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-five 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:	2
Raw Ingredient (Bulk) Api Vendors:	162
Clinical Trials:	39
Patent Applications:	4,367
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
Northwestern University	Phase 1/Phase 2
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	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
Organon	REMERON	mirtazapine	TABLET;ORAL	020415-003	Mar 17, 1997		DISCN	Yes	No
Organon Usa Organon	REMERON SOLTAB	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	021208-003	Jan 12, 2001	AB	RX	Yes	No
Organon Usa Organon	REMERON SOLTAB	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	021208-002	Jan 12, 2001	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	020415-003	Mar 17, 1997
Organon	REMERON	mirtazapine	TABLET;ORAL	020415-002	Jun 14, 1996

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/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

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0813873	Compositions pharmaceutiques comprenants de la mirtazapine et un ou plusieurs inhibiteurs sélectifs d'assimilation de sérotonine (Pharmaceutical composition comprising mirtazapine and one or more selective serotonin reuptake inhibitors)
Denmark	0813873
Australia	727851
Japan	2009137970	PHARMACEUTICAL COMPOSITION COMPRISING MIRTAZAPINE AND ONE OR MORE SELECTIVE SEROTONIN REUPTAKE INHIBITOR
Hong Kong	1006081
Norway	972816

REMERON Market Analysis and Financial Projection Experimental

Mirtazapine (Remeron) Market Dynamics and Financial Trajectory

Market Overview

Mirtazapine, commonly known by its brand name Remeron, is a tetracyclic antidepressant used in the treatment of major depressive disorder, anxiety disorders, and other mental health conditions. Here’s a comprehensive look at the market dynamics and financial trajectory of mirtazapine.

Market Size and Growth

The global mirtazapine drug market has been experiencing significant growth. As of 2022, the market size was valued at USD 1.6 billion and is projected to grow at a Compound Annual Growth Rate (CAGR) of 6% from 2022 to 2030, reaching USD 2.8 billion by 2030[1].

Another report indicates that the market size was valued at USD 800 million in 2023 and is expected to reach USD 1.53 billion by 2031, growing at a CAGR of 6.85% from 2024 to 2031[5].

Regional Market Analysis

North America

North America dominates the mirtazapine drug market due to the presence of major players, continuous technological development, a developed healthcare sector, and increasing health awareness. The region is expected to maintain its dominance, with the United States and Canada contributing significantly to the market growth[1][2].

Europe

Europe is another significant region for the mirtazapine market. Countries like the United Kingdom, Germany, and France are expected to see growth rates of 4.8%, 4.2%, and 3.2% respectively from 2024 to 2031. The Rest of Europe is projected to grow at a CAGR of 2.7% during the same period[2].

Asia Pacific

The Asia Pacific region is expected to witness the highest growth rate, with a CAGR of 7.5% from 2024 to 2031. China, in particular, is anticipated to grow at a CAGR of 7% during this period. This rapid growth is driven by increasing research and development activities and rising demand for mental health treatments[2].

Latin America and Middle East & Africa

Latin America and the Middle East & Africa also contribute to the global market, with growth rates of 4.9% and 5.2% respectively from 2024 to 2031. These regions, though smaller, are crucial for the overall market expansion[2].

Market Segmentation

By Type

The mirtazapine market is segmented based on the type of dosage forms, which include 15mg, 30mg, and 45mg tablets. Tablets are expected to dominate the market due to their simplicity, usability, and precise dosage[2].

By Application

Mirtazapine is used in various applications, including:

• Hospital: Mirtazapine is widely used in hospital settings for treating severe cases of depression and anxiety.
• Drug Stores: It is also available in drug stores, making it accessible for outpatient treatment[1].

By Product

The market is segmented by product into:

• Depression Treatment: Mirtazapine is primarily used for treating major depressive disorder.
• Anxiety Disorders: It is also used for treating anxiety disorders, including generalized anxiety disorder and panic disorders.
• PTSD: Some studies suggest its use in treating post-traumatic stress disorder (PTSD).
• Insomnia: Mirtazapine is known to help with insomnia due to its sedative properties[5].

Key Drivers

Increasing Prevalence of Mental Health Conditions

The growing prevalence of mental health conditions such as major depressive disorder and generalized anxiety disorder is a significant driver for the mirtazapine market. As more people become aware of mental health issues and seek treatment, the demand for mirtazapine is increasing[5].

Growing Geriatric Population

The elderly population is more prone to mood disorders, which further fuels the market growth. The increasing age of the global population is expected to drive the demand for mirtazapine[5].

Telemedicine and Accessibility

The surge in the use of telemedicine has made psychiatric care and prescriptions for mirtazapine more accessible. This trend is expected to continue, driving the adoption of mirtazapine[4].

Favorable Side Effect Profile

Mirtazapine has a favorable side effect profile, including limited sexual side effects and the potential to counteract weight loss, making it appealing to patients[4].

Competitive Landscape

The global mirtazapine market is competitive, with several key players including:

• Merck & Co
• Sandoz
• Teva
• Mylan
• Sun Pharmaceutical
• IMPAX
• Aurobindo Pharma
• Zydus Pharmaceuticals
• APOTEX[1].

These companies are involved in various strategies such as product development, mergers and acquisitions, and expanding their distribution networks to maintain their market share.

Financial Trajectory

Revenue Projections

The market is expected to see significant revenue growth. From a valuation of USD 1.6 billion in 2022, the market is projected to reach USD 2.8 billion by 2030, and from USD 800 million in 2023 to USD 1.53 billion by 2031[1][5].

Capital Investments and Operating Expenses

For companies looking to set up mirtazapine manufacturing plants, the report provides detailed insights into project economics, including capital investments, operating expenses, income and expenditure projections, and financial analysis. The setup involves significant capital expenditure (CapEx) and operating expenditure (OpEx), but it also promises a good return on investment (ROI) and net present value (NPV)[4].

Profitability and ROI

The profitability of the mirtazapine market is driven by its high demand and the growing need for mental health treatments. Companies investing in this market can expect a positive ROI, especially with the increasing prevalence of mental health conditions and the favorable side effect profile of mirtazapine[4].

Challenges and Opportunities

Challenges

Despite the growth, the market faces challenges such as patent expirations, which can lead to increased competition from generic versions. Additionally, regulatory hurdles and the need for continuous research and development to maintain market share are significant challenges[1].

Opportunities

The market presents several opportunities, including the potential for mirtazapine to be used in treating other conditions beyond depression and anxiety. The increasing focus on mental health awareness and the de-stigmatization of seeking treatment also open up new business opportunities for producers and healthcare providers[5].

Regulatory Environment

The setup of a mirtazapine manufacturing plant involves navigating through various regulatory procedures and obtaining necessary certifications. The report provides a comprehensive list of certifications required and financial assistance available for setting up such a plant[4].

Conclusion

The mirtazapine market is poised for significant growth driven by increasing demand for mental health treatments, a favorable side effect profile, and the growing geriatric population. With a projected CAGR of 6% to 6.85% over the next few years, the market offers lucrative opportunities for pharmaceutical companies.

Key Takeaways

• Market Growth: The global mirtazapine market is expected to grow from USD 1.6 billion in 2022 to USD 2.8 billion by 2030.
• Regional Dominance: North America dominates the market, but Asia Pacific is expected to see the highest growth rate.
• Key Drivers: Increasing prevalence of mental health conditions, growing geriatric population, and telemedicine accessibility.
• Competitive Landscape: Major players include Merck & Co, Sandoz, Teva, and others.
• Financial Trajectory: Significant revenue growth with positive ROI and NPV expected.

FAQs

Q: What is the current market size of the mirtazapine drug market?

A: The global mirtazapine drug market was valued at USD 1.6 billion in 2022[1].

Q: What is the projected growth rate of the mirtazapine market?

A: The market is expected to grow at a CAGR of 6% from 2022 to 2030[1].

Q: Which region dominates the mirtazapine market?

A: North America dominates the mirtazapine market due to the presence of major players and a developed healthcare sector[1].

Q: What are the key drivers for the mirtazapine market?

A: The key drivers include the increasing prevalence of mental health conditions, growing geriatric population, and telemedicine accessibility[5].

Q: Who are the major players in the mirtazapine market?

A: Major players include Merck & Co, Sandoz, Teva, Mylan, and others[1].

Sources

1. Contrivedatuminsights: Mirtazapine Drug Market - Global Industry Analysis, Size, Share, Growth Opportunities, Future Trends, Covid-19 Impact, SWOT Analysis, Competition and Forecasts 2022 to 2030.
2. Cognitivemarketresearch: Global Mirtazapine Market Report 2024.
3. Databridgemarketresearch: Mirtazapine Drug Market – Global Industry Trends and Forecast to 2028.
4. IMARC Group: Mirtazapine (Remeron) Manufacturing Plant Project Report 2024.
5. Market Research Intellect: Mirtazapine Drug Market Size and Projections.