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-two 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 ABRAXEOLUS on April 11^th, 1997.

Summary for LODINE

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	118
Patent Applications:	4,516
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
Wyeth Pharms Inc	LODINE	etodolac	TABLET;ORAL	018922-004	Jul 29, 1993		DISCN	Yes	No
Wyeth Pharms Inc	LODINE XL	etodolac	TABLET, EXTENDED RELEASE;ORAL	020584-003	Jan 20, 1998		DISCN	No	No

Expired US Patents for LODINE

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

International Patents for LODINE

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

Country	Patent Number	Title	Estimated Expiration
Finland	54125
Belgium	784284
Israel	39466	PYRANO(3,4-B)-AND THIOPYRANO(3,4-B)INDOLE DERIVATIVES AND THEIR PREPARATION
Spain	403343
Netherlands	7207408
United Kingdom	1391005

LODINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Lodine (Etodolac)

Introduction

Lodine, commonly known by its generic name etodolac, is a nonsteroidal anti-inflammatory drug (NSAID) widely used for the management of osteoarthritis, rheumatoid arthritis, and acute pain. This article delves into the market dynamics and financial trajectory of Lodine, highlighting its market drivers, competitive landscape, and economic implications.

Market Drivers

The demand for Lodine is driven by several key factors:

Growing Prevalence of Chronic Inflammatory Conditions

The increasing prevalence of chronic inflammatory conditions such as osteoarthritis and rheumatoid arthritis is a significant market driver. As the global population ages, the need for effective pain management solutions escalates, making Lodine a valuable option[1].

Safety Considerations

Lodine is preferred due to its relatively lower risk of causing gastrointestinal side effects, such as stomach ulcers, compared to other NSAIDs. This safety profile contributes to its sustained demand[1].

Opioid Crisis

The heightened awareness of opioid addiction has led healthcare providers to seek non-opioid pain management alternatives. Lodine, being a non-opioid NSAID, benefits from this trend[1].

Market Landscape

Global Market Overview

The global market for etodolac is segmented region-wise and by product type. The report by IMARC Group provides a detailed breakdown of the global etodolac market, including price analysis of feedstocks and industry profit margins[1].

Competitive Landscape

Lodine operates in a competitive NSAID market, where other drugs like piroxicam and ibuprofen are also prevalent. However, its efficacy and safety profile help it maintain a significant market share. Clinical trials have shown that Lodine is effective in managing rheumatoid arthritis and osteoarthritis, comparable to other NSAIDs like piroxicam[2].

Financial Trajectory

Revenue and Profitability

The financial performance of Lodine is influenced by several factors, including sales volume, pricing, and production costs. The median income return for pharmaceuticals, including NSAIDs, can be substantial. For example, a study on cancer drugs showed that for every dollar spent on research and development, the median return was $14.50, indicating the potential for high returns in the pharmaceutical industry[3].

Production Costs and Economics

Setting up a manufacturing plant for etodolac involves significant capital and operational expenditures. The IMARC Group report details the project economics, including capital investments, operating expenses, income projections, and financial analysis such as ROI and NPV. This comprehensive analysis helps in understanding the financial viability of producing Lodine[1].

Pricing and Sales

The pricing of Lodine is critical to its market success. The drug is available in various formulations, including immediate release and extended release, with dosages ranging from 200 mg to 1000 mg per day. The maximum daily dose of 1000 mg is a key factor in its pricing strategy[5].

Regulatory and Safety Considerations

Regulatory Approvals

The regulatory landscape for Lodine includes stringent approvals and compliance with safety standards. The FDA label for Lodine outlines the necessary warnings and precautions, including cardiovascular risks, gastrointestinal risks, and renal insufficiency considerations[2].

Safety Profile

Lodine's safety profile, while generally favorable, includes risks such as cardiovascular thrombotic events, gastrointestinal bleeding, and renal function impairment. These risks necessitate careful patient monitoring and dosage adjustments[2].

Market Trends and Future Outlook

Personalized Medicine

The trend towards personalized medicine is expected to influence the demand for Lodine. Patients seeking tailored treatment options with fewer side effects may prefer Lodine due to its relatively safer profile[1].

Generic Competition

As patents expire, generic versions of etodolac may enter the market, potentially affecting the sales of branded Lodine. However, the brand's established reputation and efficacy can help maintain market share[1].

Financial Analysis and Project Economics

Capital Expenditure and Operating Costs

The setup of a manufacturing plant for etodolac involves significant capital expenditure on machinery, raw materials, and infrastructure. The operating costs include expenses related to utilities, manpower, and packaging[1].

Return on Investment (ROI) and Net Present Value (NPV)

The financial analysis of setting up a Lodine manufacturing plant includes calculating ROI and NPV to determine the project's viability. These metrics help investors understand the potential returns and risks associated with the project[1].

Key Takeaways

• Growing Demand: The increasing prevalence of chronic inflammatory conditions drives the demand for Lodine.
• Safety Profile: Lodine's relatively safer profile compared to other NSAIDs is a significant market driver.
• Regulatory Compliance: Strict regulatory approvals and safety standards are crucial for the drug's market presence.
• Financial Viability: The financial trajectory of Lodine is influenced by production costs, pricing, and regulatory considerations.
• Market Trends: Trends towards personalized medicine and generic competition will shape the future market dynamics.

FAQs

What are the primary uses of Lodine?

Lodine is primarily used for the management of signs and symptoms of osteoarthritis, rheumatoid arthritis, and acute pain[4].

What are the key market drivers for Lodine?

The key market drivers include the growing prevalence of chronic inflammatory conditions, safety considerations, and the opioid crisis[1].

What are the potential side effects of Lodine?

Potential side effects include cardiovascular risks, gastrointestinal bleeding, renal function impairment, and hepatic effects[2].

How does Lodine compare to other NSAIDs in terms of safety?

Lodine has a relatively lower risk of causing gastrointestinal side effects compared to some other NSAIDs[1].

What is the financial outlook for a Lodine manufacturing plant?

The financial outlook involves significant capital and operational expenditures, with potential for high returns based on sales volume and pricing strategies[1][3].

Sources

1. IMARC Group, "Etodolac (Lodine) Manufacturing Plant Project Report 2024: Industry Trends, Plant Setup, Machinery, Raw Materials, Investment Opportunities, Cost and Revenue."
2. FDA, "Lodine - accessdata.fda.gov."
3. JAMA Network Open, "Sales Income and R&D Costs for FDA-Approved Cancer Drugs Sold in the United States."
4. DrugBank, "Etodolac: Uses, Interactions, Mechanism of Action | DrugBank Online."
5. Drugs.com, "Lodine: Uses, Dosage, Side Effects & Warnings - Drugs.com."