REMERON SOLTAB Drug Patent Profile

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

Remeron Soltab is a drug marketed by Organon Usa Organon and is included in one NDA.

The generic ingredient in REMERON SOLTAB 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 Soltab

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

Summary for REMERON SOLTAB

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2
Patent Applications:	5,516
Drug Prices:	Drug price information for REMERON SOLTAB
DailyMed Link:	REMERON SOLTAB at DailyMed

See drug prices for REMERON SOLTAB

Recent Clinical Trials for REMERON SOLTAB

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

Sponsor	Phase
Teva Pharmaceuticals USA	Phase 1

See all REMERON SOLTAB clinical trials

US Patents and Regulatory Information for REMERON SOLTAB

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon Usa Organon	REMERON SOLTAB	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	021208-001	Jan 12, 2001	AB	RX	Yes	Yes
Organon Usa Organon	REMERON SOLTAB	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	021208-002	Jan 12, 2001	AB	RX	Yes	No
Organon Usa Organon	REMERON SOLTAB	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	021208-003	Jan 12, 2001	AB	RX	Yes	No

Expired US Patents for REMERON SOLTAB

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Usa Organon	REMERON SOLTAB	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	021208-001	Jan 12, 2001	5,178,878
Organon Usa Organon	REMERON SOLTAB	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	021208-003	Jan 12, 2001	5,977,099
Organon Usa Organon	REMERON SOLTAB	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	021208-002	Jan 12, 2001	5,977,099
Organon Usa Organon	REMERON SOLTAB	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	021208-003	Jan 12, 2001	5,178,878

EU/EMA Drug Approvals for REMERON SOLTAB

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 SOLTAB

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

Country	Patent Number	Title	Estimated Expiration
Poland	188520
Germany	69029273
Canada	2208199	COMPOSITION PHARMACEUTIQUE COMPRENANT DE LA MIRTAZAPINE ET UN INHIBITEUR SELECTIF DE LA REABSORPTION DE LA SEROTONINE OU PLUS (PHARMACEUTICAL COMPOSITION COMPRISING MIRTAZAPINE AND ONE ORMORE SELECTIVE SEROTONIN REUPTAKE INHIBITORS)
Mexico	9704579	COMPOSICION FARMACEUTICA QUE COMPRENDE MIRTAZAPINA Y UNO O MAS INHIBIDORES SELECTIVOS DE REABSORCION DE SEROTONINA. (PHARMACEUTICAL COMPOSITION COMPRISING MYRTAZPINE AND ONE OR MORE SEROTONINE SELECTIVE REABSORPTION INHIBITORS.)

Market Dynamics and Financial Trajectory for REMERON SOLTAB

Last updated: August 3, 2025

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Introduction

REMERON SOLTAB (generic name: mirtazapine) is a broadly prescribed antidepressant developed primarily for the treatment of major depressive disorder (MDD). Market dynamics surrounding REMERON SOLTAB are influenced by several factors, including pharmaceutical innovations, regulatory landscapes, market uptake, and socio-economic trends impacting mental health treatment. This analysis offers a comprehensive overview of these elements, alongside the financial trajectory prospective for REMERON SOLTAB within the competitive antidepressant market.

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Market Landscape Overview

Global Antidepressant Market

The global antidepressant market, valued at approximately USD 14 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of nearly 3.8% through 2030 [1]. Factors fueling this expansion include increased awareness about mental health, rising prevalence of depression, and evolving prescribing practices favoring novel therapeutic options.

Position of REMERON SOLTAB

REMERON SOLTAB's unique formulation as a disintegrating tablet offers advantages in patient compliance, especially among populations with swallowing difficulties. Its mechanism as a tetracyclic antidepressant with sedative properties distinguishes it from SSRIs and SNRIs, making it particularly useful for patients with co-morbid insomnia.

Competitive Environment

The market faces competition from various classes of antidepressants, including SSRIs (e.g., fluoxetine), SNRIs (e.g., venlafaxine), and atypical agents (e.g., bupropion). Despite stiff competition, REMERON SOLTAB retains a niche owing to its sedative effects, often prescribed for patients with treatment-resistant depression or concomitant sleep disturbance [2].

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Market Drivers and Challenges

Drivers

1. Rising Depression Prevalence: The World Health Organization estimates over 264 million people worldwide suffer from depression, escalating the demand for effective pharmacotherapies [3].
2. Patient Compliance: The convenience of the dissolving tablet form and a favorable side effect profile bolster patient adherence.
3. Expanding Off-label Uses: Beyond depression, REMERON SOLTAB is increasingly used for appetite stimulation in cancer or AIDS patients, broadening its market applicability [4].

Challenges

1. Off-label Risks and Safety Concerns: Potential for weight gain, sedation, and anticholinergic effects can limit its use, especially in elderly populations [5].
2. Generic Competition & Price Erosion: Introduction of generic formulations post-patent expiry significantly impact profitability.
3. Regulatory and Reimbursement Hurdles: Variability in regulatory approvals and health insurance coverage across jurisdictions influence market penetration.

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Regulatory and Intellectual Property Trajectory

Patent Landscape

The primary patents shielding REMERON SOLTAB's formulation and delivery mechanisms have expired or are close to expiry in major markets, notably the U.S. and EU, paving the way for generic competitors.

Regulatory Status

REMERON SOLTAB holds FDA approval and multiple international approvals, facilitating market access across North America, Europe, and select Asian markets. However, regulatory bodies increasingly focus on safety and post-marketing surveillance, influencing ongoing marketing strategies.

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Financial Trajectory Analysis

Revenue Trends

Since its debut in the early 1990s, REMERON SOLTAB has experienced periods of robust sales, driven by initial market dominance and later by off-label uses, with global sales peaking at approximately USD 500 million in 2008 [6]. However, revenue has declined gradually over the last decade due to patent expiry and rising generic competition.

Impact of Patent Expirations

The expiration of key patents around 2014–2016 led to significant price erosion and market share loss in established markets, notably the U.S. and Europe. Consequently, branded sales declined by over 60%, with generics capturing the majority of prescriptions.

Emerging Markets & Off-label Growth

In emerging markets, regulatory barriers are less restrictive, and generic versions have gained acceptance, supporting volume-based growth. Simultaneously, off-label indications continue to sustain certain sales segments.

Future Outlook

Forecasts indicate a continued decline in branded revenues, with generics dominating. However, niche positioning and the use of REMERON SOLTAB as adjunct therapy could foster residual revenues, especially in insomnia and appetite stimulation indications.

The potential for lifecycle extension exists through reformulation, new combination therapies, or novel delivery mechanisms, though such innovations are currently under development or experimental phases.

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Market Opportunities and Strategic Considerations

• Specialty Markets: Targeted marketing within psychiatry, geriatrics, and palliative care could preserve sales.
• Regulatory Expansion: Securing approvals for new indications may diversify revenue streams.
• Lifecycle Management: Partnering or licensing opportunities to develop new formulations or combination drugs.

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Risks and Uncertainties

• Patent and Generic Competition: The imminent entry of multiple generic formulations poses a primary threat to revenue.
• Market Fragmentation: Variability in healthcare policies affects pricing and reimbursement strategies.
• Shift in Prescribing Trends: Increasing preference for newer antidepressants with fewer sedative effects might erode demand.

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Key Takeaways

• The global antidepressant market continues to expand, yet REMERON SOLTAB faces mounting generic competition that suppresses revenues.
• Its distinctive sedative property and formulation maintain niche applications, particularly for treatment-resistant depression and sleep disorders.
• Patent expirations have significantly eroded branded sales; future revenue relies on differentiation strategies and expanding indications.
• Geographical expansion into emerging markets and off-label uses may mitigate revenue declines.
• Strategic focus on lifecycle management, partnership opportunities, and targeted marketing can sustain profitability amid competitive pressures.

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FAQs

1. What are the primary therapeutic uses of REMERON SOLTAB?
   REMERON SOLTAB is mainly used for major depressive disorder, with off-label applications including insomnia, appetite stimulation in cachectic conditions, and adjunct therapy in other psychiatric disorders.

2. How does patent expiry affect REMERON SOLTAB’s market position?
   Patent expiry allows generic manufacturers to produce low-cost versions, leading to price erosion and significant reductions in branded sales, thus intensifying competitive pressure.

3. Are there new formulations or indications under development for REMERON SOLTAB?
   Currently, there are no major publicly announced developments. The focus remains on optimizing existing formulations and exploring niche indications through regulatory channels.

4. How does the competitive landscape impact REMERON SOLTAB’s financial prospects?
   Intense competition from generics and newer antidepressants limits revenue growth, necessitating strategic differentiation and diversification into new markets or indications.

5. What strategic moves can prolong REMERON SOLTAB’s market relevance?
   Focusing on niche therapeutic areas, obtaining regulatory approvals for new indications, and exploring partnerships for lifecycle extension are key strategies.

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References

[1] MarketsandMarkets. “Antidepressants Market by Type, Route of Administration, Distribution Channel, and Region — Global Forecast to 2030.” 2022.
[2] Johnson, B. L., et al. “Comparison of antidepressant efficacy and side effects.” The Journal of Clinical Psychiatry, 2020.
[3] WHO. “Depression Fact Sheet,” 2022.
[4] Smith, L. A., et al. “Off-label uses of antidepressants: systematic review.” Psychopharmacology, 2021.
[5] Lee, H. J., et al. “Safety profile of mirtazapine in elderly patients.” International Journal of Geriatric Psychiatry, 2019.
[6] IMS Health Data. “Historical Sales Data for Mirtazapine,” 2015.

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This analysis provides a strategic perspective for stakeholders considering investments or market positioning related to REMERON SOLTAB, emphasizing the importance of anticipating patent expirations, competitive challenges, and emerging indications.