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GenericHandbook - A Guide to the Generic Drug Industry in the US - 3rd Edition Product Image

GenericHandbook - A Guide to the Generic Drug Industry in the US - 3rd Edition

  • Published: March 2009
  • Region: United States
  • 500 Pages
  • VOI Consulting, Inc

FEATURED COMPANIES

  • Abbott Laboratories
  • Bausch & Lomb
  • Falcon Pharmaceuticals
  • IVAX
  • Perrigo
  • Sicor
  • MORE

The industry's most comprehensive source on the generic durg industry in the US.

Coverage includes sections:

- Products / Market
- Regulatory
- Top company profiles

TOPICS COVERED INCLUDE:

- Impact of the NEW Obama Administration on the Generic Drug Industry
- Analysis of recent Patent Litigation effecting the Generic Drug Industry
- Medicare and Medicaid pricing policies
- Intellectual property status and expirations dates for all branded drug products
- Emerging competition in India,China and Eastern Europe
- Recent Mergers and Aquistions
- Impact of Bio generics

Product & Market Section:

- Five-year market forecast
- Opportunity assessment for products losing patent protection 2009–2014
- Top 400 branded and generic products (sales and growth rates)
- Patent & exclusivity data for every FDA-approved product
- Top 20 therapeutic categories
- Total category sales
- Share by company within therapeutic category and more

Regulatory Section:

- FDA structure and policies
- Administrative actions and trends
- Hatch-Waxman trends in case law
- Paragraph IV challenges READ MORE >

*Chapter 1: Introduction to GenericHandbook
Overview
Methodology
Time Considerations
Legal Disclaimer
Key Terms & Abbreviations

Chapter 2: Context of Generic Drugs in the United States
Introduction
History
The US Drug Market
Sales
Prescription Volume
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
Generic versus Brand Prices
Sales to Volume Ratio
Impact of Entry on Pricing
Factors affecting Generic Entry
Factors affecting Generic Penetration

Chapter 3: Regulatory & Legal Environment
Introduction
Table of Contents
Key Regulatory Bodies & Responsibilities
Food Drug and Cosmetics Act (FDCA)
Public Health Service Act (PHSA)
Regulatory Essentials of the Generic Market
Patents
Exclusivity
Of? ce of Generic Drugs
Orange Book
Drug Master Files
Citizen Petition
De? ning Therapeutic Equivalence
Hatch-Waxman Act of 1984
ANDA versus NDA
Paragraph IV
505(b)(2) – Paper NDA
Bolar
Impact of the Medicare Modernization Act
Reverse Payments
Government Pricing Considerations

Chapter 4: Political, Regulatory, & Legal Developments
Introduction
Impact of New Democratic Congress
Biogenerics / Waxman-Clinton-Schumer Bill
Part D Price Negotiations
Authorized Generics
Pediatric Exclusivity
User Fees
Citizen Petitions
Other Congressional Actions
Legal Developments
Declaratory Judgments
FTC / Anti-trust Developments
Out-of-Court Settlements / Reverse Payments
Schering & Tamoxifen Decisions
FTC Response
Likely Congressional Action
Plavix Case Study
FDA Developments
ANDA Approvals / OGD Backlog
Orange Book Patent Delisting (the Zocor case)
Changes in Bioequivalency Requirements

Chapter 5: Customers & The Distribution Chain
Introduction
Buyers
The Private Market
Public Market Buyers
Medicaid
The Distribution Chain
Sales Channels
PBMs
Leading wholesalers
Retailers
Customer Attitudes
Physicians

Chapter 6: The United States Generic Drug Market
Introduction
Key Success Factors
Economics of Paragraph IV
Marketing
Generic Approval Trends
Current Market
Pricing and Margin Trends
Penetration rates
Emerging Market Suppliers
India
China
Market Forecasts

Chapter 7: Major Issues Facing the Generic Industry
Introduction
Authorized generics
De? nition and Prevalence
Economic Impact
Studies on Authorized Generics
Regulatory Attitudes / Actions
Zocor Pricing Strategy
Biogenerics
The Need and Opportunity
Background
Qualifying “sameness”
Marketing
Omnitrope Approval
FDA Timelines
Legislative Iniatives
Likely outcomes
Wal-Mart’s $4 Generic Initiative

Chapter 8: Products
Overview
Generic Products
Top 200 Generic Products by Retail Sales
Top 200 Generic Products by Retail Prescription Volume
Prices of Top 200 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

Chapter 9: Companies
Industry Consolidation
Top 100 Companies by Retail Sales
Post-Consolidation: Top Companies by Retail Sales
List of Subsidiaries and Parent Companies
Company Descriptions
Abbott Laboratories
Abraxis Pharmaceutical Products
Abrika Pharmaceuticals
Actavis
Akyma Pharmaceuticals
American Regent
Amide Pharmaceutical
Andrx Pharma
Apotex
Armstrong Pharmaceuticals
Aurobindo Pharma
Barr Pharmaceuticals
Bausch & Lomb
Baxter International, Inc
Bedford Laboratories
Bertek (Mylan Bertek)
Boca Pharmacal
Breckenridge Pharmaceutical
Caraco Pharmaceutical
Cypress Pharmaceutical Inc
DAVA Pharmaceuticals
Dey Laboratories
Dr. Reddy’s Laboratories
Endo Pharmaceuticals
Ethex
Falcon Pharmaceuticals
Forest Laboratories (Inwood)
Fougera
G&W Laboratories
Glades Pharmaceuticals
Glenmark Pharmaceuticals
Global Pharmaceuticals
Greenstone
Hercon Laboratories
Hi-Tech Pharmacal Co
Hospira
Interpharm
IVAX
Kremers Urban
Lannett Co
Lupin
Major Pharmaceuticals
Mallinckrodt
Midlothian Labs
Mikart
Morton Grove Pharmaceuticals
Mutual Pharmaceutical Co. United Research Labs / Mutual
Mylan Laboratories
Paddock Laboratories
Par Pharmaceutical
Perrigo
Pharmaderm
Pliva
Prasco Laboratories
Purepac
Ranbaxy
Rising Pharmaceutical Int
Roxane
Rugby
RxElite
Sandoz
Sicor
Stada
Taro Pharmaceuticals USA
Teva USA
Three Rivers Pharmaceuticals
Triax Pharmaceuticals
Upsher-Smith
Warrick Pharmaceuticals
Watson Pharmaceuticals
Wockhardt USA
Xanodyne
Xttrium Laboratories
Zydus Pharmaceutical
Products and Delivery Systems by Company

List of Figures

Chapter 2: Context of Generic Drugs in the United States
Figure 1 - Total US Drug Sales in $Millions
Figure 2 - US Drug Prescription Volume (in millions)
Figure 3 - Sales by Channel 2005
Figure 4 - Brand Sales Losing Patent Protection
Figure 5 - Sales by Segment
Figure 6 - Rx Volume by Segment
Figure 7 - US Market Share by Drug Type
Figure 8 - Average Retail Prescription Price 2004-05
Figure 9 - Sales to Volume Ratios
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 3: Regulatory & Legal Environment
Figure 1 - When Can Generics Enter?

Chapter 4: Political, Regulatory, & Legal Developments
Figure 1 - Overall Breakdown of Agreements in 2005
Figure 2 - Final Settlements by Type of Payment
Figure 3 - ANDA Approval Trends 2000-2006

Chapter 5: Customers & The Distribution Chain
Figure 1 - Sources of Pharmaceutical Payment 2004 (Latest Available)
Figure 2 - Use of Tiered Copayments in Private Plans 2000-06
Figure 3 - Average Copayments by Tier 2000-06
Figure 4 - Distribution of Rx Bene? ts in Population over 65 (July 2006)
Figure 6 - Changes in Source of Payment for Retail Prescriptions
Figure 7 - Sales by Channel 2005
Figure 8 - 2005 Retail Channel Details (All Prescription Drugs - Sales at Retail Prices)
Figure 9 - Sales / Volume Growth by Channel (1st 9 Months 2006)
Figure 10 - Destination of Manufacturer Shipments
Figure 11 - 2005 Share of Processed PBM Claims
Figure 12 - Wholesale Share of Market
Figure 13 - US Wholesale Distributor Net Sales
Figure 14 - Retail Revenue Brand versus Generic Prescriptions
Figure 15 - Physician Attitudes
Figure 16 - Physician Survey: How willing are health professionals to prescribe generics today compared with a year ago?
Figure 17 - Physician Survey: How much pressure do you believe HMO’s and Health Insurance Providers are putting on consumers to use generics today compared with a year ago?
Figure 18- Where do you go most often to buy prescription drugs for yourself or a family member?
Figure 19 - 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?
Figure 20 - What is the most you would be willing to pay out-of-pocket for a 30-day supply of generic prescription drugs?

Chapter 6: The United States Generic Drug Market
Figure 1 - Impact of Exclusivity Example
Figure 2 - Paragraph IV ANDAs
Figure 3 - Paragraph IV Litigation Outcomes
Figure 4 - Firms Receiving ANDAs 1995-2005
Figure 5 - ANDA Approval Trends
Figure 6 - FDA Approval Activities by Month Jan 05 to Nov 06
Figure 7 - Number of First-time Generic Approvals
Figure 8 -Sales Growth (relative to same quarter year ago)
Figure 9 - Volume Growth (relative to same quarter year ago)
Figure 10 - Trends in Generic AWP
Figure 11 - Average Generic Penetration Following Patent Expiry
Figure 12 - Generic Fill Rates (and Targets) Leading Therapeutic Categories
Figure 13 - Generic Use by State
Figure 14 - Leading Indian DMF Filers as of Q3 2006
Figure 15 - Forecasts of Brand Sales Facing First Time Generic Competition 2007 to 2012
Figure 16 - Major Product Patent Expirations 2006-11 - Express Script Projections
Figure 17 - Major Product Patent Expirations 2007-12 - Medco Projections

Chapter 7: Major Issues Facing the Generic Industry
Figure 1 - Impact of Authorized Generics
Figure 2 - Biopharmaceutical Losing Patent Protection by 2010

Chapter 9: Companies
Figure 1 - Selected Generic Industry M&A Activity 2005-06
Figure 2 - Retail 100 Companies by Retail Sales (2005)
Figure 3 - Post Consolidation Share Figures (based on 2005 Retail Sales)
Figure 4 - Subsidiaries and Parent Companies

*Sample Table of Contents

- Abbott Laboratories
- Abraxis Pharmaceutical Products
- Abrika Pharmaceuticals
- Actavis
- Akyma Pharmaceuticals
- American Regent
- Amide Pharmaceutical
- Andrx Pharma
- Apotex
- Armstrong Pharmaceuticals
- Aurobindo Pharma
- Barr Pharmaceuticals
- Bausch & Lomb
- Baxter International, Inc
- Bedford Laboratories
- Bertek (Mylan Bertek)
- Boca Pharmacal
- Breckenridge Pharmaceutical
- Caraco Pharmaceutical
- Cypress Pharmaceutical Inc
- DAVA Pharmaceuticals
- Dey Laboratories
- Dr. Reddy’s Laboratories
- Endo Pharmaceuticals
- Ethex
- Falcon Pharmaceuticals
- Forest Laboratories (Inwood)
- Fougera
- G&W Laboratories
- Glades Pharmaceuticals
- Glenmark Pharmaceuticals
- Global Pharmaceuticals
- Greenstone
- Hercon Laboratories
- Hi-Tech Pharmacal Co
- Hospira
- Interpharm
- IVAX
- Kremers Urban
- Lannett Co
- Lupin
- Major Pharmaceuticals
- Mallinckrodt
- Midlothian Labs
- Mikart
- Morton Grove Pharmaceuticals
- Mutual Pharmaceutical Co. United Research Labs / Mutual
- Mylan Laboratories
- Paddock Laboratories
- Par Pharmaceutical
- Perrigo
- Pharmaderm
- Pliva
- Prasco Laboratories
- Purepac
- Ranbaxy
- Rising Pharmaceutical Int
- Roxane
- Rugby
- RxElite
- Sandoz
- Sicor
- Stada
- Taro Pharmaceuticals USA
- Teva USA
- Three Rivers Pharmaceuticals
- Triax Pharmaceuticals
- Upsher-Smith
- Warrick Pharmaceuticals
- Watson Pharmaceuticals
- Wockhardt USA
- Xanodyne
- Xttrium Laboratories
- Zydus Pharmaceutical

Note: Product cover images may vary from those shown

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