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Last Updated: April 3, 2025

SIMVASTATIN - Generic Drug Details


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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, 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-five suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for SIMVASTATIN

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Drug Sales Revenue Trends for SIMVASTATIN

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Recent Clinical Trials for SIMVASTATIN

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

SponsorPhase
International Bio servicePhase 1
State University of New York - Downstate Medical CenterPhase 1/Phase 2
United States Department of DefenseEarly Phase 1

See all SIMVASTATIN clinical trials

Generic filers with tentative approvals for SIMVASTATIN
Applicant Application No. Strength Dosage Form
⤷  Try for Free⤷  Try for Free80MGTABLET; ORAL
⤷  Try for Free⤷  Try for Free40MGTABLET; ORAL
⤷  Try for Free⤷  Try for Free20MGTABLET; 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
Medical Subject Heading (MeSH) Categories for SIMVASTATIN

US Patents and Regulatory Information for SIMVASTATIN

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Synthon Pharms SIMVASTATIN simvastatin TABLET, ORALLY DISINTEGRATING;ORAL 021961-001 Oct 9, 2007 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Zydus Pharms Usa SIMVASTATIN simvastatin TABLET;ORAL 077837-003 Dec 20, 2006 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Micro Labs SIMVASTATIN simvastatin TABLET;ORAL 090383-002 Sep 16, 2011 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Norvium Bioscience SIMVASTATIN simvastatin TABLET;ORAL 090868-001 Jun 8, 2010 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Invagen Pharms SIMVASTATIN simvastatin TABLET;ORAL 206557-002 Nov 13, 2017 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 5 of 5 entries

Expired US Patents for SIMVASTATIN

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Organon ZOCOR simvastatin TABLET;ORAL 019766-003 Dec 23, 1991 RE36520*PED ⤷  Try for Free
Organon ZOCOR simvastatin TABLET;ORAL 019766-005 Jul 10, 1998 RE36481*PED ⤷  Try for Free
Organon ZOCOR simvastatin TABLET;ORAL 019766-001 Dec 23, 1991 4,444,784*PED ⤷  Try for Free
Organon ZOCOR simvastatin TABLET;ORAL 019766-002 Dec 23, 1991 RE36481*PED ⤷  Try for Free
Organon ZOCOR simvastatin TABLET;ORAL 019766-004 Dec 23, 1991 RE36481*PED ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 5 of 5 entries

International Patents for SIMVASTATIN

CountryPatent NumberTitleEstimated Expiration
Austria E552825 ⤷  Try for Free
Denmark 2018153 ⤷  Try for Free
European Patent Office 2018153 COMPOSITIONS ORALES LIQUIDES (LIQUID ORAL COMPOSITIONS) ⤷  Try for Free
Portugal 2018153 ⤷  Try for Free
Slovenia 2018153 ⤷  Try for Free
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 5 of 5 entries

Supplementary Protection Certificates for SIMVASTATIN

Showing 1 to 5 of 5 entries

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".

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