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 four branded drugs marketed by Angelini Pharma, Pragma, Accord Hlthcare, Aiping Pharm Inc, Alvogen, Am Therap, Apotex, Apotex Inc, Aurobindo Pharma, Crossmedika Sa, Granules, Graviti Pharms, Natco, Norvium Bioscience, Oxford Pharms, Pliva, Quantum Pharmics, Rising, Sun Pharm Industries, Teva, Teva Pharms Usa, Torrent, Usl Pharma, Watson Labs, and Zydus Pharms, and is included in thirty-five 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 is one tentative approval for this compound.

Summary for TRAZODONE HYDROCHLORIDE

International Patents:	78
US Patents:	2
Tradenames:	4
Applicants:	25
NDAs:	35
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	39
Raw Ingredient (Bulk) Api Vendors:	134
Clinical Trials:	65
Patent Applications:	2,526
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
Alzheimer's Drug Discovery Foundation	Phase 3
Simon Ducharme, MD	Phase 3
University of New Mexico	Phase 4

See all TRAZODONE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for TRAZODONE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		300MG	TABLET;ORAL
		150MG	TABLET;ORAL
		100MG	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
Alvogen	TRAZODONE HYDROCHLORIDE	trazodone hydrochloride	TABLET;ORAL	071514-001	Apr 18, 1988		DISCN	No	No
Zydus Pharms	TRAZODONE HYDROCHLORIDE	trazodone hydrochloride	TABLET;ORAL	205253-001	Oct 10, 2017	AB	RX	No	No
Quantum Pharmics	TRIALODINE	trazodone hydrochloride	TABLET;ORAL	070942-001	Dec 1, 1986		DISCN	No	No
Alvogen	TRAZODONE HYDROCHLORIDE	trazodone hydrochloride	TABLET;ORAL	071636-001	Apr 18, 1988		DISCN	No	No
Angelini Pharma	OLEPTRO	trazodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022411-002	Feb 2, 2010		DISCN	Yes	No			Y	Y

Expired US Patents for TRAZODONE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pragma	DESYREL	trazodone hydrochloride	TABLET;ORAL	018207-003	Mar 25, 1985
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
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
Canada	2616416	COMPOSITION DE TRAZODONE A ADMINISTRATION QUOTIDIENNE (TRAZODONE COMPOSITION FOR ONCE A DAY ADMINISITIATION)
Mexico	2010001094	TRAZODONA Y HIDROCLORURO DE TRAZODONA EN FORMA PURIFICADA. (TRAZODONE AND TRAZODONE HYDROCHLORIDE IN PURIFIED FORM.)
Eurasian Patent Organization	017019	ТРАЗОДОН И ГИДРОХЛОРИД ТРАЗОДОНА В ОЧИЩЕННОЙ ФОРМЕ (TRAZODONE AND TRAZODONE HYDROCHLORIDE IN PURIFIED FORM)
Canada	2693095	TRAZODONE ET CHLORHYDRATE DE TRAZODONE SOUS FORME PURIFIEE (TRAZODONE AND TRAZODONE HYDROCHLORIDE IN PURIFIED FORM)
Cyprus	1115666

TRAZODONE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Trazodone Hydrochloride

Introduction to Trazodone Hydrochloride

Trazodone hydrochloride, commonly known by its brand name Desyrel, is a medication primarily used to treat major depression and insomnia. Its versatility in addressing various mental health issues has led to a significant presence in the pharmaceutical market.

Market Growth and Expansion

The Trazodone HCl market has experienced a rapid and substantial growth phase in recent years. Projections indicate that this growth will continue from 2023 to 2031, highlighting a persistent upward trend in market dynamics[1][4].

Market Segmentation

The market for Trazodone HCl is segmented based on several key factors:

Type

• The market is categorized into different purity levels, such as Purity ≥99% and Purity ≥99.5%[1].
• For Trazodone Hydrochloride Tablets, the segmentation includes different dosages (50mg, 100mg, 150mg, 300mg)[4].

Application

• Trazodone is used in various applications, including antidepression, anxiolytic, hypnotic, and other uses[1][4].

Geographical Regions

• The market is analyzed across North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa[1][4].

Market Size and Revenue Projections

The market size of Trazodone HCl is estimated in USD million across the mentioned segments. The reports provide a detailed outlook on the development of the market in terms of revenue throughout the forecast period from 2023 to 2031. The positive momentum in market dynamics suggests robust growth rates, indicating significant and noteworthy development[1][4].

Drivers and Restraints

Drivers

• Increasing prevalence of mental health disorders such as depression and insomnia.
• Growing demand for effective antidepressants and sleep aids.
• Expanding healthcare infrastructure and access to medications in various regions[1][4].

Restraints

• Potential side effects, including sexual side effects, which can impact patient compliance and overall market growth[5].
• Regulatory challenges and FDA warnings, such as the Black Box Warning for increased risks of suicidal thoughts[5].

Opportunities and Challenges

Opportunities

• Off-label use for sleep management, although this is subject to ongoing research and caution due to potential risks[2].
• Increasing awareness and reduced stigma around mental health issues, leading to higher demand for treatments.

Challenges

• Mixed results in substance abuse treatment, with some studies indicating worse outcomes in certain patient groups[2].
• Economic, political, and social landscapes affecting market dynamics and consumer behavior[1][4].

Competitive Analysis

The Trazodone HCl market is highly competitive, with several key players operating globally. The reports provide a detailed competitor analysis, including corporate profiles and market strategies. This competitive landscape is crucial for understanding the market's direction and potential opportunities for growth[1][4].

Regional Analysis

The market is expected to be dominated by certain regions, with North America and Europe often leading due to advanced healthcare systems and higher awareness of mental health treatments. However, the Asia-Pacific region is also expected to show significant growth due to its large population and increasing healthcare expenditure[1][4].

Consumer Behavior and Economic Impact

Consumer behavior plays a critical role in the Trazodone HCl market. Factors such as product pricing, national GDP, and the economic, political, and social landscapes of countries influence market trends. The reports include a detailed analysis of consumer behavior and its impact on the market[1][4].

Technological and Regulatory Trends

Technological advancements in pharmaceutical manufacturing and distribution are expected to influence the market. Additionally, regulatory changes and FDA guidelines will continue to shape the market's trajectory. For instance, the FDA Black Box Warning on Trazodone highlights the need for careful prescribing practices[5].

Financial Trajectory

The financial trajectory of the Trazodone HCl market is promising, with sustained significant expansion projected from 2023 to 2031. The market size is expected to grow substantially, driven by increasing demand and favorable market dynamics. Here is a snapshot of the financial outlook:

• Market Size: Estimated in USD million, with significant growth projected across various segments[1][4].
• CAGR: The Compound Annual Growth Rate (CAGR) is expected to be robust, reflecting the market's strong growth potential[3].
• Revenue Projections: Detailed revenue projections are provided for the forecast period, offering insights into the market's financial trajectory[1][4].

Key Takeaways

• The Trazodone HCl market is experiencing rapid growth and is expected to continue this trend until 2031.
• Market segmentation based on type, application, and geographical regions provides a comprehensive understanding of the market.
• Drivers such as increasing demand for mental health treatments and expanding healthcare infrastructure are key to market growth.
• Restraints, including potential side effects and regulatory challenges, need to be carefully managed.
• The market is highly competitive, with several key players influencing market dynamics.
• Regional analysis highlights the dominance of certain regions and the potential for growth in emerging markets.

FAQs

Q: What are the primary applications of Trazodone HCl? A: Trazodone HCl is primarily used for the treatment of major depression, insomnia, and as an anxiolytic and hypnotic[1][4].

Q: Is Trazodone HCl addictive? A: Trazodone HCl is not believed to be addictive, but it can cause withdrawal symptoms if stopped abruptly[2][5].

Q: What are the potential side effects of Trazodone HCl? A: Potential side effects include sexual side effects such as reduced sex drive, erectile problems, and priapism risks. It also carries an FDA Black Box Warning for increased risks of suicidal thoughts[5].

Q: Which regions are expected to dominate the Trazodone HCl market? A: North America and Europe are expected to dominate, but the Asia-Pacific region is also projected to show significant growth[1][4].

Q: What is the projected CAGR for the Trazodone HCl market? A: The CAGR is expected to be robust, reflecting the market's strong growth potential, though exact figures vary by report[3].

Cited Sources

1. Market Research Intellect - Global Trazodone HCl Market Size, Scope And Forecast Report
2. DrugAbuse.com - Trazodone Use in Substance Abuse Treatment
3. Cognitive Market Research - Trazodone Market Report 2024 (Global Edition)
4. Market Research Intellect - Global Trazodone Hydrochloride Tablets Market Size, Trends and ...
5. Landmark Recovery - What Are the Sexual Side Effects of Trazodone?