LUVOX Drug Patent Profile

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

Luvox is a drug marketed by Ani Pharms, Solvay, and Jazz Pharms. and is included in three NDAs.

The generic ingredient in LUVOX 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

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

Summary for LUVOX

US Patents:	0
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	73
Patent Applications:	1,139
DailyMed Link:	LUVOX at DailyMed

US Patents and Regulatory Information for LUVOX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ani Pharms	LUVOX	fluvoxamine maleate	TABLET;ORAL	021519-001	Dec 20, 2007	AB	RX	Yes	No
Solvay	LUVOX	fluvoxamine maleate	TABLET;ORAL	020243-004	Dec 5, 1994		DISCN	Yes	No
Solvay	LUVOX	fluvoxamine maleate	TABLET;ORAL	020243-001	Dec 5, 1994		DISCN	Yes	No
Jazz Pharms	LUVOX CR	fluvoxamine maleate	CAPSULE, EXTENDED RELEASE;ORAL	022033-001	Feb 28, 2008		DISCN	Yes	No
Ani Pharms	LUVOX	fluvoxamine maleate	TABLET;ORAL	021519-002	Dec 20, 2007	AB	RX	Yes	No
Ani Pharms	LUVOX	fluvoxamine maleate	TABLET;ORAL	021519-003	Dec 20, 2007	AB	RX	Yes	No
Solvay	LUVOX	fluvoxamine maleate	TABLET;ORAL	020243-003	Dec 5, 1994		DISCN	Yes	No

Expired US Patents for LUVOX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Solvay	LUVOX	fluvoxamine maleate	TABLET;ORAL	020243-001	Dec 5, 1994	4,085,225
Solvay	LUVOX	fluvoxamine maleate	TABLET;ORAL	020243-004	Dec 5, 1994	4,085,225
Solvay	LUVOX	fluvoxamine maleate	TABLET;ORAL	020243-003	Dec 5, 1994	4,085,225
Solvay	LUVOX	fluvoxamine maleate	TABLET;ORAL	020243-002	Dec 5, 1994	4,085,225

International Patents for LUVOX

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

Country	Patent Number	Title	Estimated Expiration
Switzerland	629477	VERFAHREN ZUR HERSTELLUNG NEUER OXIMAETHERVERBINDUNGEN.
Switzerland	629184	VERFAHREN ZUR HERSTELLUNG NEUER OXIMAETHERVERBINDUNGEN.
Austria	342568
Denmark	144942
Switzerland	626057
Poland	100614
Finland	760699

LUVOX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for LUVOX (Fluvoxamine)

Introduction to LUVOX (Fluvoxamine)

LUVOX, known generically as fluvoxamine, is a selective serotonin reuptake inhibitor (SSRI) used primarily to treat obsessive-compulsive disorder (OCD), depression, and post-traumatic stress disorder (PTSD). It is available in tablet and capsule forms under the brand names Luvox and Luvox CR.

Market Growth and Forecast

The fluvoxamine market is anticipated to experience significant growth over the forecast period. According to market research, the fluvoxamine market is expected to grow at a Compound Annual Growth Rate (CAGR) of around 4% from 2022 to 2029[1][4].

Drivers of Market Growth

Several factors are driving the growth of the fluvoxamine market:

• Increasing Prevalence of Mental Health Disorders: The rise in anxiety and depression cases is a major driver for the expansion of the fluvoxamine market.
• Growing Geriatric Population: An increase in the geriatric population, who are more prone to mental health issues, is expected to boost the demand for fluvoxamine.
• Rising Healthcare Expenditure: Increased healthcare spending globally is likely to support the growth of the fluvoxamine market.
• Research and Development: Ongoing clinical trials and research activities are expected to provide beneficial opportunities for the market[1][4].

Market Segmentation

The fluvoxamine market is segmented based on several criteria:

By Drug Class

• Antidepressant
• Selective Serotonin Reuptake Inhibitor (SSRI)
• Others[1]

By Application

• Obsessive-Compulsive Disorder (OCD)
• Depression
• Post-Traumatic Stress Disorder (PTSD)
• Anxiety Disorders
• Panic Disorder[1][4]

By Demographic

• Adult
• Pediatric
• Geriatric[1][4]

By Dosage Form

• Tablet
• Capsule
• Liquid[4]

By Route of Administration

• Oral
• Others[1]

By End-Users

• Clinic
• Hospital
• Others[1]

By Distribution Channel

• Hospital Pharmacy
• Retail Pharmacy
• Online Pharmacy[1][4]

Regional Analysis

The fluvoxamine market is analyzed across various regions:

North America

North America dominates the fluvoxamine market due to the presence of major key players, high disposable income, and well-developed healthcare infrastructure in this region[1].

Asia-Pacific

The Asia-Pacific region is expected to grow significantly during the forecast period due to increasing research and development activities and the rising prevalence of OCD in this region[1].

Europe, South America, and Middle East & Africa

These regions also show potential for growth, driven by factors such as increasing awareness of mental health disorders and improving healthcare infrastructure[1][4].

Financial Performance and Challenges

Historical Financial Data

Historical financial data for companies involved in the production and distribution of fluvoxamine, such as Jazz Pharmaceuticals, highlights the financial complexities. For instance, in 2009, Jazz Pharmaceuticals faced significant financial challenges, including substantial losses from operations and default on senior secured notes. However, the company managed to raise additional capital and reduce costs to continue operations[2].

Current Financial Trajectory

Despite historical challenges, the current financial trajectory for fluvoxamine looks promising due to the growing demand for mental health treatments. The market's expected growth rate and increasing healthcare expenditure are likely to improve the financial performance of companies in this sector.

Challenges and Limitations

High Cost of the Drug

One of the significant challenges facing the fluvoxamine market is the high cost of the drug, which can limit its accessibility to a broader patient population[1].

Side Effects

Fluvoxamine is associated with several side effects, including diarrhea, headache, indigestion, nausea, dry mouth, stomach-ache, weight loss, dizziness, and fatigue. These side effects can hamper market growth[1].

Lack of Awareness

Lack of awareness about mental health disorders and the availability of treatments like fluvoxamine can further challenge the market growth[1].

Patient Epidemiology and Clinical Guidelines

Patient Epidemiology

The patient epidemiology for fluvoxamine involves a detailed analysis of disease prevalence, demographics, and treatment patterns. For example, the increasing prevalence of OCD and depression among various demographics is a key factor driving the demand for fluvoxamine[1].

Clinical Guidelines

Clinical guidelines, such as those provided by the Clinical Pharmacogenetics Implementation Consortium (CPIC), recommend dose adjustments for fluvoxamine based on genetic factors, such as CYP2D6 genotypes. This ensures more personalized and effective treatment[3].

Key Takeaways

• The fluvoxamine market is expected to grow at a CAGR of around 4% from 2022 to 2029.
• Key drivers include the increasing prevalence of mental health disorders, growing geriatric population, and rising healthcare expenditure.
• The market is segmented by drug class, application, demographic, dosage form, route of administration, end-users, and distribution channel.
• North America dominates the market, but the Asia-Pacific region is expected to grow significantly.
• High drug costs, side effects, and lack of awareness are significant challenges.
• Clinical guidelines play a crucial role in optimizing treatment outcomes.

FAQs

What is fluvoxamine used for?

Fluvoxamine is used primarily to treat obsessive-compulsive disorder (OCD), depression, and post-traumatic stress disorder (PTSD).

What are the common side effects of fluvoxamine?

Common side effects include diarrhea, headache, indigestion, nausea, dry mouth, stomach-ache, weight loss, dizziness, and fatigue.

How is the fluvoxamine market segmented?

The market is segmented by drug class, application, demographic, dosage form, route of administration, end-users, and distribution channel.

Which region dominates the fluvoxamine market?

North America currently dominates the fluvoxamine market due to the presence of major key players and well-developed healthcare infrastructure.

What are the challenges facing the fluvoxamine market?

High drug costs, side effects associated with the medication, and lack of awareness about mental health disorders are significant challenges.

Sources

1. Data Bridge Market Research - Global Fluvoxamine Market - Industry Trends and Forecast to 2029
2. Jazz Pharmaceuticals, Inc. - [PDF] JAZZ PHARMACEUTICALS, INC.
3. PharmGKB - Annotation of CPIC Guideline for fluvoxamine and CYP2D6
4. Market Research Future - Fluvoxamine Market Size, Share Forecast 2032