LESCOL XL Drug Patent Profile

When do Lescol Xl patents expire, and when can generic versions of Lescol Xl launch?

Lescol Xl is a drug marketed by Sandoz and is included in one NDA.

The generic ingredient in LESCOL XL is fluvastatin sodium. There are eleven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the fluvastatin sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lescol Xl

A generic version of LESCOL XL was approved as fluvastatin sodium by MYLAN PHARMS INC on April 11^th, 2012.

Summary for LESCOL XL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	11
Patent Applications:	3,915
Drug Prices:	Drug price information for LESCOL XL
What excipients (inactive ingredients) are in LESCOL XL?	LESCOL XL excipients list
DailyMed Link:	LESCOL XL at DailyMed

See drug prices for LESCOL XL

Recent Clinical Trials for LESCOL XL

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

Sponsor	Phase
Brigham and Women's Hospital	Phase 4
Amgen	Phase 4
University of California, San Francisco	Phase 4

See all LESCOL XL clinical trials

Pharmacology for LESCOL XL

Drug Class	HMG-CoA Reductase Inhibitor
Mechanism of Action	Hydroxymethylglutaryl-CoA Reductase Inhibitors

Paragraph IV (Patent) Challenges for LESCOL XL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LESCOL XL	Extended-release Tablets	fluvastatin sodium	80 mg	021192	1	2007-03-15

US Patents and Regulatory Information for LESCOL XL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	LESCOL XL	fluvastatin sodium	TABLET, EXTENDED RELEASE;ORAL	021192-001	Oct 6, 2000	AB	RX	Yes	Yes

Expired US Patents for LESCOL XL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	LESCOL XL	fluvastatin sodium	TABLET, EXTENDED RELEASE;ORAL	021192-001	Oct 6, 2000	5,354,772*PED
Sandoz	LESCOL XL	fluvastatin sodium	TABLET, EXTENDED RELEASE;ORAL	021192-001	Oct 6, 2000	6,242,003*PED
Sandoz	LESCOL XL	fluvastatin sodium	TABLET, EXTENDED RELEASE;ORAL	021192-001	Oct 6, 2000	5,356,896*PED

International Patents for LESCOL XL

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

Country	Patent Number	Title	Estimated Expiration
Poland	356904
Australia	6219601
New Zealand	245421	ALKALINE COMPOSITIONS OF A SALT OF A 3,5-DIHYDROXY HEPT-6-ENOIC ACID DERIVATIVE
Greece	3032929
Finland	925615
Australia	2001262196

Supplementary Protection Certificates for LESCOL XL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0114027	SPC/GB93/173	United Kingdom		SPC/GB93/173: 20031122, EXPIRES: 20080822
0114027	96C0022	Belgium		PRODUCT NAME: FLUVASTATINE SODIQUE; NAT. REGISTRATION NO/DATE: 151 IS 207 F 4 19960409; FIRST REGISTRATION: GB 0101/0360 19930823

LESCOL XL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for LESCOL XL

Introduction

LESCOL XL, a lipid-lowering agent, has been a significant player in the pharmaceutical market, particularly in the treatment of hypercholesterolemia and mixed dyslipidemia. This article delves into the market dynamics and financial trajectory of LESCOL XL, highlighting its historical performance, competitive landscape, and the impact of generic competition.

Historical Context and Approval

LESCOL XL, containing the active ingredient fluvastatin, was approved by the FDA for the treatment of hypercholesterolemia and to reduce the risk of cardiovascular events. Initially introduced by Novartis, it was one of the early statins to enter the market, following the approval of lovastatin and pravastatin[1].

Market Share and Competition

In the early years, LESCOL XL faced stiff competition from other statins such as lovastatin, pravastatin, and simvastatin. Despite this, it managed to carve out a significant market presence due to its efficacy and safety profile. However, as the statin market evolved, generic versions of these drugs began to dominate the market. By the late 1990s and early 2000s, simvastatin had taken over the dominant position, capturing around 30% of the market share[1].

Financial Performance

Novartis, the original manufacturer of LESCOL XL, saw significant revenue from this drug in its early years. However, as generic competition increased, particularly with the entry of generic simvastatin and atorvastatin, the revenue from LESCOL XL began to decline. In 2007, Novartis reported a decline in net sales in the US pharmaceutical division, partly due to generic competition affecting drugs like LESCOL XL[3].

Revenue Impact

The financial impact of generic competition on LESCOL XL was substantial. For instance, in 2007, Novartis faced a sharp decline in US net sales following the entry of generic versions of several key drugs, including those in the statin class. This decline represented a loss of more than 10% of the global Pharmaceuticals Division net sales for Novartis[3].

Generic Competition and Market Shift

The approval of generic statins marked a significant shift in the market dynamics. Generic atorvastatin, for example, has become one of the most prescribed statins, with market shares by expenditure increasing to 95.6% and by prescriptions to 99.9% by 2022[1].

Impact on LESCOL XL

As generic versions of statins became more prevalent, the market share and revenue from LESCOL XL continued to erode. The drug, once a key player in the lipid-lowering market, saw its sales decline as healthcare providers and patients opted for more affordable generic alternatives.

Strategic Adjustments by Manufacturers

In response to the changing market landscape, pharmaceutical companies have had to adapt their strategies. Novartis, for instance, has focused on diversifying its product portfolio and investing in new product development. The company has seen growth in other divisions such as Vaccines and Diagnostics, and has made significant investments in new products to offset the decline in sales from older drugs like LESCOL XL[3].

Current Market Status

Today, LESCOL XL remains available but is no longer a dominant force in the statin market. Its use is largely limited to specific patient populations where it may still offer unique benefits or where generic alternatives are not suitable.

Prescription Trends

Prescription trends indicate a continued preference for generic statins over brand-name drugs like LESCOL XL. This shift is driven by cost considerations and the equivalent efficacy of generic alternatives.

Financial Trajectory

The financial trajectory of LESCOL XL reflects the broader trends in the pharmaceutical industry, particularly the impact of generic competition on brand-name drugs.

Revenue Decline

The revenue from LESCOL XL has declined significantly over the years as generic competition has intensified. This decline is part of a larger trend where brand-name drugs face substantial revenue erosion upon the expiration of their patents.

Cost Savings and Operational Efficiency

Companies like Novartis have implemented various cost-saving measures and operational efficiencies to mitigate the financial impact of declining sales from drugs like LESCOL XL. These measures include restructuring, consolidating manufacturing facilities, and reducing workforce costs[2].

Key Takeaways

• Market Share Erosion: LESCOL XL has seen a significant erosion in its market share due to the rise of generic statins.
• Financial Impact: The entry of generic statins has led to a substantial decline in revenue from LESCOL XL.
• Strategic Adjustments: Pharmaceutical companies have diversified their portfolios and invested in new product development to offset declines in sales from older drugs.
• Current Market Status: LESCOL XL is still available but is no longer a dominant player in the statin market.
• Prescription Trends: Generic statins are now the preferred choice due to their cost-effectiveness and equivalent efficacy.

FAQs

What is LESCOL XL used for?

LESCOL XL is used to reduce elevated total cholesterol, low-density lipoprotein cholesterol (LDL-C), triglycerides, and apolipoprotein B levels, and to increase high-density lipoprotein cholesterol (HDL-C) levels. It is also indicated to reduce the risk of undergoing coronary revascularization procedures and to slow the progression of coronary atherosclerosis[4].

How has generic competition affected LESCOL XL?

Generic competition has significantly reduced the market share and revenue of LESCOL XL. Generic statins like atorvastatin have become the preferred choice due to their lower cost and equivalent efficacy[1].

What strategies have pharmaceutical companies adopted to mitigate the impact of generic competition?

Companies have diversified their product portfolios, invested in new product development, and implemented cost-saving measures such as restructuring and consolidating manufacturing facilities[2][3].

Is LESCOL XL still prescribed today?

Yes, LESCOL XL is still prescribed, although its use is limited to specific patient populations where it may offer unique benefits or where generic alternatives are not suitable.

How has the financial performance of Novartis been affected by the decline of LESCOL XL?

The decline of LESCOL XL has contributed to a decline in Novartis's US pharmaceutical division sales. However, the company has offset this decline through growth in other divisions and by investing in new products[3].

Sources

1. A Retrospective Trend Analysis of Utilization, Spending, and Prices for Generic Statins in the US Medicaid Population, 1991-2022. AHDB Online.
2. UNITED STATES SECURITIES AND EXCHANGE COMMISSION. Annual Reports.
3. Novartis Annual Report 2007. Novartis.
4. LESCOL XL. Novartis.