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Last Updated: December 22, 2024

INDOMETHACIN SODIUM - Generic Drug Details


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What are the generic drug sources for indomethacin sodium and what is the scope of patent protection?

Indomethacin sodium is the generic ingredient in two branded drugs marketed by Recordati Rare, Hospira, Navinta Llc, and West-ward Pharms Int, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for indomethacin sodium.

Summary for INDOMETHACIN SODIUM
Recent Clinical Trials for INDOMETHACIN SODIUM

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

SponsorPhase
Ciusss de L'Est de l'Île de MontréalN/A
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityN/A
Haining Health-Coming Biotech Co., Ltd.Phase 2

See all INDOMETHACIN SODIUM clinical trials

US Patents and Regulatory Information for INDOMETHACIN SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
West-ward Pharms Int INDOMETHACIN SODIUM indomethacin sodium INJECTABLE;INJECTION 078713-001 Jul 16, 2008 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Recordati Rare INDOCIN indomethacin sodium INJECTABLE;INJECTION 018878-001 Jan 30, 1985 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Navinta Llc INDOMETHACIN SODIUM indomethacin sodium INJECTABLE;INJECTION 206561-001 Jul 19, 2017 AP RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hospira INDOMETHACIN SODIUM indomethacin sodium INJECTABLE;INJECTION 204118-001 Apr 19, 2016 AP RX 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

INDOMETHACIN SODIUM Market Analysis and Financial Projection Experimental

Indomethacin Market Dynamics and Financial Trajectory

Market Overview

Indomethacin, a nonsteroidal anti-inflammatory drug (NSAID), is widely used to relieve pain and swelling in patients suffering from arthritis, gout, bursitis, tendonitis, and other inflammatory conditions. Here’s a detailed look at the market dynamics and financial trajectory of indomethacin.

Market Size and Growth

The indomethacin market was valued at USD 1.2 billion in 2023 and is projected to reach USD 2.1 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 6.5% from 2024 to 2031[1][4].

Market Segmentation

The indomethacin market is segmented based on several key factors:

By Application

  • Pain management
  • Inflammation reduction
  • Gout
  • Rheumatoid arthritis
  • Osteoarthritis[1][4].

By Product

  • Indomethacin capsules
  • Indomethacin suppositories
  • Indomethacin oral suspension
  • Indomethacin powder[1][4].

By Geography

  • North America
  • Europe
  • Asia-Pacific
  • South America
  • Middle East and Africa[1][4].

Market Drivers

Increasing Prevalence of Inflammatory Diseases

The rising incidence of inflammatory diseases such as gout and arthritis is a significant driver of the indomethacin market. These conditions necessitate the use of effective NSAIDs like indomethacin, thereby increasing demand[1][4].

Growing Pharmaceutical Industry

The expansion of the pharmaceutical industry in developing nations is creating new growth opportunities for indomethacin. This growth is fueled by increasing healthcare access and global awareness of efficient therapies for inflammatory illnesses and chronic pain[1][4].

Continuous Research and Development

The development of novel formulations that enhance the safety and efficacy of indomethacin is crucial for market growth. Companies are focusing on improving the product's administration methods and formulations to meet market demands[1][4].

Market Restraints

Side Effects and Safety Concerns

Indomethacin, like other NSAIDs, can have side effects such as gastrointestinal issues, renal sodium and chloride excretion changes, and other systemic effects. These safety concerns can limit market growth if not adequately addressed through research and development[5].

Regulatory Challenges

The approval process for new formulations and the stringent regulatory environment can pose challenges to market expansion. Companies must navigate these regulatory hurdles to bring new products to market[2].

Competitive Landscape

Key Players

The indomethacin market is dominated by several key players, including Merck & Co., Teva Pharmaceuticals, Mylan, Novartis, GlaxoSmithKline, Sun Pharmaceutical, Zydus Cadila, Cipla, Lupin, and Aurobindo Pharma. These companies are engaged in various organic and inorganic growth strategies such as product launches, acquisitions, and partnerships to expand their market presence[1][4].

Recent Developments

ANI Pharmaceuticals, for instance, has recently received FDA approval for the Abbreviated New Drug Application (ANDA) for Indomethacin Oral Suspension, USP, and has launched other significant products. This highlights the company's commitment to expanding access to high-quality generics and niche products[2].

Financial Trajectory

Revenue Projections

The indomethacin market is expected to grow significantly, with a projected market size of USD 2.1 billion by 2031. This growth is driven by the increasing demand for effective NSAIDs and the expanding pharmaceutical industry in developing regions[1][4].

Company Performance

ANI Pharmaceuticals, a key player in the generics market, is on a robust growth trajectory. The company reported record net revenues of $137.4 million in the first quarter of 2024, marking a 28.7% year-over-year increase. The company's financial projections for 2024 include net revenues between $520 million and $542 million and adjusted non-GAAP EBITDA between $135 million and $145 million[2].

Regional Analysis

Global Market

The indomethacin market is analyzed across five major regions: North America, Europe, Asia-Pacific, Middle East and Africa, and South & Central America. Each region is further sub-segmented by country, providing a detailed overview of the market dynamics and growth opportunities in each area[1][4].

Market Dynamics Analysis

Porter’s Five Forces Analysis

The market dynamics are further elucidated through a Porter’s Five Forces analysis, which includes the bargaining power of buyers, the bargaining power of suppliers, the threat of new entrants, the threat of substitutes, and the degree of competition within the market. This analysis helps in understanding the competitive landscape and the forces that shape the market[1].

PEST Analysis

The report also includes a PEST analysis, evaluating the political, economic, social, and technological factors affecting the indomethacin market in different regions. This analysis provides a comprehensive understanding of the external factors influencing market growth[4].

Key Takeaways

  • The indomethacin market is expected to grow from USD 1.2 billion in 2023 to USD 2.1 billion by 2031, driven by the increasing prevalence of inflammatory diseases and the growing pharmaceutical industry.
  • Key players are focusing on developing novel formulations and expanding their product portfolios through strategic acquisitions and partnerships.
  • Regulatory challenges and safety concerns are significant restraints that need to be addressed.
  • The market is segmented by application, product type, and geography, with each segment offering unique growth opportunities.

FAQs

What is the projected market size of the indomethacin market by 2031?

The indomethacin market is projected to reach USD 2.1 billion by 2031[1].

What are the primary drivers of the indomethacin market?

The primary drivers include the increasing prevalence of inflammatory diseases, growing pharmaceutical industry in developing nations, and continuous research and development of novel formulations[1][4].

Which companies are key players in the indomethacin market?

Key players include Merck & Co., Teva Pharmaceuticals, Mylan, Novartis, GlaxoSmithKline, Sun Pharmaceutical, Zydus Cadila, Cipla, Lupin, and Aurobindo Pharma[1].

What recent developments have contributed to the growth of ANI Pharmaceuticals in the indomethacin market?

ANI Pharmaceuticals has received FDA approval for the Abbreviated New Drug Application (ANDA) for Indomethacin Oral Suspension, USP, and has launched other significant products, contributing to its robust growth trajectory[2].

What are the potential side effects of indomethacin that could impact market growth?

Indomethacin can cause side effects such as gastrointestinal issues and changes in renal sodium and chloride excretion, which could limit market growth if not adequately addressed[5].

How does the competitive landscape of the indomethacin market look?

The market is highly competitive with key players engaging in organic and inorganic growth strategies such as product launches, acquisitions, and partnerships to expand their market presence[1][4].

More… ↓

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