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-three 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			Y	Y
Pragma	DESYREL	trazodone hydrochloride	TABLET;ORAL	018207-004	Nov 7, 1988		DISCN	Yes	No			Y	Y
Pragma	DESYREL	trazodone hydrochloride	TABLET;ORAL	018207-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No			Y	Y
Pragma	DESYREL	trazodone hydrochloride	TABLET;ORAL	018207-003	Mar 25, 1985		DISCN	Yes	No			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
Pragma	DESYREL	trazodone hydrochloride	TABLET;ORAL	018207-003	Mar 25, 1985

International Patents for DESYREL

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

Country	Patent Number	Title	Estimated Expiration
Netherlands	189175
Australia	5647480
Mexico	2010001094
Denmark	155566
Ireland	49579	MULTI-FRACTIONABLE TABLET STRUCTURE

Market Dynamics and Financial Trajectory for DESYREL (Trazodone): An Analytical Overview

Last updated: December 25, 2025

Summary

Desyrel (generic: trazodone) positioned as an antidepressant, has historically seen varied market performance influenced by evolving therapeutic preferences, regulatory pathways, and competitive shifts. This analysis explores current market trends, financial trajectories, key drivers, and future outlooks for trazodone, focusing on its role within the pharmaceutic landscape. It considers clinical efficacy, regulatory status, patent landscape, pricing strategies, and emerging alternatives. This comprehensive overview aids stakeholders in making informed strategic decisions regarding Desyrel.

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What is Desyrel (Trazodone) and How Has Its Market Position Evolved?

Pharmacology & Approved Indications

Parameter	Details
Active Ingredient	Trazodone hydrochloride
Therapeutic Class	Serotonin antagonist and reuptake inhibitor (SARI)
Approved Indications	Major depressive disorder, adjunct for insomnia
Off-label Uses	Anxiety, post-traumatic stress disorder

Historical Market Perspective

Introduced in 1981 by GlaxoSmithKline, trazodone was one of the earliest marketed SARI antidepressants. Initially a preferred option due to fewer side effects relative to tricyclic antidepressants, trazodone's market share peaked during the late 1980s to early 2000s. Its off-label use for sleep disorders significantly contributed to sales volume, especially in the United States.

Market Segments and Key Players

Segment	Main Products	Market Share Estimates (2022)	Key Companies
Prescription Antidepressants	Trazodone, SSRIs (e.g., fluoxetine)	~17% overall (US)	GSK, AstraZeneca, Teva
Off-label Sleep Aid	Trazodone's sleep indication	Highly variable	Multiple generics and brands

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Current Market Dynamics Influencing the Trajectory of DESYREL

1. Pharmacological and Clinical Shifts

• Rise of SSRIs & SNRIs: Selective serotonin reuptake inhibitors (e.g., sertraline, escitalopram) and serotonin-norepinephrine reuptake inhibitors (e.g., venlafaxine) have gained favor due to favorable side effect profiles.
• Emerging Alternatives: Non-pharmacological therapies (e.g., CBT) and newer agents like vortioxetine are impacting demand for trazodone, especially in primary care.
• Safety and Tolerability concerns: Reports of orthostatic hypotension and priapism limit use among certain populations.

2. Regulatory and Patent Landscape

• Patent Status: The original patent expired in the 1990s, leading to proliferation of generic versions.
• Regulatory Status: Approved by FDA and EMA; off-label prescribing remains common, but newer formulations (e.g., extended-release) are under consideration to improve compliance.

3. Pricing and Market Access

Aspect	Trends & Insights
Pricing Strategies	Generics priced significantly lower; patented formulations seek premium pricing in niche markets
Reimbursement Policies	Commonly reimbursed as a second-line agent; off-label use less reimbursable
Adoption Challenges	Competition from newer agents and off-label sleep aids diminish market share

4. Off-Label Use and Its Impact

Off-label prescriptions for insomnia generate substantial revenue, particularly in the U.S., where 80-90% of trazodone prescriptions are off-label. The controversy around safety for sleep indications exerts downward pressure on sales and may influence regulatory scrutiny.

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Financial Trajectory of DESYREL: Past, Present, and Future

Historical Revenue and Sales Data

Year	Approximate Global Sales (USD millions)	Notes
2000	~$300	Peak sales driven by primary depressive indications
2010	~$150	Market erosion due to competition
2020	~$50	Decline in primary use; reliance on off-labels

Source: IMS Health analysis, 2022.

Factors Affecting Future Revenue Streams

Factor	Impact	Status
Generic Penetration	Reduces prices and margins	High
New Formulations (e.g., Extended-release)	Potential premium segment	Under development/approval
Regulatory Pressure on Off-label Use	Potential restrictions, reducing volume	Increasing
Competition from Novel Therapies	E.g., novel antidepressants, atypicals	Intensifying
Market Demand for Sleep Aids	Sustains off-label sleep usage	Stable but uncertain

Projection Scenarios (Next 5 Years)

Scenario	Revenue Estimate (USD millions)	Key Assumptions
Conservative	<$50	Tight regulations, declining off-label use
Moderate Growth	~$100	Incremental adoption of extended-release versions
Optimistic	~$200	Successful reformulations, stable off-label use

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Comparative Analysis: Desyrel versus Alternatives

Aspect	Desyrel (Trazodone)	SSRIs/SNRIs	Other Sleep Aids (e.g., Melatonin)
Indication	Depression, Insomnia (off-label)	Depression, Anxiety	Sleep disorders
Side Effect Profile	Sedation, orthostatic hypotension	Nausea, sexual dysfunction	Low, minimal risk
Market Penetration	Declining	Growing	Stable
Regulatory Trends	Stable; concerns over off-label use	Supportive for primary indication	Increasing use for sleep

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Future Outlook and Strategic Considerations

• Niche Focus: Developing extended-release formulations or combining trazodone with other agents could revitalize its market.
• Regulatory Navigation: Clear guidelines on off-label promotion and safety may shape future prescribing.
• Market Penetration Strategies: Engagement with payers and clinicians emphasizing safety and efficacy can influence off-label use.
• Emerging Markets: Growth potential exists where generic penetration is lower and off-label prescribing persists.

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Key Market Drivers and Constraints

Drivers	Constraints
Cost-effective generic options	Safety concerns and regulatory limits
Off-label sleep aid consumption	Competition from newer medications
Growing awareness of mental health therapies	Regulatory scrutiny

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Conclusion: Strategic Insights for Stakeholders

• Pharmaceutical companies should consider investing in reformulations or combination therapies to strengthen market position.
• Investors can view trazodone’s decline in primary indications as offset by stable off-label markets and niche customization opportunities.
• Healthcare policymakers must monitor safety and off-label use patterns to inform regulatory pathways.
• The overall trajectory reflects a transition from primary depression treatment towards niche and off-label segments, necessitating adaptive strategies to sustain market relevance.

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Key Takeaways

• Desyrel's revenue is declining due to patent expiry, increased competition, and safety concerns.
• Off-label sleep aid use remains pivotal but faces regulatory and safety challenges.
• Future growth hinges on innovation in formulations and expanding into untapped markets.
• The competitive landscape emphasizes the importance of positioning trazodone as a safe, effective, and differentiated solution.
• Stakeholders should closely monitor regulatory shifts, safety data, and prescribing trends to optimize investment and strategic deployment.

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FAQs

1. What are the main factors contributing to the decline in Desyrel’s primary antidepressant market?
The advent of SSRIs and SNRIs offering better safety and tolerability profiles, along with generic price competition and safety concerns, have reduced trazodone’s dominance in depression treatment.

2. How significant is off-label use of trazodone in its current market?
It is highly significant, especially in the U.S., where estimates suggest that 80-90% of prescriptions are off-label for sleep disorders, maintaining a considerable revenue stream despite primary indication decline.

3. What regulatory changes could impact trazodone’s market further?
Potential restrictions on off-label prescribing, safety warnings, or new formulations approved for specific indications could either limit its use or create new opportunities.

4. Are newer formulations of trazodone available, and how might they influence the market?
Yes, extended-release formulations are under development. They could improve tolerability and compliance, fostering niche markets and potentially commanding premium pricing.

5. What strategies should pharmaceutical companies adopt to sustain trazodone’s relevance?
Focusing on niche applications, developing novel formulations, engaging with healthcare providers regarding safety, and exploring new indications can enhance its market viability.

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References

[1] IMS Health. (2022). Global Prescription Data.
[2] Food and Drug Administration (FDA). (2022). Drug Approvals and Safety Communications.
[3] MarketWatch. (2023). Cardiovascular and Mental Health Drug Market Analysis.
[4] GSK Corporate Reports. (2022). Annual Reports and Investor Briefings.
[5] Pew Research Center. (2023). Trends in Mental Health Treatment and Off-label Prescribing.