Generics in the Animal Health Industry: Threats and opportunities

CONTENTS

CHAPTER 1 GENERICS IN THE ANIMAL HEALTH INDUSTRY

1.1 Introduction

1.2 History of generic pharmaceuticals

1.3 The generic age

1.4 Definition of generic products

1.5 The quality of generics

1.6 Generic company types

1.7 Generic representation

1.7.1 The European Group for Generic Veterinary Products

1.7.2 The US Generic Animal Drug Alliance

CHAPTER 2 PATENT ISSUES

2.1 The rationale behind patenting

2.2 Patent law

2.2.1 Patent application

2.2.1.1 The European procedure: the UK as a case study

2.2.1.2 The United States procedure

2.2.1.3 Patent protection in other countries

2.2.2 Global patent treaties

2.2.2.1 World Intellectual Property Organisation (WIPO)

2.2.2.2 Patent Co-operation Treaty (PCT)

2.2.2.3 Trade Related Aspects of Intellectual Property Rights (TRIPS)

2.2.3 Extension of patent protection

2.2.3.1 EU: Supplementary Protection Certificates

2.2.3.2 EU: additional protection from registration legislation

2.2.3.3 US: Hatch?Waxman legislation

2.2.4 Data protection

CHAPTER 3 REGISTERING A GENERIC ANIMAL HEALTH PRODUCT

3.1 Introduction

3.2 Registration in the EU

3.2.1 Pre-registration product development

3.2.2 Registration procedures

3.2.2.1 National procedures

3.2.2.2 Mutual recognition

3.2.2.3 Centralised procedure

3.2.3 Abridged applications for generics

3.2.4 Prescribing veterinary pharmaceuticals in the EU: the cascade principle

3.3 Registration in the US

3.3.1 Abbreviated New Animal Drug Applications

3.3.1.1 Requirements

3.3.1.2 Bioequivalence studies

3.3.2 Marketing exclusivity

3.4 Registration in other countries

3.4.1 Brazil

3.4.2 Argentina

3.4.3 Australia

3.4.4 China

3.4.5 India

CHAPTER 4 THE WORLD MARKET FOR GENERIC ANIMAL HEALTH PRODUCTS

4.1 Market size and market breakdowns

4.2 European Union

4.2.1 Cascade regulations

4.2.2 Parallel imports

4.2.3 National characteristics

4.2.3.1 France

4.2.3.2 Germany

4.2.3.3 Spain

4.2.3.4 UK

4.2.3.5 EU expansion

4.3 The US

4.3.1 Generic approvals

4.3.2 Extra-label use of veterinary products

4.4 Market prospects for the generic animal health industry

4.5 Trends and key issues

4.5.1 Driving forces

4.5.2 Generics exporting countries

4.5.3 Litigation

4.5.4 Life-cycle management

4.5.5 Parallel trade

CHAPTER 5 STRATEGIES FOR R&D-BASED COMPANIES

5.1 Introduction

5.2 Defending the patent

5.2.1 Extending the family of patents

5.2.2 Patenting and marketing related compounds

5.3 Developing the brand

5.3.1 Marketing and promotion

5.3.2 Adding value to the product

5.3.2.1 New formulations

5.3.2.2 New delivery methods

5.3.2.3 Combination products

5.3.3 Competing on price

5.3.3.1 Reducing production costs

5.4 Company-wide strategies

5.4.1 Rationalising the product portfolio

5.4.2 Becoming a generics manufacturer

CHAPTER 6 STRATEGIES FOR GENERICS COMPANIES

6.1 Introduction

6.2 Improving the image of the generics industry

6.3 Competing on price: under-cutting R&D competitors

6.4 Focusing on niche markets

6.5 Developing brands at the product and company level

6.6 Adding value to generics

6.7 Developing patented products

6.8 Distribution

6.9 Improved after-sales service

6.10 Selling human generics for veterinary use

6.11 Out-licensing and in-licensing

6.12 Contracting for R&D companies

CHAPTER 7 CASE STUDIES

7.1 Ancare

7.2 Bayer

7.3 Ceva

7.4 Eurovet

7.5 Ivy Laboratories

7.6 Merial

7.7 Norbrook

7.8 Phoenix Scientific

7.9 Vetoquinol

7.10 Virbac

CHAPTER 8 FUTURE TRENDS IN THE ANIMAL HEALTH GENERICS INDUSTRY

8.1 Generics market share to rise

8.2 The rise of emerging market generics companies

8.3 Distinctions blur between generics producers and R&D companies

8.4 Harmonisation ? Steady as she goes

8.5 Future generic animal health products

8.6 Biotech generics

8.7 Added value generics

APPENDIX A USEFUL CONTACTS

APPENDIX B WIPO AND ITS MEMBERS

APPENDIX C DRUGS USED IN BOTH HUMAN AND VETERINARY MEDICINE

LIST OF TABLES

Table 1.1 Product competition in the UK market (selected, off-patent products)

Table 1.2 Product competition in the US market (selected, off-patent products)

Table 1.3 Example of the nomenclature of a veterinary drug

Table 4.1 World animal health and nutrition market structure by major product sector, 2002

Table 4.2 Geography of the world animal health and nutrition market, 2002

Table 4.3 Generic animal health products sales, $ billion, 2002-2010

Table 4.4 Generic animal health products by region, 2002

Table 4.5 Global animal health sales and generic share of market, 2002

Table 4.6 Global generic animal health products, market breakdown by sector, 2002

Table 4.7 Global veterinary pharmaceuticals markets: total and generic shares, 2002

Table 4.8 Examples of recent generic approvals, US

Table 5.1 Long-acting generic versions of antibacterials

Table 6.1 Price/volume relationship ? The decrease in volume sales that maintains profits at a given growth margin when prices are increased

Table 6.2 Price/volume relationship ? The increase in volume sales required to maintain profits when prices are decreased

Table 7.1 Summary of case studies

Table 7.2 Ceva: geographical expansion through acquisition

Table 7.3 Merial' s leading formulations of ivermectin

Table 8.1 Classification of animal health companies