Fluvastatin sodium - Generic Drug Details

What are the generic sources for fluvastatin sodium and what is the scope of freedom to operate?

Fluvastatin sodium is the generic ingredient in three branded drugs marketed by Mylan Pharms Inc, Teva Pharms, Novartis, Beijing, Pharmobedient, Teva Pharms Usa, and Sandoz, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for fluvastatin sodium. Five suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for fluvastatin sodium

US Patents:	0
Tradenames:	3
Applicants:	7
NDAs:	7
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	137
Clinical Trials:	6
Drug Prices:	Drug price trends for fluvastatin sodium
What excipients (inactive ingredients) are in fluvastatin sodium?	fluvastatin sodium excipients list
DailyMed Link:	fluvastatin sodium at DailyMed

See drug prices for fluvastatin sodium

Recent Clinical Trials for fluvastatin sodium

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

Sponsor	Phase
Shenzhen Salubris Pharmaceuticals Co., Ltd.	PHASE1
Federal University of São Paulo	Phase 4
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4

See all fluvastatin sodium clinical trials

Generic filers with tentative approvals for FLUVASTATIN SODIUM

Applicant	Application No.	Strength	Dosage Form
		80MG	TABLET, EXTENDED RELEASE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for fluvastatin sodium

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

Anatomical Therapeutic Chemical (ATC) Classes for fluvastatin sodium

C10AA	HMG CoA reductase inhibitors
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

Paragraph IV (Patent) Challenges for FLUVASTATIN SODIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LESCOL	Capsules	fluvastatin sodium	20 mg and 40 mg	020261	1	2008-06-04
LESCOL XL	Extended-release Tablets	fluvastatin sodium	80 mg	021192	1	2007-03-15

US Patents and Regulatory Information for fluvastatin sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms	FLUVASTATIN SODIUM	fluvastatin sodium	CAPSULE;ORAL	078407-002	Jun 12, 2012	AB	RX	No	No
Mylan Pharms Inc	FLUVASTATIN SODIUM	fluvastatin sodium	CAPSULE;ORAL	090595-001	Apr 11, 2012	AB	RX	No	No
Pharmobedient	FLUVASTATIN SODIUM	fluvastatin sodium	TABLET, EXTENDED RELEASE;ORAL	202458-001	Sep 11, 2015		DISCN	No	No
Teva Pharms Usa	FLUVASTATIN SODIUM	fluvastatin sodium	TABLET, EXTENDED RELEASE;ORAL	079011-001	Jan 27, 2016	AB	RX	No	No
Sandoz	LESCOL XL	fluvastatin sodium	TABLET, EXTENDED RELEASE;ORAL	021192-001	Oct 6, 2000	AB	RX	Yes	Yes

Expired US Patents for fluvastatin sodium

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
Novartis	LESCOL	fluvastatin sodium	CAPSULE;ORAL	020261-001	Dec 31, 1993	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
Novartis	LESCOL	fluvastatin sodium	CAPSULE;ORAL	020261-002	Dec 31, 1993	5,356,896*PED

Market Dynamics and Financial Trajectory for Fluvastatin Sodium

Last updated: July 27, 2025

Introduction

Fluvastatin sodium, a widely prescribed statin, operates primarily as an HMG-CoA reductase inhibitor used in managing hyperlipidemia and preventing cardiovascular diseases. Since its initial approval by the FDA in 1994, its market landscape has undergone significant transformation driven by evolving clinical guidelines, competitive pressures, generics entry, and emerging scientific insights. This analysis delineates current market dynamics and offers an outlook on the financial trajectory of fluvastatin sodium within the global pharmaceutical sector.

Pharmacological Profile and Clinical Utility

Fluvastatin sodium modulates cholesterol biosynthesis via inhibition of HMG-CoA reductase, the rate-limiting enzyme in cholesterol production. Its efficacy in reducing LDL cholesterol levels makes it a mainstay in lipid management protocols. Its safety profile, coupled with established clinical efficacy, has embedded it into treatment regimens, especially for patients with familial hypercholesterolemia and those at high cardiovascular risk.

Despite being succeeded in some areas by newer agents such as PCSK9 inhibitors and ezetimibe, traditional statins like fluvastatin continue to command a significant market share, especially in generic form.

Market Dynamics

1. Competition and Market Share Shifts

The competitive landscape of fluvastatin sodium is heavily characterized by a multitude of generic manufacturers following patent expirations. The original branded versions, such as Lescol by Novartis, have seen their market share decline substantially post-patent expiry. Generic versions dominate the market, offering more affordable options that align with healthcare cost containment strategies globally.

Emerging drugs, including more potent statins (rosuvastatin, atorvastatin) and non-statin lipid-lowering therapies, exert pressure on fluvastatin's market share. However, due to its affordability and well-established safety profile, fluvastatin remains relevant, particularly in cost-sensitive healthcare settings.

2. Regulatory and Reimbursement Trends

Regulatory agencies have continued to streamline approval processes for generic formulations, further eroding branded market dominance. Reimbursement policies favor cost-effective options, boosting demand for generic fluvastatin formulations. Countries with universal healthcare, such as Canada and certain European nations, prioritize generic substitution, reinforcing market growth.

3. Adoption and Prescribing Trends

Physician prescribing behavior is influenced by emerging clinical guidelines. Recent risk stratification approaches and the increased emphasis on individualized therapy have led to some shifts away from older statins. Nonetheless, longstanding clinical familiarity and extensive safety data sustain their prescribing volumes.

4. Impact of Patent Expiry and Generic Entry

The pivotal patent expiry of original brands like Lescol, primarily in the early 2000s, catalyzed global generic proliferation. This significantly reduced drug prices—some estimates suggest a drop of up to 80% in average retail prices—making fluvastatin accessible in a wider demographic, including low-income populations.

5. Market Penetration and Geographic Variability

Developed markets, such as North America and Western Europe, historically represented the largest segments. However, growth avenues in emerging economies like India, China, and Latin America are expanding rapidly due to increasing awareness of cardiovascular risk and expanding healthcare infrastructure.

6. Patent Litigation and Market Exclusivity

Legal disputes over manufacturing rights and patent extensions occasionally influence availability and pricing. In certain jurisdictions, patent litigation has delayed generic entry, temporarily maintaining higher prices and margins for specific formulations.

Financial Trajectory Analysis

1. Revenue Trends

Global revenues for fluvastatin continue to decline in branded segments but remain stable due to the dominance of generics. Market reports estimate the global statin market at over USD 20 billion, with fluvastatin constituting approximately 5-8% of this figure (roughly USD 1-1.6 billion), principally driven by generics sales.

2. Profitability and Cost Dynamics

Manufacturers benefit from high-volume, low-margin models for generic fluvastatin. Production costs are minimized through established synthesis processes, but price competition compresses profit margins. Small molecule generic production, however, retains attractive margins due to low R&D costs and regulatory hurdles.

3. R&D and Pipeline Considerations

Limited investment is observed in R&D for fluvastatin-specific innovations. Focus has shifted toward combination formulations or novel lipid agents. However, some companies explore fixed-dose combination therapies incorporating fluvastatin to enhance compliance and market share.

4. Market Outlook and Growth Potential

While the outlook projects a gradual decline in prescriptions as newer therapies gain ground, fluvastatin’s position as a low-cost, effective solution ensures stable revenues in existing markets. Emerging economies, with expanding healthcare access, present growth opportunities, although lateral competition from other generics constrains multiplicative growth.

5. Regulatory and Policy Impact on Financials

Health policy shifts favoring generic substitution and price caps could further impact revenue streams. Conversely, countries implementing stricter clinical guidelines may influence prescribing patterns, potentially suppressing demand in certain regions.

Strategic Insights

• Market Consolidation: Companies with extensive manufacturing capabilities and global distribution channels can capitalize on generics proliferation.
• Pricing Strategies: Cost leadership will be crucial to remain competitive amid mounting price pressures.
• Diversification: Investment in combination therapies or novel formulations might offer new revenue streams.
• Geographic Expansion: Penetrating untapped markets with growing cardiovascular disease prevalence offers long-term growth.

Key Takeaways

• Market dominance of generic fluvastatin: Post-patent expiration, generics comprise the majority of sales, with key markets in North America, Europe, and emerging economies.
• Revenue stabilization amid declining branded sales: Declining branded revenues are offset by widespread generic adoption, ensuring ongoing profitability.
• Pricing pressures and competitive landscape: Fierce price competition necessitates cost-effective manufacturing and strategic market positioning.
• Emerging markets as growth engines: Increasing healthcare infrastructure and awareness in emerging economies position them as future growth hubs.
• Remaining relevance despite competitive advances: Cost-effectiveness and long-term safety data preserve fluvastatin’s market niche against newer lipid-lowering agents.

Conclusion

The financial trajectory of fluvastatin sodium will evolve along a pathway characterized by sustained demand in generic form, significant cost-driven competition, and incremental growth in emerging economies. Companies leveraging economies of scale, innovative delivery formulations, and strategic geographic expansion will optimize their market positioning. Strategic focus on cost containment and market diversification will be essential for maintaining profitability amid an increasingly competitive landscape.

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FAQs

1. How has patent expiration impacted flavastatin sodium’s market?
Patent expiry led to widespread generic entry, drastically reducing prices and shifting dominance from branded to generic products, thereby expanding access and stabilizing revenues through high-volume sales.

2. What are the primary factors influencing fluvastatin sodium’s declining market share?
Emergence of newer, more potent statins, non-statin therapies, evolving clinical guidelines favoring personalized treatment, and regulatory policies promoting generics are primary drivers.

3. How do emerging economies influence the global market for fluvastatin?
Rapid healthcare infrastructure growth and increasing CVD prevalence create expanding demand, offering avenues for volume-driven growth despite intense price competition.

4. What strategic moves can pharmaceutical companies make to sustain profitability?
Focusing on cost-efficient manufacturing, expanding geographic presence, developing combination therapies, and engaging in targeted marketing to regions with rising CVD burden.

5. Are there upcoming scientific developments that could threaten fluvastatin’s market position?
Advances in lipid management, including gene therapy and novel pharmacological classes, might reshape treatment paradigms, potentially reducing reliance on traditional statins over the long term.

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References

1. Statin Market Analysis, GlobalData, 2022.
2. U.S. Food and Drug Administration (FDA). Drug Approvals and Labeling, 2023.
3. World Health Organization (WHO). Cardiovascular Disease Statistics, 2021.
4. IMS Health. Global Pharmaceutical Market Reports, 2022.
5. Clinical Guidelines for Lipid Management, American Heart Association, 2023.