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-five 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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DESYREL

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

International Patents for DESYREL

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

Country	Patent Number	Title	Estimated Expiration
Italy	MI20071603	TRAZODONE E TRAZODONE CLORIDRATO IN FORMA PURIFICATA
Canada	1133393	COMPRIME MULTI-SECABLE (MULTI-FRACTIONABLE TABLET STRUCTURE)
Japan	2017141246	精製された形態のトラゾドンおよびトラゾドン塩酸塩 (TRAZODONE AND TRAZODONE HYDROCHLORIDE WITH PURIFIED FORM)

Investment Scenario, Market Dynamics, and Financial Trajectory for DESYREL (Trazodone)

Last updated: February 3, 2026

Executive Summary

Desyrel (generic: trazodone) is an antidepressant primarily prescribed for major depressive disorder (MDD), with off-label uses including insomnia. Market dynamics for trazodone are influenced by factors such as evolving treatment guidelines, the landscape of antidepressant therapy, patent status, and emerging competition. This report analyzes its current market position, projection of future revenue streams, regulatory environment, and investment considerations.

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1. Investment Scenario Overview

Aspect	Details
Market Size (Global)	Estimated at USD 8.5 billion in 2022, projected CAGR of 3.2% (2023-2030) ([1])
Major Players	Mylan, Teva, Pfizer, and generics manufacturers
Revenue (2022)	Approximate global sales of trazodone: USD 1.8 billion ([2])
Patent Status	Generic availability, no active patents, leading to price erosion and increased competition

Investment Risks:

• Patent expiry leading to commoditization
• Off-label restrictions and safety concerns
• Competition from newer antidepressants with improved side-effect profiles

Potential Upside:

• Growing off-label use for insomnia
• Expansion into emerging markets with rising mental health awareness
• Potential formulation enhancements or combination therapies

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2. Market Dynamics

How does the global antidepressant market influence trazodone?

Key Drivers	Impact
Growing Mental Health Needs	Increased demand for antidepressants, driven by rising depression rates globally. WHO estimates over 264 million depressed worldwide ([3]).
Evolving Prescribing Practices	Shift towards selective serotonin reuptake inhibitors (SSRIs), but trazodone remains popular for sleep disorders.
Off-Label Use	Significant off-label consumption for insomnia, estimated at 20-30% of prescriptions ([4]), sustaining demand despite limited official approval.
Regulatory Environment	Strict FDA and EMA oversight on off-label prescribing; however, off-label use persists due to clinical practice inertia.

Competitive Landscape

Competitors	Market Share (Est.)	Notes
Mylan & Sandoz (Generics)	35%	Largest producers of trazodone generics.
Pfizer & Others (Branded)	10%	Limited due to patent expiry; minimal branded activity.
Newer Antidepressants (e.g., Vortioxetine, Esketamine)	15%	Alternative therapies gaining popularity.
Off-Label Sleep Aids	20-30%	Driven by healthcare provider prescribing habits.

Pricing Trends

Year	Average Price per 50mg Tablet	Change (%)	Sources
2018	USD 0.10	-	[5]
2020	USD 0.08	-20%	[5]
2022	USD 0.07	-12.5%	[6]

Price erosion due to generic competition continues, impacting revenue potential.

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3. Financial Trajectory and Revenue Projections

Historical Revenue Data (Global)

Year	Revenue (USD billions)	Notes
2019	1.5	Stable with minor growth
2020	1.6	Pandemic-driven demand for sleep aids
2021	1.7	Slight increase due to off-label use
2022	1.8	Plateau due to price competition

Projected Revenue (2023-2030)

Year	Estimated Revenue (USD billions)	Assumptions
2023	1.75	Stabilized market, slight growth from emerging markets
2024	1.8	Continuing off-label demand, patent exclusivity ends
2025	1.8	Competition limits, slight hikes possible in emerging markets
2026	1.75	Market saturation, price erosion persists
2027-2030	USD 1.7 - 1.8	Market stabilization, slow decline expected

Revenue Breakdown by Source

Source	Share Est.	Notes
Brand/Branded	10%	Minimal, post-patent expiry
Generic Market	70-80%	Dominant revenue driver
Off-Label Use for Insomnia	10-20%	Significant driver, less predictable

Investment Implications

• Stable revenue streams from off-label use and generics likely persist till 2025.
• Long-term decline expected as newer therapeutics enter and market saturation occurs.
• Investing in formulations or combination therapies may diversify revenue.

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4. Regulatory and Patent Landscape

Aspect	Details
Patent Protection	Expired for trazodone, leading to open markets
Regulatory Approvals	Widely approved globally; off-label use common in clinical practice
Potential Regulatory Challenges	Increased scrutiny over off-label marketing, especially in the US ([7])

Policy Outlook:

• New formulations or delivery methods (e.g., extended-release) could attract regulatory approval and premium pricing.
• Ongoing patent litigation or new exclusivity opportunities are unlikely due to the drug’s age and patent expiry.

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5. Comparative Analysis with Similar Drugs

Drug	Indications	Market Size (USD)	Patent Status	Key Differentiators
Trazodone (Desyrel)	Depression, Insomnia (off-label)	8.5 billion	Expired	Cost-effective off-label sleeping aid
Sertraline (Zoloft)	Depression, Anxiety	USD 2.5 billion	Patented (initially)	Modern SSRIs with fewer side effects
Vortioxetine (Trintellix)	Depression	USD 700 million	Patented (expires 2024)	Better tolerated, newer mechanism

Note: Trazodone’s off-label prominence secures its niche despite competition.

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6. Strategic Recommendations for Investors

Opportunities

• Develop formulations targeting sleep disorders, e.g., extended-release (ER) trazodone.
• Expand into regions where mental health awareness is rising (Asia-Pacific, Latin America).
• Invest in combination therapies leveraging trazodone's sedative properties.

Risks

• Market saturation and price decline.
• Regulatory restrictions on off-label promotion.
• Competition from newer classified drugs with better safety profiles.

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7. FAQs

Q1: What is the current patent status of Desyrel (trazodone)?

A: Trazodone’s patent protection has expired globally, leading to widespread generic manufacturing and significant price competition.

Q2: How significant is off-label use of trazodone for insomnia?

A: Off-label prescriptions account for an estimated 20-30% of total trazodone prescriptions, sustaining demand despite limited official approval for insomnia.

Q3: What are the primary drivers of demand for trazodone over the next decade?

A: Growing mental health awareness, aging populations, off-label sleep aid use, and emerging markets’ expansion are key drivers.

Q4: How does competition impact the revenue trajectory of trazodone?

A: Generics dominate market share, pressuring prices downward. Newer antidepressants with improved safety profiles are gradually eroding its market.

Q5: Are there any regulatory innovations or developments that could affect trazodone's market?

A: Introduction of new formulations (e.g., ER), combination drugs, or regulatory approvals for new indications could provide revenue boosts; ongoing safety assessments remain critical.

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Key Takeaways

• Trazodone remains a cost-effective, off-label preferred treatment for sleep disorders, ensuring steady demand.
• Its patent expiry has led to intense generic competition, causing price erosion.
• Future growth depends on market expansion in emerging economies and formulation innovations.
• Regulatory scrutiny over off-label use poses risks but is unlikely to halt demand significantly.
• Investors should consider diversification strategies—such as developing specialized formulations—to capitalize on trazodone’s entrenched position.

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References

1. MarketsandMarkets. “Antidepressants Market by Product, Distribution Channel, Region.” 2023.
2. IQVIA. “Global Pharmaceutical Sales Data,” 2022.
3. World Health Organization. “Depression Fact Sheet,” 2022.
4. Johnson, A. et al. “Off-Label Use of Trazodone for Sleep Disorders,” Journal of Clinical Psychiatry, 2021.
5. Prescriber’s Digital Reference. “Pricing Data for Trazodone,” 2018-2022.
6. National Drug Code Directory, U.S. FDA, 2022.
7. U.S. Federal Trade Commission. “Off-Label Promotion Policies,” 2022.

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This analysis provides a comprehensive framework for evaluating trazodone’s investment landscape, integrating current market data, competitive dynamics, and future outlooks to facilitate informed decision-making.