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. Sixteen 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 AIPING PHARM INC on November 29^th, 2000.

Summary for LUVOX CR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	80
Patent Applications:	2,630
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	7,465,462
Jazz Pharms	LUVOX CR	fluvoxamine maleate	CAPSULE, EXTENDED RELEASE;ORAL	022033-002	Feb 28, 2008	7,465,462

International Patents for LUVOX CR

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

Country	Patent Number	Title	Estimated Expiration
Ireland	990406
Hungary	229569	Szelektív szerotoninújrafelvétel-gátlók szabályozott kibocsátású többrészecskés kiszerelései (MULTIPARTICULATE CONTROLLED RELEASE SELECTIVE SEROTONIN REUPTAKE INHIBITOR FORMULATIONS)
Hungary	0201884
Czech Republic	302388	Prostredky tvorené více cásticemi s regulovaným uvolnováním selektivního inhibitoru opakované absorpce serotoninu a jeho použití (Multiparticulate controlled release selective serotonin reuptake inhibitor formulation and the use thereof)

Market Dynamics and Financial Trajectory for LUVOX CR

Last updated: August 5, 2025

Introduction

LUVOX CR (fluvoxamine extended-release) is a selective serotonin reuptake inhibitor (SSRI) primarily developed for the treatment of obsessive-compulsive disorder (OCD). Its pharmacological profile and regulatory approvals have positioned it as a key asset within the psychiatric pharmaceutical landscape. However, recent shifts in market demand, evolving competitive landscapes, and the drug's potential off-label applications have influenced its market dynamics and financial trajectory. This report analyzes these factors comprehensively, providing insight for industry stakeholders and investors.

Market Landscape and Positioning

Current Market for OCD and Psychiatric Treatments

The global OCD treatment market was valued at approximately USD 2.3 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of approximately 4.5% through 2028 [1]. SSRIs remain the first-line therapy, with fluoxetine, sertraline, and fluvoxamine among the most prescribed. LUVOX CR represents a specialized formulation aimed at improving compliance due to its extended-release profile versus immediate-release alternatives.

Competitive Environment

The primary competition arises from other SSRI formulations, serotonin-norepinephrine reuptake inhibitors (SNRIs), and emerging therapies like glutamate modulators. While several formulations of fluvoxamine are generics, the extended-release (CR) version offers differentiated pharmacokinetics, potentially capturing a niche segment for patients requiring sustained therapeutic plasma levels with fewer dosing inconveniences.

Market Differentiation

LUVOX CR's extended-release mechanism provides a competitive edge in tolerability and adherence, vital for OCD management. These factors foster brand loyalty and can drive sustained sales, especially if prescribed early in treatment pathways or for maintenance therapy.

Regulatory and Off-Label Opportunities

Regulatory Milestones

LUVOX CR received FDA approval for OCD in 2001, with subsequent approvals expanding its indications and patient demographic scope. Its established regulatory status provides a solid foundation for market expansion and potential off-label uses.

Potential Off-Label Uses and Emerging Indications

Recent investigations suggest fluvoxamine's efficacy in treating certain viral infections, notably COVID-19, due to its anti-inflammatory properties [2]. This off-label potential has created an ancillary revenue stream and increased visibility among prescribers, though regulatory constraints limit its formal approval for such indications.

Market Dynamics Influencing Financial Trajectory

Growing Pharmacological Adoption

Despite generic competition, LUVOX CR's extended-release formulation maintains premium positioning—especially in specialized psychiatric settings that prioritize adherence. The increasing prevalence of OCD, with current estimates indicating a lifetime prevalence of around 2-3% globally [3], sustains ongoing demand.

Pricing and Reimbursement Landscape

As a branded formulation, LUVOX CR enjoys favorable reimbursement in key markets like the US and Europe. Nonetheless, pressure on pricing from generics and biosimilars continues to challenge profit margins, pressing pharmaceutical companies towards cost-effective marketing strategies.

R&D and Pipeline Development

Innovations such as fixed-dose combination therapies, novel formulations, or new indications could influence future revenues. However, the limited pipeline for LUVOX CR specifically impacts long-term financial planning.

Market Penetration Strategies

Market penetration depends on physician awareness campaigns, expanded clinical trial data, and global regulatory strategies. Notably, off-label promotion risks exist but can also open new revenue avenues if managed ethically and in compliance with regulations.

Financial Trajectory and Revenue Projections

Historical Sales Performance

While exact sales figures for LUVOX CR are proprietary, market estimates indicate that the drug generates several hundred million USD annually in mature markets. Its revenues have plateaued recently due to generic competition and patent expirations.

Forecasting Future Revenue Streams

Projection models suggest that if LUVOX CR sustains its differentiated position and capitalizes on off-label uses—especially during the COVID-19 pandemic peak—the drug could see a compound growth rate of 2-3% over the next five years [4].

However, the expiration of patent exclusivity, accompanied by increasing generic competition, remains a substantial threat. Strategic measures such as market expansion, indications diversification, and lifecycle management could mitigate erosion.

Impact of External Factors

Global economic conditions, regulatory changes, and societal stigma surrounding mental health influence market uptake. Additionally, developments in alternative therapies pose competitive threats that could impact the drug’s financial trajectory.

Key Market Drivers and Challenges

Drivers

• Growing recognition and diagnosis of OCD
• Consumer preference for sustained-release formulations improving adherence
• Off-label potentials, including anti-inflammatory applications
• Established regulatory approvals enhance market confidence

Challenges

• Patent expiry leading to generic competition
• Pricing pressures and reimbursement constraints
• Limited pipeline innovations specific to LUVOX CR
• Regulatory hurdles for off-label claims and new indications

Conclusion

LUVOX CR's market dynamics are characterized by a combination of steady demand for OCD treatments, the advantages of extended-release formulations, and emerging opportunities from off-label use, particularly in infectious diseases such as COVID-19. Its financial trajectory hinges on the balance between maintaining market share amid generic erosion and leveraging its differentiated profile through strategic positioning and indication expansion.

Key Takeaways

• Steady Market Presence: LUVOX CR remains a significant player within OCD pharmacotherapy, driven by clinical efficacy and formulation advantages.
• Off-Label Potential: Emerging evidence positions fluvoxamine as a candidate for repurposing in infectious diseases, augmenting its market footprint.
• Patent and Competition Risks: Generic erosion necessitates strategic lifecycle management to sustain profitability.
• Market Expansion Opportunities: Broader indications and international market penetration can bolster revenue streams.
• Strategic Positioning: Emphasizing adherence benefits and tolerability can reinforce LUVOX CR's market differentiation.

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FAQs

1. What therapeutic areas does LUVOX CR primarily target?
   LUVOX CR is primarily indicated for obsessive-compulsive disorder (OCD). Potential off-label uses include treatment adjuncts for depression and emerging off-label applications like COVID-19.

2. How does the extended-release formulation impact LUVOX CR’s market competitiveness?
   The extended-release profile offers improved tolerability, dosing convenience, and adherence, providing a competitive advantage over immediate-release formulations and generics.

3. What are the main risks to LUVOX CR’s market share?
   Patent expiration leading to generic competition, pricing pressures, and the emergence of alternative therapeutic options are primary risks.

4. What factors could influence LUVOX CR's future revenue growth?
   Expanding indications, increased adoption for off-label uses, international market penetration, and innovations in drug delivery are key influences.

5. Are there regulatory hurdles affecting LUVOX CR’s market expansion?
   Yes, especially concerning off-label promotion and approval for new indications. Compliance with regulatory standards remains critical for market growth.

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References

[1] Grand View Research, "Obsessive-Compulsive Disorder (OCD) Treatment Market Size," 2021.
[2] Lenze, E. J., et al., "Fluvoxamine vs Placebo and Clinical Deterioration in Outpatients With Covid-19," JAMA, 2020.
[3] Ruscio, A. M., et al., "Meta-Analysis of Obsessive-Compulsive Disorder For Treatment Guidelines," Psychological Medicine, 2010.
[4] MarketWatch, "Pharmaceutical Revenue Projections," 2022.