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Generic Drugs

GenericHandbook - Third Edition (2009)

A Guide to the Generic Drug Industry in the US

Publication Date April 2009
Publisher VOI Consulting
Product Type Book
Pages 548
ISBN Number 0-9795443-1-9
Product Code VOI00014

Price

£500.00
approximately: $751 | €548

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Summary

NEW 3rd Edition GenericHandbook provides an in-depth, up-to-date analysis of the issues, trends, regulations, markets, companies and products in the U.S. generic drug industry. Topics covered include patent litigation, emerging competition from low-cost providers in China and India, authorized generic drugs, bio generic drugs, mergers and the impact of the NEW Obama Administration on the Drug Industry.

Contents

  • Introduction
    • Overview
    • Methodology
    • Time Considerations
    • Legal Disclaimer
    • Glossary of Key Terms
  • Chapter 3. Context
    • Introduction
    • History
    • The U.S. Drug Market
    • Sales
    • Prescription Volume
    • Reasons for Declining Growth Levels
    • Sales Channels
    • Generic Availability
    • Generics versus Brands
    • Brands Losing Patent Protection
    • Generic versus Brand Sales
    • Generic versus Brand Prescription Volume
    • Generic versus Brand Market Share
    • Sales to Volume Ratio
    • Generic versus Brand Prices at Retail
    • Impact of Entry on Pricing
    • Factors affecting Generic Entry
    • Factors affecting Generic Penetration
  • Chapter 4. Legal & Regulatory
    • Environment
    • Introduction
    • Key Regulatory Bodies & Responsibilities
    • Food Drug and Cosmetics Act (FDCA)
    • Public Health Service Act (PHSA)
    • Regulatory Essentials of the Generic Market
    • Patents
    • Exclusivity
    • Office of Generic Drugs
    • Orange Book
    • Patent Listings in the Orange Book
    • Drug Master Files
    • Citizen Petition
    • Therapeutic Equivalence
    • Therapeutic Equivalence-Related Terms
    • Statistical Criteria for Bioequivalence
    • Therapeutic Equivalence Evaluation Codes
    • TE Codes
    • Hatch-Waxman Act of 1984
    • ANDA versus ANDA
    • The Four ANDA Paragraphs:
    • Paragraph IV
    • 180 day exclusivity
    • 30-month stay
    • The Judicial Appeals Process
    • Duty of Care in Paragraph IV Filings
    • Injunctive Relief
    • 505(b)(2) - Paper NDA
    • Bolar
    • Impact of the Medicare Modernization Act
    • Multiple 30-month Stays:
    • Failure to Sue
    • 180 Day Exclusivity
    • Post-MMA developments with
    • failure-to-market provisions
    • At-Risk Launches
    • Post MMA Summary
    • Reverse Payments
    • Government Pricing Considerations
    • Price Regulations and Reimbursement Rates
    • Medicare Pricing Considerations
    • Part A
    • Part B
    • Part D
    • Medicaid
    • Medicaid Price Issues
    • Impact of the Deficit Reduction Act (DRA)
    • Pharmacies and the DRA
    • 340B Program
    • Department of Veterans Affairs
    • Price Schedules
    • Generic Substitution Policies
  • Chapter 5. Political, Legal &
    • Regulatory Developments
    • Introduction
    • Impact of Obama Administration
    • Biosimilar Legislation
    • Part D Price Controls
    • Authorized Generics
    • User Fees
    • Citizen Petitions
    • Legal Developments
    • Declaratory Judgments
    • FTC / Anti-trust Developments
    • Out-of-Court Settlements/Reverse Payments
    • Court Decisions
    • FTC Response
    • Provigil Case
    • Solvay Case
    • Likely Congressional Action
    • FDA Developments
    • ANDA Approvals / OGD Backlog
  • Chapter 6. Customers
    • Introduction
    • Buyers
    • The Private Market
    • Public Market Buyers
    • Medicare
    • Medicare Part D: The Medicare
    • Drug Benefit
    • Part D Impact
    • Medicaid
    • The Distribution Chain
    • Sales Channels
    • PBMs
    • Leading wholesalers
    • Wholesale Drug Revenues
    • Retailers
    • Wal-Mart's $4 Generic Initiative
    • Customer Attitudes
    • Physicians
    • Patients
    • Pharmacists
  • Chapter 7. Market
    • Introduction
    • Generic Approval Trends
    • Current Market
    • Market Forecasts
    • Brands Losing Patent Protection
    • Pricing Trends
    • Discount Generic Programs
    • Penetration rates
    • Generic Penetration Forecasts
    • Impact of Electronic Prescribing
    • Economics of Paragraph IV
    • Paragraph IV Filings
    • Predicting Paragraph IV Outcomes
    • At-Risk Launches
    • Brand Defense Strategies
    • Lines between Brand and Generic
    • Companies are Blurring
    • Emerging Market Suppliers
    • India
    • China
    • Comparing Indian and Chinese Activity
  • Chapter 8. Issues
    • Introduction
    • Authorized generics
    • Background
    • Economic Impact of Authorized Generics
    • Example of Economic Impact
    • Actual Market Data
    • Market Developments
    • Prevalence of AGs
    • Companies in the AG Space
    • Financial Risk / Reward Tradeoff of AGs
    • The Authorized Generic Debate
    • Regulatory Attitudes / Actions
    • FDA Position
    • Court Rulings
    • FTC Position
    • Best Price Issues and the Deficit
    • Reduction Act
    • Potential Legislative Actions
    • Potential Brand Responses
    • The Status Quo or a Future of Price Wars?
    • Hypothetical Price War Example
    • Conclusion
    • Manufacturing Quality Problems
  • Chapter 9. Biosimilars
    • Introduction
    • Biosimilars
    • The Need
    • The Opportunity
    • Cost of Entry
    • Marketing
    • Legal and Regulatory Background
    • Definition of ""Biologics""
    • Terminology
    • PHS Act
    • Manufacturing Issues
    • Qualifying ""sameness""
    • Need for additional trials
    • Substitution and Incentives for Use
    • Intellectual Property Issues
    • Omnitrope Approval
    • Potential Lovenox Generic
    • Other Countries
    • Australia
    • Japan
    • Canada
    • European Regulatory Framework
    • EU Approval Patterns
    • Substitution of Biosimilar for
    • Branded Products
    • U.S. Path Forward
    • Data Exclusivity: the Latest Major
    • Stumbling Block
    • Naming
    • Legislative Initiatives
    • Pathway for Biosimilars Act
    • [No Bill number assigned at this writing]
    • H.R. 1956 [110th]: Patient Protection
    • and Innovative Biologic Medicines Act
    • S. 1695 [110th]: Biologics Price
    • Competition and Innovation Act of 2007
    • S. 1505 [110th]: Affordable Biologics
    • for Consumers Act
    • Likely outcomes
    • Companies in the Biogeneric Segment
    • Market Experience: Current and Future
    • The Bio-better Model
  • Chapter 10. Products
    • Overview
    • Generic Products
    • Top 200 Generic Products by Retail Sales
    • Top 200 Generic Products by
    • Retail Prescription Volume
    • Prices of Top 150 Generics
    • Active Companies by First Listed
    • Active Ingredient
    • Active Companies by Precise Compound(s)
    • Branded Products
    • Top 200 Branded Products by Retail Sales
    • Innovative Products Arranged by
    • Generic Compound Name
    • Details of Innovative Product
    • Intellectual Property
    • Note on Patent and Exclusivity Codes
  • Chapter 11. Companies
    • Industry Consolidation
    • Top Companies by Total U.S. Prescriptions
    • List of Subsidiaries and Parent Companies
    • Company Profiles
    • Actavis
    • Financials
    • Other Information
    • North America
    • Press releases
    • Feb 25 2009
    • Dec 12 2009
    • Amneal Pharmaceuticals
    • Financials
    • Other Information
    • Anchen Pharmaceuticals
    • Financials
    • Other Information
    • Apotex
    • Other Information
    • Aurobindo Pharma
    • Other Information
    • Bedford Laboratories
    • Financials
    • Other Information
    • Boca Pharmacal
    • Financials
    • Other Information
    • Breckenridge Pharmaceutical
    • Financials
    • Other Information
    • Cadista Pharmaceuticals
    • Caraco Pharmaceutical
    • Financials
    • Other Information
    • Carlsbad Technology, Inc
    • Other Information
    • Cypress Pharmaceutical Inc
    • Other Information
    • Cipla
    • Financials
    • Other Information
    • Cobalt Laboratories
    • Other Information
    • Corepharma
    • DAVA Pharmaceuticals
    • Financials
    • Other Information
    • Dr. Reddy's Laboratories
    • Financials
    • Other Information
    • Ethex
    • Financials
    • Other Information
    • Falcon Pharmaceuticals
    • Other Information
    • Glenmark Pharmaceuticals
    • Financials
    • Greenstone LLC
    • Financials
    • Other Information
    • Hi-Tech Pharmacal Co
    • Financials
    • Other Information
    • Hospira
    • Financials
    • Other Information
    • Other Pharmaceuticals
    • Inwood
    • Financials
    • Other Information
    • Lannett Co
    • Financials
    • Other Information
    • Lupin
    • Other Information
    • Mallinckrodt
    • Other Information
    • Mylan Laboratories
    • Financials
    • Other Information
    • Nycomed
    • Other Information
    • Paddock Laboratories
    • Financials
    • Other Information
    • Par Pharmaceutical
    • Financials
    • Other Information
    • Strativa Segment
    • Perrigo
    • Financials
    • Other Information
    • Prasco Laboratories
    • Other Information
    • Qualitest
    • Other Information
    • Ranbaxy
    • Financials
    • USA
    • USFDA update:
    • Other Information
    • Roxane
    • Other Information
    • Sagent Pharmaceuticals
    • Other Information
    • Sandoz
    • Financials
    • Other Information
    • Silarx Pharmaceuticals
    • Other Information
    • Sun Pharmaceuticals
    • Financials
    • US Generics - Top priority
    • Update on Taro
    • Taro Pharmaceuticals USA
    • Financials
    • 2008 Financial Performance
    • Other Information
    • Teva USA
    • Financials
    • Operating Data
    • Other Information
    • Strategy
    • North America
    • Three Rivers Pharmaceuticals
    • Other Information
    • United Research Labs / Mutual
    • Other Information
    • Watson Pharmaceuticals
    • Financials
    • Other Information
    • Generic Strategy
    • Wockhardt USA
    • Other Information
    • Europe Business:
    • India Business:
    • Zydus Pharmaceutical
    • Other Information
    • Products and Delivery Systems by Company
    • Products and Delivery Systems by Company
  • List of Figures
    • Chapter 3. Context
      • Figure 1 - Total U.S. Drug Sales in $Millions
      • Figure 2 - U.S. Drug Prescription Volume (in millions)
      • Figure 4 - Brand Sales Losing Patent Protection Historical: 1998-2008
      • Figure 5 - Sales by Segment 2004-08
      • Figure 6 - Rx Volume by Segment 2004-08
      • Figure 7 - U.S. Market Share by Drug Type 2001-08
      • Figure 8 - Sales to Volume Ratios
      • Figure 9 - Average Retail Prescription Price 2004-05
      • Figure 10 - Impact of Generic Entry on Generic Price
      • Figure 11 - Generic Entry and Pre-Generic Brand Value
      • Figure 12 - Generic Share and Pre-Generic Brand Value
    • Chapter 4. Legal & Regulatory
      • Environment
      • Figure 1 - When Can Generics Enter?
    • Chapter 5. Political, Legal &
      • Regulatory Developments
      • Figure 1 - Breakdown of Settlement Agreements FY 2005-2007
      • Figure 2 - Final Settlements by Type of Payment FY 2005-2007
      • Figure 3 - ANDA Approval Trends 2002-200
    • Chapter 6. Customers
      • Figure 1 - 2005-2008 Sources of
      • Pharmaceutical Payment
      • Figure 2 - Use of Tiered Copayments in Private Plans
      • Figure 3 - Average Copayments by Formulary Status
      • Figure 4 - Medicare Part D Coverage:2009 Standard Plan Benefits
      • Figure 5 - Distribution of Average Retail Rx Payment(includes brand and generic)
      • Figure 6 - Sales by Channel 2004-08
      • Figure 7 - 2007 Retail Channel Details(All Prescription Drugs - Sales at Retail Prices)
      • Figure 8 - Where do you go most often to buy prescription drugs for yourself or a family member?
      • Figure 9 - 2007 Share of Processed PBM Claims
      • Figure 10 - Wholesale Share of Market 2007
      • Figure 11 - U.S. Wholesale Distributor Net Sales
      • Figure 12 - Retail Revenue Brand versus Generic Prescriptions
      • Figure 13 - Physician Attitudes
      • Figure 14 - If you had a choice between getting a brand name prescription drug or a generic drug, how often would you choose one over the other?
    • Chapter 7. Market
      • Figure 1 - ANDA Approval Trends 2002-2008
      • Figure 2 - FDA Approval Activities by MonthJan 05 to Feb 09
      • Figure 3 - Number of First-time Generic Approvals
      • Figure 4 - Firms Receiving ANDAs 1995-2008
      • Figure 5 - U.S. Sales of Unbranded Generics 2001-08
      • Figure 6 - Forecasts of Brand Sales Facing First Time Generic Competition 2009 to 2015 ($ Mil)
      • Figure 7 - Major Product Patent Expirations 2009-14 - Medco Projections
      • Figure 8 - Major Product Patent Expirations 2009-11 - CVS/Caremark Projections
      • Figure 9 - Trends in Generic AWP
      • Figure 10 - Retail Discount Generic Programs
      • Figure 11 - 2007 Generic Fill Rates (and Targets)Leading Therapeutic Categories
      • Figure 12 - Impact of Exclusivity Example
      • Figure 13 - Lawsuits involving Paragraph IV ANDAs : 2004-2008
      • Figure 14 - Paragraph IV Litigation Outcomes
      • Figure 15 - At-Risk Generic Launches 2005-08
    • Chapter 8. Issues
      • Table 1 - Impact of Authorized Generics
      • Table 2 - Market Share by Product Type for the 4 Weeks Ending 12/1/06
      • Table 3 - Authorized Generics Launched 1992-2007
      • Table 4 - Savings from DRA Best Price Provisions($ in Mil)
      • Table 5 - Hypothetical Brand Response to Banning AGs
      • Table 6 - Price War Scenario
    • Chapter 9. Biosimilars
      • Figure 1 - Forecasts of Global Biosimilar Market Value in $Bil: 2008-12
      • Figure 2 - Biopharmaceuticals Likely to face first time competition 2013-17
      • Figure 3 - Biosimilars approved in the E.U
      • Figure 4 - EU National Policies Regarding Biosimilar Substitutability
      • Figure 5 - Generic Companies Active in Biosimilars
      • Figure 6 - Innovative Drug Companies Active in Biosimilars
      • Figure 7 - Recent Studies on Biosimilars with Links to Original Documents
    • Chapter 10. Products
    • Chapter 11. Companies
      • Figure 1 - Selected Generic Industry M&A Activity 2005-08
      • Figure 2 - Share of Total U.S. Generic Prescriptions by Company 2007-08
      • Figure 3 - Subsidiaries and Parent Companies