DESYREL Drug Patent Profile

Which patents cover Desyrel, and what generic alternatives are available?

Desyrel is a drug marketed by Pragma and is included in one NDA. There is one patent protecting this drug.

This drug has thirty-two patent family members in twenty-three countries.

The generic ingredient in DESYREL is trazodone hydrochloride. There are fourteen drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the trazodone hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Desyrel

A generic version of DESYREL was approved as trazodone hydrochloride by APOTEX on March 25^th, 1987.

Summary for DESYREL

International Patents:	32
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	134
Clinical Trials:	14
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DESYREL
What excipients (inactive ingredients) are in DESYREL?	DESYREL excipients list
DailyMed Link:	DESYREL at DailyMed

See drug sales revenues for DESYREL

Recent Clinical Trials for DESYREL

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

Sponsor	Phase
Johns Hopkins University	Phase 2
National Institute on Aging (NIA)	Phase 2
University of Southern California	Phase 4

See all DESYREL clinical trials

US Patents and Regulatory Information for DESYREL

DESYREL is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pragma	DESYREL	trazodone hydrochloride	TABLET;ORAL	018207-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No	8,133,893		Y	Y
Pragma	DESYREL	trazodone hydrochloride	TABLET;ORAL	018207-004	Nov 7, 1988		DISCN	Yes	No	8,133,893		Y	Y
Pragma	DESYREL	trazodone hydrochloride	TABLET;ORAL	018207-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No	8,133,893		Y	Y
Pragma	DESYREL	trazodone hydrochloride	TABLET;ORAL	018207-003	Mar 25, 1985		DISCN	Yes	No	8,133,893		Y	Y

Expired US Patents for DESYREL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pragma	DESYREL	trazodone hydrochloride	TABLET;ORAL	018207-003	Mar 25, 1985	4,215,104
Pragma	DESYREL	trazodone hydrochloride	TABLET;ORAL	018207-003	Mar 25, 1985	4,258,027

International Patents for DESYREL

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

Country	Patent Number	Title	Estimated Expiration
Spain	263036
Canada	2693095
Italy	MI20071603
Germany	3011680	Mehrfach-teilbare Tablette

Market Dynamics and Financial Trajectory for DESYREL (Trazodone)

Last updated: July 28, 2025

Introduction

Desyrel, whose active ingredient is trazodone, is an antidepressant initially developed in the 1960s and approved by the U.S. Food and Drug Administration (FDA) in 1982. Although originally prescribed primarily for depression, its off-label uses and evolving market landscape significantly influence its market dynamics and financial trajectory. This analysis examines the global market factors, competitive landscape, regulatory environment, and commercialization strategies that shape DESYREL’s positioning and growth prospects.

Market Overview and Key Drivers

Indications and Clinical Utility

Trazodone’s primary FDA-approved indications include major depressive disorder (MDD). Over time, its off-label applications have expanded to include insomnia, anxiety disorders, and certain behavioral disturbances in dementia patients. Its sedative properties, low dependency risk relative to benzodiazepines, and favorable side effect profile for some populations bolster its appeal.

Market Size and Demand Trends

The global antidepressant market is projected to reach approximately USD 17 billion by 2025, driven by rising mental health awareness, increasing depression prevalence, and demographic shifts toward aging populations [1]. Trazodone currently constitutes a modest share of this market but benefits from off-label prescribing trends.

The insomnia segment, globally valued at over USD 4 billion, witnesses robust growth owing to evolving sleep disorder diagnostics and management protocols. Trazodone’s off-label use for sleep management is consequently an important revenue channel, despite limited labeling.

Competitive Landscape

Trazodone faces competition from newer antidepressants (e.g., SSRIs, SNRIs), atypical antipsychotics, and non-pharmacologic interventions. Its non-controlled substance status offers a competitive advantage over benzodiazepines, especially amidst regulatory scrutiny and the opioid crisis.

Generic formulations predominate the market, exerting downward pressure on pricing. However, branded or specialized formulations with improved formulations, extended-release delivery systems, or combined indications could carve niche segments.

Regulatory and Patent Considerations

Patent and Market Exclusivity

Since patent exclusivity expired in many regions in the late 1990s and early 2000s, generic trazodone dominates. This commoditization constrains pricing power and revenue growth prospects for original manufacturers.

Regulatory Environment

Regulatory agencies have generally maintained trazodone’s safety profile, but increased scrutiny for off-label use, especially for insomnia, could impact prescribing habits. Future regulatory actions or warnings could influence market accessibility.

Off-Label Use and Labeling

Physicians increasingly prescribe trazodone off-label. While legally permissible, this practice varies by jurisdiction and is less incentivized by regulatory agencies, complicating the potential for label-based expansion.

Market Challenges and Opportunities

Challenges

• Price Erosion: The widespread availability of generics limits revenue potential.
• Limited Patent Protection: Absence of current patent barriers reduces incentives for innovation or marketing.
• Off-label Use Risks: Regulatory and legal risks surrounding off-label prescribing can influence prescribing behavior.
• Emerging Competition: Newer antidepressants with favorable side effect profiles and targeted mechanisms threaten Trazodone’s market share.

Opportunities

• Formulation Innovations: Developing extended-release or combination formulations to improve adherence and efficacy.
• Expanding Indications: Pursuing label extensions for sleep disorders or anxiety through clinical trials could unlock new markets.
• Niche Market Focus: Targeting specific populations such as elderly patients with comorbidities, leveraging its sedative profile.
• Strategic Partnerships: Collaborations with healthcare providers and payers to support formulary inclusion.

Financial Trajectory Projections

Given generic dominance and intense competitive pressures, future revenue growth for DESYREL is likely modest unless strategic changes occur. Historically, revenue from trazodone as a branded product has declined steadily; current estimates suggest annual markets worth hundreds of millions globally, primarily driven by existing prescription volumes.

Revenue Outlook (Next 5 Years)

• Stable or Slight Decline: Without significant innovation or expanded indications, revenues could decline by 2–5% annually due to generic competition.
• Potential Growth via Niche Markets: If companies develop improved formulations or secure regulatory approvals for new indications, revenue could stabilize or slightly increase, in the range of 3–5% annually.

Investment and Market Valuation

Biotechnology firms emphasizing pipeline expansion or formulation breakthroughs might see increased valuation tied to trazodone derivatives or delivery system innovations. Conversely, generic manufacturers benefit from high-volume, low-margin sales.

Market Entry and Strategic Considerations

Companies seeking market entry should explore niche segments with unmet needs, such as elderly care or sleep disorders, leveraging trazodone’s safety profile. Differentiating through extended-release formulations or combination therapies could provide competitive edges.

Conclusion and Strategic Insights

The long-term financial trajectory of DESYREL hinges on innovation, regulatory navigation, and market positioning. While generic proliferation constrains pricing and revenue, targeted strategies—such as indication expansion and formulation improvements—may unlock growth opportunities. In an evolving mental health and sleep disorder treatment landscape, trazodone’s established efficacy and safety profile serve as foundational assets.

Key Takeaways

• Stable but Limited Revenue Growth: Due to widespread generic competition and patent expiration, DESYREL's revenue prospects are modest unless strategic innovations are pursued.
• Off-label Usage as a Double-Edged Sword: While off-label prescribing sustains demand, regulatory scrutiny may impact prescribing practices.
• Niche Opportunities: Development of new formulations, extended-release variants, and expanded indications hold potential for revenue enhancement.
• Competitive Pressures: Innovation must address challenges from newer antidepressants and sleep aids offering superior side effect profiles or mechanisms.
• Market Focus: Targeting specific populations, such as elderly patients with comorbidities or sleep disorders, can help maintain market relevance.

FAQs

1. Why has DESYREL faced declining revenues over the past decade?
The expiration of patents and the advent of generic trazodone have led to significant price competition, reducing profitability for brand-name products and suppressing revenue growth.

2. How does trazodone compare to newer antidepressants in market share and efficacy?
While effective and often preferred for certain populations, trazodone's market share has declined relative to SSRIs and SNRIs, which offer more favorable side effect profiles for depression but less sedative effect.

3. Are there clinical trials or regulatory efforts to expand trazodone's approved uses?
Yes, ongoing research explores its utility in sleep disorders, anxiety, and behavioral disturbances, but regulatory approval for these indications remains limited.

4. What strategies can pharmaceutical companies adopt to increase trazodone's market value?
Innovations such as extended-release formulations, combination therapies, and pursuing new indications via clinical trials can create competitive advantages.

5. Is DESYREL a viable acquisition target for emerging biotech firms?
Potentially, especially if they focus on developing trazodone derivatives or formulations that address unmet needs. However, the market’s commoditized nature and patent landscape necessitate clear differentiation strategies.

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Sources
[1] MarketWatch, "Antidepressant Drugs Market Size, Share & Trends."