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Last Updated: March 16, 2025

Trazodone hydrochloride - Generic Drug Details


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What are the generic sources for trazodone hydrochloride and what is the scope of patent protection?

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, 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-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. Forty suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for trazodone hydrochloride
Recent Clinical Trials for trazodone hydrochloride

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

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

See all trazodone hydrochloride clinical trials

Generic filers with tentative approvals for TRAZODONE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Try for Free⤷  Try for Free300MGTABLET;ORAL
⤷  Try for Free⤷  Try for Free150MGTABLET;ORAL
⤷  Try for Free⤷  Try for Free100MGTABLET;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
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

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Pragma DESYREL trazodone hydrochloride TABLET;ORAL 018207-001 Approved Prior to Jan 1, 1982 DISCN Yes No 8,133,893 ⤷  Try for Free Y Y ⤷  Try for Free
Usl Pharma TRAZODONE HYDROCHLORIDE trazodone hydrochloride TABLET;ORAL 070491-001 Apr 29, 1987 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Natco TRAZODONE HYDROCHLORIDE trazodone hydrochloride TABLET;ORAL 071406-001 Feb 27, 1991 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Crossmedika Sa TRAZODONE HYDROCHLORIDE trazodone hydrochloride TABLET;ORAL 211116-004 May 20, 2024 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Granules TRAZODONE HYDROCHLORIDE trazodone hydrochloride TABLET;ORAL 218988-002 Aug 8, 2024 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 5 of 5 entries

Expired US Patents for trazodone hydrochloride

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Pragma DESYREL trazodone hydrochloride TABLET;ORAL 018207-003 Mar 25, 1985 4,258,027 ⤷  Try for Free
Pragma DESYREL trazodone hydrochloride TABLET;ORAL 018207-003 Mar 25, 1985 4,215,104 ⤷  Try for Free
Angelini Pharma OLEPTRO trazodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022411-001 Feb 2, 2010 6,607,748 ⤷  Try for Free
Angelini Pharma OLEPTRO trazodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022411-002 Feb 2, 2010 6,607,748 ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 4 of 4 entries

International Patents for trazodone hydrochloride

CountryPatent NumberTitleEstimated Expiration
Argentina 067773 ⤷  Try for Free
Israel 203294 טראזודון וטראזודון הידרוכלוריד בצורה טהורה (Trazodone and trazodone hydrochloride in purified form) ⤷  Try for Free
South Korea 20080047538 ⤷  Try for Free
Spain 2620293 ⤷  Try for Free
Taiwan 200812646 ⤷  Try for Free
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 5 of 5 entries

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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.