動物医療業界におけるジェネリック薬

Abstract

Overview:

This report examines the latest developments in the animal health industry relating to 'generics' - the term traditionally used to differentiate non-proprietary drugs from the original, branded versions.

Since the first emergence of generics in the veterinary sector there has been a significant change in the way manufacturers handle their business. Today, there are both local and international manufacturers selling large quantities of inexpensive, quality products... so, what does the future hold for this important, but controversial sector?

This report examines in detail the future prospects for this area and provides useful case studies, which profile today's market leaders.

Table of Contents

ABBREVIATIONS

CHAPTER 1 GENERICS IN THE ANIMAL HEALTH INDUSTRY

• 1.1 I ntroduction
• 1.2 Definitions
• 1.3 Com pany types
  • 1.3.1 I ndustry representation
  • 1.3.2 The European Group for Generic Veterinary Products
  • 1.3.3 The US Animal Drug Alliance

CHAPTER 2 PATENT ISSUES

• 2.1 Reasons for patent protection
• 2.2 Patent protection law
  • 2.2.1 National and reg ional procedures
    • 2.2.1.1 Europe
    • 2.2.1.2 The United States
    • 2.2.1.3 Patent protection in other countries
      • South Am erica
      • Eastern Europe
      • China
      • I ndia
      • Australia
    • 2.2.2 I nternational ag reem ents
    • 2.2.2.1 W orld I ntellectual Property Org anization
    • 2.2.2.2 Patent Co-operation Treaty
    • 2.2.2.3 Trade Related Aspects of I ntellectual Property Rig hts 30
  • 2.2.3 Extension of patent protection
    • 2.2.3.1 EU: Supplem entary Protection Certificates
    • 2.2.3.2 US: Hatch-W axm an leg islation
  • 2.2.4 Data protection
  • 2.2.5 Experim ental Use exceptio

CHAPTER 3 REGISTER IN GAGENERIC ANIMAL HEALTH PRODUCT

• 3.1 Reg istration in Europe
  • 3.1.1 Leg al backg round
  • 3.1.2 Abridg ed applications for generics
  • 3.1.3 Reg istration procedures
    • 3.1.3.1 National procedures
    • 3.1.3.2 Mutual recog nition
    • 3.1.3.3 Centralized procedure
  • 3.1.4 EU accession countries: transitory provisions
• 3.2 Reg istration in the US
  • 3.2.1 Abbreviated New Anim al Drug Application
    • 3.2.1.1 Marketing exclusivity
    • 3.2.1.2 Requirem ents
    • 3.2.1.3 Bioequivalence studies
• 3.3 Reg istration in other countries
  • 3.3.1 Australia
  • 3.3.2 Brazil
  • 3.3.3 Canada
  • 3.3.4 China
  • 3.3.5 I ndia

CHAPTER 4 THE WORLD MARKET FOR GENERIC ANIMAL HEALTH PRODUCTS

• 4.1 Key issues and driving forces
• 4.2 Market size and breakdow ns
• 4.3 European Union
  • 4.3.1 Cascade reg ulations
  • 4.3.2 Parallel im ports
  • 4.3.3 National particularities
    • 4.3.3.1 France
    • 4.3.3.2 Germ any
    • 4.3.3.3 Spain
    • 4.3.3.4 UK
• 4.4 The US
  • 4.4.1 Generic approvals
  • 4.4.2 Extra-label use of veterinary products
  • 4.4.3 The US m arket for generics
• 4.5 Generics exporter countries
  • 4.5.1 China

CHAPTER 5 SURVEY OF STRATEGIC ISSUES FOR ANIMAL HEALTH COMPANIES

• 5.1 What is your company type?
• 5.2 What size is the company you w ork for?
• 5.3 W here does your company m arket and distribute its products?
• 5.4 On what percentage of your comapany's product range? hold at least one currently valid patent or one licence from a patent holder?
• 5.5 What is the largest segment of your comapan's product range?
• 5.6 In your view , over the next 5-10 years, w hich products or product sector w ill be m ost affected by the launch of new generic products?
• 5.7 In 2005 generics accounted for about 46% of world animal health sales, ie $7.2 billion out of total sales of $16.1 billion.By 2010 what do you think this percentag e figure will be?
• 5.8 What is your view of current patent protection leg islation in your key m arkets?
• 5.9 What changes w ould you m ake to patent protection leg islation if it were your responsibility?
• 5.10 What is your opinion of current abbreviated application rules for generic products in your keys m arkets?
• 5.11 What chang es w ould you m ake to abbreviated application rules if it w ere your responsibility?
• 5.12 Does your company conduct any form al R& D?
• 5.13 What inform ation sources does your company use to identify veterinary pharm aceuticals that are newly off-patent, or are coming off-patent in the near future, and can therefore be manufactured and sold as generics?
• 5.14 What strateg ies does your company use to com pete w ith other generics products and R& D-based com panies?
• 5.15 I s your company currently m aking use of the US Bolar provision or sim ilar European provision to conduct developm ent w ork on a generic version of a product w hose patent has not yet expired?
• 5.16 What strateg ies does your company use to com pete w ith generics com panies w hen the patent on your ow n products in running out?
• 5.17 Do you feel that hum an pharm aceutical com panies do a better job of defending their off-patent drug s than veterinary pharm aceutical companies?
• 5.18 Do you believe that I FAH, I FAH-Europe and the AHI do enough to m anufacturers?

CHAPTER 6 STRATEGIES FOR R&D-BASED COMPANIES

• 6.1 Defending or opposing
• 6.2 Life-cycle m anag em ent
• 6.3 Prolong ing the life of patents
  • 6.3.1 Extending the fam ily of patents
  • 6.3.2 Patenting and m arketing related com pounds
• 6.4 Prom oting the brand name of the product
• 6.5 Adding value to the product
  • 6.5.1 Drug delivery
    • 6.5.1.1 Long -acting formulations
    • 6.5.1.2 Adding m inerals
  • 6.5.2 New delivery m ethods
    • 6.5.2.1 Pour-on and spot-on delivery systems
    • 6.5.2.2 Derm al treatm ents for companion animals
    • 6.5.2.3 Slow -release bolus delivery
    • 6.5.2.4 I m plants
  • 6.5.3 Com bination products
• 6.6 Com peting on price
  • 6.6.1 Cutting prices to keep out generics
• 6.7 Com peting on quality
• 6.8 Other m eans to defend ag eing products
  • 6.8.1 Chang ing m anufacturers
  • 6.8.2 Dem onstrating superiority
• 6.9 Alternative strateg ies
  • 6.9.1 Rationalizing the range
  • 6.9.2 Becom ing a generics m anufacturer
• 6.10 Parallel trade and its effect on generics

CHAPTER 7 STRATEGIES FOR GENERICS COMPANIES

• 7.1 I m proving the im ag e of the generics industry
• 7.2 Form ulating veterinary generics
• 7.3 Marketing options for generics com panies
  • 7.3.1 Pricing
  • 7.3.2 Generic m arket niches
  • 7.3.3 'Branded generics'
  • 7.3.4 Distribution
  • 7.3.5 Key account selling
  • 7.3.6 Selling hum an generics for veterinary use
  • 7.3.7 Out-licensing
  • 7.3.8 Cooperate w ith R&D com panies

CHAPTER 8 CASE STUDIES

• 8.1 Ancare
• 8.2 Bayer
• 8.3 Bimeda
• 8.4 Ceva
• 8.5 Elanco
• 8.6 Esteve
• 8.7 Eurovet
• 8.8 Farnam
• 8.9 Fort Dodge
• 8.10 I ntervet
• 8.11 I VX Anim al Health
• 8.12 I vy Anim al Health
• 8.13 Merial
• 8.14 Norbrook
• 8.15 Novartis
• 8.16 Pfizer
• 8.17 Schering -Ploug h
• 8.18 Vetoquinol
• 8.19 Virbac

CHAPTER 9 FUTURE TRENDS IN THE ANIMAL HEALTH GENERICS INDUSTRY

• 9.1 Outlook
• 9.2 Future developm ent of the m arket
  • 9.2.1 Merg er of generics producers and R& D com panies
  • 9.2.2 Defining generics
• 9.3 Trends in generics activity
  • 9.3.1 Generics-changes in direction
  • 9.3.2 Grow th in product availability
  • 9.3.3 Super generics
  • 9.3.4 Driving forces in the future
  • 9.3.5 Shift of em phasis
  • 9.3.6 New areas for developm ent

APPENDIX A USEFUL CONTACTS

APPENDIX BDRUGS USED IN BOTH HUMAN AND VETERINARYM EDICINE