LODINE Drug Patent Profile

Which patents cover Lodine, and when can generic versions of Lodine launch?

Lodine is a drug marketed by Wyeth Pharms Inc and is included in two NDAs.

The generic ingredient in LODINE is etodolac. There are twenty-three drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the etodolac profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lodine

A generic version of LODINE was approved as etodolac by PANGEA on April 11^th, 1997.

Summary for LODINE

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	4,667
DailyMed Link:	LODINE at DailyMed

US Patents and Regulatory Information for LODINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Pharms Inc	LODINE	etodolac	CAPSULE;ORAL	018922-002	Jan 31, 1991		DISCN	Yes	No
Wyeth Pharms Inc	LODINE XL	etodolac	TABLET, EXTENDED RELEASE;ORAL	020584-002	Oct 25, 1996		DISCN	Yes	No
Wyeth Pharms Inc	LODINE	etodolac	TABLET;ORAL	018922-005	Jun 28, 1996		DISCN	Yes	No
Wyeth Pharms Inc	LODINE	etodolac	CAPSULE;ORAL	018922-003	Jan 31, 1991		DISCN	Yes	No

Expired US Patents for LODINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms Inc	LODINE	etodolac	CAPSULE;ORAL	018922-002	Jan 31, 1991	3,939,178
Wyeth Pharms Inc	LODINE	etodolac	CAPSULE;ORAL	018922-003	Jan 31, 1991	4,076,831
Wyeth Pharms Inc	LODINE	etodolac	TABLET;ORAL	018922-004	Jul 29, 1993	4,076,831
Wyeth Pharms Inc	LODINE	etodolac	CAPSULE;ORAL	018922-003	Jan 31, 1991	3,939,178

International Patents for LODINE

See the table below for patents covering LODINE around the world.

Country	Patent Number	Title	Estimated Expiration
Hong Kong	13078	1,3,4,9-TETRAHYDRO(PYRANO OR THIOPYRANO)(3,4-B)-INDOLE DERIVATIVES
Philippines	11673	A PROCESS FOR THE PREPARATION OF PYRANO(THIOPYRANO)(3,4-B)INDOLE DERIVATIVES
Switzerland	580101
Sweden	387122	FORFARANDE FOR FRAMSTELLNING AV PYRANO(3,4-B)INDOL- ELLER TIOPYRANO(3,4-B)INDOLDERIVAT MED TERAPEUTISK VERKAN

Market Dynamics and Financial Trajectory for LODINE (Etoricoxib)

Last updated: July 28, 2025

Introduction

LODINE, the brand name for etoricoxib, is a selective cyclooxygenase-2 (COX-2) inhibitor developed by Merck & Co. It is utilized primarily for the treatment of osteoarthritis, rheumatoid arthritis, gouty arthritis, ankylosing spondylitis, and acute pain management. Since its initial approval, LODINE has experienced evolving market dynamics influenced by regulatory changes, competitive landscape shifts, and advancing pharmaceutical innovations. This article offers an in-depth analysis of the current market environment and explores the financial trajectory of LODINE to assist stakeholders in strategic decision-making.

Market Overview

Global Market Size and Growth Trends

The global NSAID market, encompassing both non-selective NSAIDs and selective COX-2 inhibitors like etoricoxib, is projected to reach approximately $15 billion by 2027, growing at a compound annual growth rate (CAGR) of 4.2% from 2020 to 2027 [1]. Within this landscape, etoricoxib has held a significant market share owing to its favorable gastrointestinal tolerability compared to traditional NSAIDs. However, its growth trajectory is subject to regulatory scrutiny and competition from newer agents.

Regulatory Environment and Market Access

Etoricoxib's regulatory journey has been complex. Initially approved in several countries, including Japan and India, it faced regulatory hurdles in the United States, primarily due to safety concerns. The U.S. Food and Drug Administration (FDA) deferred approval citing cardiovascular risk assessments [2]. Conversely, in markets like India and Japan, it has captured considerable market share because of its efficacy profile and reduced gastrointestinal side effects.

The approval status significantly impacts market access. Ever-changing regulatory guidance, especially concerning cardiovascular safety, influences prescribing practices and market penetration. The ongoing re-evaluation of COX-2 inhibitors by authorities like the FDA continues to shape the drug’s market prospects.

Competitive Landscape

Etoricoxib’s primary competitors include celecoxib (Celebrex), meloxicam, and non-selective NSAIDs like naproxen and ibuprofen. Recent launches of novel analgesics and biologics targeting inflammatory conditions further fragment the market. Importantly, the safety profile remains a substantial differentiator.

In markets where etoricoxib retains regulatory approval, its growth is supported by its once-daily dosing, favorable gastrointestinal profile, and cost-effectiveness, especially in emerging markets. Conversely, the presence of biosimilars and patent expirations for competitors exert downward pressure on prices.

Financial Trajectory Analysis

Historical Performance

Etoricoxib's revenues peaked in the late 2010s in countries where regulatory barriers were minimal. For example, in India, sales exceeded $150 million annually. However, the U.S. market remains largely inaccessible, limiting overall revenue potential. The product's financial performance in Europe and Japan remains steady but modest amid tight regulatory conditions.

Revenue Streams and Market Penetration

In markets where approval persists, etoricoxib's revenue streams are driven primarily by orthopedic and rheumatological indications. The drug benefits from higher generic penetration as patent protections have lapsed in certain jurisdictions. The trend toward cost-sensitive healthcare in emerging economies boosts sales of etoricoxib due to its affordability.

Future Revenue Projections

Forecasts suggest a cautious growth outlook. The global COX-2 inhibitor market may see a CAGR of approximately 3-4% over the next five years, influenced by regulatory environments and patent cliffs. In the absence of new formulations or indications, etoricoxib’s peak sales are projected to stabilize, with incremental growth primarily driven by emerging markets.

In India, for example, continued adoption and expansion into secondary indications could insert annual revenues between $200 million and $250 million by 2027. In contrast, the U.S. remains an inaccessible market without regulatory approval, capping its growth potential in North America.

Pricing Strategies and Reimbursement Landscape

Pricing varies significantly across regions. In developing countries, etoricoxib’s lower cost compared to branded alternatives sustains its market position. In developed markets, reimbursement policies, especially where generic versions are available, influence profit margins. The emergence of off-label prescribing and healthcare cost containment strategies could further impact revenue streams.

Market Challenges and Opportunities

Safety and Regulatory Concerns

Cardiovascular safety remains at the forefront. The FDA’s initial hesitation, along with post-market safety evaluations, have compelled Merck to implement risk mitigation strategies, including labeling updates and physician advisories. Such measures influence prescribing patterns and thereby impact revenue.

Emerging Indications and Formulation Innovations

Potential expansion into new therapeutic areas, such as acute pain or pediatric indications, offers growth opportunities. Additionally, reformulations—like combination therapies or extended-release platforms—could improve patient adherence and expand market reach.

Digital and Data-Driven Strategies

Integration of digital health tools and real-world evidence (RWE) for safety monitoring bolster confidence among prescribers and payers, potentially leading to increased utilization.

Conclusion

The market dynamics surrounding LODINE (etoricoxib) reflect a complex interplay between regulatory safety profiles, competitive pressures, and strategic adaptability. While its established efficacy and gastrointestinal safety advantage underpin its market position in certain regions, regulatory uncertainties and emerging competitors challenge its growth trajectory. Financially, the drug's future hinges on regulatory approvals in key markets, especially the U.S., and its capacity to expand into new indications and regions.

Key Takeaways

• The global COX-2 inhibitor market is robust but constrained by safety concerns, particularly cardiovascular risks.
• Regulatory approvals significantly influence etoricoxib's market access and revenue potential, with notable disparities across geographies.
• In emerging markets, etoricoxib benefits from cost-effectiveness and a favorable gastrointestinal profile, supporting steady growth.
• The drug’s future revenue depends on regulatory trajectories, safety innovations, and expansion into new indications.
• Stakeholders should monitor evolving safety data, regulatory decisions, and competitive innovations to optimize market strategies.

FAQs

1. Why is etoricoxib not approved in the United States?
The FDA has not approved etoricoxib primarily due to concerns over its cardiovascular safety profile, especially the increased risk of thrombotic events observed in clinical trials, leading to regulatory hesitancy.

2. How does etoricoxib compare to other NSAIDs in terms of safety?
Etoricoxib offers a gastrointestinal safety advantage over non-selective NSAIDs due to its COX-2 selectivity, reducing gastrointestinal adverse events. However, its cardiovascular safety remains under scrutiny, similar to other selective COX-2 inhibitors.

3. What factors influence etoricoxib's pricing in different regions?
Pricing depends on regulatory environment, patent status, healthcare reimbursement policies, competitive landscape, and manufacturing costs, with lower prices typically seen in emerging markets due to cost-based pricing strategies.

4. Are there emerging indications for etoricoxib?
Research explores its potential in acute pain management, postoperative analgesia, and possibly in certain inflammatory or oncologic conditions, though regulatory approval for these indications is pending or limited.

5. What is the outlook for etoricoxib’s market share over the next decade?
In regions where approval persists, its market share is expected to stabilize or grow slowly, primarily driven by generic availability and expanding indications. However, in key markets like the U.S., growth remains unlikely without regulatory approval.

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References

1. MarketWatch. "NSAID Market Size & Growth Analysis". (2022)
2. FDA. "Etoricoxib (LODIN). Safety Evaluation and Regulatory Status". (2021)