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Last Updated: December 22, 2024

TRAZODONE HYDROCHLORIDE Drug Patent Profile


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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, 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-two NDAs.

The generic ingredient in TRAZODONE HYDROCHLORIDE 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 Trazodone Hydrochloride

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

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Drug patent expirations by year for TRAZODONE HYDROCHLORIDE
Recent Clinical Trials for TRAZODONE HYDROCHLORIDE

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

SponsorPhase
Simon Ducharme, MDPhase 3
Alzheimer's Drug Discovery FoundationPhase 3
University of New MexicoPhase 4

See all TRAZODONE HYDROCHLORIDE clinical trials

Pharmacology for TRAZODONE HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for TRAZODONE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for TRAZODONE HYDROCHLORIDE
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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Norvium Bioscience TRAZODONE HYDROCHLORIDE trazodone hydrochloride TABLET;ORAL 090514-001 Jun 2, 2009 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Torrent TRAZODONE HYDROCHLORIDE trazodone hydrochloride TABLET;ORAL 202180-003 Nov 27, 2013 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Zydus Pharms TRAZODONE HYDROCHLORIDE trazodone hydrochloride TABLET;ORAL 205253-004 Oct 10, 2017 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Pharms Usa TRAZODONE HYDROCHLORIDE trazodone hydrochloride TABLET;ORAL 071523-001 Dec 11, 1987 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Torrent TRAZODONE HYDROCHLORIDE trazodone hydrochloride TABLET;ORAL 202180-004 Nov 27, 2013 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs TRAZODONE HYDROCHLORIDE trazodone hydrochloride TABLET;ORAL 070858-001 Oct 10, 1986 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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?

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