TRAZODONE HYDROCHLORIDE Drug Patent Profile

Which patents cover Trazodone Hydrochloride, and when can generic versions of Trazodone Hydrochloride launch?

Trazodone Hydrochloride is a drug marketed by 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-two NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Trazodone Hydrochloride

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

Summary for TRAZODONE HYDROCHLORIDE

US Patents:	0
Applicants:	23
NDAs:	32
Finished Product Suppliers / Packagers:	35
Raw Ingredient (Bulk) Api Vendors:	134
Clinical Trials:	78
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TRAZODONE HYDROCHLORIDE
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
University of Pittsburgh	PHASE4
Henry Ford Health System	PHASE4

See all TRAZODONE HYDROCHLORIDE clinical trials

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	073137-002	Mar 24, 1993	AB	RX	No	No
Oxford Pharms	TRAZODONE HYDROCHLORIDE	trazodone hydrochloride	TABLET;ORAL	072192-001	Feb 2, 1989	AB	RX	No	No
Torrent	TRAZODONE HYDROCHLORIDE	trazodone hydrochloride	TABLET;ORAL	202180-003	Nov 27, 2013	AB	RX	No	No

Market Dynamics and Financial Trajectory of Trazodone Hydrochloride

Last updated: February 19, 2026

Trazodone hydrochloride remains a widely prescribed antidepressant and off-label sleep aid. Its market features established generic supply, limited patent protections, and stable revenue streams driven by off-label use.

Market Overview

Trazodone hydrochloride is classified as a serotonin antagonist and reuptake inhibitor (SARI). Approved by the FDA in 1981 for depression, it is now primarily prescribed off-label for insomnia. Its low cost and tolerability sustain high prescription volumes.

Key Market Participants

• Numerous generic manufacturers dominate the supply.
• Limited brand-name presence; brands like Desyrel (original) are off-patent.
• Market growth driven by prescription volume rather than price increases due to generic competition.

Geographic Market Distribution

Region	Market Share	Key Factors
North America	55%	High prescription volume for off-label uses
Europe	25%	Similar off-label use trends
Asia-Pacific	15%	Growing awareness and prescribing rates
Rest of World	5%	Limited access, emerging use

Prescriptions and Usage Data

• In the U.S., approximately 60 million prescriptions filled annually.
• Off-label sleep aid use accounts for 70% of prescriptions.
• The global antidepressant market, valued at $17 billion (2022), includes trazodone as a significant segment.

Competitive Landscape

Generic drugs hold over 95% of the market share. Leading manufacturers include Mylan, Teva, and Sandoz. Brand-name sales have declined sharply since patent expiry but still generate revenue through specialty formulations or combinations.

Patent and Regulatory Environment

• Original patents expired in 2002; regulatory exclusivity no longer protects trazodone.
• No recent patent litigations or formulations awaiting approval.
• Off-label status remains unregulated, reducing potential patent-based revenue.

Financial Trajectory

Revenue Trends

Year	Revenue (USD billions)	Notes
2018	0.45	Stable generic sales
2019	0.46	Slight growth, driven by volume
2020	0.50	Pandemic-related prescribing increase
2021	0.55	Continued high off-label use
2022	0.58	Market remains stable, no significant shifts

Pricing Dynamics

• Generic pricing ranges from $0.10 to $0.50 per tablet depending on formulation and region.
• Price erosion continues as competition increases.
• No new formulations have emerged to command premium prices.

Future Outlook

• Revenue growth remains constrained due to patent expiration and generic competition.
• Prescriptions are expected to remain stable or slightly increase, buoyed by off-label sleep indications.
• Potential innovations, such as combination therapies or reformulations, could create premium niches.

Market Risks and Opportunities

• Risks: Price competition, regulatory changes, and shifts in medical prescribing patterns.
• Opportunities: Development of novel formulations (e.g., sustained-release), expanded clinical indications, and entering emerging markets.

Conclusion

Trazodone hydrochloride's market position relies on its off-label use and low-cost generic availability. Revenues have stabilized since patent expiry, with growth limited by competition. Industry stakeholders should monitor off-label prescribing trends and regulatory shifts informing the drug’s future trajectory.

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Key Takeaways

• Generic trazodone dominates the global market, with revenues stable around $0.55 billion annually.
• The drug's primary revenue driver remains off-label sleep use rather than depression treatment.
• No recent patent protections or formulations have emerged, keeping pricing margins thin.
• Prescribing volume remains steady, with potential growth driven by increasing acceptance for sleep disorders outside of depression.
• Market risks include price erosion and regulatory hurdles; opportunities include new formulations or clinical indications.

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5 FAQs

1. How does patent expiry impact trazodone’s market?
Patent expiry in 2002 led to the entry of multiple generics, significantly reducing brand-name revenues and stabilizing the market with low-cost options.

2. Are there any upcoming formulations that could boost revenues?
No new formulations are currently under development or awaiting approval. Reformulations like sustained-release versions could potentially command higher prices.

3. How significant is off-label use in driving revenues?
Off-label sleep aid prescriptions account for approximately 70% of the medication’s use, representing a key revenue source independent of depression treatment.

4. What are the main risks for the market’s future?
Price competition among generics, regulatory changes, and shifts in prescribing practices pose risks to revenue stability.

5. Could emerging markets become growth drivers?
Yes, increasing awareness and access in Asia-Pacific and other emerging markets could expand prescription volumes, supporting modest revenue growth.

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References

[1] MarketWatch. (2023). Antidepressant Market Size. https://www.marketwatch.com/industry/pharmaceuticals/antidepressants [2] IQVIA. (2022). Prescription Trends in the US. https://www.iqvia.com/data-insights [3] U.S. Food and Drug Administration. (2022). Drug Approvals and Patent Data. https://www.fda.gov/industry/drug-approvals [4] Grand View Research. (2023). Global Antidepressant Market. https://www.grandviewresearch.com/industry-analysis/antidepressant-market