TRAZODONE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for trazodone hydrochloride and what is the scope of freedom to operate?

Trazodone hydrochloride is the generic ingredient in five branded drugs marketed by Kamat, Angelini Pharma, Pragma, Accord Hlthcare, Aiping Pharm Inc, Alvogen, Am Therap, Apotex, Apotex Inc, Aurobindo Pharma, Crossmedika Sa, Granules, Graviti Pharms, Natco, Oxford Pharms, Pharmobedient, Pliva, Quantum Pharmics, Rising, Sun Pharm Industries, Teva, Teva Pharms Usa, Torrent, Usl Pharma, Watson Labs, and Zydus Pharms, and is included in thirty-six NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Trazodone hydrochloride has seventy-eight patent family members in thirty countries.

There are thirteen drug master file entries for trazodone hydrochloride. Thirty-nine suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for TRAZODONE HYDROCHLORIDE

International Patents:	78
US Patents:	2
Tradenames:	5
Applicants:	26
NDAs:	36
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	39
Raw Ingredient (Bulk) Api Vendors:	134
Clinical Trials:	77
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TRAZODONE HYDROCHLORIDE
What excipients (inactive ingredients) are in TRAZODONE HYDROCHLORIDE?	TRAZODONE HYDROCHLORIDE excipients list
DailyMed Link:	TRAZODONE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for TRAZODONE HYDROCHLORIDE

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

Sponsor	Phase
VA Office of Research and Development	PHASE4
Patient-Centered Outcomes Research Institute	PHASE4
University of Utah	PHASE4

See all TRAZODONE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for TRAZODONE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		100MG	TABLET;ORAL
		50MG	TABLET;ORAL
		300MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for TRAZODONE HYDROCHLORIDE

Drug Class

Serotonin Reuptake Inhibitor

Medical Subject Heading (MeSH) Categories for TRAZODONE HYDROCHLORIDE

Anti-Anxiety Agents

Antidepressive Agents, Second-Generation

Serotonin Uptake Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for TRAZODONE HYDROCHLORIDE

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for TRAZODONE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OLEPTRO	Extended-release Tablets	trazodone hydrochloride	150 mg and 300 mg	022411	1	2010-10-18

US Patents and Regulatory Information for TRAZODONE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm Industries	TRAZODONE HYDROCHLORIDE	trazodone hydrochloride	TABLET;ORAL	073137-001	Mar 24, 1993	AB	RX	No	No
Pragma	DESYREL	trazodone hydrochloride	TABLET;ORAL	018207-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No			Y	Y
Aurobindo Pharma	TRAZODONE HYDROCHLORIDE	trazodone hydrochloride	TABLET;ORAL	204852-001	Feb 5, 2020	AB	RX	No	No
Pharmobedient	TRAZODONE HYDROCHLORIDE	trazodone hydrochloride	TABLET;ORAL	090514-004	Jun 2, 2009		DISCN	No	No

Expired US Patents for TRAZODONE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Angelini Pharma	OLEPTRO	trazodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022411-001	Feb 2, 2010
Pragma	DESYREL	trazodone hydrochloride	TABLET;ORAL	018207-003	Mar 25, 1985
Pragma	DESYREL	trazodone hydrochloride	TABLET;ORAL	018207-003	Mar 25, 1985
Angelini Pharma	OLEPTRO	trazodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022411-002	Feb 2, 2010

International Patents for TRAZODONE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Taiwan	200812585	Trazodone composition for once a day administration
World Intellectual Property Organization (WIPO)	2009019133
Ecuador	SP088239
New Zealand	565591	Trazodone and cross linked high amylose starch composition for once a day administration

Market Dynamics and Financial Trajectory for Trazodone Hydrochloride

Last updated: August 19, 2025

Introduction

Trazodone Hydrochloride, a serotonin antagonist and reuptake inhibitor (SARI), was initially introduced in the 1980s for the treatment of major depressive disorder (MDD). Over decades, its off-label uses—particularly for insomnia—have significantly shaped its market profile. Analyzing the market dynamics and financial trajectory of trazodone hydrochloride necessitates a comprehensive understanding of its clinical positioning, regulatory landscape, competitive environment, and evolving pharmacoeconomic factors.

Market Overview

Trazodone hydrochloride remains a widely prescribed antidepressant in numerous countries, including the United States, Europe, and parts of Asia. While it was primarily developed as an antidepressant, its sedative properties have driven off-label prescribing for insomnia, often overshadowing newer hypnotics. The global antidepressant market was valued at approximately USD 15.8 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of around 4–5% through 2028, reflecting rising mental health awareness and expanding diagnostic rates [1].

Despite the proliferation of newer antidepressants and hypnotics, trazodone maintains a stable presence due to its affordability, established safety profile, and clinician familiarity. Its off-label use for sleep aids, particularly among elderly populations, sustains continuous demand, influencing its market dynamics.

Key Market Drivers

1. Rising Prevalence of Mental Health Disorders
   The global increase in depression and anxiety disorders propels demand for effective pharmacological interventions. According to WHO, over 264 million people suffer from depression worldwide, catalyzing sustained prescribing of net antidepressants like trazodone [2].

2. Aging Population and Insomnia Cases
   Elderly demographics are particularly susceptible to insomnia and comorbid depression, often receiving trazodone as a treatment option due to its sedative effects and favorable side effect profile compared to benzodiazepines. The aging population contributes to stable or increasing off-label consumption.

3. Cost-Effectiveness and Generic Availability
   As a generic pharmaceutical, trazodone hydrochloride is widely accessible, with low-cost formulations dominating many markets. Cost considerations impact prescribing behaviors, especially in resource-constrained healthcare systems.

4. Regulatory and Prescribing Trends
   While trazodone is not FDA-approved specifically for insomnia, its off-label use is legal and widespread; this regulatory environment sustains its market. Conversely, increasing scrutiny over off-label prescribing practices may influence future market access.

Market Challenges

1. Emergence of Newer Therapies
   Novel antidepressants and hypnotics—such as vortioxetine, vilazodone, and non-benzodiazepine sleep aids like zolpidem—offer improved side effect profiles and targeted mechanisms, gradually encroaching upon trazodone’s market segment.

2. Safety and Side Effect Profile
   Trazodone is associated with adverse effects, notably orthostatic hypotension, priapism, and sedation, which can limit its use in certain populations. Such safety concerns may hinder uptake compared to newer agents with better tolerability.

3. Regulatory Developments and Off-Label Limitations
   While current off-label use sustains demand, regulatory agencies may tighten guidelines, especially amid safety concerns, potentially impacting market volume.

Financial Trajectory

The financial trajectory of trazodone hydrochloride has historically been characterized by steady revenues driven primarily by generics. In the U.S., sales of trazodone formulations peaked in the early 2010s, reaching over USD 300 million annually (post-discount), primarily driven by off-label sleep indications. Although newer brand-name drugs have gained market share, the overall sales have plateaued due to generic competition and the clinical limitations mentioned earlier [3].

Proprietary formulations like Desyrel® (brand name) have divided market share with generic counterparts. The revenue impact is moderate in developed markets, with key revenue streams concentrated among generic manufacturers and some specialized psychiatric formulary providers.

Future Outlook

The future financial trajectory of trazodone hydrochloride hinges on several factors:

• Sustained Off-Label Use: With increasing awareness of mental health issues and sleep disorders, off-label prescribing will likely persist, maintaining baseline revenue.

• Regulatory Environment: Potential reclassification or safety warnings could restrict use, negatively impacting sales.

• Generic Price Erosion: Continued market entry of generics will suppress prices, constraining profit margins.

• Emergence of Alternatives: Advances in pharmacotherapy, including non-pharmacological interventions like cognitive-behavioral therapy for insomnia (CBT-I), may displace trazodone in certain indications.

• Potential for FDA-Indicated Uses: If future trials establish trazodone’s efficacy for specific approved indications, brand differentiation and pricing power could rebound. Currently, such developments appear unlikely given the existing evidence base.

Competitive Landscape

Trazodone faces intense competition from both older antidepressants (e.g., amitriptyline) and newer agents. The hypnotic market is increasingly dominated by non-Benzodiazepine receptor agonists and melatonin receptor agonists, which often demonstrate superior safety profiles. The competition intensifies across markets as pharmacies favor cost-effective generics, though brand-name derivatives with improved formulations offer niche advantages.

Regulatory and Market Implications

Regulatory bodies like the FDA and EMA monitor trazodone’s safety signals, including risks of hypotension and priapism. Heightened regulatory scrutiny could lead to warnings or restrictions, influencing both clinical use and sales. At the same time, reclassification can open avenues for new, expanded indications, possibly impacting the financial trajectory positively.

Conclusion

Trazodone hydrochloride’s market and financial landscape are shaped by its longstanding clinical use, affordability, and off-label applications against a backdrop of emerging competition and regulatory shifts. While its revenue remains relatively stable in developed markets, the increasing availability of newer, better-tolerated therapies and evolving prescribing guidelines pose long-term challenges. The drug's future will depend on regulatory policies, clinical guideline updates, and the global burden of mental health and sleep disorders.

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Key Takeaways

• Trazodone hydrochloride maintains stable demand driven by off-label use, affordability, and an established safety profile.
• Market growth is modest, with revenues plateauing due to generic competition and emerging alternatives.
• The aging global population sustains demand for sleep and depression treatments, presenting continued, albeit limited, opportunities.
• Regulatory actions and safety concerns could reshape prescribing patterns and market access.
• Future prospects hinge on potential new indications or formulations, balanced against evolving clinical and regulatory landscapes.

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FAQs

1. Is trazodone hydrochloride still a profitable medication for generic manufacturers?
Yes. Its low-cost production and widespread off-label use sustain profitable margins for generic manufacturers, although prices are declining due to increased generic competition.

2. Are there upcoming regulatory changes that could impact trazodone's market?
Potential safety warnings, especially concerning adverse effects like priapism, could be introduced, which may restrict or alter prescribing practices.

3. Can trazodone be used as a first-line treatment for depression now?
Typically, no. While it’s prescribed for depression, newer antidepressants with better side effect profiles often dominate first-line therapy.

4. What role does trazodone play in treating sleep disorders currently?
Off-label, trazodone is common for sleep management among the elderly and those intolerant to other hypnotics, but this use is not FDA-approved and may face regulatory scrutiny.

5. How does the market for trazodone compare in different regions?
Developed markets see stable demand through generics, while emerging markets may exhibit higher growth potential due to increasing mental health awareness and limited access to newer medications.

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References

[1] Grand View Research. “Antidepressant Drugs Market Size & Trends Report, 2022-2028.”
[2] World Health Organization. “Depression Fact Sheet.” 2022.
[3] IQVIA. “Pharmaceutical Market Reports, 2021.”