SIMVASTATIN - Generic Drug Details

What are the generic sources for simvastatin and what is the scope of patent protection?

Simvastatin is the generic ingredient in four branded drugs marketed by Salerno Pharms, Synthon Pharms, Accord Hlthcare, Aurobindo Pharma, Biocon Pharma, Chartwell Rx, Dr Reddys Labs Inc, Hetero Labs Ltd Iii, Invagen Pharms, Ivax Sub Teva Pharms, Lupin, Micro Labs, Norvium Bioscience, Oxford Pharms, Sun Pharm Inds Ltd, Watson Labs Teva, Zydus Pharms Usa, Organon, and Merck Sharp Dohme, and is included in nineteen 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-eight 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:	19
NDAs:	19
Drug Master File Entries:	40
Finished Product Suppliers / Packagers:	38
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	583
Patent Applications:	8,116
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
International Bio service	Phase 1
State University of New York - Downstate Medical Center	Phase 1/Phase 2
United States Department of Defense	Early Phase 1

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
Aurobindo Pharma	SIMVASTATIN	simvastatin	TABLET;ORAL	077691-002	Dec 20, 2006	AB	RX	No	No
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-002	Oct 7, 2011		DISCN	Yes	No	7,326,708*PED				Y
Sun Pharm Inds Ltd	SIMVASTATIN	simvastatin	TABLET;ORAL	076285-004	Dec 20, 2006		DISCN	No	No
Oxford Pharms	SIMVASTATIN	simvastatin	TABLET;ORAL	078735-003	Aug 30, 2010	AB	RX	No	No
Sun Pharm Inds Ltd	SIMVASTATIN	simvastatin	TABLET;ORAL	076285-002	Dec 20, 2006		DISCN	No	No
Aurobindo Pharma	SIMVASTATIN	simvastatin	TABLET;ORAL	077691-001	Dec 20, 2006	AB	RX	No	No
Salerno Pharms	FLOLIPID	simvastatin	SUSPENSION;ORAL	206679-002	Apr 21, 2016		RX	Yes	Yes	10,300,041		Y

Expired US Patents for SIMVASTATIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	ZOCOR	simvastatin	TABLET;ORAL	019766-004	Dec 23, 1991	4,444,784*PED
Organon	ZOCOR	simvastatin	TABLET;ORAL	019766-005	Jul 10, 1998	RE36481*PED
Organon	ZOCOR	simvastatin	TABLET;ORAL	019766-002	Dec 23, 1991	RE36481*PED
Organon	ZOCOR	simvastatin	TABLET;ORAL	019766-003	Dec 23, 1991	RE36520*PED
Organon	ZOCOR	simvastatin	TABLET;ORAL	019766-001	Dec 23, 1991	4,444,784*PED
Organon	ZOCOR	simvastatin	TABLET;ORAL	019766-005	Jul 10, 1998	RE36520*PED
Organon	ZOCOR	simvastatin	TABLET;ORAL	019766-003	Dec 23, 1991	4,444,784*PED

International Patents for SIMVASTATIN

Country	Patent Number	Title	Estimated Expiration
Cyprus	1112917
World Intellectual Property Organization (WIPO)	2007125339
Denmark	2018153
Austria	E552825
Japan	2009534459
Slovenia	2018153
China	101431982	Liquid oral compositions

Supplementary Protection Certificates for SIMVASTATIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	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	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

SIMVASTATIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Simvastatin

Introduction

Simvastatin, a widely used statin, has been a cornerstone in the management of hypercholesterolemia and cardiovascular diseases for decades. The market dynamics and financial trajectory of simvastatin are influenced by several key factors, including generic competition, regional demand, and healthcare infrastructure.

Global Market Size and Growth

The global simvastatin drug market is projected to expand at a compound annual growth rate (CAGR) of 5.20% from 2023 to 2030. This growth is driven by increasing demand for cholesterol management solutions, particularly in regions with high prevalence of lifestyle-related diseases[1].

Regional Market Analysis

North America

North America emerges as the largest region for simvastatin, commanding a substantial 40% market share. The United States dominates this region, driven by the high prevalence of hypercholesterolemia and cardiovascular disorders. Robust healthcare infrastructure and advanced diagnostic capabilities further contribute to the widespread usage of simvastatin in this region[1].

Asia Pacific

The Asia Pacific region stands out as the fastest-growing market for simvastatin, representing 24% of the global market share and growing at a CAGR of 6.6%. This growth is propelled by rising awareness about heart health, lifestyle changes leading to increased cardiovascular diseases, and improving healthcare infrastructure across the region[1].

Europe, South America, and Middle East & Africa

Europe, South America, and the Middle East & Africa also show significant growth, with CAGRs of 4.5%, 5%, and 5.1%, respectively. These regions are driven by similar factors, including increasing awareness of heart health and expanding healthcare infrastructure[1].

Impact of Generic Competition

The expiration of simvastatin's patent has led to the entry of numerous generic versions into the market. This has significantly reduced the cost of the drug, making it more affordable for consumers. However, it poses challenges for original manufacturers, leading to reduced profit margins and intensified pricing pressures.

Cost Savings

A study using data from the Medical Expenditure Panel Survey found that the introduction of generic statins, including simvastatin, resulted in significant cost savings. On average, individuals saved $925.60 annually, translating to $11.9 billion in savings for the US healthcare system[2].

Market Share and Revenue

The entry of generic simvastatin has led to a decline in brand-name statin purchases. For instance, the number of brand-name statin purchases decreased by 90.9% nationally and 27.4% individually after the end of market exclusivity. This shift has resulted in reduced revenue for original manufacturers, while generic versions have seen a surge in prescriptions and spending[2].

Therapeutic and Economic Impact

Cost-Effectiveness

Studies have shown that simvastatin is cost-effective in reducing vascular events among individuals with vascular disease or diabetes. A study involving 20,536 adults found that simvastatin allocation was associated with a 22% reduction in hospitalization costs for vascular events, highlighting its economic benefits[5].

Healthcare Expenditures

The introduction of generic simvastatin has significantly impacted healthcare expenditures. For example, private insurance spending on Lipitor (a brand-name statin) dropped from $4.72 billion to $0.01 billion after the end of market exclusivity, while spending on generic atorvastatin and rosuvastatin increased substantially[2].

Market Segments and End Users

Drug Class

Simvastatin is part of the broader statin market, which includes other drugs like atorvastatin, rosuvastatin, and lovastatin. The statin market is segmented by drug class, with simvastatin being one of the key players[4].

Therapeutic Treatment

Simvastatin is primarily used for treating cardiovascular disorders, but it also has applications in managing obesity and inflammatory disorders. The demand for simvastatin is driven by its efficacy in these therapeutic areas[4].

End Users

The primary end users of simvastatin include hospitals and clinics. The drug is widely prescribed in these settings due to its effectiveness in managing cholesterol levels and reducing the risk of cardiovascular events[4].

Future Outlook

Market Size and CAGR

The global statin market, which includes simvastatin, is expected to grow from $15.39 billion in 2023 to $18.93 billion by 2030, with a CAGR of 3% during the forecast period. This growth is driven by increasing prevalence of cholesterol-related diseases and the expanding use of statins in various therapeutic areas[4].

Regional Growth

The Asia Pacific region is expected to continue its rapid growth, driven by increasing awareness of heart health and improving healthcare infrastructure. North America will remain a significant market, while other regions will also contribute to the overall growth of the simvastatin market[1].

Key Takeaways

• The global simvastatin market is growing at a CAGR of 5.20% from 2023 to 2030.
• North America and Asia Pacific are the largest and fastest-growing regions, respectively.
• Generic competition has significantly reduced the cost of simvastatin, leading to cost savings for consumers and healthcare systems.
• Simvastatin is cost-effective in reducing vascular events and is widely used in managing cardiovascular disorders.
• The market is segmented by drug class, therapeutic treatment, and end users, with hospitals and clinics being primary end users.

FAQs

What is the projected CAGR for the global simvastatin market from 2023 to 2030?

The global simvastatin market is projected to expand at a CAGR of 5.20% from 2023 to 2030[1].

How has generic competition affected the simvastatin market?

Generic competition has led to significant cost savings, reduced brand-name statin purchases, and increased prescriptions for generic versions, posing challenges for original manufacturers in terms of revenue and market share[2].

Which regions are the largest and fastest-growing markets for simvastatin?

North America is the largest region, commanding a 40% market share, while the Asia Pacific region is the fastest-growing, with a CAGR of 6.6%[1].

What are the primary therapeutic uses of simvastatin?

Simvastatin is primarily used for treating cardiovascular disorders but also has applications in managing obesity and inflammatory disorders[4].

How does simvastatin impact healthcare expenditures?

Simvastatin, especially in its generic form, has significantly reduced healthcare expenditures by decreasing the cost of statin therapy and reducing hospitalization costs for vascular events[2][5].

Sources

1. Cognitive Market Research, "Simvastatin Drug Market Report 2024 (Global Edition)".
2. JAMA Network Open, "Use and Expenditures for Brand-name Statins After Introduction of Generic Competition".
3. Market Research Intellect, "Ezetimibe and Simvastatin Sales Market Size, Scope And Forecast".
4. Maximize Market Research, "Statin Market: Global Industry Analysis and Forecast (2024-2030)".
5. PubMed, "Cost-effectiveness of simvastatin in people at different levels of vascular disease risk".