Etodolac - Generic Drug Details

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

Etodolac is the generic ingredient in three branded drugs marketed by Ani Pharms, Apotex, Biopharm, Chartwell Molecules, Ipca Labs Ltd, Mylan, Natco Pharma, Sandoz, Taro, Wyeth Pharms Inc, Actavis Elizabeth, Bayshore Pharms Llc, Teva, Watson Labs Florida, Zydus Pharms, Abraxeolus, Adaptis, Amneal Pharms Co, Apotex Inc, Ivax Sub Teva Pharms, Oxford Pharms, Ranbaxy Labs Ltd, Shree Hari Intl, Taro Pharm Inds, and Watson Labs, and is included in forty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-three drug master file entries for etodolac. Thirty-two suppliers are listed for this compound.

Summary for etodolac

US Patents:	0
Tradenames:	3
Applicants:	25
NDAs:	41
Drug Master File Entries:	23
Finished Product Suppliers / Packagers:	32
Raw Ingredient (Bulk) Api Vendors:	118
Clinical Trials:	29
Patent Applications:	7,120
Drug Prices:	Drug price trends for etodolac
Drug Sales Revenues:	Drug sales revenues for etodolac
What excipients (inactive ingredients) are in etodolac?	etodolac excipients list
DailyMed Link:	etodolac at DailyMed

See drug prices for etodolac

See drug sales revenues for etodolac

Recent Clinical Trials for etodolac

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

Sponsor	Phase
Kutahya Health Sciences University	Phase 4
Memorial Sloan Kettering Cancer Center	N/A
Apsen Farmaceutica S.A.	Phase 3

See all etodolac clinical trials

Pharmacology for etodolac

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

Medical Subject Heading (MeSH) Categories for etodolac

Cyclooxygenase 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for etodolac

M01AB	Acetic acid derivatives and related substances
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

US Patents and Regulatory Information for etodolac

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ipca Labs Ltd	ETODOLAC	etodolac	CAPSULE;ORAL	205448-002	Aug 1, 2024	AB	RX	No	No
Shree Hari Intl	ETODOLAC	etodolac	TABLET;ORAL	074839-001	Jul 11, 1997		DISCN	No	No
Natco Pharma	ETODOLAC	etodolac	TABLET;ORAL	075104-001	Feb 6, 1998		DISCN	No	No
Ranbaxy Labs Ltd	ETODOLAC	etodolac	TABLET;ORAL	075226-001	Nov 24, 1998		DISCN	No	No
Ipca Labs Ltd	ETODOLAC	etodolac	CAPSULE;ORAL	205448-001	Aug 1, 2024	AB	RX	No	No

Expired US Patents for etodolac

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms Inc	LODINE XL	etodolac	TABLET, EXTENDED RELEASE;ORAL	020584-001	Oct 25, 1996
Wyeth Pharms Inc	LODINE	etodolac	CAPSULE;ORAL	018922-002	Jan 31, 1991
Wyeth Pharms Inc	LODINE XL	etodolac	TABLET, EXTENDED RELEASE;ORAL	020584-002	Oct 25, 1996
Wyeth Pharms Inc	LODINE XL	etodolac	TABLET, EXTENDED RELEASE;ORAL	020584-003	Jan 20, 1998
Wyeth Pharms Inc	LODINE	etodolac	CAPSULE;ORAL	018922-003	Jan 31, 1991

Etodolac Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Etodolac

Introduction

Etodolac, a nonsteroidal anti-inflammatory drug (NSAID), is widely used for treating mild to moderate pain and relieving symptoms of arthritis, including osteoarthritis and rheumatoid arthritis. Here, we delve into the market dynamics and financial trajectory of etodolac, highlighting key factors driving its growth and challenges it faces.

Market Size and Growth

The etodolac market was valued at USD 450 million in 2023 and is projected to reach USD 657.15 million by 2031, growing at a compound annual growth rate (CAGR) of 5% from 2024 to 2031[1][4].

Segmentation and Application

The market is segmented based on application (tablets, capsules, extended-release tablets, and oral suspension) and product type (pain relief, anti-inflammatory treatment, osteoarthritis treatment, and rheumatoid arthritis treatment). Geographically, the market is divided into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa[1][4].

Drivers of Market Growth

Several factors are driving the growth of the etodolac market:

Increasing Incidence of Chronic Pain

The rising incidence of chronic pain problems and the growing need for safer and more effective NSAID alternatives are significant drivers. Etodolac's effectiveness in reducing pain and inflammation, particularly for musculoskeletal diseases and arthritis, makes it a preferred choice[1].

Improvements in Formulation

Advancements in formulation, such as extended-release tablets, enhance therapeutic outcomes and patient compliance. These improvements contribute to the market's expansion by offering better treatment options[1].

Availability and Affordability of Generic Formulations

The availability of generic etodolac formulations reduces costs and increases accessibility, thereby expanding the patient base and promoting market growth[1].

Competitive Landscape

The etodolac market is competitive, with key players including Pfizer, Novartis, Teva Pharmaceuticals, Mylan N.V., Sanofi, GlaxoSmithKline, Abbott, Merck & Co., Johnson & Johnson, and Bayer. These companies are involved in various market-related activities such as new service/product launches, collaborations, company expansions, and acquisitions[1].

Clinical Effectiveness and Safety Profile

Etodolac has been shown to be equally efficacious as non-selective NSAIDs, with superior gastrointestinal (GI) tolerability. Studies have indicated that etodolac is associated with significantly fewer clinical UGI events compared to non-selective NSAIDs[3].

Cost and Cost-Effectiveness

While etodolac is associated with higher costs compared to some non-selective NSAIDs, its generic form offers a more cost-effective option. Economic modeling suggests that the incremental cost per quality-adjusted life-year (QALY) for etodolac, especially in its generic form, is relatively lower compared to other COX-2 selective NSAIDs[3].

Regional Analysis

The market is analyzed across various regions, with North America, Europe, and Asia-Pacific being significant contributors. Regional analysis helps in understanding market dynamics, including revenue share, current trends, and future prospects in each region[1][4].

Challenges and Side Effects

Despite its benefits, etodolac comes with potential side effects and precautions. These include the risk of heart attack or stroke, stomach and intestinal bleeding, serious skin reactions, and kidney problems. Regular monitoring by healthcare professionals is crucial to manage these risks[2].

Future Research Needs

There is a need for further research to compare the effectiveness and cost-effectiveness of COX-2 selective NSAIDs, including etodolac, relative to non-selective NSAIDs with proton pump inhibitors (PPIs). Pragmatic studies involving a wider range of patients, especially older age groups with a greater burden of arthritis, are necessary to inform clinical practice[3].

Market Trends and Opportunities

The etodolac market is influenced by various trends, including the increasing awareness of efficient pain management techniques and the growing demand for safer NSAID alternatives. The COVID-19 pandemic has also impacted the market, with changes in consumer behavior and healthcare priorities[4].

Financial Projections

The financial trajectory of etodolac is positive, with a steady growth rate anticipated over the forecast period. The market's expansion is driven by the increasing demand for effective pain relief medications and the availability of affordable generic formulations[1][4].

Key Takeaways

• The etodolac market is expected to grow at a CAGR of 5% from 2024 to 2031.
• The market is driven by the increasing incidence of chronic pain, improvements in formulation, and the availability of generic formulations.
• Etodolac has a favorable safety profile compared to other NSAIDs, particularly in terms of GI tolerability.
• Regional analysis highlights the significance of North America, Europe, and Asia-Pacific in the global market.
• Future research needs to focus on comparative effectiveness and cost-effectiveness studies.

Frequently Asked Questions (FAQs)

Q: What is the projected market size of etodolac by 2031? A: The etodolac market is expected to reach USD 657.15 million by 2031[1].

Q: What are the primary drivers of the etodolac market growth? A: The market growth is driven by the increasing incidence of chronic pain, improvements in formulation, and the availability of affordable generic formulations[1].

Q: Which regions are significant contributors to the etodolac market? A: North America, Europe, and Asia-Pacific are significant contributors to the global etodolac market[1][4].

Q: What are the potential side effects of etodolac? A: Etodolac can cause side effects such as stomach and intestinal bleeding, serious skin reactions, and kidney problems. Regular monitoring is necessary to manage these risks[2].

Q: Who are the key players in the etodolac market? A: Key players include Pfizer, Novartis, Teva Pharmaceuticals, Mylan N.V., Sanofi, GlaxoSmithKline, Abbott, Merck & Co., Johnson & Johnson, and Bayer[1].

Cited Sources:

1. Market Research Intellect - Etodolac Market Size, Overview & Research Report [2024-2031]
2. Mayo Clinic - Etodolac (oral route)
3. NCBI - Cyclooxygenase-2 selective non-steroidal anti-inflammatory drugs
4. Cognitive Market Research - Global Etodolac Market Report 2024 Edition