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Last Updated: December 22, 2024

DEMECLOCYCLINE HYDROCHLORIDE - Generic Drug Details


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What are the generic sources for demeclocycline hydrochloride and what is the scope of freedom to operate?

Demeclocycline hydrochloride is the generic ingredient in two branded drugs marketed by Lederle, Corepharma, Amneal Pharm, Barr, Epic Pharma Llc, and Impax Labs, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for demeclocycline hydrochloride. Five suppliers are listed for this compound.

Summary for DEMECLOCYCLINE HYDROCHLORIDE
US Patents:0
Tradenames:2
Applicants:6
NDAs:8
Drug Master File Entries: 9
Finished Product Suppliers / Packagers: 5
Raw Ingredient (Bulk) Api Vendors: 79
Clinical Trials: 5
Patent Applications: 1,406
What excipients (inactive ingredients) are in DEMECLOCYCLINE HYDROCHLORIDE?DEMECLOCYCLINE HYDROCHLORIDE excipients list
DailyMed Link:DEMECLOCYCLINE HYDROCHLORIDE at DailyMed
Recent Clinical Trials for DEMECLOCYCLINE HYDROCHLORIDE

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

SponsorPhase
Massachusetts General HospitalPhase 1
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4
Federal University of São PauloPhase 4

See all DEMECLOCYCLINE HYDROCHLORIDE clinical trials

Pharmacology for DEMECLOCYCLINE HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for DEMECLOCYCLINE HYDROCHLORIDE

US Patents and Regulatory Information for DEMECLOCYCLINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Impax Labs DEMECLOCYCLINE HYDROCHLORIDE demeclocycline hydrochloride TABLET;ORAL 065094-002 Mar 22, 2004 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Impax Labs DEMECLOCYCLINE HYDROCHLORIDE demeclocycline hydrochloride TABLET;ORAL 065094-001 Mar 22, 2004 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Corepharma DECLOMYCIN demeclocycline hydrochloride TABLET;ORAL 050261-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Epic Pharma Llc DEMECLOCYCLINE HYDROCHLORIDE demeclocycline hydrochloride TABLET;ORAL 065447-002 Aug 18, 2015 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Corepharma DECLOMYCIN demeclocycline hydrochloride TABLET;ORAL 050261-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lederle DECLOMYCIN demeclocycline hydrochloride CAPSULE;ORAL 050262-001 Approved Prior to Jan 1, 1982 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

DEMECLOCYCLINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Demeclocycline Hydrochloride

Introduction to Demeclocycline Hydrochloride

Demeclocycline hydrochloride is a tetracycline antibiotic used to treat a variety of susceptible bacterial infections. It is known for its slow excretion, which maintains effective blood levels for longer periods compared to other tetracyclines[4].

Market Size and Growth Projections

The demeclocycline hydrochloride market has experienced significant growth in recent years and is projected to continue this trend. The market size is expected to expand substantially from 2023 to 2031, driven by various factors such as increasing demand for antibiotics and the prevalence of bacterial infections[1].

Segmentation of the Market

The demeclocycline hydrochloride market is segmented based on several key factors:

  • Type: The market is categorized into segments such as 95% purity and others. The 95% purity segment is expected to dominate due to its higher efficacy and demand in clinical settings[1].
  • Application: The primary applications include Lyme disease, acne, and bronchitis. The market is also seeing growth in other bacterial infections due to the antibiotic's broad-spectrum activity[1].
  • Geography: The market is divided into regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region has its own growth dynamics influenced by local healthcare policies, disease prevalence, and market competition[1].

Market Drivers

Several factors are driving the growth of the demeclocycline hydrochloride market:

  • Increasing Prevalence of Bacterial Infections: The rising incidence of bacterial infections globally is a significant driver. As the population grows and antibiotic resistance becomes a concern, the demand for effective antibiotics like demeclocycline hydrochloride increases[3].
  • Global Antibiotic Demand: The demand for antibiotics across various industries, including healthcare and veterinary, is on the rise. This demand is fueled by the need for effective treatments against bacterial infections[3].
  • Advancements in Healthcare: Improvements in healthcare infrastructure and access to antibiotics in developing regions are also contributing to market growth[1].

Market Restraints

Despite the positive outlook, there are several restraints that could impact the market:

  • Antibiotic Resistance: The increasing resistance to antibiotics is a significant concern. This could reduce the effectiveness of demeclocycline hydrochloride over time and impact its market growth[2].
  • Regulatory Challenges: Strict regulatory environments and the need for continuous clinical trials to ensure safety and efficacy can slow down market expansion[2].
  • Side Effects and Adverse Reactions: Demeclocycline hydrochloride, like other tetracyclines, can have side effects such as gastrointestinal disturbances and photosensitivity, which may limit its use in certain patient populations[4].

Market Opportunities

The market presents several opportunities for growth and expansion:

  • Emerging Markets: Developing countries offer significant opportunities due to their growing healthcare needs and increasing access to antibiotics[1].
  • New Indications: Research into new indications for demeclocycline hydrochloride, such as its use in treating other bacterial infections, could expand its market reach[4].
  • Combination Therapies: The potential for demeclocycline hydrochloride to be used in combination with other antibiotics or treatments could enhance its market position[4].

Competitive Landscape

The competitive landscape of the demeclocycline hydrochloride market is characterized by:

  • Key Players: Companies such as CKD Bio and VIVAN Life Sciences are prominent players in the market. These companies are involved in various activities including new product launches, partnerships, and mergers and acquisitions to strengthen their market presence[1].
  • Market Share: The top five companies in the market hold a significant share, with a strong presence in regional and global markets. The competitive landscape is also influenced by the entry of new players and the expansion of existing ones[1].

Financial Trajectory

The financial trajectory of the demeclocycline hydrochloride market is optimistic:

  • Revenue Projections: The market is expected to generate significant revenue, with projections indicating substantial growth from 2023 to 2031. The revenue is measured in USD million and is expected to increase due to the growing demand for antibiotics[1].
  • Cost Analysis: The development and approval costs for demeclocycline hydrochloride are relatively lower compared to other types of drugs. For instance, antimicrobial drugs, including demeclocycline hydrochloride, have average to high development costs but lower capitalized development and approval costs when considering the cost of failures and opportunity costs of capital[2].

Pricing and Penetration

The pricing of demeclocycline hydrochloride is influenced by several factors:

  • Product Pricing: The pricing strategy is crucial and is influenced by the degree of product penetration at national and regional levels. The report highlights that product pricing is a key consideration in the market analysis[1].
  • Market Penetration: The market penetration of demeclocycline hydrochloride varies by region, with higher penetration in areas with greater access to healthcare and higher demand for antibiotics[1].

Macro-Economic and Regulatory Factors

Macro-economic and regulatory factors play a significant role in shaping the market:

  • Economic Analysis: The economic landscape, including factors such as GDP growth and healthcare expenditure, influences the market's financial trajectory. A strong economy with increased healthcare spending can boost the demand for demeclocycline hydrochloride[1].
  • Regulatory Environment: Regulatory policies and approvals are critical for the market. A favorable regulatory environment can expedite the approval process and enhance market growth[1].

Porter's 5 Forces Analysis

The Porter's 5 Forces Framework provides a comprehensive analysis of the market's competitive environment:

  • Threat of New Entrants: The threat of new entrants is moderate due to the regulatory barriers and the need for significant investment in research and development[1].
  • Bargaining Power of Suppliers: The bargaining power of suppliers is relatively low as there are multiple suppliers of raw materials and intermediates[1].
  • Bargaining Power of Buyers: The bargaining power of buyers is moderate, influenced by the availability of alternative treatments and the sensitivity to price changes[1].
  • Threat of Substitute Products: The threat of substitute products is high due to the availability of other antibiotics and treatments for bacterial infections[1].
  • Competitive Rivalry Among Existing Competitors: The competitive rivalry is high, driven by the presence of several key players and the ongoing efforts to innovate and expand market share[1].

Value Chain Analysis

The value chain analysis highlights the various stages involved in the production and distribution of demeclocycline hydrochloride:

  • Raw Material Sourcing: The sourcing of raw materials is a critical stage, with suppliers playing a vital role in ensuring the quality and availability of these materials[1].
  • Manufacturing: The manufacturing process involves the synthesis of demeclocycline hydrochloride, which requires specialized facilities and equipment[1].
  • Distribution: The distribution network is extensive, involving wholesalers, retailers, and healthcare providers. Efficient distribution is crucial for ensuring the product reaches the end-users promptly[1].

Key Takeaways

  • The demeclocycline hydrochloride market is expected to grow significantly from 2023 to 2031.
  • The market is driven by the increasing prevalence of bacterial infections and global antibiotic demand.
  • Key players such as CKD Bio and VIVAN Life Sciences dominate the market.
  • The financial trajectory is optimistic, with substantial revenue projections.
  • Regulatory and macro-economic factors play a crucial role in shaping the market.

FAQs

What is the expected market size of demeclocycline hydrochloride by 2031?

The demeclocycline hydrochloride market is projected to expand substantially by 2031, with significant growth anticipated due to increasing demand and favorable market dynamics[1].

What are the primary applications of demeclocycline hydrochloride?

The primary applications include Lyme disease, acne, and bronchitis, along with other bacterial infections[1].

Who are the key players in the demeclocycline hydrochloride market?

Key players include CKD Bio and VIVAN Life Sciences, among others. These companies are involved in various market-related activities to strengthen their presence[1].

What are the main drivers of the demeclocycline hydrochloride market?

The main drivers include the increasing prevalence of bacterial infections and global antibiotic demand, as well as advancements in healthcare infrastructure[1][3].

How does the regulatory environment impact the demeclocycline hydrochloride market?

A favorable regulatory environment can expedite the approval process and enhance market growth, while strict regulations can pose challenges to market expansion[1].

Sources Cited

  1. Market Research Intellect: Demeclocycline Hydrochloride Market Size, Scope And Forecast.
  2. ASPE: Antimicrobial Drugs Market Returns Analysis.
  3. Business Research Insights: Minocycline Hydrochloride Market Size, Trends, Report, 2032.
  4. DrugBank: Demeclocycline: Uses, Interactions, Mechanism of Action.

More… ↓

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