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Last Updated: December 26, 2024

Spectinomycin hydrochloride - Generic Drug Details


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

Spectinomycin hydrochloride is the generic ingredient in one branded drug marketed by Pfizer and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for spectinomycin hydrochloride.

Summary for spectinomycin hydrochloride
Recent Clinical Trials for spectinomycin hydrochloride

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

SponsorPhase
Assistance Publique - Hôpitaux de ParisPhase 2
Merz Pharmaceuticals GmbHPhase 2
Universita di VeronaPhase 2

See all spectinomycin hydrochloride clinical trials

Medical Subject Heading (MeSH) Categories for spectinomycin hydrochloride
Anatomical Therapeutic Chemical (ATC) Classes for spectinomycin hydrochloride

US Patents and Regulatory Information for spectinomycin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer TROBICIN spectinomycin hydrochloride INJECTABLE;INJECTION 050347-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pfizer TROBICIN spectinomycin hydrochloride INJECTABLE;INJECTION 050347-002 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

Spectinomycin hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Spectinomycin Hydrochloride

Introduction

Spectinomycin hydrochloride, an antibiotic used primarily to treat infections caused by Neisseria gonorrhoeae, is a crucial component in the global pharmaceutical market. This article delves into the market dynamics and financial trajectory of spectinomycin hydrochloride, highlighting key drivers, restraints, opportunities, and challenges.

Market Size and Segmentation

The spectinomycin hydrochloride market is segmented based on type (human use, dog use) and application (urinary tract infections, rectal infections, and others), as well as geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa)[1].

Geographical Segmentation

The market is expected to witness significant growth across various regions, with Asia-Pacific emerging as a key driver due to increasing healthcare needs and growing populations. North America and Europe also contribute substantially, driven by advanced healthcare systems and higher awareness of antibiotic treatments.

Application Segmentation

The primary applications of spectinomycin hydrochloride include treating urinary tract infections and rectal infections caused by Neisseria gonorrhoeae. These applications are critical in both developed and developing countries, where such infections are prevalent.

Market Drivers

Several factors drive the growth of the spectinomycin hydrochloride market:

Increasing Prevalence of Infections

The rising incidence of Neisseria gonorrhoeae infections globally is a significant driver. As the population grows and urbanization increases, the demand for effective treatments like spectinomycin hydrochloride is on the rise[1].

Government Initiatives and Public Health Programs

Government initiatives to combat antibiotic resistance and improve public health infrastructure also boost the market. Programs aimed at increasing access to antibiotics, especially in low- and middle-income countries (LMICs), contribute to market growth[5].

Technological Advancements

Advancements in pharmaceutical manufacturing and distribution networks enhance the availability and efficacy of spectinomycin hydrochloride, making it more accessible to a broader population.

Market Restraints

Despite the growth drivers, several restraints impact the market:

Economic Factors

The development and marketing of antibiotics like spectinomycin hydrochloride face economic challenges. High registration costs, limited volume sales, and low prices make it less lucrative for pharmaceutical companies to invest in these products[2].

Regulatory Hurdles

Stringent regulatory requirements and the need for rigorous clinical trials before market approval can slow down the introduction of new antibiotics, including spectinomycin hydrochloride.

Antimicrobial Resistance

The increasing problem of antimicrobial resistance (AMR) necessitates the conservative use of antibiotics, which can limit their market potential. The need to balance treatment efficacy with resistance prevention complicates market dynamics[2].

Market Opportunities

Several opportunities exist for the spectinomycin hydrochloride market:

Growing Demand in Emerging Markets

Emerging markets, particularly in Asia-Pacific and Latin America, offer significant growth opportunities due to increasing healthcare demands and improving economic conditions[5].

Generic and Biosimilar Markets

The expiration of patents for branded antibiotics can lead to the development of generic and biosimilar versions of spectinomycin hydrochloride, increasing competition and potentially lowering prices, thus expanding market reach[3].

Market Challenges

The market faces several challenges:

Low Profit Margins

Antibiotics generally offer low profit margins compared to other pharmaceutical products. This makes it less attractive for companies to invest heavily in research and development (R&D) for new antibiotics[2].

Consolidation in the Pharmaceutical Industry

The pharmaceutical industry is experiencing consolidation, with some companies divesting their antibiotic businesses due to low returns and high R&D costs. This can reduce the number of players in the market and impact innovation[2].

Financial Trajectory

The financial trajectory of the spectinomycin hydrochloride market is characterized by:

Projected Growth

The market is expected to experience significant growth from 2023 to 2031, driven by increasing demand and expanding healthcare infrastructure. The market size is projected to increase substantially, measured in USD million across various segments[1].

Revenue Projections

The revenue from spectinomycin hydrochloride is anticipated to rise, fueled by growing applications and geographical expansion. The Asia-Pacific region is expected to be a major contributor to this growth.

Key Players

Companies such as Zhejiang Hisun Pharmaceutical Co. Ltd., Sinopharm Group Guorui Pharmaceutical Co. Ltd., and Shandong Lukang Pharmaceutical Co. Ltd. are key players in the market. These companies are profiled in market reports, highlighting their market entry, product offerings, and market-related factors[1].

Competitive Environment

The competitive environment is marked by:

Established and Emerging Players

Both established pharmaceutical companies and emerging players are active in the market. Established companies leverage their existing infrastructure and R&D capabilities, while emerging players focus on innovative manufacturing and distribution strategies[1].

Pricing Analysis

Pricing remains a critical factor, with generic and biosimilar versions potentially offering more competitive pricing. However, the pricing strategy must balance profitability with accessibility, especially in LMICs[3].

Market Outlook

The market outlook is positive, with several factors contributing to its growth:

Porter's 5 Forces Framework

An analysis using Porter's 5 Forces Framework reveals that the market is influenced by competitive rivalry, bargaining power of buyers and suppliers, threat of new entrants, and the threat of substitute products. Understanding these forces helps in strategizing market entry and expansion[1].

Macroeconomic Scrutiny

Macroeconomic factors such as national GDP, healthcare policies, and economic stability of regions play a significant role in shaping the market. A stable economic environment supports market growth[1].

Key Takeaways

  • The spectinomycin hydrochloride market is segmented by type, application, and geographical region.
  • Increasing prevalence of Neisseria gonorrhoeae infections and government initiatives drive market growth.
  • Economic factors, regulatory hurdles, and antimicrobial resistance are significant restraints.
  • Emerging markets and the generic/biosimilar market offer growth opportunities.
  • The market is expected to grow significantly from 2023 to 2031, driven by expanding healthcare needs and infrastructure.

FAQs

Q: What are the primary applications of spectinomycin hydrochloride?

A: The primary applications include treating urinary tract infections and rectal infections caused by Neisseria gonorrhoeae.

Q: Which regions are expected to drive the growth of the spectinomycin hydrochloride market?

A: Asia-Pacific, North America, and Europe are expected to be key drivers due to growing healthcare needs and advanced healthcare systems.

Q: What are the major restraints facing the spectinomycin hydrochloride market?

A: Economic factors, regulatory hurdles, and the issue of antimicrobial resistance are significant restraints.

Q: How does the consolidation in the pharmaceutical industry impact the spectinomycin hydrochloride market?

A: Consolidation can reduce the number of players and impact innovation, as companies may divest their antibiotic businesses due to low returns and high R&D costs.

Q: What is the projected financial trajectory of the spectinomycin hydrochloride market?

A: The market is expected to experience significant growth from 2023 to 2031, with substantial increases in revenue across various segments.

Sources

  1. Market Research Intellect, "Global Spectinomycin Hydrochloride for Injection Market Size, Scope And Forecast 2021-2031".
  2. Access to Medicine Foundation, "Antimicrobial Resistance Benchmark 2018".
  3. Access to Medicine Foundation, "Generic & Biosimilar Medicines Programme 2023".
  4. 6Wresearch, "Congo Spectinomycin Hydrochloride For Injection Market (2024-2030)".
  5. Access to Medicine Foundation, "Antimicrobial Resistance Benchmark 2020".

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