Simvastatin - Generic Drug Details

What are the generic drug sources for simvastatin and what is the scope of freedom to operate?

Simvastatin is the generic ingredient in four branded drugs marketed by Salerno Pharms, Synthon Pharms, Accord Hlthcare, Aurobindo Pharma, Biocon Pharma, Chartwell Rx, Hetero Labs Ltd Iii, Invagen Pharms, Ivax Sub Teva Pharms, Lupin, Micro Labs, Oxford Pharms, Pharmobedient, Rising, Sun Pharm Inds Ltd, Watson Labs Teva, Yiling, Zydus Pharms Usa, Organon, and Merck Sharp Dohme, and is included in twenty NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Simvastatin has twelve patent family members in twelve countries.

There are forty drug master file entries for simvastatin. Thirty-one suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for simvastatin

International Patents:	12
US Patents:	3
Tradenames:	4
Applicants:	20
NDAs:	20
Drug Master File Entries:	40
Finished Product Suppliers / Packagers:	31
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	601
Drug Prices:	Drug price trends for simvastatin
Drug Sales Revenues:	Drug sales revenues for simvastatin
What excipients (inactive ingredients) are in simvastatin?	simvastatin excipients list
DailyMed Link:	simvastatin at DailyMed

See drug prices for simvastatin

See drug sales revenues for simvastatin

Recent Clinical Trials for simvastatin

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

Sponsor	Phase
National Cancer Institute, Naples	PHASE2
Chang Gung Memorial Hospital	NA
Indian Council of Medical Research	NA

See all simvastatin clinical trials

Generic filers with tentative approvals for SIMVASTATIN

Applicant	Application No.	Strength	Dosage Form
		80MG	TABLET; ORAL
		40MG	TABLET; ORAL
		20MG	TABLET; 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 simvastatin

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

Medical Subject Heading (MeSH) Categories for simvastatin

Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Hypolipidemic Agents

Anatomical Therapeutic Chemical (ATC) Classes for simvastatin

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

US Patents and Regulatory Information for simvastatin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Biocon Pharma	SIMVASTATIN	simvastatin	TABLET;ORAL	078034-002	Dec 20, 2006	AB	RX	No	No
Zydus Pharms Usa	SIMVASTATIN	simvastatin	TABLET;ORAL	077837-004	Dec 20, 2006	AB	RX	No	No
Invagen Pharms	SIMVASTATIN	simvastatin	TABLET;ORAL	206557-001	Nov 13, 2017	AB	RX	No	No
Sun Pharm Inds Ltd	SIMVASTATIN	simvastatin	TABLET;ORAL	076285-001	Dec 20, 2006		DISCN	No	No
Hetero Labs Ltd Iii	SIMVASTATIN	simvastatin	TABLET;ORAL	200895-002	Nov 25, 2014	AB	RX	No	No
Yiling	SIMVASTATIN	simvastatin	TABLET;ORAL	211394-003	Nov 27, 2024	AB	RX	No	No
Micro Labs	SIMVASTATIN	simvastatin	TABLET;ORAL	090383-001	Sep 16, 2011	AB	RX	No	No

Expired US Patents for simvastatin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	ZOCOR	simvastatin	TABLET;ORAL	019766-003	Dec 23, 1991
Organon	ZOCOR	simvastatin	TABLET;ORAL	019766-005	Jul 10, 1998
Organon	ZOCOR	simvastatin	TABLET;ORAL	019766-004	Dec 23, 1991
Organon	ZOCOR	simvastatin	TABLET;ORAL	019766-001	Dec 23, 1991
Organon	ZOCOR	simvastatin	TABLET;ORAL	019766-003	Dec 23, 1991
Organon	ZOCOR	simvastatin	TABLET;ORAL	019766-005	Jul 10, 1998
Organon	ZOCOR	simvastatin	TABLET;ORAL	019766-003	Dec 23, 1991

International Patents for simvastatin

Country	Patent Number	Title	Estimated Expiration
Cyprus	1112917
World Intellectual Property Organization (WIPO)	2007125339
Austria	E552825
Poland	2018153
Slovenia	2018153
World Intellectual Property Organization (WIPO)	2007125339
China	101431982	Liquid oral compositions

Supplementary Protection Certificates for simvastatin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0720599	SPC/GB05/010	United Kingdom		PRODUCT NAME: EZETIMIBE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH SIMVASTATIN; REGISTERED: DE 58874.00.00 20040402; DE 58874.01.00 20040402; DE 58874.02.00 20040402; DE 58874.03.00 20040402; DE 58878.00.00 20040402; DE 58878.01.00 20040402; DE 58878.02.00 20040402; DE 58878.03.00 20040402; DE 58866.00.00 20040402; DE 58866.01.00 20040402; DE 58866.02.00 20040402; DE 58866.03.00 20040402; DE 58870.00.00 20040402; DE 58870.01.00 20040402; DE 58870.02.00 20040402; DE 58870.03.00 20040402; UK PL 19945/0003 20041118; UK PL 19945/0004 20041118; UK PL 19945/0005 20041118; UK PL 19945/0006 20041118; UK PL 19945/0007 20041118; UK PL 19945/0008 20041118; UK PL 19945/0009 200411
0720599	122004000026	Germany		PRODUCT NAME: EZETIMIB ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON IN KOMBINATION MIT SIMVASTATIN; NAT. REGISTRATION NO/DATE: 58866.00.00 58866.01.00 58866.02.00 58866.03.00 58870.00.00 58870.01.00 58870.02.00 58870.03.00 58874.00.00 58874.01.00 58874.02.00 58874.03.00 58878.00.00 58878.01.00 58878.02.00 58878.03.00 20040402 FIRST REGISTRATION: DE 58866.00.00 - 58866.03.00 58870.00.00 - 58870.03.00 58874.00.00 - 58874.03.00 58878.00.00 - 58878.03.00 20040402
0720599	26/2005	Austria		PRODUCT NAME: EZETIMIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON KOMBINIERT MIT SIMVASTATIN; NAT. REGISTRATION NO/DATE: 1-25673 - 1-25676 20041228; FIRST REGISTRATION: DE 58874.00.00 - 58874.03.00; 58878.00.00 - 20040402
0720599	05C0040	France		PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402
0720599	C300172	Netherlands		PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN SIMVASTATINE; NAT. REGISTRATION NO/DATE: RVG 30927RVG 30928RVG 30929RVG 30930 2004221122; FIRST REGISTRATION: 58874.00.0058874.01.0058874.02.0058874.03.0058878.00.0058878.01.0058878.02.0058878.03.0058866.00.0058866.01.0058866.02.0058866.03.0058870.00.0058870.01.0058870.02.0058870.03.00 2004020402

Market Dynamics and Financial Trajectory for Simvastatin

Last updated: July 27, 2025

Introduction

Simvastatin, a widely prescribed statin medication for managing hypercholesterolemia and reducing cardiovascular risk, has historically been a cornerstone in cholesterol-lowering therapy. While its patent expired in 2006, the drug remains a significant product in the global pharmaceutical landscape, subject to evolving market dynamics, regulatory shifts, and competitive forces. This comprehensive analysis explores the current market environment and forecasts the financial trajectory of simvastatin, providing business professionals with strategic insights.

Market Overview

Simvastatin belongs to the class of HMG-CoA reductase inhibitors, recognized for their efficacy in lowering low-density lipoprotein cholesterol (LDL-C). The drug's mainstream adoption has been driven by its proven benefits in reducing coronary events, its favorable safety profile, and broad generic availability.

However, the landscape has shifted due to several factors:

• Generic Competition: Post-patent expiration, numerous generic manufacturers entered the market, resulting in significant price erosion. According to IMS Health data, generic simvastatin accounts for over 80% of prescriptions in many markets, notably the U.S. (2019-2021) [1].

• Emerging Alternatives: PCSK9 inhibitors, such as evolocumab and alirocumab, have entered the scene, offering more potent LDL-C reduction, especially for high-risk patients. Although more expensive, their increasing adoption has affected simvastatin's market share in specialized settings [2].

• Guideline Evolution: Updated clinical guidelines now emphasize individualized therapy, including the use of high-intensity statins and combination regimens, influencing prescribing patterns [3].

• Healthcare Policies: Price controls and reimbursement policies in various jurisdictions pressure margins for both branded and generic suppliers.

Market Dynamics

Supply Chain and Manufacturing

The widespread generic availability has streamlined supply chains, reducing costs and facilitating access. Major pharmaceutical companies and a multitude of generics manufacturers operate globally, leading to intense price competition. Nonetheless, manufacturing quality and regulatory compliance remain critical, with some regions facing shortages or quality concerns affecting supply stability.

Demand Trends

Demand for simvastatin remains steady, driven by its inclusion in treatment protocols for dyslipidemia. The global rise in cardiovascular disease prevalence sustains its relevance, especially in emerging markets such as India and China, where increasing healthcare infrastructure enhances access [4].

Pricing Strategies

Price erosion has drastically lowered the per-unit cost of simvastatin. For instance, in the U.S., the average retail price for a month's supply of generic simvastatin has decreased by approximately 85% since 2006 [5]. This trend pressures profit margins but also expands access.

Competitive Landscape

Generic manufacturers dominate the market, leading to thin profit margins. Meanwhile, branded formulations are largely phased out or relegated to niche indications. Innovative therapies and lifestyle interventions also indirectly impact demand.

Regulatory Environment

Regulatory frameworks have aimed to ensure drug safety and quality. Some jurisdictions enforce strict bioequivalence standards for generics, influencing market stability. Patent litigations and exclusivities, although less relevant post-patent, occasionally impact certain formulations or formulations with proprietary delivery systems.

Financial Trajectory Forecast

Current Revenue Streams

While specific revenue figures are proprietary, estimations suggest that globally, simvastatin generates billions annually, primarily from generic sales. In markets like the U.S., top pharmaceutical distributors report that simvastatin accounted for approximately $1.5 billion in sales in 2021 [6].

Future Growth Drivers

• Market Penetration in Developing Countries: Rising cardiovascular disease prevalence and healthcare expansion in developing regions will sustain demand. For example, China's statin market is projected to grow at a CAGR of 7% over the next five years, with simvastatin being a significant contributor [7].

• Combination Therapies: Development of fixed-dose combinations (FDCs) with other lipid-lowering agents may create incremental revenue streams, though regulatory and patent considerations influence this trajectory.

• Digital and Precision Medicine Initiatives: Monitoring and optimizing therapy via digital health tools may influence prescribing practices, potentially improving adherence and outcomes.

Challenges to Financial Growth

• Market Saturation: High generic penetration limits pricing power, constraining profit margins.

• Pricing Pressures: Payers increasingly negotiate for lower prices, especially in public healthcare systems.

• Competitive Innovations: Introduction of newer agents with superior efficacy and safety profiles could diminish simvastatin's market share in specific indications.

• Regulatory & Legislation Risks: Reforms aimed at reducing drug costs may further compress margins.

Projected Revenue Outlook (2023–2030)

Most industry analysts concur that simvastatin's revenues will experience a gradual decline post-2025 as newer alternatives gain prominence and market saturation deepens. However, in emerging markets, demand is expected to remain stable or grow modestly due to increased healthcare access. Overall, the global market may contract at a CAGR of approximately 1-2% over the next decade, primarily driven by price erosion and competition [8].

Profitability Outlook

Manufacturers focusing on cost-efficient production and diversification into FDCs or combination therapies may sustain healthier margins. Conversely, pure generic suppliers operating on thin margins could see declining profitability, especially if volume growth plateaus or declines.

Strategic Implications

Business professionals should consider the following strategies:

• Market Diversification: Expand into emerging markets with unmet needs.

• Innovation & FDC Development: Invest in combination therapies to differentiate offerings and extend lifecycle.

• Cost Optimization: Streamline manufacturing and supply chains to maintain profitability amid price declines.

• Regulatory Engagement: Proactively manage compliance to prevent market disruptions.

• Collaborative Models: Partner with healthcare systems and payers to enhance access and adherence.

Key Takeaways

• Simvastatin's market has transitioned from a proprietary drug to a predominantly generic product, resulting in significant price reductions but sustained demand globally.

• Market saturation and stiff competition from both generic manufacturers and newer lipid-lowering agents are pressuring revenues and margins.

• Emerging markets present opportunities for growth, driven by increasing cholesterol awareness and healthcare infrastructure development.

• Strategic innovation, particularly within combination therapies and digital health integration, can help entities preserve profitability.

• The financial trajectory suggests a slow decline in global revenues, emphasizing the need for diversification and efficiency strategies.

FAQs

1. Will simvastatin still be prescribed in the next decade?
Yes. Despite increased competition, simvastatin remains foundational in lipid management, especially in low- to middle-income countries and primary care settings, ensuring continued demand.

2. How do newer therapies impact simvastatin's market share?
Newer agents like PCSK9 inhibitors target high-risk populations unresponsive to statins, reducing simvastatin's share in specialized niches but not replacing it entirely due to cost and accessibility considerations.

3. Can patent protections be renewed or extended for simvastatin?
No, since its patent expired in 2006, and subsequent patent protections have been exhausted. Future innovation likely resides in formulations or combination products rather than the original molecule.

4. What role do regulatory agencies play in simvastatin's market evolution?
Regulators ensure drug safety and quality, influencing generic approval processes, bioequivalence standards, and reimbursement policies, all of which shape market dynamics.

5. Are there regions where simvastatin's demand is expected to decline sharply?
Demand could decline where newer therapies or stricter regulatory policies limit use, especially in high-income regions following guideline updates favoring alternative treatments.

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Sources:
[1] IMS Health data on generic statin market share, 2019–2021.
[2] FDA approvals and clinical practice guidelines, 2020.
[3] American College of Cardiology/American Heart Association guidelines update, 2018.
[4] World Health Organization, global burden of cardiovascular diseases, 2022.
[5] A. PharmaTrade Analytics, pharmaceutical pricing database, 2022.
[6] IQVIA reports, U.S. pharmaceutical sales, 2021.
[7] Market Research Future, statins market forecast in China, 2022–2027.
[8] Global Market Insights, lipid-lowering agents market analysis, 2023.