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-three 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:	5,020
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	020415-003	Mar 17, 1997
Organon	REMERON	mirtazapine	TABLET;ORAL	020415-001	Jun 14, 1996
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/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
Germany	69710390
Indonesia	17051
South Africa	9705335
Japan	2009137970	PHARMACEUTICAL COMPOSITION COMPRISING MIRTAZAPINE AND ONE OR MORE SELECTIVE SEROTONIN REUPTAKE INHIBITOR
Israel	121076	Pharmaceutical combinations comprising mirtazapine and one or more selective serotonin reuptake inhibitors
Hungary	9701068

REMERON: Patent Landscape and Market Trajectory Analysis

Last updated: February 19, 2026

Remeron (mirtazapine) is an atypical antidepressant approved for the treatment of major depressive disorder. Its market trajectory is shaped by patent expirations, generic competition, and evolving treatment guidelines. This analysis examines the patent landscape and financial performance of Remeron.

What is the Current Patent Status of Remeron?

Remeron's primary U.S. patents have expired. The compound patent for mirtazapine expired in August 2007. Formulation patents and method of use patents also have expired.

• Compound Patent Expiration: August 2007
• Key Formulation Patent Expiration: May 2008
• U.S. Market Exclusivity: Ended with patent expirations.

The expiration of these patents opened the door for generic manufacturers to enter the market, significantly impacting Remeron's market share and pricing.

How Has Generic Entry Affected Remeron's Sales and Market Share?

Following patent expirations, Remeron experienced a substantial decline in market share and revenue as generic versions of mirtazapine became available.

• Pre-Generic Peak Sales (2006): Approximately $650 million globally for Organon (the original developer).
• Post-Generic Sales Decline: Sales for the branded product have seen a continuous downward trend.
• Market Share Erosion: Generic mirtazapine now constitutes the majority of the mirtazapine market.

The availability of multiple generic options intensified price competition, leading to a lower average selling price for mirtazapine products overall.

What is the Competitive Landscape for Mirtazapine?

The competitive landscape for mirtazapine is dominated by generic manufacturers. Several companies hold Abbreviated New Drug Applications (ANDAs) approved by the U.S. Food and Drug Administration (FDA) for mirtazapine tablets.

Key generic players include:

• Teva Pharmaceuticals
• Mylan (now Viatris)
• Sun Pharmaceutical Industries
• Apotex Inc.
• Dr. Reddy's Laboratories

These companies compete on price, distribution, and formulation variations, including orally disintegrating tablets.

What are the Approved Indications and Dosage Forms for Remeron?

Remeron is primarily approved for the treatment of major depressive disorder (MDD). It is available in various dosage forms and strengths.

Dosage Forms:

• Oral tablets
• Orally disintegrating tablets (ODTs)

Strengths (mg):

• 7.5
• 15
• 30
• 45

The development of ODT formulations aimed to improve patient compliance, particularly for individuals experiencing nausea or difficulty swallowing.

What is the Current Market Size and Growth Outlook for Mirtazapine?

The global market for mirtazapine, encompassing both branded Remeron and its generic equivalents, remains significant due to the widespread prevalence of depression. However, growth is constrained by generic pricing pressures.

• Estimated Global Market Size (Mirtazapine Products): In the range of several hundred million dollars annually, with precise figures varying by market research source.
• Growth Projection: Low single-digit growth is anticipated, primarily driven by increased diagnosis rates and market penetration in emerging economies, offset by price erosion in developed markets.

The outlook is characterized by a mature market with established generic competition.

What are the Key Differentiating Factors for Branded Remeron?

Post-patent expiration, branded Remeron's differentiating factors have diminished. However, historical brand recognition and established physician familiarity continue to play a role.

• Brand Recognition: Decades of market presence have established awareness.
• Physician Trust: Prescribing patterns are influenced by historical experience with the branded product.
• Formulation Availability: Offering a comprehensive range of dosage forms, including ODTs, can still attract certain patient populations.

However, these factors are increasingly challenged by the cost-effectiveness and accessibility of generic mirtazapine.

What are the Potential Future Developments or Challenges for Mirtazapine?

Future developments for mirtazapine will likely focus on therapeutic niche applications, drug-drug interaction management, and competition from newer antidepressant classes.

• Off-Label Use: Mirtazapine is sometimes used off-label for conditions such as anxiety disorders, insomnia, and chemotherapy-induced nausea.
• Pharmacoeconomic Considerations: Payers and healthcare systems will continue to favor lower-cost generic options.
• Emerging Antidepressants: The development of novel antidepressants with different mechanisms of action or improved side-effect profiles could impact mirtazapine's market share over the long term.
• Manufacturing Costs: Fluctuations in active pharmaceutical ingredient (API) costs and manufacturing efficiency among generic producers will influence market pricing.

The long-term trajectory will depend on its established efficacy profile against newer therapeutic options and its cost-effectiveness.

Key Takeaways

• Remeron's U.S. compound and formulation patents have expired, leading to a mature market dominated by generic mirtazapine.
• Generic entry resulted in a significant decline in branded Remeron sales and market share, with competition driven primarily by price.
• The mirtazapine market is characterized by widespread generic availability and low single-digit growth projections, constrained by price erosion.
• While branded Remeron benefits from historical recognition, these advantages are increasingly offset by the cost-effectiveness of generics.
• Future market dynamics will be influenced by off-label uses, pharmacoeconomic pressures, and the emergence of newer antidepressant therapies.

Frequently Asked Questions

1. When did the primary patent for Remeron expire in the United States? The compound patent for mirtazapine expired in August 2007.

2. What is the current market status for branded Remeron versus generic mirtazapine? The market is predominantly served by generic mirtazapine, with branded Remeron holding a minimal share due to patent expirations and intense price competition.

3. Are there any specific clinical advantages that branded Remeron still holds over generics? Post-patent expiration, direct clinical advantages are minimal. Brand recognition and physician familiarity are the primary remaining differentiators, though these are often superseded by cost considerations.

4. What are the main therapeutic indications for mirtazapine? The primary approved indication for mirtazapine is the treatment of major depressive disorder (MDD).

5. How does the development of orally disintegrating tablets (ODTs) affect the mirtazapine market? ODTs offer improved patient compliance and convenience, providing a specific formulation advantage for certain patient populations, and are available in both branded and generic forms.

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Citations

[1] U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-approved-drug-products-therapeutic-equivalence-evaluations [2] Pharmaceutical market research reports (various proprietary sources). [3] Company annual reports and SEC filings (historical).