTICULATE CONTROLLED RELEASE SELECTIVE SEROTONIN REUPTAKE INHIBITOR FORMULATIONS)
Canada	2374039	PREPARATIONS D'INHIBITEURS SPECIFIQUES DU RECAPTAGE DE LA SEROTONINE A LIBERATION MULTIPARTICULAIRE REGULEE (MULTIPARTICULATE CONTROLLED RELEASE SELECTIVE SEROTONIN REUPTAKE INHIBITOR FORMULATIONS)
Ireland	990406
Algeria	3256	PREPARATIONS D'INHIBITEURS SPECIFIQUES DU RECAPTAGE DE LA SEROTONINE A LIBERATION MULTIPARTICULAIRE REGULEE
Slovakia	286865
Hungary	0201884
Austria	367153

LUVOX CR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for LUVOX CR

Introduction to LUVOX CR

LUVOX CR, or fluvoxamine maleate extended-release capsules, is a selective serotonin reuptake inhibitor (SSRI) approved by the FDA for the treatment of social anxiety disorder (SAD) and obsessive-compulsive disorder (OCD) in adults. This medication incorporates Elan's SODAS® (Spheroidal Oral Drug Absorption System) technology, designed to minimize peak-to-trough plasma level fluctuations over a 24-hour period, enabling once-daily dosing[3][4].

Market Opportunity

The market for LUVOX CR is driven by the prevalence of anxiety disorders such as OCD and SAD. These conditions are chronic and often underdiagnosed and undertreated, affecting millions of people worldwide. For instance, approximately 15 million Americans suffer from SAD, and 2.2 million from OCD[4].

Clinical Efficacy and Approval

The FDA approval of LUVOX CR was based on a data package involving approximately 600 patients worldwide, including three clinical trials that demonstrated positive outcomes in terms of efficacy and safety. These trials showed statistically significant improvements in SAD symptoms as measured by the Liebowitz Social Anxiety Scale (LSAS) and in OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)[4].

Market Launch and Commercialization

LUVOX CR was launched in the first quarter of 2008 by Jazz Pharmaceuticals, following an exclusive licensing agreement with Solvay Pharmaceuticals. Jazz Pharmaceuticals has the rights to market and distribute LUVOX CR in the U.S., while Solvay retained the rights outside of the U.S.[3][4].

Financial Aspects

The financial trajectory of LUVOX CR is closely tied to its market performance and the overall financial health of Jazz Pharmaceuticals.

Revenue Generation

The launch of LUVOX CR contributed to the revenue growth of Jazz Pharmaceuticals. For example, the company recorded significant revenues from product sales, including those from LUVOX CR, which helped in offsetting some of the operational expenses. In the financial reports, product sales, royalties, and contract revenues were key components of the total revenue[2].

Costs and Expenses

The costs associated with the development, marketing, and distribution of LUVOX CR are substantial. These include research and development expenses, selling, general, and administrative costs, and the amortization of intangible assets. For instance, in the six months ended June 30, 2009, Jazz Pharmaceuticals incurred significant research and development expenses and selling, general, and administrative costs[2].

Challenges and Risks

Despite the market potential, there are several challenges that could impact the financial trajectory of LUVOX CR. These include high drug costs, side effects associated with fluvoxamine, and lack of awareness about the condition and the treatment. Additionally, any failure by Elan to supply the necessary quantities of LUVOX CR could have a material adverse effect on Jazz Pharmaceuticals' business and financial condition[2][3].

Market Growth Drivers

Several factors are expected to drive the growth of the LUVOX CR market:

Increasing Prevalence of Anxiety Disorders

The rise in the prevalence of anxiety and depression, including OCD and SAD, is a major driver for the expansion of the fluvoxamine market. This increasing demand is expected to continue, driven by growing awareness and better diagnostic tools[1].

Geriatric Population and Healthcare Expenditure

The increasing geriatric population and rising healthcare expenditure are also expected to contribute to market growth. Older adults are more likely to suffer from anxiety disorders, and increased healthcare spending can lead to higher adoption rates of treatments like LUVOX CR[1].

Research and Development Activities

Ongoing research and development activities, including clinical trials, will provide beneficial opportunities for the fluvoxamine market. The post-marketing commitment to conduct safety and efficacy studies in adolescent patients and long-term studies in patients with SAD will further enhance the market potential[1][4].

Regional Market Performance

The market performance of LUVOX CR varies by region:

North America

North America dominates the fluvoxamine market due to the presence of major key players, high disposable income, and well-developed healthcare infrastructure. Jazz Pharmaceuticals' strong presence in this region has been a significant factor in the market success of LUVOX CR[1].

Asia-Pacific

The Asia-Pacific region is expected to grow during the forecast period due to increasing research and development activities and the rise in the prevalence of OCD in this region. This growth is anticipated to contribute to the overall market expansion of fluvoxamine-based treatments like LUVOX CR[1].

Patient Epidemiology and Compliance

The once-daily dosing regimen of LUVOX CR significantly improves patient compliance and acceptability. This formulation, combined with its proven efficacy and favorable tolerability profile, makes it an attractive treatment option for patients with OCD and SAD[3][4].

Key Takeaways

• Market Growth: The fluvoxamine market, including LUVOX CR, is expected to grow at a CAGR of 4% from 2022 to 2029.
• Clinical Efficacy: LUVOX CR has demonstrated statistically significant improvements in treating OCD and SAD.
• Financial Performance: The launch of LUVOX CR has contributed to the revenue growth of Jazz Pharmaceuticals, despite significant operational expenses.
• Regional Performance: North America dominates the market, with Asia-Pacific expected to show significant growth.
• Challenges: High drug costs, side effects, and lack of awareness are potential challenges to market growth.

FAQs

1. What is LUVOX CR used for? LUVOX CR is used for the treatment of social anxiety disorder (SAD) and obsessive-compulsive disorder (OCD) in adults.

2. What technology does LUVOX CR use? LUVOX CR incorporates Elan's SODAS® (Spheroidal Oral Drug Absorption System) technology, designed to minimize peak-to-trough plasma level fluctuations over a 24-hour period.

3. Who are the key players involved in the market for LUVOX CR? Jazz Pharmaceuticals, Solvay Pharmaceuticals, and Elan are key players involved in the development, licensing, and distribution of LUVOX CR.

4. What are the major drivers for the growth of the LUVOX CR market? The major drivers include the increasing prevalence of anxiety disorders, the growing geriatric population, rising healthcare expenditure, and ongoing research and development activities.

5. What are the potential challenges to the market growth of LUVOX CR? High drug costs, side effects associated with fluvoxamine, and lack of awareness about the condition and the treatment are potential challenges.

Cited Sources

1. Data Bridge Market Research - Global Fluvoxamine Market - Industry Trends and Forecast to 2029[1].
2. Jazz Pharmaceuticals, Inc. - Financial Reports and Investor Information[2].
3. Jazz Pharmaceuticals, Inc. - FDA Approval and Commercialization Details[3].
4. Jazz Pharmaceuticals, Inc. - FDA Approval Press Release for LUVOX CR[4].