Introduction

• Study Goal And Objectives
• Reasons For Doing The Study
• Contributions Of The Study And For Whom
• Scope And Format
• Methodology
• Information Sources
• Related Bcc Work Credentials Including Work Done By Other Authors
• Bcc On-Line Service
• Internet

Summary

Overview

• Definition Of A Generic Drug
• The Worldwide Market For Generic Drugs
• Generic Drug Markets By Therapeutic Category
• Growth In Generic Prescriptions
  • Percentage Of The Market Held By Generic Drugs
• Leading Generics Firms Worldwide
• Challenges In The International Generic Drug Market
  • The Influence Of The Bulk Pharmaceutical Actives Sector
• The U.S. Generic Pharmaceuticals Market
  • History Of The U.S. Generic Pharmaceuticals Market
  • Current Status Of The U.S. Generic Drug Industry
    • Substitution Rates Following Patent Loss
    • Leading Generic Firms In The U.S.
  • The Outlook For Anda Approvals
  • Challenges Facing Generics Manufacturers
    • Falling And Rising Prices
• The Role Of The Pharmacist In Generic Substitution
  • Percentage Of The Market Held By Generic Drugs
  • Therapeutic Categories In Which Pharmacists Are Reluctant To Substitute A Generic
• Pharmacy Buying Practices
• The Impact Of Managed Care
  • Prescription Benefits Managers
  • Maximum Allowable Cost
• The Department Of Veterans Affairs National Drug Formulary
• The Opinion Of Patients About Generic Drugs
• Markets For Generic Drugs
  • Mail Service Pharmacies
    • Drug Categories Most Frequently Sold Through Mail Service Pharmacies

Government Regulation In The U.S.

• The Drug Price Competition And Patent Term Restoration (Hatch-Waxman) Act Of 1984
• The Uruguay Round Agreements Act Of 1994
• 30-Month Limit On Delaying Introduction Of Generics Via Litigation
• Food And Drug Administration Modernization Act Of 1997
• Bioequivalency And Anda Requirements
  • New Bioequivalency Guidelines Proposed
  • Therapeutic Equivalence
  • State Positive Formularies
• Changes To The Hatch-Waxman Act
• The Question Of User Fees

Patent Analysis

• Terms Of Patents
• Expiration Of Patents On Top-Selling Drugs
  • Generic Opportunities In Injectables
  • Generic Opportunities In Complex Pharmaceuticals
• Impact Of Gatt Patent Extensions
• Regulatory Changes Relating To Patents And Their Effect On The Generics Industry

The U.S. Market For Generic Drugs

• Generic Drugs With U.S. Sales Exceeding $100 Million In 1997
• Generic Drugs Approved In 1997
• Antiarthritic And Analgesic Agents
  • The Market For Antiarthritic And Analgesic Agents
• Anticancer Agents
  • The Market For Generic Anticancer Agents
• Anti-Infective Agents
  • The Market For Generic Anti-Infective Agents
  • Antibacterial Agents
    • Cephalosporins
    • Macrolides
    • Penicillins
    • Quinolones
    • Tetracyclines
    • Other Antibacterial Agents
  • Antifungal Agents
  • Antiviral Agents
• Biotechnology Drugs
  • The Market For Generic Biotechnology Agents
• Cardiovascular Agents
  • The Market For Generic Cardiovascular Agents
    • Loss Of Patent Protection And Generic Competition
    • Adrenergic Inhibitors
    • Angiotensin Converting Enzyme (Ace) Inhibitors
    • Antiarrhythmics
    • Anticoagulants, Antiplatelet Agents And Thrombolytics
    • Beta-Blockers
    • Calcium Channel Blockers
    • Cholesterol-Reducing Agents
    • Diuretics
    • Vasodilators
    • Other Cardiovascular Agents
• Central Nervous System Agents
  • Anticonvulsants
  • Antidepressants
  • Antimigraine Agents
  • Antiparkinson's Agents
  • Antipsychotic Agents
  • Tranquilizers
  • The Market For Generic Central Nervous System Agents
• Gastrointestinal Agents
  • The Market For Generic Gastrointestinal Agents
• Hormones
  • The Market For Generic Hormone Drugs
• Respiratory Agents
  • Allergy Treatments
  • Beta Agonists
  • Steroidal Bronchodilators
  • Xanthines And Related Bronchodilators
  • Other Respiratory Agents
  • The Market For Generic Respiratory Agents
• Other Therapeutic Agents
  • Anesthetic Agents
  • Antidiabetic Drugs
  • Antiemetic Drugs
  • Dermatological Drugs
  • Immunosuppressive Drugs
  • Ophthalmic Drugs
  • Treatments For Benign Prostatic Hyperplasia
  • The Market For Other Generic Therapeutic Agents

The International Generic Drug Industry

• World Health Organization Guidelines For Generic Drugs
• The Generic Drug Industry Goes Global
• The U.S. Generic Drug Industry
• The European Generic Drug Industry
  • The European Generic Medicines Association
  • Regulatory Issues
  • Growth In The European Generic Drug Market
    • The French Generic Drug Industry
    • The German Generic Drug Industry
    • The Italian Generic Drug Industry
    • The Portuguese Generic Drug Industry
    • The Spanish Generic Drug Industry
    • The U.K. Generic Drug Industry
• The Canadian Generic Drug Industry
• The Japanese Generic Drug Industry
• Other International Generic Drug Industries
  • Mexico
  • Russia
  • Venezuela

Generic Drug Market Strategies

• Primary Challenges Facing The Generic Drug Market
  • Consolidation Of Distributors And Growth Of Large Retail Pharmacy Chains
• Strategies Employed By Generics Drug Companies
  • First On The Market
  • Full Anda Pipelines
  • Specialization And Niche Marketing
  • Successful Patent Challenges
  • Exclusive Providers
  • Exclusive Supplier Arrangements
  • Breadth Of Product Line
  • Proprietary Products
  • Strategic Advertising
  • Mergers
  • Cost-Effective Production
  • Cooperation With Branded Product Manufacturers
  • Access To Managed Care
• Strategies Employed By Branded Pharmaceutical Companies
  • Developing Or Acquiring A Generics Business
  • Defensive Strategies Employed By Branded Pharmaceutical Companies
    • Litigation
    • Withdrawal Of The Reference Drug
    • Submission Of Citizen Petitions
    • Discounts To Managed Care
    • Offering New Or Improved Products To Replace Existing Agents At Patent Expiration
    • Seeking Support At The Federal Level To Bar Generic Competition
    • Seeking Support At The State Level To Bar Generic Substitution
    • Appealing To International Regulatory Agencies To Make Generic Approvals More Difficult

Company Profiles

• Independent Generic Drug Companies
  • Alpharma Inc.
    • Business Overview
    • Corporate Strengths
    • Leading Products
    • Recent Developments
  • Barr Laboratories
    • Business Overview
    • Corporate Strengths
    • Leading Products
    • Recent Developments
  • Duramed Pharmaceuticals, Inc.
    • Business Overview
    • Corporate Strengths
    • Products
    • Recent Developments
  • Ivax Corporation
    • Business Overview
    • Corporate Strengths
    • Products
    • Recent Developments
  • Mylan Laboratories, Inc.
    • Business Overview
    • Corporate Strengths
    • New Products
    • Recent Developments
  • Pharmaceutical Resources, Inc.
    • Business Overview
    • Corporate Strengths
    • New Products
    • Recent Developments
  • Schein Pharmaceutical, Inc.
    • Business Overview
    • Corporate Strengths
    • New Products
    • Recent Developments
  • Teva Pharmaceutical Industries Ltd.
    • Business Overview
    • Corporate Strengths
    • New Products
    • Recent Developments
  • Watson Pharmaceuticals Inc.
    • Business Overview
    • Corporate Strengths
    • New Products
    • Recent Developments
  • Other Independent Generics Firms - Brief Profiles
    • Faulding Pharm
    • Halsey Drug Company
  • Generic Divisions Of Branded Product Companies
  • Apothecon
  • Esi Lederle
  • Geneva Generics

Appendix: Company Names And Addresses

List Of Tables

Summary Table: Worldwide Generic Market Shares By Value Of All Prescription Pharmaceuticals For Selected Countries, 1998 And Projected To 2003
1 Geographic Shares Of Generic Drugs, 1998 And Projected For 2003
2 Worldwide Generic Market Share By Volume And By Value Of All Prescription Pharmaceuticals For Selected Countries, 1998 And Projected To 2003
3 Percent Of Selected International Prescription Pharmaceutical Markets Held By Generics, By Value, 1996 And Projected To 2003
4 Generic Drug Company Revenues: Worldwide, 1997
5 Selected Brand Name Pharmaceutical Firms And Their Generic Subsidiaries, 1998
6 Generic Drug Market By Therapeutic Category: U.S., 1996, 1997, 1998 And 2003
7 Growth In Prescription Unit Market Share Of Generic Drugs*, 1984 To 1997
8 U.S. Unit Market Share And Number Of Generic Drugs Manufactured, By Company, 1997
9 U.S. Andas Pending And Estimated Generic Product Launches, By Company In 1998
10 Manufacturing Capabilities Of Selected Generic Companies
11 Sales Representatives Marketing Generic And Branded Products, By Company, 1997 And Projected For 1998
12 Prescription Shares Of Leading Suppliers Of Generically Available Agents, U.S., 1997
13 U.S. Anda Approvals In 1997 And Projected Anda Filings And Generic Product Launches For 1998, By Company
14 Average Prescription Price Comparison Of Generic And Innovator Drugs, By Number Of Manufacturers, 1994
15 Average Retail Price And Market Share, By Type Of Drug, 1994
16 Average Percentage Change In Drug Prices Of All Pharmaceuticals, Branded Products, And Generic Products From 1996 To 1997
17 U.S. Market Share Percentage Of Prescriptions Held By Generics, 1986-1997
18 Percentage Of Pharmacists Who Are Reluctant To Substitute Generic Drugs, By Therapeutic Category, 1997
19 Percentage Of Pharmacists Who Prefer Originator's Brand, By Product, 1997
20 Decision-Making Among Pharmacists Regarding Dispensing Generic For Specific Drugs
21 Most Commonly Cited Problems With Generic Products
22 Percent Of Sales By Venue For Top-Selling Generic Versus Branded Products, By Chemical Entity, 1997
23 Average Duration Of Hatch-Waxman Extensions For Drugs Approved Between 1992 And 1995
24 FDA Orange Book Therapeutic Equivalence Rating Codes
25 U.S. Patent/Exclusivity Expiration Dates Of Major Pharmaceuticals And Estimated Sales, 1996-2003
26 1997 Sales And Projected Sales Of Branded Pharmaceuticals Losing U.S. Patent Protection, 1998-2003
27 Injectable Agents Losing U.S. Patent Protection From 1998-2002 And U.S. Sales In 1997
28 U.S. Sales Of Complex Drugs Available For Generic Competition, 1997
29 Generic Drug Market, By Therapeutic Category: U.S., 1996, 1997, 1998 And 2003
30 Generic Products With U.S. Retail Sales In Excess Of $100 Million, 1997
31 Generic Drugs Approved For The First Time In 1997
32 Estimated Worldwide Sales And Patent Expirations Of Leading Antiarthritic And Analgesic Agents
33 Market For Generic Antiarthritic And Analgesic Agents: U.S., 1996, 1997, 1998 And 2003
34 Forecast Of The Generic Market Share Of Antiarthritic And Analgesic Agents: U.S., 1998 And 2003
35 Estimated Worldwide Sales And Patent Expirations Of Leading Anticancer Agents
36 Market For Generic Anticancer Agents: U.S., 1996, 1997, 1998 And 2003
37 Forecast Of The Generic Market Share Of Anticancer Agents: U.S., 1998 And 2003
38 Market For Generic Anti-Infective Agents: U.S., 1996, 1997, 1998 And 2003
39 Estimates Of Generic Market Share Of Anti-Infective Drugs, By Category: U.S., 1996, 1997, 1998 And 2003
40 Estimated Worldwide Sales And Patent Expirations Of Leading Antibacterial Agents
41 Estimated Worldwide Sales And Patent Expirations Of Leading Antifungal Agents
42 Estimated Worldwide Sales And Patent Expirations Of Leading Antiviral Agents
43 Estimated Worldwide Sales And Patent Expirations Of Leading Biotechnology Drugs
44 Market For Generic Biotechnology Drugs: U.S., 1996, 1997, 1998 And 2003
45 Estimates Of Generic Market Share Of Biotechnology Drugs: U.S., 1998 And 2003
46 Market For Generic Cardiovascular Agents: U.S., 1996, 1997, 1998 And 2003
47 Estimates Of Generic Market Shares Of Cardiovascular Drugs, By Category: U.S., 1998 And 2003
48 Leading Cardiovascular Drugs, 1996 Sales, And Year Of U.S. Patent Expiration
49 Estimated Worldwide Sales And Patent Expirations Of Leading Adrenergic Inhibitors
50 Estimated Worldwide Sales And Patent Expirations Of Leading Ace Inhibitors
51 Estimated Worldwide Sales And Patent Expirations Of Leading Anticoagulant, Antiplatelet And Thrombolytic Agents
52 Estimated Worldwide Sales And Patent Expirations Of Leading Beta Blockers
53 Estimated Worldwide Sales And Patent Expirations Of Leading Calcium Channel Blockers
54 Estimated Worldwide Sales And Patent Expirations Of Leading Cholesterol-Reducing Agents
55 Estimated Worldwide Sales And Patent Expirations Of Leading Vasodilators
56 Estimated Worldwide Sales And Patent Expiration Of Leading Central Nervous System Agents
57 Market For Generic Central Nervous System Agents: U.S., 1996, 1997, 1998 And 2003
58 Forecast Of The Generic Market Share Of Central Nervous System Agents: U.S., 1998 And 2003
59 Estimated Worldwide Sales And Patent Expirations Of Leading Gastrointestinal Drugs
60 Market For Generic Gastrointestinal Agents: U.S., 1996, 1997, 1998 And 2003
61 Forecast Of The Generic Market Share Of Gastrointestinal Agents: U.S., 1998 And 2003
62 Estimated Worldwide Sales And Patent Expirations Of Leading Hormone Drugs
63 Market For Generic Hormones: U.S., 1996, 1997, 1998 And 2003
64 Forecast Of The Generic Market Share Of Hormones: U.S., 1998 And 2003
65 Estimated Worldwide Sales And Patent Expirations Of Leading Respiratory Drugs
66 Market For Generic Respiratory Agents: U.S., 1996, 1997, 1998 And 2003
67 Forecast Of The Generic Market Share Of Respiratory Agents: U.S., 1998 And 2003
68 Estimated Worldwide Sales And Patent Expirations Of Leading Drugs In Other Therapeutic Categories
69 Market For Other Generic Therapeutic Agents: U.S., 1996, 1997, 1998 And 2003
70 Forecast Of The Generic Market Share Of Other Therapeutic Agents: U.S., 1998 And 2003
71 Market For Generic Drugs: France, 1996, 1997, 1998 And 2003
72 Market For Generic Drugs: Germany, 1996, 1997, 1998 And 2003
73 Market For Generic Drugs: Italy, 1996, 1997, 1998 And 2003
74 Projected Share (By Value And Volume) Of Generics Within Total Molecular Entity Sales For Selected Agents Projected For 2001: Italy
75 Market For Generic Drugs: U.K., 1996, 1997, 1998 And 2003
76 Market For Generic Drugs: Canada, 1996, 1997, 1998 And 2003
77 Market For Generic Drugs: Japan, 1996, 1997, 1998 And 2003
78 Market For Generic Drugs: Russia, 1996, 1997, 1998 And 2003
79 The Top 10 Generics Companies By Advertising Expenditures, 1997
80 The Top 10 Generics Companies By Advertising Expenditures, 1996
81 Selected Generic And Branded Drug Firm Alliances
82 Generics Subsidiaries Of Brand-Name Pharmaceutical Companies
83 Products Manufactured And/Or Marketed By Duramed
84 Mylan Laboratories Revenue Forecast, 1997 Through 2000
85 Mylan's Product Pipeline
86 Schein's Percentage Of Net Revenues By Business Sector, 1995, 1996 And 1997

List Of Figures

Summary Figure: Worldwide Generic Market Shares By Value Of All Prescription Pharmaceuticals For Selected Countries, 1998 And Projected To 2003
1 Percent Of Selected International Prescription Pharmaceutical Markets Held By Generics, By Value, 1996 And Projected To 2003
2 Generic Drug Market By Therapeutic Category: U.S., 1996, 1997, 1998 And 2003
3 Growth In Prescription Unit Market Share Of Generic Drugs, 1984 To 1997
4 U.S. Unit Market Share And Number Of Generic Drugs Manufactured, By Company, 1997