Generic Animal Health Products: 2nd Edition

Products

Generic Animal Health Products: 2nd Edition provides you with an essential guide to survival in today's ruthlessly competitive animal health market.

The report analyses the impact of generics and the strategies that companies must consider to maximise their products' lifecycles in the face of increasing competition. It provides you with all the information that you need to maintain your competitive advantage and remain one step ahead.

Written from a strategic marketing perspective, this report provides you with a practical examination and explanation of:

PUBLISHED: MARCH 2000
REF: SR190E
PAGES: 90
PRICE: £395/$830/¥95,000

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CONTENTS
LIST OF TABLES
LIST OF FIGURES
EXECUTIVE SUMMARY
ABBREVIATIONS


CHAPTER 1 GENERICS AND PATENTS IN THE ANIMAL HEALTH INDUSTRY
1.1 What is a generic?
1.2 Patents
1.2.1 Why patent a product?
1.2.2 Applying for a patent
1.2.3 General procedures and definitions
1.2.3.1 Initial filing - establishing 'priority'
1.2.3.2 'Convention year'
1.2.3.3 'Completion' or 'substantive application'
1.2.3.4 Publication
1.2.3.5 'Prosecution'
1.2.4 Differences between the United Kingdom and other European Patent Convention states
1.2.5 The European Union's Supplementary Protection Certificate
1.2.6 The United States procedure
1.2.7 Patent protection in other countries
1.3 Intellectual Property and Trade Related Aspects of Intellectual Property Rights
1.3.1 World Trade Organisation, Trade Related Aspects of Intellectual Property Rights and the World Intellectual Property Organisation
1.3.2 Patent Co-operation Treaty
1.3.3 The need for speed, accuracy and knowledge
1.3.4 Data protection/data exclusivity
1.4 The struggle by R&D manufacturers to retain market share
1.4.1 Commercial considerations


CHAPTER 2 SURVIVAL OF A PATENTED PRODUCT
2.1 Introduction
2.2 Promoting the brand name of a patented product
2.3 Patenting and marketing related compounds
2.4 How new delivery systems can prolong patent life
2.4.1 Pour-on and spot-on delivery systems
2.4.2 Dermal treatments for companion animals
2.4.3 Slow-release bolus delivery
2.4.4 Implants
2.4.5 Long-acting formulations
2.5 Added value
2.5.1 Selenium and cobalt
2.5.2 Combination products
2.6 Other tactics to maintain success beyond patent expiry
2.6.1 Changing to another manufacturer
2.6.2 Extending the family of patents
2.6.3 Showing that the original product and generic copies are not equivalent
2.6.4 Raising technical standards
2.6.5 Cutting prices to keep out generics
2.6.6 Using another company to market products
2.6.7 Altering the distribution chain by changing the product's regulatory status
2.6.8 Revamping the package
2.7 Putting together a strategy
2.8 Alternative strategies
2.8.1 Rationalising the range
2.8.2 Becoming a generics manufacturer
2.8.3 Screening human drugs and agrochemicals for veterinary uses


CHAPTER 3 THE GENERIC AGE
3.1 Introduction
3.2 The prevalence of generics
3.2.1 The European cascade principle
3.3 Attitudes to generics
3.4 Generic representation
3.4.1 The United States Generic Animal Drug Alliance
3.4.2 The European Generic Medicines Association
3.5 Protecting the national industry
3.6 The quality of generics
3.7 Generic competition
3.8 Generic company types


CHAPTER 4 REGISTERING A GENERIC ANIMAL PRODUCT
4.1 Introduction
4.2 Registration of generics in the United States
4.2.1 Abbreviated New Animal Drug Application
4.2.2 Submitting the Abbreviated New Animal Drug Application
4.2.3 Products eligible to be copied as generics
4.2.4 The Generic Animal Health Drug and Patent Term Restoration Act and marketing exclusivity
4.2.5 Information required in an Abbreviated New Animal Drug Application
4.2.6 Performing a bioequivalence study
4.2.7 Requesting a waiver from in vivo bioequivalence studies
4.2.8 Suitability Petitions
4.2.9 Time taken for approval to market a generic in the United States
4.3 Registration in Europe
4.3.1 Registration in the United Kingdom
4.4 Registration in other countries
4.4.1 Brazil
4.4.2 Argentina
4.4.3 Australia
4.4.4 India
4.5 How to help ensure registration worldwide


CHAPTER 5 MARKETING A GENERIC
5.1 Introduction
5.2 Improving the public image of the generics industry
5.3 Formulating veterinary generics
5.4 Manufacturing a variety of generic veterinary pharmaceuticals
5.5 Marketing generic products
5.5.1 Selling and distribution
5.5.2 Key account selling
5.5.3 Marketing/selling human or agrochemical generics for veterinary use
5.5.4 Working in partnership with a generics formulator
5.5.5 Consultancy - a means to marketing success
5.5.6 Adding value and after-sales support
5.6 Pricing
5.6.1 Devaluing the market
5.6.2 Pricing strategies


CHAPTER 6 GENERIC MARKETING CASE STUDIES
6.1 AgriLabs
6.1.1 Overview
6.1.2 Case study
6.1.2.1 Sulphur drugs
6.2 Ancare
6.2.1 Overview
6.2.2 Case study
6.2.2.1 Ivermectin
6.2.2.2 Fenbendazole
6.2.2.3 Pricing
6.2.2.4 Anthelmintic market
6.3 Ivy Laboratories
6.3.1 Overview
6.3.2 Case study
6.3.2.1 Strategy changes
6.3.2.2 The 'Benchmark' programme
6.4 Merck and Merial
6.4.1 Overview
6.4.2 Case study
6.4.2.1 Ivermectin
6.5 Norbrook
6.5.1 Overview
6.5.2 Case study
6.5.2.1 Research and development
6.5.2.2 Licensing
6.5.2.3 Internal investment


CHAPTER 7 GENERIC ISSUES IN EUROPE
7.1 Introduction
7.2 The European Union
7.2.1 Supplementary Protection Certificates
7.2.2 Cascade regulations
7.2.3 Europe's grey and black markets
7.3 National peculiarities
7.3.1 France
7.3.2 Germany
7.3.3 Spain
7.4 Central and Eastern Europe


CHAPTER 8 GENERIC ISSUES IN THE UNITED STATES
8.1 Introduction
8.2 Generic approvals
8.2.1 The 180-day generic drug exclusivity provision
8.3 Human generics and extra-label use of veterinary products
8.4 The United States Animal Drug Alliance and industry concerns


CHAPTER 9 THE MARKET FOR GENERIC PRODUCTS
9.1 Introduction
9.2 The world market
9.3 The prevalence of generics
9.4 Market prospects for the generic animal health industry


APPENDIX A
REFERENCES

LIST OF TABLES
Table 1.1 Example of a veterinary medicine

Table 2.1 Merial's ivermectin-based product range registered in the United States and patent expiry

Table 3.1 Product competition in the United Kingdom cattle endoparasiticide market
Table 3.2 Product competition in the United States cattle endoparasiticide market

Table 5.1 Drugs used in both human and veterinary medicine
Table 5.2 Agricultural chemicals also used in veterinary medicine
Table 5.3 Price/volume relationships - the effect of reducing prices (percentage increase in sales required)
Table 5.4 Price/volume relationships - the effect of increasing prices (percentage decrease in sales allowed)

Table 6.1 Case studies in this chapter

Table 8.1 Recent United States generic drug approvals
Table 8.2 Recent United States suitability petitions submitted for potential generic drug approvals

Table 9.1 World sales by product category, 1998
Table 9.2 Regional differences in percentage market share by species, 1998
Table 9.3 Branded/generic shares of leading active substances, 1998

LIST OF FIGURES
Figure 9.1 Geography of the world market, 1998


EXECUTIVE SUMMARY
Generic animal health products are becoming an increasingly important contributor to the animal health market. Once a patent has expired, a product is open to generic competition and new generic products. However, this does not create a free-for-all market as many vital issues exist that must first be evaluated while considering when and how to enter the animal health generics arena. This report discusses these issues and the strategies that may be employed to improve the market potential for new generic entries. The defensive strategies of research and development-based companies are also analysed.

Generic products have long played a significant role in the antibiotics market, but with continued pressure to address resistance issues this area of veterinary medicine has become less attractive to manufacturers. In the antiparasitics market, however, several key products have in the last decade reached the end of their patented life. Antiparasitics are now an extremely valuable sector for the generic products industry.


. . . brand loyalty
As patents for high-selling branded products approach expiry, research and development-based companies must consider the options available to them in the face of stiff competition from the generics sector. Companies need to protect their market share through brand loyalty or purchasing incentives. Brand loyalty is doubly important today, as fewer new products are reaching the marketplace and maintaining a high revenue stream.


. . . maximising older products
As a result of lower revenue streams, both generics and research and development companies will have to rely more on maximising their sales of older products. The key issue is to move these products forward. Swamping the market with direct copies and cutting prices eventually leads to a reduction in sales value and ultimately a 'no win' situation. Generics companies need to adopt a two-fold approach: firstly, improving upon the original and bringing added value to the product through, for example, better formulations or delivery technique. Secondly, the research and development-based companies need to continually seek new indications for their active substances and extend the family of patents held on the molecules, their manufacturing process and/or their formulation. In this way the life of the brand is extended.


. . . promotion
The actual promotion of a brand is as important as the range that is available under the brand name. The brand name must conjure up an image of quality, reliable products. Unfortunately, the old adage of 'mud sticks' is only too true, and a bad image could also be associated with the brand. Company image and reputation is therefore paramount, whether one is a manufacturer of blockbuster brands or of long-established generics. Promoting the image is not a static process, it must be continual; customers will like to see support, a friendly and knowledgeable representative as well as prompt supply of attractively priced products.


. . . regulations
Research and development companies have lobbied regulatory authorities to bring national patent protection into line with the requirements laid down by the World Trade Organisation. Most countries have, or are in the process of, modernising their legislation to provide a standard 20-years patent term for innovative products. Twenty years may seem like a long time, but once the product has been fully developed and has been granted a marketing authorisation, the effective patent will have been considerably eroded.


Addressing this situation, many countries have introduced new legislation that provides for patent extensions so that the research and development company is able to enjoy sufficient time on the market, unchallenged by generics competitors. In the European Union the extension is provided through Supplementary Protection Certificates, while in the United States it was introduced through the enactment of the Generic Animal Drug and Patent Term Restoration Act. However, this Act also sought to protect the market from an onslaught of generics following patent expiry through the 180-day generic drug exclusivity provision. The 180-day exclusivity ensures that the generics drug manufacturer also has the opportunity to maximise the new product's potential without facing challenges from competitors within the allocated time-period. The Act dictates that no other generics may be approved for the same claims within 180 days after the approval of the first.


Another change in legislation that is being sought is an improvement in the level of data protection provided by European Union patents. At present, any new data that is generated or requested, as is often the case for establishing a maximum residue level or assessing environmental impact, will not itself enjoy patent protection beyond the expiry of the patent for the product for which it is submitted. Research and development companies argue that this is increasing their costs and that the fruits of their labour are not being recognised in terms of financial return. Some argue that the provision works in favour of the generics industry since generics companies are able to use the data without having to go to the expense of generating it.


. . . human-product generics companies versus animal-product generics companies
In the human sector, the distinction between brand and generics companies is being redefined. Generics companies are increasingly developing orphan drugs and traditional pioneer companies are supplementing their portfolios with generic ranges. This trend is being reflected in the veterinary industry; an example is Boehringer Ingelheim Animal Health. As a result of market pressures, the dearth of new products entering the veterinary arena and the increasing sophistication of today's generics companies, generics are set to play an increasingly important role in the world market of animal health products.

© PJB Publications Ltd. 2000
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