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-nine 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 Applications:	1,767
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	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
Pragma	DESYREL	trazodone hydrochloride	TABLET;ORAL	018207-003	Mar 25, 1985		DISCN	Yes	No	8,133,893		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	4,215,104
Pragma	DESYREL	trazodone hydrochloride	TABLET;ORAL	018207-003	Mar 25, 1985	4,258,027

International Patents for DESYREL

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

Country	Patent Number	Title	Estimated Expiration
Luxembourg	82297
Italy	1143959	PERFEZIONAMENTO NELLE PASTIGLIE IN PARTICOLARE DI PRODOTTI FARMACEUTICI CON POSSIBILITA' DI FRAZIONEMANTO MULTIPLO PER LA SUDDIVISIONE IN DOSI UNITARIE E SOTTODOSI
Kenya	3571	MULTI-FRACTIONABLE TABLET STRUCTURE
European Patent Office	2178850	TRAZODONE ET CHLORHYDRATE DE TRAZODONE SOUS FORME PURIFIÉE (TRAZODONE AND TRAZODONE HYDROCHLORIDE IN PURIFIED FORM)
Israel	203294	טראזודון וטראזודון הידרוכלוריד בצורה טהורה (Trazodone and trazodone hydrochloride in purified form)
Eurasian Patent Organization	201070228	ТРАЗОДОН И ГИДРОХЛОРИД ТРАЗОДОНА В ОЧИЩЕННОЙ ФОРМЕ

DESYREL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Desyrel (Trazodone Hydrochloride)

Introduction to Desyrel

Desyrel, known generically as trazodone hydrochloride, is an antidepressant medication primarily used to treat major depressive disorder (MDD) in adults. It works by increasing the activity of serotonin in the brain[3][5].

Market Overview

The global trazodone hydrochloride market is influenced by several key factors, including market dynamics, competitive landscape, and regional analysis.

Market Size and Growth

The global trazodone hydrochloride market is projected to grow significantly from 2025 to 2031. The market size is estimated based on historical data from 2019 to 2023, with 2023 serving as the base year for calculations. The forecast period extends from 2025 to 2031, providing a comprehensive outlook on the market's potential growth[1][4].

Competitor Analysis

The market is competitive, with several pharmaceutical companies involved in the production and distribution of trazodone hydrochloride. Companies like Pernix Therapeutics, which has a history of aggressive product acquisition and life cycle management, play a significant role in shaping the market landscape[2].

Regional Analysis

The trazodone hydrochloride market is segmented into various regions, each with its own growth trajectory.

Dominant Regions

The market is expected to be dominated by regions with high prevalence of depression and strong healthcare infrastructure. North America and Europe are likely to be key regions due to their advanced healthcare systems and high demand for antidepressant medications[1][4].

Market Drivers

Several factors drive the growth of the trazodone hydrochloride market.

Increasing Prevalence of Depression

The rising incidence of major depressive disorder globally is a significant driver. As more people seek medical treatment for depression, the demand for effective antidepressants like trazodone hydrochloride increases[1][4].

Advancements in Healthcare

Improvements in healthcare infrastructure and increased access to mental health services also contribute to market growth. Advanced diagnostic techniques and better patient awareness further boost the demand for trazodone hydrochloride[1][4].

Market Restraints

Despite the growth drivers, there are several restraints that impact the market.

Side Effects and Safety Concerns

Trazodone hydrochloride is associated with several side effects, including serotonin syndrome, cardiac arrhythmias, and orthostatic hypotension. These safety concerns can limit its adoption and affect market growth[5].

Regulatory Challenges

Stringent regulatory requirements and the need for continuous monitoring of patients can also act as restraints. The FDA's strict guidelines and the requirement for gradual dose reduction upon discontinuation add to the complexity of using this medication[5].

Financial Trajectory of Key Players

Companies involved in the production and distribution of trazodone hydrochloride have shown significant financial growth and strategic maneuvers.

Pernix Therapeutics

Pernix Therapeutics, for example, has demonstrated strong financial performance through strategic acquisitions and life cycle management. In 2014, the company generated $121.7 million in revenue, a 43% increase from the previous year, driven by acquisitions like Treximet® and improved execution within their base business. The company also transitioned to profitability on an adjusted EBITDA and non-GAAP net income basis[2].

Revenue and Profitability

The financial trajectory of such companies is marked by increased revenue through organic and inorganic growth strategies. By focusing on profitable products and improving operational efficiencies, these companies aim to maintain healthy financial momentum. For instance, Pernix Therapeutics reduced its blended cost of capital from 11% to 9% through a convertible notes offering, which provided additional working capital to accelerate growth[2].

Market Trends and Opportunities

The market for trazodone hydrochloride is influenced by several trends and opportunities.

Personalized Medicine

The trend towards personalized medicine could offer opportunities for tailored treatment plans, potentially increasing the demand for trazodone hydrochloride as part of a broader treatment strategy[1][4].

Technological Advancements

Technological advancements in drug delivery systems and the development of extended-release formulations can enhance patient compliance and improve the overall efficacy of the medication[5].

Consumer Behavior Analysis

Consumer behavior plays a crucial role in the market dynamics of trazodone hydrochloride.

Patient Compliance

Patient compliance is a significant factor, as the medication requires a gradual dose increase and careful monitoring. Educational programs and support from healthcare providers can improve compliance rates[5].

Awareness and Stigma

Reducing the stigma associated with mental health disorders and increasing awareness about the effectiveness of antidepressants like trazodone hydrochloride can drive market growth by encouraging more people to seek treatment[1][4].

COVID-19 Impact

The COVID-19 pandemic has had a mixed impact on the trazodone hydrochloride market.

Increased Demand

The pandemic has led to increased stress and anxiety, resulting in a higher incidence of depression. This has driven up the demand for antidepressant medications, including trazodone hydrochloride[1][4].

Supply Chain Disruptions

However, the pandemic has also caused supply chain disruptions, affecting the production and distribution of pharmaceuticals. This has posed challenges for companies operating in the market[1][4].

SWOT Analysis

A SWOT analysis provides a comprehensive view of the market's strengths, weaknesses, opportunities, and threats.

Strengths

• Established brand presence
• Effective treatment for MDD
• Strong distribution networks

Weaknesses

• Side effects and safety concerns
• Regulatory challenges
• Dependence on patent protection

Opportunities

• Growing demand for antidepressants
• Technological advancements
• Expanding into new markets

Threats

• Competition from generic drugs
• Economic downturns
• Regulatory changes[1][4].

Key Takeaways

• The global trazodone hydrochloride market is expected to grow significantly from 2025 to 2031.
• The market is driven by increasing prevalence of depression, advancements in healthcare, and strategic maneuvers by pharmaceutical companies.
• Key players like Pernix Therapeutics have demonstrated strong financial performance through acquisitions and operational efficiencies.
• The market faces restraints such as side effects, regulatory challenges, and supply chain disruptions.
• Consumer behavior and awareness play crucial roles in market dynamics.

Frequently Asked Questions

1. What is the primary use of Desyrel (trazodone hydrochloride)?

Desyrel (trazodone hydrochloride) is primarily used to treat major depressive disorder (MDD) in adults by increasing the activity of serotonin in the brain[3][5].

2. Which regions are expected to dominate the trazodone hydrochloride market?

North America and Europe are expected to dominate the market due to their advanced healthcare systems and high demand for antidepressant medications[1][4].

3. What are the key side effects associated with trazodone hydrochloride?

Key side effects include serotonin syndrome, cardiac arrhythmias, orthostatic hypotension, and increased risk of bleeding[5].

4. How has the COVID-19 pandemic impacted the trazodone hydrochloride market?

The pandemic has increased the demand for antidepressants due to higher stress and anxiety levels but has also caused supply chain disruptions[1][4].

5. What strategies have companies like Pernix Therapeutics employed to enhance their financial trajectory?

Companies like Pernix Therapeutics have employed strategies such as aggressive product acquisitions, life cycle management, and improving operational efficiencies to enhance their financial trajectory[2].

Cited Sources:

1. Cognitivemarketresearch.com - Trazodone Hydrochloride Market Report 2024 (Global Edition)
2. Annualreports.com - HEALTHY FUTURES - Annual Reports
3. Mayoclinic.org - Trazodone (oral route) - Mayo Clinic
4. Cognitivemarketresearch.com - Trazodone Market Report 2024 (Global Edition)
5. Accessdata.fda.gov - DESYREL® (trazodone hydrochloride) tablets, for oral use