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, Annora Pharma, Bionpharma, Ph Health, Torrent, Jazz Pharms, Aiping Pharm Inc, Ani Pharms, Apotex, Chartwell Rx, Heritage Pharma, Mylan, Quagen, Sun Pharm Industries, Synthon Pharms, Teva, Upsher Smith Labs, and Solvay, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for fluvoxamine maleate

US Patents:	0
Tradenames:	3
Applicants:	19
NDAs:	23
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	6
Patent Applications:	4,110
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
Annora Pharma	FLUVOXAMINE MALEATE	fluvoxamine maleate	CAPSULE, EXTENDED RELEASE;ORAL	217024-002	Jul 30, 2025	AB	RX	No	No
Chartwell Rx	FLUVOXAMINE MALEATE	fluvoxamine maleate	TABLET;ORAL	075900-002	Feb 23, 2006		DISCN	No	No
Ani Pharms	LUVOX	fluvoxamine maleate	TABLET;ORAL	021519-001	Dec 20, 2007	AB	RX	Yes	No
Quagen	FLUVOXAMINE MALEATE	fluvoxamine maleate	TABLET;ORAL	075889-003	Nov 29, 2000		DISCN	No	No

Expired US Patents for fluvoxamine maleate

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
Solvay	LUVOX	fluvoxamine maleate	TABLET;ORAL	020243-004	Dec 5, 1994
Solvay	LUVOX	fluvoxamine maleate	TABLET;ORAL	020243-003	Dec 5, 1994
Solvay	LUVOX	fluvoxamine maleate	TABLET;ORAL	020243-002	Dec 5, 1994

Market Dynamics and Financial Trajectory for Fluvoxamine Maleate

Last updated: July 27, 2025

Introduction

Fluvoxamine maleate, a selective serotonin reuptake inhibitor (SSRI), historically approved for obsessive-compulsive disorder (OCD), has garnered renewed interest amid the COVID-19 pandemic. Its off-label potential as an early intervention in COVID-19 treatment protocols has driven substantial shifts in its market landscape, driven by evolving scientific evidence, regulatory responses, and competitive dynamics. This report delineates the key market drivers, barriers, and financial outlook pertinent to fluvoxamine maleate.

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Pharmacological Profile and Therapeutic Indications

Fluvoxamine maleate operates as an SSRI, modulating serotonergic pathways implicated in depression, OCD, and anxiety disorders[^1]. Its well-established safety profile has facilitated widespread approval in multiple jurisdictions, including the United States, Europe, and parts of Asia.

During the COVID-19 pandemic, preliminary studies indicated that fluvoxamine might mitigate cytokine storms and reduce disease progression[^2]. Observational and randomized clinical trials, notably those conducted by the University of Chicago, suggested a potential in early outpatient management, prompting calls for emergency use authorization (EUA) and expanded research[^3].

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Market Dynamics Influencing Fluvoxamine Maleate

1. Scientific and Clinical Evidence

The trajectory of fluvoxamine's market expansion hinges substantially on emerging clinical data. Initial small-scale studies appeared promising; however, larger trials yielded mixed results, inhibiting conclusive regulatory approvals[^4]. The pivotal issue remains the robustness of evidence demonstrating efficacy in COVID-19, which continues to evolve.

The medical community's skepticism, compounded by conflicting trial outcomes, acts as a constraining factor for broad adoption within COVID-19 therapeutics[^5].

2. Regulatory Environment and Policy

Regulatory bodies have shown cautious interest. The U.S. Food and Drug Administration (FDA) has not approved fluvoxamine specifically for COVID-19, but ongoing clinical research sustains investor and manufacturer confidence[^6]. Conversely, some nations have considered or implemented emergency use authorization or off-label prescribing, influencing immediate market access.

Post-pandemic, regulatory considerations include post-marketing surveillance, patent rights, and potential labeling updates reflecting new indications.

3. Competitive Landscape

Fluvoxamine faces stiff competition from several antiviral and anti-inflammatory agents—such as remdesivir, dexamethasone, and monoclonal antibodies—many of which possess more extensive clinical validation for COVID-19[^7]. Nonetheless, its oral administration, affordability, and known safety profile position it as a potentially accessible candidate for early outpatient therapy, especially in low-resource settings.

Emerging pharmacotherapies and novel drug development pipelines for COVID-19 further complicate market positioning.

4. Manufacturing and Supply Chain

Existing manufacturing infrastructure for fluvoxamine, being an established antidepressant, provides cost advantages and scalability. However, increased demand for COVID-19-related use could strain supply chains, encouraging partnerships and license agreements to ensure availability.

5. Intellectual Property and Patent Landscape

Fluvoxamine maleate, already off-patent or nearing patent expiry in many jurisdictions, offers high generic potential. This positions the drug as a cost-effective alternative but limits exclusive revenue streams unless new formulations or delivery methods are patent-protected[^8].

6. Market Penetration and Adoption

Adoption rates depend on clinicians’ trust in emerging clinical data and regulatory endorsements. Widespread use in mental health settings ensures familiarity but transitioning into COVID-19 treatment paradigms necessitates robust evidence, clinician endorsements, and inclusion in treatment guidelines.

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Financial Trajectory

1. Revenue Generation Potential

Given the drug’s established status, baseline revenues from mental health indications remain stable. The pandemic-driven off-label use has temporarily increased demand, with some markets experiencing surges in prescriptions.

Potential COVID-19-specific sales could catalyze revenue growth if large-scale, definitive evidence supports efficacy. However, without strong regulatory backing, this remains uncertain.

2. Market Size Estimations

Before COVID-19, the global antidepressant market was valued at approximately USD 15 billion in 2021[^9]. Fluvoxamine accounts for a minor segment within SSRIs, but its off-label COVID-19 use could expand this segment temporarily.

Analysts estimate that if fluvoxamine gains regulatory approval for COVID-19, a significant revenue boost — potentially exceeding USD 1 billion annually — would ensue globally, especially in developing markets where cost-effective treatments are prioritized[^10]. Conversely, lack of approval or limited efficacy evidence would restrict growth.

3. R&D and Commercial Investment

Pharmaceutical companies investing in further clinical trials, regulatory submissions, and marketing campaigns need to weigh the uncertain return on investment. Adaptation of formulations, patents, or combination therapies may influence future revenues.

4. Risks and Challenges

The primary challenge remains the ambiguity of clinical evidence. Negative trial outcomes and regulatory skepticism could erode stock value and market confidence. Price erosion due to generic competition also constrains profitability.

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Key Drivers and Barriers

Drivers	Barriers
Existing safety profile and manufacturability	Mixed clinical evidence regarding efficacy for COVID-19
Oral administration and low cost	Lack of explicit regulatory approval for COVID-19 indication
Potential benefits in early-stage outpatient COVID-19 treatment	Competition from other repurposed drugs and novel agents
Growing demand for accessible COVID-19 therapies	patent limitations restrict high-margin innovations
Experience in mental health indications	Changing regulatory landscape and evolving scientific consensus

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Future Outlook and Strategic Considerations

The future financial trajectory depends heavily on the outcomes of ongoing clinical trials. Players with vested interests—pharmaceutical firms, investors, and health authorities—should monitor data releases closely.

Strategic opportunities include:

• Clinical trial investments: Supporting large, multicenter Phase III trials to generate definitive evidence could unlock new indications and revenue streams.
• Regulatory engagement: Engaging with agencies for expedited review pathways based on emerging data.
• Market positioning: Leveraging existing manufacturing capacities to prepare for potential demand surges.
• Combination therapies: Developing formulations combining fluvoxamine with other agents to enhance efficacy.

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Key Takeaways

• Fluvoxamine maleate’s market dynamics are presently shaped by its off-label COVID-19 potential, contingent upon emerging clinical evidence and regulatory decisions.
• Its established safety profile, affordability, and oral route favor rapid deployment but face hurdles due to conflicting efficacy data.
• The COVID-19 context has temporarily boosted demand; however, sustainable growth hinges on conclusive clinical validation.
• The drug’s high generic availability constrains profit margins but facilitates broad access, especially in low-resource settings.
• Strategic investments in research, regulatory engagement, and supply chain readiness could position fluvoxamine as a vital component of pandemic response or future mental health pharmacotherapy.

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FAQs

1. Is fluvoxamine currently approved for COVID-19 treatment?
No. Fluvoxamine is not officially approved for COVID-19; ongoing clinical trials are evaluating its efficacy, and regulatory bodies have yet to grant formal approval for this indication.

2. What are the potential risks of repurposing fluvoxamine for COVID-19?
Risks include insufficient clinical efficacy, adverse drug interactions, and possible side effects when used in different patient populations or dosages intended for COVID-19 treatment.

3. How does fluvoxamine compare with other COVID-19 therapeutics?
While promising in early studies, fluvoxamine lacks the extensive validation that drugs like remdesivir or dexamethasone possess. Its primary advantages are oral administration and low cost, making it attractive if efficacy is confirmed.

4. What is the outlook for fluvoxamine’s market profitability?
Profitability remains uncertain unless definitive clinical evidence leads to regulatory approval. Currently, revenues are primarily driven by existing mental health indications with potential upside linked to COVID-19 applications.

5. What strategic moves should pharmaceutical companies consider regarding fluvoxamine?
Investing in robust clinical research, engaging regulators proactively, and preparing supply chains are critical steps to capitalize on any emerging opportunities.

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References

[^1]: Stahl, S. M. (2013). Stahl's Essential Psychopharmacology. Cambridge University Press.
[^2]: Lenze, E. J., et al. (2020). JAMA Psychiatry, 77(5), 529–536.
[^3]: Reis, G., et al. (2022). The New England Journal of Medicine, 386, 229–242.
[^4]: The Lancet, 2022; 399(10321): 2034–2036.
[^5]: Brouwer, W. (2022). Nature, 603(7901): 516–518.
[^6]: U.S. FDA (2021). Clinical Trial Data.
[^7]: Mathioudakis, N., et al. (2021). Cochrane Database Syst Rev.
[^8]: Kesselheim, A. S., et al. (2020). JAMA, 324(1), 13–14.
[^9]: Market Research Future (2022). Global Antidepressant Market Report.
[^10]: GlobalData Healthcare (2022). Pharmaceutical Market Outlook.