REMERON Drug Patent Profile

Which patents cover Remeron, and what generic alternatives are available?

Remeron is a drug marketed by Organon and Organon Usa Organon and is included in two NDAs.

The generic ingredient in REMERON is mirtazapine. There are eighteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the mirtazapine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Remeron

A generic version of REMERON was approved as mirtazapine by TEVA on January 24^th, 2003.

Summary for REMERON

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	39
Patent Applications:	5,778
Drug Prices:	Drug price information for REMERON
What excipients (inactive ingredients) are in REMERON?	REMERON excipients list
DailyMed Link:	REMERON at DailyMed

See drug prices for REMERON

See drug sales revenues for REMERON

Recent Clinical Trials for REMERON

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

Sponsor	Phase
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 1/Phase 2
Northwestern University	Phase 1/Phase 2
Ain Shams University	Early Phase 1

See all REMERON clinical trials

US Patents and Regulatory Information for REMERON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon	REMERON	mirtazapine	TABLET;ORAL	020415-001	Jun 14, 1996	AB	RX	Yes	Yes
Organon Usa Organon	REMERON SOLTAB	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	021208-001	Jan 12, 2001	AB	RX	Yes	Yes
Organon	REMERON	mirtazapine	TABLET;ORAL	020415-002	Jun 14, 1996	AB	RX	Yes	No

Expired US Patents for REMERON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	REMERON	mirtazapine	TABLET;ORAL	020415-001	Jun 14, 1996
Organon	REMERON	mirtazapine	TABLET;ORAL	020415-002	Jun 14, 1996
Organon	REMERON	mirtazapine	TABLET;ORAL	020415-003	Mar 17, 1997

EU/EMA Drug Approvals for REMERON

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Dechra Regulatory B.V.	Mirataz	mirtazapine	EMEA/V/C/004733For bodyweight gain in cats experiencing poor appetite and weight loss resulting from chronic medical conditions.	Authorised	no	no	no	2019-12-10

International Patents for REMERON

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

Country	Patent Number	Title	Estimated Expiration
South Africa	9705335
Japan	H1067663	PHARMACEUTICAL COMPOSITION COMPRISING MIRTAZAPINE AND ONE OR MORE SELECTIVE SEROTONIN REUPTAKE INHIBITORS
New Zealand	328113	PHARMACEUTICAL COMPOSITION COMPRISING MIRTAZAPINE AND ONE OR MORE SELECTIVE SEROTONIN REUPTAKE INHIBITORS (SSRI'S)

Market Dynamics and Financial Trajectory for REMERON (Mirtazapine)

Last updated: July 29, 2025

Introduction

REMERON, generically known as mirtazapine, is an atypical antidepressant primarily prescribed for major depressive disorder (MDD). Since its approval by the U.S. Food and Drug Administration (FDA) in 1996, REMERON has maintained a notable presence in the psychiatric pharmacotherapy landscape. Its unique mechanism of action, favorable side-effect profile, and longstanding market penetration have established its significance among antidepressants. This report provides a comprehensive analysis of the market dynamics and financial trajectory of REMERON, emphasizing past trends, current market positioning, and future prospects within the evolving pharmaceutical environment.

Mechanism of Action and Clinical Profile

Mirtazapine functions as a noradrenergic and specific serotonergic antidepressant (NaSSA). By antagonizing central presynaptic α2-adrenergic receptors, it enhances noradrenergic and serotonergic neurotransmission. Additionally, it blocks serotonergic 5-HT2 and 5-HT3 receptors, which may reduce certain side effects observed with other antidepressants. Its sedative properties, due to H1 antihistamine activity, make it suitable for patients with comorbid insomnia. Its tolerability and broad efficacy support its sustained prescription use, contributing to its market stability.

Market Dynamics

1. Competitive Landscape

Mirtazapine faces stiff competition from other classes of antidepressants, including selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and atypical options like trazodone and agomelatine. Landmark drugs such as sertraline, escitalopram, and venlafaxine have encroached on the antidepressant segment traditionally occupied by REMERON. Notably, the introduction of generic versions has significantly impacted market pricing, accessibility, and overall sales volume.

2. Patent Status and Generic Penetration

The original patent for REMERON expired in the early 2000s, enabling generic manufacturers to produce mirtazapine. Generics have captured the majority of prescriptions due to substantial cost savings, which have broadened access but concurrently exerted downward pressure on the drug’s price and revenue streams for brand-name providers. The proliferation of generics has led to an environment characterized by intense price competition and commoditization.

3. Regulatory and Off-label Use Influence

While primarily approved for depression, off-label use of REMERON extends to anxiety, insomnia, and appetite stimulation in certain populations such as HIV-positive patients. This off-label application sustains demand despite competitive pressures. Regulatory adjustments, including changes in prescribing guidelines and psychiatric treatment protocols, influence prescribing behaviors and sales volume.

4. Market Penetration and Demographics

REMERON’s strength lies in specific patient segments. Its sedative and appetite-stimulating effects render it favorable for older adults and patients with comorbid conditions. The expanding global mental health awareness, coupled with the rising prevalence of depression (globally estimated at over 280 million people as per WHO), contributes to sustained demand. However, the trend toward newer, potentially more tolerable antidepressants influences market share dynamics.

5. Pricing and Reimbursement Environment

In developed markets, reimbursement policies heavily influence REMERON’s market performance. Price sensitivity, especially post-patent expiry, incentivizes generic utilization. Health plans favor cost-effective medications, which enhances generic uptake at the expense of branded versions. Conversely, in emerging markets with less rigorous price controls, brand-name sales may persist longer.

Financial Trajectory

1. Historical Revenue Trends

Since the patent expiration, revenue generated from REMERON has declined significantly for branded manufacturers. According to IQVIA data, U.S. sales peaked in the late 1990s at over $300 million annually but have since diminished due to generic competition. Current estimates suggest annual sales hover around $50 million, predominantly driven by legacy brand prescriptions and hospital formulations. Globally, revenues are uneven, with emerging markets accounting for a small yet growing share due to increasing mental health awareness.

2. R&D Investment and Lifecycle Management

Given the patent expirations, pharmaceutical companies have sought lifecycle management strategies, including formulation enhancements, combination therapies, and new indications. Yet, for REMERON, such efforts have been limited, partly due to the drug’s established pharmacokinetic profile and market maturity. Consequently, the financial trajectory is characterized by declining revenues, with revenue stabilization contingent upon off-label uses, formulary positioning, and healthcare provider preferences.

3. Market Share and Revenue Outlook

Forecasts indicate that REMERON’s market share will continue to decline gradually over the next decade unless disrupted by significant clinical or regulatory shifts. The advent of novel antidepressants, such as esketamine and digital therapeutics, further challenges its competitive standing. Nevertheless, stable demand within niche populations and off-label applications could sustain modest revenues.

4. Impact of COVID-19 Pandemic

The pandemic has heightened mental health issues globally, potentially increasing antidepressant prescriptions. However, economic constraints and healthcare access disruptions have curtailed overall pharmaceutical spending. For REMERON, this has resulted in marginally stabilized or slightly increased prescriptions in outpatient settings but insufficient to reverse long-term revenue decline.

5. Future Revenue Streams

Opportunities for revenue stabilization lie in differentiation via unique indications, combination therapies, or formulary positioning. However, without significant innovation, REMERON’s financial trajectory appears to be one of gradual decline, aligning with generic drug market trends. Emerging markets present potential expansion avenues but require strategic investment and regulatory navigation.

Key Market Trends Influencing Future Trajectory

• Growth in Mental Health Awareness: Global increases in depression diagnosis could sustain demand.
• Drug Price Pressures: Rising emphasis on cost-effectiveness favors generics.
• Emergence of Novel Therapies: Innovations like ketamine and digital treatments threaten traditional antidepressant markets.
• Regulatory Shifts: Policy reforms encouraging generic substitution and biosimilars impact revenue.

Conclusion

The market dynamics of REMERON are shaped predominantly by its patent expiry, robust generic competition, and evolving clinical landscape. While it retains a dedicated niche in treating depression, its financial trajectory demonstrates a steady decline, typical of established branded drugs facing contemporary market pressures. Nonetheless, the drug maintains relevance within specific patient populations and off-label applications, offering incremental revenue opportunities. Future prospects hinge on strategic repositioning, expanding indications, and capitalizing on unmet needs within mental health treatment paradigms.

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Key Takeaways

• Generic Competition Dominates: Post-patent expiry, REMERON’s revenues have declined sharply, driven by generics capturing most prescriptions.
• Market Segment Stability: Niche uses, particularly for insomnia and appetite stimulation, sustain residual demand.
• Evolving Therapeutic Landscape: Emerging therapies and digital health solutions threaten to further erode market share.
• Pricing and Reimbursement Influence: Cost considerations favor generic adoption, constraining brand-name revenue potential.
• Future Outlook: Without significant innovation or new indications, REMERON’s financial performance will likely decline steadily, emphasizing the importance of lifecycle management strategies.

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FAQs

1. What factors led to the decline of REMERON’s market share?
The expiration of its patent facilitated generic entry, significantly reducing prices and sales. Increased competition from other antidepressants, especially SSRIs and SNRIs, further diminished its market share.

2. Are there any new formulations or indications for REMERON?
Currently, no major new formulations or indications are in advanced development. Its primary uses remain within the scope of existing approved indications, with some off-label applications maintaining marginal demand.

3. How does the global market for REMERON differ from the U.S.?
In emerging markets, patent enforcement is less consistent, and generic versions are more prevalent, leading to lower retail prices and modest growth. Developed markets exhibit stricter regulatory standards and reimbursement policies favoring generics.

4. What strategies could extend REMERON’s market viability?
Developing novel formulations, exploring new therapeutic indications, and forming strategic partnerships may help maintain relevance, though such efforts require significant investment and regulatory approval.

5. How does REMERON’s competitive profile compare to newer antidepressants?
While REMERON offers sedative benefits and a favorable side-effect profile for certain populations, newer agents with rapid onset, fewer side effects, and digital integration are increasingly preferred, limiting REMERON’s competitive edge.

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Sources:

1. IQVIA. Pharmaceutical Sales Data, 2022.
2. U.S. Food and Drug Administration (FDA). REMERON approval history.
3. World Health Organization. Depression global prevalence.
4. Market Research Future. Antidepressant Market Analysis, 2023.
5. National Institute of Mental Health. Trends in Mental Health Treatment.