Indomethacin - Generic Drug Details

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

Indomethacin is the generic ingredient in six branded drugs marketed by Zyla, Able, Amneal Pharms, Aurobindo Pharma, Avanthi Inc, Chartwell Rx, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Inwood Labs, Jubilant Generics, Mylan, Novast Labs, Sandoz, Watson Labs Inc, Zydus Pharms, Teva, Zyla Life Sciences, Ani Pharms, Chartwell Molecules, Cycle, Duramed Pharms Barr, Halsey, Heritage, Heritage Pharma, Ivax Sub Teva Pharms, Mutual Pharm, Parke Davis, Pioneer Pharms, Rising, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, Watson Labs, Zydus Lifesciences, Genus, Fresenius Kabi Usa, Amneal, Cosette, Hikma, Novitium Pharma, Recordati Rare, Hospira, and Navinta Llc, and is included in seventy-four NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Indomethacin has thirty-seven patent family members in twenty-one countries.

There are fifteen drug master file entries for indomethacin. Thirty-one suppliers are listed for this compound.

Summary for indomethacin

International Patents:	37
US Patents:	3
Tradenames:	6
Applicants:	43
NDAs:	74
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	31
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	178
Drug Prices:	Drug price trends for indomethacin
Drug Sales Revenues:	Drug sales revenues for indomethacin
What excipients (inactive ingredients) are in indomethacin?	indomethacin excipients list
DailyMed Link:	indomethacin at DailyMed

See drug prices for indomethacin

See drug sales revenues for indomethacin

Recent Clinical Trials for indomethacin

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

Sponsor	Phase
University of Mostar	Phase 2/Phase 3
GlaxoSmithKline	Phase 1
Moti Lal Nehru Medical College	N/A

See all indomethacin clinical trials

Pharmacology for indomethacin

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

Medical Subject Heading (MeSH) Categories for indomethacin

Anti-Inflammatory Agents, Non-Steroidal

Cardiovascular Agents

Cyclooxygenase Inhibitors

Gout Suppressants

Tocolytic Agents

US Patents and Regulatory Information for indomethacin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Parke Davis	INDOMETHACIN	indomethacin	CAPSULE;ORAL	018806-002	Nov 23, 1984		DISCN	No	No
Able	INDOMETHACIN	indomethacin	CAPSULE;ORAL	076666-002	Dec 17, 2003		DISCN	No	No
Ani Pharms	INDOMETHACIN	indomethacin	CAPSULE;ORAL	071149-001	Mar 18, 1987		DISCN	No	No
Rising	INDOMETHACIN	indomethacin	CAPSULE;ORAL	018858-002	Apr 20, 1984		DISCN	No	No
Hetero Labs Ltd Iii	INDOMETHACIN	indomethacin	CAPSULE, EXTENDED RELEASE;ORAL	201807-001	Sep 28, 2012	AB	RX	No	Yes
Novitium Pharma	INDOMETHACIN	indomethacin	SUSPENSION;ORAL	217883-001	Jan 12, 2024	AB	RX	No	No
Watson Labs	INDOMETHACIN	indomethacin	CAPSULE;ORAL	072996-001	Jul 31, 1991		DISCN	No	No

Expired US Patents for indomethacin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Zyla Life Sciences	INDOCIN	indomethacin	SUPPOSITORY;RECTAL	017814-001	Aug 13, 1984
Zyla	INDOCIN SR	indomethacin	CAPSULE, EXTENDED RELEASE;ORAL	018185-001	Feb 23, 1982
Zyla Life Sciences	INDOCIN	indomethacin	SUPPOSITORY;RECTAL	017814-001	Aug 13, 1984

International Patents for indomethacin

Country	Patent Number	Title	Estimated Expiration
Israel	247034	תכשיר של אינדומטאצין (Formulation of indomethacin)
Tunisia	2011000544	A NOVEL FORMUALTION OF INDOMETHACIN
China	102438594	A novel formulation of indomethacin
Denmark	2421513
Singapore	175315	A NOVEL FORMULATION OF INDOMETHACIN
South Africa	201108646	A NOVEL FORMULATION OF INDOMETHACIN
Australia	2016200397	A Novel Formulation of Indomethacin

Market Dynamics and Financial Trajectory of Indomethacin

Market Overview

The indomethacin market is experiencing significant growth, driven by its extensive applications in treating various inflammatory and pain-related conditions. Here are the key points outlining 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].

Segmentation

By Application

• The market is segmented based on applications such as pain management, inflammation reduction, gout, rheumatoid arthritis, and osteoarthritis. The increasing incidence of inflammatory diseases like gout and arthritis is a major driver of market growth[1][4].

By Product

• Indomethacin is available in various forms, including capsules, suppositories, oral suspension, and powder. Each form has its own market share and growth prospects, with innovations in formulations contributing to market expansion[1][4].

By Geography

• The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region has its own growth trajectory, influenced by local healthcare access, awareness, and regulatory environments[1][4].

Drivers of Growth

Increasing Incidence of Inflammatory Diseases

• The rising incidence of chronic pain and inflammatory disorders is a significant driver of the indomethacin market. As the global population ages and the prevalence of conditions like arthritis and gout increases, the demand for effective NSAIDs like indomethacin is expected to rise[1][4].

Advancements in Formulations

• Continuous research and development of novel formulations that enhance the safety and efficacy of indomethacin are crucial for market growth. Improved administration methods and formulations are attracting more patients and healthcare providers to this medication[1][4].

Expanding Healthcare Access and Awareness

• Growing healthcare access and global awareness of efficient therapies for inflammatory illnesses and chronic pain are also driving the market. As more people gain access to healthcare services, the demand for indomethacin is likely to increase[1].

Key Players and Market Landscape

• 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 profiled based on their product offerings, market entry year, and other market-related factors[1].

Financial Performance and Recent Developments

• Companies like Zyla Life Sciences (formerly Egalet Corporation) have reported significant financial gains from the acquisition and promotion of indomethacin products. For instance, Zyla Life Sciences saw a substantial increase in net product sales after acquiring products like TIVORBEX (indomethacin) and INDOCIN (indomethacin) suppositories and oral suspension[2].

Market Dynamics Analysis

Porter’s Five Forces Analysis

• The market dynamics are analyzed using Porter’s Five Forces, which include buyers' bargaining power, suppliers' bargaining power, 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 shaping the market[1].

SWOT Analysis

• A SWOT analysis (Strengths, Weaknesses, Opportunities, and Threats) is also conducted to provide a comprehensive view of the market. This includes evaluating the strengths of established players, the weaknesses of current formulations, opportunities for growth through new applications, and threats from regulatory changes or competitor activities[4].

Regional Analysis

• The market is analyzed across various regions, each with its own growth prospects and challenges. For example, the Asia-Pacific region is expected to show significant growth due to increasing healthcare access and a large patient population[1][4].

Technological and Regulatory Trends

• Technological advancements in drug delivery systems and regulatory approvals are critical for the growth of the indomethacin market. Innovations in formulations and administration methods, such as the development of new suppositories or oral suspensions, can significantly impact market dynamics[1][4].

Consumer Behavior and ESG Analysis

• Consumer behavior analysis reveals that patients are increasingly seeking effective and safe treatments for chronic pain and inflammatory conditions. Environmental, Social, and Governance (ESG) analysis also highlights the importance of sustainable and responsible practices in the pharmaceutical industry, which can influence market perceptions and growth[4].

COVID-19 Impact

• The COVID-19 pandemic has had various impacts on the pharmaceutical industry, including disruptions in supply chains and changes in consumer behavior. However, the demand for essential medications like indomethacin has remained relatively stable, with some regions experiencing increased demand due to the pandemic's impact on healthcare systems[4].

Key Takeaways

• The indomethacin market is poised for significant growth driven by increasing demand for NSAIDs, advancements in formulations, and expanding healthcare access.
• Key players are investing heavily in research and development to improve the safety and efficacy of indomethacin.
• Regional analysis indicates varying growth prospects, with the Asia-Pacific region showing promising potential.
• Technological and regulatory trends are crucial for market expansion.

FAQs

What is the projected market size of indomethacin by 2031?

The indomethacin market is expected to reach USD 2.1 billion by 2031, growing at a CAGR of 6.5% from 2024 to 2031[1].

Which regions are expected to dominate the indomethacin market?

North America and the Asia-Pacific region are expected to be significant contributors to the indomethacin market, driven by increasing healthcare access and a large patient population[1][4].

What are the key drivers of the indomethacin market?

The key drivers include the increasing incidence of inflammatory diseases, advancements in formulations, and expanding healthcare access and global awareness of efficient therapies[1][4].

Who are the major players in the indomethacin market?

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

How has the COVID-19 pandemic impacted the indomethacin market?

The pandemic has had a mixed impact, with some disruptions in supply chains but overall stable demand for essential medications like indomethacin[4].

Sources

1. Market Research Intellect: Global Indomethacin Market Size, Share and Trends [2024-2031][1].
2. BioSpace: Egalet Reports First Quarter 2019 Financial Results and Plan to Change Company Name to Zyla Life Sciences[2].
3. Cognitive Market Research: Indomethacin Market Report 2024 (Global Edition)[3].
4. Market Research Intellect: Global Indometacin (Indomethacin) Market Size, Trends and Forecast[4].

Last updated: 2024-12-16