1 Executive Summary
1.1 Lipitor Was the World's Best Selling Drug In 2006
1.2 Lipitor Will Face Strong Competition After Patent Expiration In Key Markets
1.3 Lipitor Is Embroiled In Patent Challenges With Ranbaxy
2 Overview of Lipitor (Atorvastatin)
2.1 Lipitor (Atorvastatin) - The Cholesterol Reducing Drug
2.1.1 Pfizer Acquires Lipitor After Merging With Warner-Lambert
2.1.2 Dyslipidemia
2.1.2.1 Classification of Dyslipidaemia
2.1.3 Dyslipidaemia - a Major Risk Factor In Developing Coronary Heart Disease In The Western Population
2.1.4 Aetiology of Dyslipidaemia
2.1.4.1 Primary Causes of Dyslipidemia
2.1.4.2 Secondary Causes of Dyslipidaemia
2.1.4.3 Diabetes A Leading Cause of Secondary Dyslipidaemia
2.2 Obesity Is a Major Environmental Factor Associated With Dyslipidaemia
2.2.1 Strong Link Between Diabetes And Obesity
2.2.2 Diet Remains An Important Component In Regulating Lipid levels
2.2.3 Behaviour
2.2.4 Regular Physical Exercise
2.3 Symptoms and Signs of Dyslipidaemia
2.4 Diagnosis, Screening and Markers of Dyslipidaemia
2.4.1 Direct Measurement of Total cholesterol, Triglycerides, And HDL
2.4.2 Estimation of Low-density Lipoprotein (LDL) And Very Low-Density Lipoprotein (VLDL)
2.4.3 Fasting Lipid Profile
2.4.4 Screening Patients Under 20 Years For Atherosclerotic Risk Factors
2.4.5 Screening For Lipoprotein(a) levels
3 Treatment of Dyslipidaemia
3.1 Lipid Regulating Drugs Are Central To Treating Dyslipidaemia
3.1.1 Statins are First Choice Lipid-Regulating Drugs
3.1.2 Statin Drugs Are Significant Market for Leading Pharmaceutical Companies
3.1.3 Lipitor A Second-Generation 3-hydroxy-3-methygulutaryl coenzyme A (HMGCoA) Reductase Inhibitor Gold Standard Drug
3.2 Posology And Method of Administration of Lipitor
3.2.1 Primary Hypercholesterolaemia and Combined (Mixed) Hyperlipidaemia In Adults And Children aged 10-17 years
3.2.1.1 Heterozygous Familial Hypercholesterolaemia in Adults and Children aged 10-17 years
3.2.1.2 Homozygous Familial Hypercholesterolaemia in Adults and Children aged 10-17 years
3.2.1.3 Lipitor Dosage in Patients With Renal Insufficiency
3.2.1.4 Lipitor Dosage in Patients With Hepatic Dysfunction
3.2.1.5 Lipitor Dosage in Geriatric
4 Lipitor World Market Analysis
4.1 Lipid-regulating/ Anti-Atheroma Preparations Is The Largest In Cardiovascular System Market
4.1.1 Pfizer Is The Leader In Cardiovascular Pharmaceuticals
4.1.2 Cholesterol And Triglycerides Reduction Drugs Generate Highest Individual Sales
4.1.3 The US Market For Cholesterol and Triglyceride Drugs Sees The largest Sales
4.2 Lipitor (Atorvastatin) Revenue Dominates all Cholesterol & Triglyceride Drugs
4.2.1 Lipitor Sales in North America, Europe, Africa, Asia & Australasia and Latin America
4.2.1.1 Lipitor Sales are Most Significant In US
4.2.1.2 Lipitor Drives Sales For Cholesterol & Triglyceride Reducers In The EU Market
4.2.1.3 UK is Lipitor's Largest Market In Europe
4.2.1.4 Lipitor Sales Decline in France
4.2.1.5 Lipitor Sales Grow By 10% In 2006
4.2.1.6 Lipitor Experiences Strong Market Growth In Italy
4.2.1.7 Lipitor Year-on-Year Sales Decline Continued In Germany
4.2.1.8 Japan is Lipitor's Strongest Market in Africa, Asia & Australasia
4.3 Lipitor's Faces Competitions From Key Rivals In Major Markets
4.3.1 Lipitor's Prescription Volume Eroded Steeply Due To Generic Statins
4.3.2 AstraZeneca's Crestor, Merck & Co and Schering Plough's Vytorin Dampens Lipitor's Market Share
4.3.3 Head-to-Head Clinical Study Proves Lipitor to Be More Potent Than Crestor
4.3.4 Vytorin A Strong Contender For Market Share With Lipitor During Near-Term
4.4 Pfizer's Lipitor Challenge With Ranbaxy Will Have Significant Implications On Future Sales
4.5 US WellPoint Demonstrates Generic Statins- Lovastatin, Simvastatin And Pravastatin To Elicit Cardiovascular Benefits
4.6 Lipitor Global Sales Forecast 2008-2023
4.6.1 Lipitor's Five New Indications Will Be key To Sales Growth After Patent Expiration
4.6.2 Lipitor Major Market Sales Forecast 2008-2023
4.6.3 US Lipitor Market Forecasts 2008-2023
4.6.4 Japan Lipitor Market Forecast 2008-2023
4.6.5 EU Lipitor Market Forecast 2008-2023
4.6.6 UK Lipitor Market Forecast 2008-2023
4.6.7 France Lipitor Market Forecast 2008-2023
4.6.8 Spain Lipitor Market Forecast 2008-2023
4.6.9 Italy Lipitor Market Forecast 2008-2023
4.6.10 Germany Lipitor Market Forecast 2008-2023
4.7 Lipitor Competes With Other Non-Statin Drugs
4.7.1 Bristol Myers Questran Is leading Anion Exchange Resin
4.7.2 MSD and Schering-Plough's Ezetrol An Adjunct Therapy for Inhibiting Absorption of Cholesterol
4.7.3 Fibrates Constitute A Significant Market
4.7.4 Niaspan Is Key Nicotinic Acid Competitor To Lipitor
4.7.5 Simcor- Niaspan And Generic Simivastatin Will Increase Lipitor Competition
4.7.6 US National Heart, Lung and Blood Institute Sponsors Niaspan And Simvastatin AIM-HIGH Study
4.7.7 Fish Oils Industry A Growing Market and A deterrent To Lipitor Growth
4.8 Pfizer Has Large Resources To Promo
5. Lipitor’s Key Patent Challenges
5.1 Patent Expiration is the Major Driver in All Generic Markets
5.2 The US Has The Largest Generics Market
5.3 The US and European Regulation of Generic Drugs
5.4 Pfizer’s Lipitor Patent Protection Sets Benchmark In Pharmaceutical Industry For Protecting Brands
5.5 Pfizer Struggles To Block Early Generic Lipitor Market Entry
5.6 The Hatch-Waxman Act, Patent Expiration and the Promotion of Generic Drugs: Title I of the Act
5.6.1 Ranbaxy To Benefit From The Hatch-Waxman Title I
5.6.2 US First To Market 180-Day Exclusivity Period Incentive Will Be Key To Rambaxy’s Initial Sales Success of Generic Atorvastatin
5.7 Ranbaxy Receives Favourable Lipitor Decisions in Key EU Markets
5.7.1 Federal Patent Court of Germany Revokes Lipitor Patent
5.8 Lipitor Expanding Patent Contention
5.8.1 Pfizer Versus Teva Pharmaceuticals’ ANDA For Generic Atorvastatin
5.8.2 Pfizer Versus Cobalt Pharmaceuticals For Atorvastatin Sodium A Potentially Marketable Product
5.8.3 Pfizer Vs Apotex Generic Atorvastatin In Canada
5.9 Ranbaxy Will Cover Cost of Legal Challenges From Sales of Atorvastatin in Key Markets
6 Lipitor- Product Life Cycle Management (PML)
6.1 Pfizer To Use Product Lifecycle Management to Drive Sales of Lipitor
6.2 Pfizer’s Prominent PLM Is Caduet- "uber-pill", a combination of Lipitor And Norvasc
6.2.1 Caduet Sales Rises Significantly By 99% in 2006
6.3 Pfizer’s Torcetrapib- The Lipitor Follow-Up Drug Fails To Deliver
6.4 Pfizer Lipitor and Peripheral Vascular Diseases
6.5 Pfizer's LEAD Trial investigates Lipitor in Combination with Aricept in AD patients
6.6. Other Lipitor Significant Clinical Studies
6.6.1 Lipitor Pre-Clinical Data
6.6.1.1 Atorvastatin Proves to be More Liver Selective Than Pravastatin
6.6.2 Atorvastastin Clinical Data
6.6.2.1 Atorvastatin Was Tolerated in Healthy Volunteers
6.7 Cardiovascular Disease
6.7.1 Ten milligram (10 mg) of Atorvastatin Has Significant Effect Lipid-Lowering Ability
6.7.2 Coronary Artery Disease-AVERT (Atorvastatin Versus Revascularization Treatment)
6.7.3 Ten milligram (10 mg) Atorvastatin is Effective in Australian Atorvastatin Assessment Study
6.7.4 Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering (MIRACL) Study
6.7.5 ASCOT trial Demonstrates Atorvastatin to Reduce Risk of Heart Attack Induced by Hypertension
6.7.6 Head-To-Head REVERSAL Trial Demonstrates that Highest Dose of Atorvastatin, Halted Atherosclerosis
6.7.7 Post-Hoc Analysis in Treating New Targets (TNT ) Trial Demonstrates Atorvastatin 80 mg with Less Cardiovascular Events Than 10 mg dose
6.7.8 Atorvastatin - Incremental Decrease in Endpoints Through Aggressive Lipid Lowering (IDEAL) Trial Reveals Significantly Fewer Risk of Secondary Heart Attacks
6.7.9 CARDS study (Collaborative AtoRvastatin Diabetes Study)-Shows Marked Reduction in Percentages Risk of Cardiovascular Events in Diabetes Patients
6.7.10 SPARCL study (Stroke Prevention by Aggressive Reduction in Cholesterol Study)
6.7.11 Atorvastatin Lowers Cardiovascular Disease By a Significant Percentage
6.8 Paediatric Studies Demonstrated Significant Therapeutic benefits of Lipitor
6.9 Lipitor Post Marketing Studies
7 Lipitor Competitor Studies & Pipeline
7.1 Lipitor worldwide clinical studies
7.2 Competitor Agents in Development
7.2.1 Abbott And AstraZeneca's Developmental Fibrate /Cholesterol reducing Agent Shows Significant Potential
7.2.2 First Horizon's Fenofibrate (Triglide) And Aegerion's MTP Inhibitor (AEGR 733)
8 Lipitor SWOT Analysis
8.1 Lipitor First Drug of Choice For Cholesterol Treatment
8.2 Lipid Regulator Market Will Continue to Generate High Revenues
8.3 An Expanding Patient Population Constitutes the Principal Driver in the Statins Market
8.4 Changes to Treatment Guidelines in US and Europe Can Benefit Sales Of Lipitor
8.5 The US Market Will Continue To Be Key for Lipitor's Sales Growth
8.6 Generic Rivals Will Drive The Erosion of Lipitor's Market Share
8.6.1 The US has the Largest Generics Market
8.6.2 Generic Statins A Growing Presence In The US Market
8.6.3 Rising Generic Uptake in Key EU Markets Will Impact On Lipitor Sales
8.6.4 Generic Statins Potential Threat To Lipitor Growth As They Become Mainstay In Japan
8.7 Pfizer And Astellas Reach Lipitor Settlement In Japan
8.8 US and EU Two -Year Statin Approval Timelines Increase Competitiveness
8.9 Lipitor A Testimony of The Crumbling Blockbuster Business Model
8.10 Pfizer Will Need Strategies That Will Yield High ROI After Lipitor's Patent Expiration
8.11 New Reformulation Will be Significant To Drive Lipitor ‘s Long-Term Revenues
8.12 Liptor Still Has Significant Developmental Possibilities
8.13 Lipitor’s Prominent Indications For Diverse Cardiovascular and Metabolic Areas Will be Significant For Future Sales
8.14 Lipitor Significant Trial Results Will Drive Sales
8.15 Is Pfizer’s Lipitor Success Repeatable?
8.16 US House of Democrats Investigate Lipitor's Director-To-Customer Advertisement Campaign
8.17 OTC Simvastatin Adds To Lipitor’s Competition
8.18 Anti-Counterfeiting Initiatives Will Safeguard Lipitor in Emerging Markets
8.19 Lipitor Will Face Pricing Competition From Generic Statins
9 Conclusion
9.1 Lipitor (Atorvastatin) - The Cholesterol Reducing Drug
9.2 Lipid-regulating Drugs Generate The Highest Revenues In Cardiovascular Market
9.3 Statin Drugs Are Significant Market for Leading Pharmaceutical Companies
9.4 Lipitor (Atorvastatin) Is The World's Highest Selling Drug
9.5 Lipitor Sales Are Most Significant In the US Market
9.5.1 Lipitor Sales in other Key Markets
9.5.2 Lipitor Global Sales Forecast 2008-2023
9.6 Lipitor's Faces Competition From Key Rivals
9.7 Non-Statin Drug Therapies Market Expands
9.8 Pfizer Using Product Lifecycle Management to Drive Sales of Lipitor
9.9 Caduet Positioned To Experience Strong Sales After Lipitor Expiration
9.10 Ranbaxy’s Successsful Patent Lawsuits Against Pfizer In Key Markets Will Be Costly To Lipitor’s Future Sales
9.11 Visiongain Concludes that Loyalty from Pfizer and Brand "Lipitor's" Key Stakeholders Will Confer Future Sales
List of Tables
Table 2.1 Lipoprotein Patterns (Fredrickson Phenotypes)
Table 2.2 Genetic Variations In Dyslipidaemia
Table 2.3 Obese Population in Major Countries by Percentage (%)
Table 4.1 Sales Distribution of Cardiovascular Disease Market, 2006
Table 4.2 Leading Companies in Cardiovascular Market, 2006
Table 4.3 Sales Distribution of Leading Anti-Atheroma Therapies, 2006
Table 4.4 Leading Markets In Cholesterol and Triglyceride Drugs
Table 4.5 Global Sales of Top Ten Leading Statin Drugs, 2006
Table 4.6 Market Share of Lipitor in leading Markets, 2003-2006
Table 4.7 Lipitor Sales in Key EU Markets, 2003-2006
Table 4.8 Comparison of Effects on Cholesterol Levels
Table 4.9 Comparison of Dose Effects on LDL Cholesterol (LDL-C)
Table 4.10 Lipitor (Atorvastatin) Patents Expiration In Major Markets
Table 4.11 Lipitor Global Sales Forecast 2008-2023
Table 4.12 US Lipitor Global Sales Forecast 2008-2023
Table 4.13 Japan Lipitor Global Sales Forecast 2008-2023
Table 4.14 UK Lipitor Global Sales Forecast 2008-2023
Table 4.15 France Lipitor Global Sales Forecast 2008-2023
Table 4.16 Spain Lipitor Market Forecasts 2008-2023
Table 4.17 Italy Lipitor Market Forecasts 2008-2023
Table 4.18 Lipitor Sales In Germany, 2003-2006
Table 4.19 Germany Lipitor Market Forecasts 2008-2023
Table 4.20 Leading Fibrate Drugs, 2006
Table 4.21 Leading Anti-atheroma Preparations Of Natural Origin (Fish Oil Products), 2006
Table 5.1 The Top Ten US Generic Drugs by Revenue ($m) and Units, 2006
Table 5.2 US Top Ten Generic Drugs as a Function of Combined Branded and Generic Drugs by Prescription Number (m) and Revenues ($m),2006
Table.5.3 Prescription Number (m), 2004 Top 10 Generic Drugs, Dispensed by Prescriptions in the US, 2006
Table 5.4 Lipitor (Atorvastatin) Patents In Major Markets
Table 5.5 Ranbaxy /Pfizer (Atorvastatin) Patents Challenges In Other Markets
Table 6.1 Pfizer Post Marketing Lipitor Studies
Table 6.2 Pfizer’s Lipitor Phase III Studies
Table 7.1 Competitors Post Marketing Cardiovascular Agents Studies Including Lipitor
Table 7.2 Competitors Comparative Phase III Cardiovascular Agents Including Lipitor
Table 7.3 Competitors Comparative Phase II Cardiovascular Agents Including Lipitor
Table 7.4 Competitors Comparative Phase I Cardiovascular Agents Including Lipitor
Table 7.5 Competitors Other Comparative Cardiovascular Agents Including Lipitor
Table 8.1 Lipitor Market SWOT Analysis
List of Figures
Figure 1.1 Market Shares of Leading Statin Drugs, 2006
Figure 1.2 Lipitor Sales in key leading markets, 2003-2006
Figure 1.3 Lipitor Market Share in key leading markets, 2003-2006
Figure 4.1 Sales Distribution of Cardiovascular Disease Market, 2006
Figure 4.2 Leading Companies in Cardiovascular Market, 2006
Figure 4.3 Sales Distribution of Leading Anti-Atheroma Therapies, 2006
Figure 4.4 Leading Markets Share In Cholesterol and Triglyceride Drugs
Figure 4.5 Sales Distribution of Top Ten Leading Statin Drugs, 2006
Figure 4.6 Sales Distribution of Top Five Leading Statin Drugs, 2006
Figure 4.7 Market Share of Lipitor in leading Markets, 2006
Figure 4.8 Lipitor Sales in Key EU Market, 2006
Figure 4.9 Market Share of Lipitor in Key EU Market, 2006
Figure 4.10 Lipitor Global Sales Forecast 2008-2023
Figure 4.11 US Lipitor Market Forecasts 2008-2023
Figure 4.12 Japan Lipitor Market Forecasts 2008-2023
Figure 4.13 UK Lipitor Market Forecasts 2008-2023
Figure 4.14 France Lipitor Market Forecasts 2008-2023
Figure 4.15 Spain Lipitor Market Forecasts 2008-2023
Figure 4.16 Italy Lipitor Market Forecasts 2008-2023
Figure 4.17 Lipitor Sales In Germany, 2003-2006
Figure 4.18 Germany Lipitor Market Forecasts 2008-2023