Mirtazapine - Generic Drug Details

What are the generic sources for mirtazapine and what is the scope of patent protection?

Mirtazapine is the generic ingredient in three branded drugs marketed by Actavis Elizabeth, Actavis Labs Fl Inc, Aurobindo Pharma, Impax Labs Inc, Square Pharms, Organon Usa Organon, Apotex Inc, Aurobindo, Chartwell Rx, Ivax Sub Teva Pharms, Mylan, Norvium Bioscience, Prasco, Roxane, Sun Pharm Inds Inc, Teva, Upsher Smith Labs, Watson Labs, and Organon, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for mirtazapine. Thirty-five suppliers are listed for this compound.

Summary for mirtazapine

US Patents:	0
Tradenames:	3
Applicants:	19
NDAs:	23
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	35
Raw Ingredient (Bulk) Api Vendors:	162
Clinical Trials:	100
Patent Applications:	6,486
Drug Prices:	Drug price trends for mirtazapine
Drug Sales Revenues:	Drug sales revenues for mirtazapine
What excipients (inactive ingredients) are in mirtazapine?	mirtazapine excipients list
DailyMed Link:	mirtazapine at DailyMed

See drug prices for mirtazapine

See drug sales revenues for mirtazapine

Recent Clinical Trials for mirtazapine

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

Sponsor	Phase
Centre hospitalier de l'Université de Montréal (CHUM)	Phase 1
Quebec Researchnetwork on aging	Phase 1
Pakistan Institute of Living and Learning	Phase 3

See all mirtazapine clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for mirtazapine

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

US Patents and Regulatory Information for mirtazapine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Impax Labs Inc	MIRTAZAPINE	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	076901-003	Jun 28, 2005		DISCN	No	No
Organon	REMERON	mirtazapine	TABLET;ORAL	020415-002	Jun 14, 1996	AB	RX	Yes	No
Upsher Smith Labs	MIRTAZAPINE	mirtazapine	TABLET;ORAL	076189-002	Jun 19, 2003		DISCN	No	No
Watson Labs	MIRTAZAPINE	mirtazapine	TABLET;ORAL	076312-003	Jun 19, 2003		DISCN	No	No
Impax Labs Inc	MIRTAZAPINE	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	076901-002	Jun 28, 2005		DISCN	No	No

Expired US Patents for mirtazapine

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	REMERON	mirtazapine	TABLET;ORAL	020415-003	Mar 17, 1997	5,977,099
Organon Usa Organon	REMERON SOLTAB	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	021208-001	Jan 12, 2001	5,178,878
Organon	REMERON	mirtazapine	TABLET;ORAL	020415-001	Jun 14, 1996	5,977,099
Organon Usa Organon	REMERON SOLTAB	mirtazapine	TABLET, ORALLY DISINTEGRATING;ORAL	021208-003	Jan 12, 2001	5,977,099

EU/EMA Drug Approvals for mirtazapine

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

Mirtazapine Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Mirtazapine

Introduction

Mirtazapine, an antidepressant medication, is widely used for treating major depressive disorder, insomnia, obsessive-compulsive disorder, and anxiety disorders. The market for mirtazapine is influenced by several key factors, which are crucial for understanding its current and future financial trajectory.

Market Size and Growth

The global mirtazapine market is projected to experience significant growth over the next few years. As of 2024, the market size is estimated to be USD XX million, with a forecasted compound annual growth rate (CAGR) of 5.50% from 2024 to 2031. This growth is driven by several factors, including an increasing geriatric population and a rise in the prevalence of depression and other mental health disorders[1][3][4].

Regional Market Analysis

The market for mirtazapine is segmented across various regions, each with its own growth trajectory:

• North America: This region dominates the mirtazapine market due to the presence of major key players, continuous technological development, and a well-developed healthcare sector. The CAGR for North America is estimated at 3.7% from 2024 to 2031[1].
• Europe: Europe is expected to grow at a CAGR of 4% during the same period, with countries like the UK and Germany showing significant growth rates of 4.8% and 4.2%, respectively[1].
• Asia Pacific: This region is anticipated to be the fastest-growing market, with a CAGR of 7.5% from 2024 to 2031. Countries like India and Australia are expected to contribute significantly to this growth, with CAGRs of 9.3% and 7.2%, respectively[1].
• Latin America and Middle East & Africa: These regions are also expected to grow, albeit at a slower pace, with CAGRs of 4.9% and 5.2%, respectively[1].

Market Drivers

Several factors are driving the growth of the mirtazapine market:

• Increasing Geriatric Population: The rising number of elderly individuals, who are more prone to depression and other mental health issues, is a significant driver[1][3][4].
• Rise in Prevalence of Depression: The increasing incidence of depression globally is boosting the demand for antidepressant medications like mirtazapine[3][4].
• Growing Awareness and Government Initiatives: Rising awareness about mental health and increasing government initiatives to improve mental health care are also contributing to market growth[3][4].
• Lifestyle Changes and Stress: Changes in lifestyle and increasing levels of stress and anxiety among adults are additional drivers[3][4].

Market Restraints

Despite the positive growth trends, there are some restraints to consider:

• Side Effects: The various side effects associated with mirtazapine, such as weight gain, drowsiness, and increased appetite, can deter some patients and limit market growth[4].
• Competition from Other Antidepressants: The presence of other effective antidepressants in the market can also pose a challenge to the growth of mirtazapine[4].

Dosage and Application

Mirtazapine is available in various dosages, including 15mg, 30mg, and 45mg tablets, as well as orally disintegrating tablets. The drug is primarily used for treating depression, but it is also prescribed for other conditions like insomnia, obsessive-compulsive disorder, and anxiety disorders[3][4].

End-Users and Distribution Channels

The market is segmented based on end-users such as hospitals, clinics, and drug stores. Distribution channels include hospital pharmacies, retail pharmacies, and online pharmacies. The ease of access through these channels contributes to the market's growth[3].

Financial Considerations

The cost of mirtazapine can vary based on several factors, including the treatment plan, insurance coverage, and the pharmacy used. Generic versions of mirtazapine, such as those available under the brand names Remeron and Remeron Soltab, tend to be more cost-effective compared to brand-name drugs. Strategies to reduce long-term costs include obtaining a 90-day supply and using savings programs or coupons[5].

Clinical Efficacy

Clinical trials have shown that mirtazapine is effective in treating major depressive disorder. For instance, a study published in Psychological Medicine found that mirtazapine, either as monotherapy or in combination with paroxetine, was equally effective in patients who did not show early improvement after 2 weeks of antidepressant treatment[2].

Key Takeaways

• The global mirtazapine market is expected to grow at a CAGR of 5.50% from 2024 to 2031.
• Key drivers include the increasing geriatric population, rising prevalence of depression, and growing awareness about mental health.
• Regional markets, especially Asia Pacific, are expected to show significant growth.
• Side effects and competition from other antidepressants are potential restraints.
• The cost of mirtazapine can be managed through generic options and savings programs.

FAQs

Q: What is the projected CAGR for the global mirtazapine market from 2024 to 2031? A: The global mirtazapine market is projected to grow at a CAGR of 5.50% from 2024 to 2031[1].

Q: Which region is expected to be the fastest-growing market for mirtazapine? A: The Asia Pacific region is anticipated to be the fastest-growing market, with a CAGR of 7.5% from 2024 to 2031[1].

Q: What are the primary drivers of the mirtazapine market? A: The primary drivers include the increasing geriatric population, rise in the prevalence of depression, and growing awareness about mental health[1][3][4].

Q: How can the cost of mirtazapine be reduced? A: The cost can be reduced by obtaining a 90-day supply, using generic versions, and utilizing savings programs or coupons[5].

Q: What are the common side effects associated with mirtazapine? A: Common side effects include weight gain, drowsiness, and increased appetite[4].

Cited Sources:

1. Cognitive Market Research - Global Mirtazapine Market Report 2024
2. Cambridge University Press - Effectiveness of mirtazapine as add-on to paroxetine v. paroxetine or mirtazapine monotherapy in patients with major depressive disorder with early non-response to paroxetine
3. Data Bridge Market Research - Global Mirtazapine Drug Market
4. The Insight Partners - Mirtazapine Tablets Market Developments by 2031
5. Medical News Today - Mirtazapine and cost: Reducing long-term drug costs and more