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-five 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:	162
Clinical Trials:	2
Patent Applications:	4,361
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	021208-003	Jan 12, 2001	5,178,878
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	021208-002	Jan 12, 2001	5,178,878
Organon Usa Organon	REMERON SOLTAB	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	021208-001	Jan 12, 2001	5,977,099

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/004733 For 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
Japan	3412694
Japan	2003231629	FOAMABLE DOSAGE FORM
Canada	2061917	FORME POSOLOGIQUE EFFERVESCENTE POUR ENFANTS (PEDIATRIC EFFERVESCENT DOSAGE FORM)
Australia	727851
Spain	2097155
China	1173330

REMERON SOLTAB Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for REMERON SOLTAB (Mirtazapine)

Market Overview

REMERON SOLTAB, also known as mirtazapine, is an antidepressant medication used primarily for the treatment of major depressive disorder, as well as other conditions such as insomnia, obsessive-compulsive disorder, and anxiety disorders. Here’s a detailed look at the market dynamics and financial trajectory of this drug.

Market Drivers

Rise in Incidences of Depression

The global increase in depression cases is a significant driver for the mirtazapine market. As the prevalence of depression rises, so does the demand for effective treatments like mirtazapine[3].

Changing Lifestyle and Increasing Stress

Modern lifestyles, characterized by prolonged work stress and other societal pressures, contribute to higher levels of anxiety and depression, thereby increasing the demand for antidepressants like mirtazapine[1].

Growing Geriatric Population

The rise in the geriatric population is another key driver, as older adults are more likely to experience depression and other mental health issues that mirtazapine can treat[1][3].

Increasing Awareness and Government Initiatives

Growing awareness about mental health and government initiatives to improve mental health care also boost the market for mirtazapine. These initiatives often include better access to medications and therapies[3].

Market Restraints

Side Effects

One of the major restraints for the mirtazapine market is the various side effects associated with the drug. These include somnolence, weight gain, cholesterol and triglyceride increases, and orthostatic hypotension, which can deter some patients from using the medication[4][5].

Regulatory and Competitive Challenges

The presence of other antidepressants and the regulatory hurdles in bringing new formulations to market can also act as restraints. Additionally, the expiration of patents can lead to generic competition, affecting the market share of branded versions like REMERON SOLTAB[1].

Regional Market Analysis

North America

North America dominates the mirtazapine market due to the presence of major pharmaceutical companies, a well-developed healthcare sector, and high awareness about mental health. The region is expected to continue its dominance due to ongoing technological advancements and increasing prevalence of mental health disorders[3].

Europe and Asia-Pacific

Europe and the Asia-Pacific region are also expected to show significant growth. This is driven by increasing research and development activities, rising investments in the healthcare sector, and a growing patient population seeking treatment for mental health issues[3].

Financial Trajectory

Revenue Projections

The global mirtazapine market is anticipated to grow at a CAGR of around 5% from 2021 to 2028. This growth is driven by the increasing demand for antidepressants and the expanding patient population[3].

Market Size

While specific financial figures for REMERON SOLTAB are not provided in the sources, the overall mirtazapine market size is expected to increase significantly over the forecast period. The market size in 2023 and projected size by 2031 indicate a substantial growth trajectory, although exact figures are not specified[1].

Company Performance

Pharmaceutical companies like those involved in the mirtazapine market often report financial results that reflect the overall market trends. For example, companies like AbbVie, which operates in the broader pharmaceutical market, have reported significant revenues and growth in their neuroscience portfolios, which can include antidepressants like mirtazapine[2].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the mirtazapine market. On one hand, the pandemic has increased the incidence of mental health disorders due to lockdowns, economic stress, and other factors, thereby increasing the demand for antidepressants. On the other hand, supply chain disruptions and business shutdowns have negatively impacted the manufacturing and delivery of these medications[1].

Competitive Landscape

The mirtazapine market is characterized by both organic and inorganic growth strategies among market players. Companies are focusing on product launches, approvals, and partnerships to expand their market share. The competitive landscape includes key players with strong market strategies, including SWOT analysis and financial performance over the past few years[1].

Patient Epidemiology and Clinical Trials

Clinical trials have established the efficacy of mirtazapine in treating major depressive disorder. Studies have shown that patients treated with mirtazapine experience lower relapse rates compared to those receiving placebo. However, these trials also highlight the need for caution due to potential side effects such as somnolence and weight gain[4].

Regulatory Considerations

Mirtazapine is indicated for the treatment of major depressive disorder and must be used with caution in patients with compromised renal or hepatic function. Regulatory bodies like the FDA provide guidelines and precautions for the use of mirtazapine, which can impact its market dynamics[4][5].

Key Takeaways

• The mirtazapine market is driven by increasing incidences of depression, changing lifestyles, and a growing geriatric population.
• Side effects and regulatory challenges act as restraints.
• North America dominates the market, with Europe and Asia-Pacific showing significant growth potential.
• The COVID-19 pandemic has increased demand but also disrupted supply chains.
• Companies are adopting both organic and inorganic growth strategies to expand their market share.

Frequently Asked Questions (FAQs)

1. What is the primary use of REMERON SOLTAB (mirtazapine)?

REMERON SOLTAB is primarily used for the treatment of major depressive disorder.

2. What are the key drivers of the mirtazapine market?

The key drivers include the rise in incidences of depression, changing lifestyles, increasing geriatric population, and growing awareness about mental health.

3. What are the major side effects associated with mirtazapine?

Major side effects include somnolence, weight gain, cholesterol and triglyceride increases, and orthostatic hypotension.

4. How has the COVID-19 pandemic impacted the mirtazapine market?

The pandemic has increased the demand for antidepressants due to rising mental health issues but has also disrupted supply chains and manufacturing.

5. Which regions are expected to show significant growth in the mirtazapine market?

North America, Europe, and the Asia-Pacific region are expected to show significant growth due to various market and demographic factors.

Sources:

1. The Insight Partners. Mirtazapine Tablets Market Developments by 2031.
2. AbbVie. AbbVie Reports Full-Year and Fourth-Quarter 2023 Financial Results.
3. Data Bridge Market Research. Global Mirtazapine Drug Market – Global Industry Trends and Forecast to ...
4. FDA. REMERON (mirtazapine) Tablets and REMERONSolTab (mirtazapine) Orally Disintegrating Tablets.
5. FDA. REMERONSolTab (mirtazapine) Orally Disintegrating Tablets.