LODINE XL Drug Patent Profile

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

Lodine Xl is a drug marketed by Wyeth Pharms Inc and is included in one NDA.

The generic ingredient in LODINE XL 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 Xl

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

Summary for LODINE XL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	118
Patent Applications:	4,525
DailyMed Link:	LODINE XL at DailyMed

US Patents and Regulatory Information for LODINE XL

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 XL	etodolac	TABLET, EXTENDED RELEASE;ORAL	020584-001	Oct 25, 1996		DISCN	No	No
Wyeth Pharms Inc	LODINE XL	etodolac	TABLET, EXTENDED RELEASE;ORAL	020584-003	Jan 20, 1998		DISCN	No	No
Wyeth Pharms Inc	LODINE XL	etodolac	TABLET, EXTENDED RELEASE;ORAL	020584-002	Oct 25, 1996		DISCN	Yes	No

Expired US Patents for LODINE XL

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 XL	etodolac	TABLET, EXTENDED RELEASE;ORAL	020584-003	Jan 20, 1998
Wyeth Pharms Inc	LODINE XL	etodolac	TABLET, EXTENDED RELEASE;ORAL	020584-002	Oct 25, 1996

International Patents for LODINE XL

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0309157	SUSTAINED RELEASE ETODOLAC
Hungary	200920
United Kingdom	8821749
Bulgaria	60697

LODINE XL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lodine XL (Etodolac)

Introduction

Lodine XL, known generically as etodolac, is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain and symptoms of arthritis, including osteoarthritis and rheumatoid arthritis. Here, we will delve into the market dynamics and financial trajectory of this medication.

Market Position and Usage

Etodolac, under the brand name Lodine XL, has been a significant player in the NSAID market. It is prescribed to reduce pain, swelling, and joint stiffness associated with arthritis, thereby improving the patient's ability to perform daily activities[1][4].

Brand and Generic Status

The Lodine XL brand has been discontinued in the U.S., but generic versions of etodolac are still available. This transition from a branded to a generic product has significant implications for market dynamics and financial performance[1].

Competitive Landscape

The NSAID market is highly competitive, with numerous branded and generic options available. The competitive landscape is influenced by factors such as the availability of generic alternatives, the introduction of new drugs, and changes in prescribing patterns. For instance, the rapid erosion of brand revenues after patent expiration, as seen with drugs like Prozac, can significantly impact a drug's market share[3].

Financial Performance

Historically, Lodine XL contributed to the revenue streams of its manufacturers. However, with the brand's discontinuation and the availability of generic versions, the financial performance has shifted. Generic drugs typically lead to reduced revenue for the original manufacturer but can increase accessibility and affordability for patients.

Revenue Erosion Post-Patent Expiration

When a drug goes off-patent, it often faces rapid revenue erosion due to the entry of generic competitors. This was observed with Prozac, where the brand's market share dropped significantly shortly after generics entered the market. In contrast, drugs with complex formulations or those that are less critical to managed care organizations (MCOs) may experience slower revenue erosion, as seen with Intal[3].

Impact on Pharmaceutical Companies

Pharmaceutical companies must strategize to manage the financial impact of patent expiration. This includes diversifying product portfolios, investing in research and development for new drugs, and employing lifecycle management tactics to extend the revenue life of existing products[3].

Example from Shire Pharmaceuticals

Shire Pharmaceuticals, which has been involved in various pharmaceutical acquisitions and product launches, illustrates how companies manage financial trajectories in a competitive market. Shire's acquisition of New River Pharmaceuticals and its focus on ADHD and other specialty markets demonstrate strategies to maintain financial growth despite patent expirations and generic competition[2][5].

Side Effects and Safety Concerns

The financial trajectory of a drug can also be influenced by its safety profile. Etodolac, like other NSAIDs, carries risks such as increased cardiovascular events and gastrointestinal bleeding. These safety concerns can affect prescribing rates and, consequently, revenue[1][4].

Regulatory Environment

Regulatory approvals and warnings can significantly impact a drug's market dynamics. For example, the FDA's warnings about the cardiovascular risks associated with NSAIDs have led to increased scrutiny and potentially reduced prescriptions for these drugs[1][4].

Patient and Market Impact

The discontinuation of the Lodine XL brand and the availability of generic etodolac have made the medication more accessible to patients. However, this shift also means that patients may experience changes in their treatment plans as healthcare providers adjust to the new market conditions.

Future Outlook

The future financial trajectory of etodolac will likely be influenced by its generic status, competition from other NSAIDs, and any new safety data or regulatory actions. As the pharmaceutical landscape continues to evolve, companies will need to adapt their strategies to maintain market share and financial stability.

Key Takeaways

• Brand Discontinuation: The Lodine XL brand has been discontinued, but generic versions of etodolac remain available.
• Competitive Market: The NSAID market is highly competitive, with significant revenue erosion post-patent expiration.
• Financial Impact: Generic competition leads to reduced revenue for original manufacturers but increases patient accessibility.
• Safety Concerns: Safety profiles, including cardiovascular and gastrointestinal risks, influence prescribing rates and revenue.
• Regulatory Environment: FDA warnings and approvals significantly impact market dynamics.

Frequently Asked Questions (FAQs)

1. What is Lodine XL used for? Lodine XL (etodolac) is used to treat mild to moderate pain and symptoms of arthritis, including osteoarthritis and rheumatoid arthritis.

2. Why was the Lodine XL brand discontinued? The Lodine XL brand has been discontinued in the U.S., but generic versions of etodolac are still available. This is a common practice when patents expire and generic alternatives enter the market.

3. What are the potential side effects of etodolac? Etodolac can cause serious side effects, including increased risk of heart attack or stroke, and gastrointestinal bleeding, especially in older adults or those with a history of stomach ulcers.

4. How does the transition to a generic drug affect patients? The transition to a generic drug typically makes the medication more affordable and accessible to patients. However, it may also lead to changes in treatment plans as healthcare providers adjust to the new market conditions.

5. What strategies do pharmaceutical companies use to manage revenue erosion post-patent expiration? Pharmaceutical companies employ various strategies, including diversifying product portfolios, investing in R&D for new drugs, and using lifecycle management tactics to extend the revenue life of existing products.

Cited Sources:

1. Drugs.com - Lodine XL Advanced Patient Information.
2. Biospace - Shire Pharmaceuticals Group plc On Time Execution Of Operating Plan Delivers Strong 2006 Performance.
3. Analysis Group - Beyond Lifecycle Management – Optimizing Performance Following Patent Expiration.
4. MedicineNet - etodolac sustained-action - oral, Lodine XL.
5. Biospace - Shire Pharmaceuticals Group plc Announces Good Start To The Year And Guidance Reaffirmed.