FLUVOXAMINE MALEATE - Generic Drug Details

What are the generic drug sources for fluvoxamine maleate and what is the scope of patent protection?

Fluvoxamine maleate is the generic ingredient in three branded drugs marketed by Actavis Elizabeth, Ajanta Pharma Ltd, Bionpharma, Endo Operations, Torrent, Jazz Pharms, Ani Pharms, Apotex, Chartwell Rx, Heritage Pharma, Mylan, Norvium Bioscience, Sun Pharm Industries, Synthon Pharms, Teva, Upsher Smith Labs, and Solvay, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for fluvoxamine maleate. Thirteen suppliers are listed for this compound.

Summary for FLUVOXAMINE MALEATE

US Patents:	0
Tradenames:	3
Applicants:	17
NDAs:	22
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	142
Clinical Trials:	6
Patent Applications:	2,762
Drug Prices:	Drug price trends for FLUVOXAMINE MALEATE
What excipients (inactive ingredients) are in FLUVOXAMINE MALEATE?	FLUVOXAMINE MALEATE excipients list
DailyMed Link:	FLUVOXAMINE MALEATE at DailyMed

See drug prices for FLUVOXAMINE MALEATE

Recent Clinical Trials for FLUVOXAMINE MALEATE

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

Sponsor	Phase
AbbVie	Phase 4
The Medical Research Network	Phase 4
Haining Health-Coming Biotech Co., Ltd.	Phase 2

See all FLUVOXAMINE MALEATE clinical trials

Pharmacology for FLUVOXAMINE MALEATE

Drug Class	Serotonin Reuptake Inhibitor
Mechanism of Action	Serotonin Uptake Inhibitors

Medical Subject Heading (MeSH) Categories for FLUVOXAMINE MALEATE

Anti-Anxiety Agents

Antidepressive Agents, Second-Generation

Cytochrome P-450 CYP1A2 Inhibitors

Cytochrome P-450 CYP2C19 Inhibitors

Serotonin Uptake Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for FLUVOXAMINE MALEATE

N06AB	Selective serotonin reuptake inhibitors
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for FLUVOXAMINE MALEATE

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 FLUVOXAMINE MALEATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actavis Elizabeth	FLUVOXAMINE MALEATE	fluvoxamine maleate	TABLET;ORAL	075901-003	Dec 28, 2000		DISCN	No	No
Actavis Elizabeth	FLUVOXAMINE MALEATE	fluvoxamine maleate	TABLET;ORAL	075901-002	Dec 28, 2000		DISCN	No	No
Ajanta Pharma Ltd	FLUVOXAMINE MALEATE	fluvoxamine maleate	CAPSULE, EXTENDED RELEASE;ORAL	219055-002	Oct 17, 2024	AB	RX	No	No
Ani Pharms	FLUVOXAMINE MALEATE	fluvoxamine maleate	TABLET;ORAL	075898-003	Mar 12, 2001		DISCN	No	No
Actavis Elizabeth	FLUVOXAMINE MALEATE	fluvoxamine maleate	TABLET;ORAL	075901-001	Dec 28, 2000		DISCN	No	No
Synthon Pharms	FLUVOXAMINE MALEATE	fluvoxamine maleate	TABLET;ORAL	075899-001	Jan 17, 2001		DISCN	No	No

Expired US Patents for FLUVOXAMINE MALEATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Solvay	LUVOX	fluvoxamine maleate	TABLET;ORAL	020243-003	Dec 5, 1994
Jazz Pharms	LUVOX CR	fluvoxamine maleate	CAPSULE, EXTENDED RELEASE;ORAL	022033-001	Feb 28, 2008
Solvay	LUVOX	fluvoxamine maleate	TABLET;ORAL	020243-004	Dec 5, 1994
Solvay	LUVOX	fluvoxamine maleate	TABLET;ORAL	020243-002	Dec 5, 1994
Solvay	LUVOX	fluvoxamine maleate	TABLET;ORAL	020243-001	Dec 5, 1994
Jazz Pharms	LUVOX CR	fluvoxamine maleate	CAPSULE, EXTENDED RELEASE;ORAL	022033-002	Feb 28, 2008

FLUVOXAMINE MALEATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fluvoxamine Maleate

Introduction to Fluvoxamine Maleate

Fluvoxamine maleate is a selective serotonin reuptake inhibitor (SSRI) commonly used to treat depression, obsessive-compulsive disorder (OCD), and other mental health conditions. The drug is available in various forms, including tablets and extended-release capsules, and is marketed under brand names such as Luvox and Luvox CR.

Market Size and Growth Projections

The global fluvoxamine maleate market has been experiencing significant growth and is projected to continue this trend. As of 2023, the market size was valued at several billion USD and is expected to reach even higher figures by 2031, with a compound annual growth rate (CAGR) that indicates robust expansion[3][5].

Segmentation of the Market

The fluvoxamine maleate market is segmented based on several key factors:

• Type: The market is categorized by dosage strengths such as 25mg, 50mg, 75mg, and 100mg tablets[3][5].
• Application: The primary applications include the treatment of depression and obsessive-compulsive disorder (OCD)[3][5].
• Geographical Regions: The market is analyzed across North America, Europe, Asia-Pacific, South America, and the Middle East and Africa[3][5].

Market Drivers

Several factors are driving the growth of the fluvoxamine maleate market:

• Increasing Prevalence of Mental Health Disorders: The rise in anxiety, depression, and OCD cases is a significant driver. As mental health awareness increases, more people are seeking treatment, which in turn boosts the demand for fluvoxamine maleate[4].
• Aging Population: The growing geriatric population is more prone to mental health issues, contributing to the market's expansion[4].
• Healthcare Expenditure: Increased healthcare spending and improved healthcare infrastructure, particularly in regions like North America, are supporting market growth[4].
• Research and Development: Ongoing clinical trials and research activities are expected to provide new opportunities for the market[4].

Market Restraints

Despite the positive trends, there are several challenges that could hamper the market growth:

• High Cost of the Drug: The expensive nature of fluvoxamine maleate can limit its accessibility, especially in regions with lower healthcare budgets[4].
• Side Effects: Common side effects such as diarrhea, headache, indigestion, and others can deter some patients from using the drug[4].
• Lack of Awareness: In some regions, there is a lack of awareness about mental health conditions and the available treatments, which can slow market growth[4].

Regional Analysis

• North America: This region dominates the fluvoxamine maleate market due to the presence of major pharmaceutical companies, high disposable income, and well-developed healthcare infrastructure[4].
• Asia-Pacific: This region is expected to grow significantly due to increasing research and development activities and a rising prevalence of OCD[4].

Competitive Landscape

Key players in the fluvoxamine maleate market include Solvay Pharmaceuticals, Abbott Laboratories, and Jazz Pharmaceuticals. These companies are focusing on strengthening their product portfolios and expanding their business through strategic agreements and milestones. For instance, Jazz Pharmaceuticals has been involved in the development and commercialization of Luvox CR, an extended-release formulation of fluvoxamine maleate[2].

Financial Trajectory

The financial performance of companies involved in the fluvoxamine maleate market is influenced by several factors:

• Revenue from Sales: Companies like Jazz Pharmaceuticals generate significant revenue from the sales of fluvoxamine maleate products. For example, the net product sales of related medications can be substantial, although specific figures for fluvoxamine maleate are not always disclosed separately[2].
• Milestone Payments and Royalties: Companies often make milestone payments and pay royalties based on net product sales, which can impact their financials. For instance, Jazz Pharmaceuticals has agreements with Solvay and Elan that involve such payments[2].
• Research and Development Expenses: The cost of ongoing clinical trials and research activities is a significant expense for these companies. However, these investments are crucial for future market growth and product development[2].

Market Dynamics Analysis

The market dynamics are shaped by a combination of drivers, restraints, opportunities, and challenges. Here are some key points:

• Drivers and Restraints: Positive factors include the increasing prevalence of mental health disorders and rising healthcare expenditure, while negative factors include the high cost of the drug and side effects[4].
• Opportunities: Ongoing research and development activities and the growing awareness of mental health treatments present opportunities for market expansion[4].
• Challenges: Lack of awareness in some regions and the presence of side effects are challenges that need to be addressed[4].

Technological and Regulatory Trends

• Extended-Release Formulations: The development of extended-release formulations like Luvox CR is a technological advancement that enhances patient compliance and efficacy[2].
• Regulatory Approvals: The process of obtaining regulatory approvals, such as the FDA's approvable letter for Luvox CR, is crucial for market entry and growth[2].

Consumer Behavior Analysis

Consumer behavior plays a significant role in the fluvoxamine maleate market:

• Increasing Awareness: As awareness about mental health conditions increases, more consumers are seeking treatment, driving the demand for fluvoxamine maleate[4].
• Patient Compliance: The availability of extended-release formulations improves patient compliance, which is a positive factor for market growth[2].

Key Takeaways

• The fluvoxamine maleate market is expected to grow significantly due to increasing mental health awareness and rising healthcare expenditure.
• Key drivers include the growing prevalence of anxiety and depression, an aging population, and ongoing research activities.
• Challenges such as high drug costs and side effects need to be addressed.
• North America dominates the market, but the Asia-Pacific region is expected to grow rapidly.
• Technological advancements and regulatory approvals are crucial for market growth.

FAQs

Q: What are the primary applications of fluvoxamine maleate? A: The primary applications include the treatment of depression and obsessive-compulsive disorder (OCD)[3][5].

Q: Which region dominates the fluvoxamine maleate market? A: North America dominates the market due to the presence of major pharmaceutical companies and well-developed healthcare infrastructure[4].

Q: What are the key drivers of the fluvoxamine maleate market? A: Key drivers include the increasing prevalence of mental health disorders, an aging population, and rising healthcare expenditure[4].

Q: What are some of the challenges facing the fluvoxamine maleate market? A: Challenges include the high cost of the drug, side effects, and lack of awareness in some regions[4].

Q: Which companies are major players in the fluvoxamine maleate market? A: Major players include Solvay Pharmaceuticals, Abbott Laboratories, and Jazz Pharmaceuticals[1][2].

Cited Sources

1. Cognitivemarketresearch.com: Fluvoxamine Maleate Market Report 2024 (Global Edition)
2. Jazzpharma.com: JAZZ PHARMACEUTICALS, INC. - Investors
3. Marketresearchintellect.com: Global Fluvoxamine Maleate Tablets Market
4. Databridgemarketresearch.com: Global Fluvoxamine Market - Industry Trends and Forecast to 2029
5. Marketresearchintellect.com: Fluvoxamine Maleate Tablets Market Size, Scope And Forecast Report