LESCOL Drug Patent Profile

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

Lescol is a drug marketed by Novartis and Sandoz and is included in two NDAs.

The generic ingredient in LESCOL 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

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

Summary for LESCOL

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	11
Patent Applications:	4,313
Drug Prices:	Drug price information for LESCOL
What excipients (inactive ingredients) are in LESCOL?	LESCOL excipients list
DailyMed Link:	LESCOL at DailyMed

See drug prices for LESCOL

Recent Clinical Trials for LESCOL

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 clinical trials

Paragraph IV (Patent) Challenges for LESCOL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LESCOL	Capsules	fluvastatin sodium	20 mg and 40 mg	020261	1	2008-06-04

US Patents and Regulatory Information for LESCOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	LESCOL	fluvastatin sodium	CAPSULE;ORAL	020261-001	Dec 31, 1993		DISCN	Yes	No
Novartis	LESCOL	fluvastatin sodium	CAPSULE;ORAL	020261-002	Dec 31, 1993		DISCN	Yes	No
Sandoz	LESCOL XL	fluvastatin sodium	TABLET, EXTENDED RELEASE;ORAL	021192-001	Oct 6, 2000	AB	RX	Yes	Yes

Expired US Patents for LESCOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	LESCOL	fluvastatin sodium	CAPSULE;ORAL	020261-001	Dec 31, 1993	5,354,772*PED
Novartis	LESCOL	fluvastatin sodium	CAPSULE;ORAL	020261-002	Dec 31, 1993	5,356,896*PED
Novartis	LESCOL	fluvastatin sodium	CAPSULE;ORAL	020261-002	Dec 31, 1993	5,354,772*PED
Novartis	LESCOL	fluvastatin sodium	CAPSULE;ORAL	020261-001	Dec 31, 1993	5,356,896*PED

International Patents for LESCOL

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

Country	Patent Number	Title	Estimated Expiration
New Zealand	245421	ALKALINE COMPOSITIONS OF A SALT OF A 3,5-DIHYDROXY HEPT-6-ENOIC ACID DERIVATIVE
Greece	3032929
Finland	925615
European Patent Office	0114027	ANALOGS OF MEVALOLACTONE AND DERIVATIVES THEREOF, PROCESSES FOR THEIR PRODUCTION, PHARMACEUTICAL COMPOSITIONS CONTAINING THEM AND THEIR USE AS PHARMACEUTICALS
Canada	1210405	ANALOGUES DE MEVALOLACTONES, ET LEURS DERIVES (ANALOGS OF MEVALOLACTONE AND DERIVATIVES THEREOF)
Greece	79042

Supplementary Protection Certificates for LESCOL

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 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for LESCOL (Fluvastatin Sodium)

Introduction to LESCOL

LESCOL, known generically as fluvastatin sodium, is a statin medication used to lower cholesterol and prevent cardiovascular disease. It is available in various formulations, including capsules and extended-release tablets.

Market Size and Growth Projections

The market for fluvastatin sodium is anticipated to experience significant growth over the coming years. Here are some key projections:

• The fluvastatin sodium market is projected to grow from USD 0.131 billion in 2023 to USD 0.22 billion by 2032, with a Compound Annual Growth Rate (CAGR) of 5.9%[2].
• The market expansion is driven by increasing demand for cholesterol-lowering medications, particularly in the segments of hypercholesterolemia and cardiovascular diseases[3].

Market Segmentation

The fluvastatin sodium market is segmented based on several factors:

• Type: The market is categorized into 20 mg capsules and 40 mg tablets, as well as the extended-release formulation, LESCOL XL 80 mg[3].
• Application: The primary applications are hypercholesterolemia and cardiovascular diseases[3].
• Geography: The market is analyzed across regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa[3].

Key Players and Competition

The market for fluvastatin sodium is competitive, with several major pharmaceutical companies involved:

• Novartis International AG: The original developer and marketer of LESCOL.
• AbbVie Inc., Teva Pharmaceutical Industries Ltd., Dr. Reddy's Laboratories Ltd., Apotex Inc., Aurobindo Pharma Limited, Sandoz International GmbH, Mylan N.V., Cipla Limited, and Sun Pharmaceutical Industries Ltd. are among the key generic manufacturers[3].

Financial Performance and Trends

Historical Performance

• The introduction of generic versions of fluvastatin sodium has significantly impacted the market. The entry of generics led to a sharp decline in the quality-adjusted price of anti-cholesterol drugs, including statins like fluvastatin[4].

Current and Future Outlook

• Despite the competition from generics, the market for fluvastatin sodium continues to grow due to its established efficacy and safety profile.
• The upward trajectory in market dynamics suggests strong growth rates in the forecasted period from 2023 to 2031[3].

Drivers and Restraints

Drivers

• Increasing Prevalence of Cardiovascular Diseases: The rising incidence of hypercholesterolemia and cardiovascular diseases drives the demand for cholesterol-lowering medications like fluvastatin sodium[3].
• Advancements in Healthcare: Improvements in healthcare infrastructure and increased access to medications contribute to market growth.

Restraints

• Generic Competition: The presence of multiple generic manufacturers can reduce the market share of the original branded product, LESCOL.
• Side Effects and Safety Concerns: Although rare, side effects such as liver function abnormalities and muscle pain can affect patient compliance and market growth[1][5].

Clinical Studies and Efficacy

• LESCOL Intervention Prevention Study (LIPS): This study demonstrated the efficacy of LESCOL in reducing the risk of recurrent cardiac events in patients with coronary heart disease who had undergone percutaneous coronary intervention (PCI)[1].

Safety Profile

• Liver Function: Persistent transaminase elevations (>3 times the upper limit of normal) occurred in a small percentage of patients, with most cases occurring within 12 weeks of therapy. However, the majority of these patients were asymptomatic[1][5].
• Other Adverse Reactions: Common adverse reactions include musculoskeletal myalgia, upper abdominal pain, dyspepsia, fatigue, and diarrhea[1].

Regulatory and Patent Landscape

• Patent Expiration: The original patents for LESCOL have expired, allowing for the entry of generic versions.
• Approval Dates: LESCOL capsules were approved in 2008, and LESCOL XL extended-release tablets were approved in 2007[2].

Market Opportunities and Challenges

Opportunities

• Expanding Patient Base: Growing awareness and diagnosis of hypercholesterolemia and cardiovascular diseases present opportunities for market expansion.
• Emerging Markets: Regions like Asia-Pacific and Latin America offer significant growth potential due to increasing healthcare spending and access to medications[3].

Challenges

• Competition from New Therapies: The development of new cholesterol-lowering therapies, such as PCSK9 inhibitors, could pose a challenge to the market share of traditional statins like fluvastatin sodium.
• Regulatory Scrutiny: Strict regulatory requirements and safety monitoring can impact the market dynamics and the financial performance of pharmaceutical companies involved in this segment.

Conclusion

The market for LESCOL (fluvastatin sodium) is poised for significant growth driven by increasing demand for cholesterol-lowering medications. Despite competition from generics and potential challenges from new therapies, the established efficacy and safety profile of fluvastatin sodium ensure its continued relevance in the treatment of hypercholesterolemia and cardiovascular diseases.

Key Takeaways

• The fluvastatin sodium market is projected to grow from USD 0.131 billion in 2023 to USD 0.22 billion by 2032.
• The market is segmented by type, application, and geography.
• Key players include Novartis and several generic manufacturers.
• Drivers include increasing prevalence of cardiovascular diseases and advancements in healthcare.
• Restraints include generic competition and safety concerns.
• Clinical studies have demonstrated the efficacy of LESCOL in reducing cardiac events.

FAQs

Q: What is the primary use of LESCOL (fluvastatin sodium)?

A: LESCOL is used to lower cholesterol levels and prevent cardiovascular diseases.

Q: What are the common adverse reactions associated with LESCOL?

A: Common adverse reactions include musculoskeletal myalgia, upper abdominal pain, dyspepsia, fatigue, and diarrhea.

Q: How does the market for fluvastatin sodium project to grow in the future?

A: The market is projected to grow from USD 0.131 billion in 2023 to USD 0.22 billion by 2032, with a CAGR of 5.9%.

Q: Which companies are key players in the fluvastatin sodium market?

A: Key players include Novartis International AG, AbbVie Inc., Teva Pharmaceutical Industries Ltd., and several other generic manufacturers.

Q: What are the main drivers of the fluvastatin sodium market?

A: The main drivers include the increasing prevalence of cardiovascular diseases and advancements in healthcare infrastructure.

Sources

1. Accessdata.fda.gov: Lescol Label[1]
2. DrugPatentWatch.com: Fluvastatin Sodium - Generic Drug Details[2]
3. MarketResearchIntellect.com: Global Fluvastatin Sodium Drug Sales Market Size, Scope And Forecast[3]
4. Bea.gov: Drug Innovations and Welfare Measures Computed from Market Data[4]
5. Novartis.com: Lescol® XL[5]