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US and European Prescription Generic Markets: An Examination of Commercial and Regulatory Contrasts

Arrowhead Publishers, Sep 2005


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The US generics market was estimated at US$18.1 billion in 2004; the leading European generics markets together totalled between US$10–US$11 billion for the same period. This new report asks why there is such a difference in value?

Contrasts in regulatory systems, legislative background and market characteristics increase the difficulties for companies from one area who are trying to enter another market. US and European Prescription Generic Markets reviews these divergent characteristics and also looks at those areas where the two sides are moving closer together.

One major finding that emerges from this analysis is the surprising absence of the majority of US domestic generic companies from overseas markets. The report contrasts this with the increasing presence of foreign generic companies in the US, looks at where these new competitors have come from and assesses how much of a threat they represent to the major US companies.

US and European Prescription Generic Markets provides an in-depth examination of:

- Successful generic growth strategies and how they vary
- Defensive tactics of the multinationals
- Generic industry growth prospects and possible threats
- A history of the generic markets
- The legislative and regulatory background
- How differences between the US and European markets have developed
- Who are the major players and how they rose to the top

Who should buy this report?

- Generic companies interested in understanding the opportunities and challenges in the American and European markets.

- Pharma/biotech companies with branded products in these markets, in order to identify threats and learn of defense strategies.

- For US companies considering a venture into Europe, it is an invaluable tool for formulating a suitable strategy.

- For European or other non-US companies that are looking at opportunities in the US, the report provides a concise summary of the legal, regulatory and commercial issues that they will need to address.

About the Author

Peter Wittner is an independent pharmaceutical marketing consultant who has been in the pharmaceutical industry for over 30 years. Out of this, more than half has been in the area of generics.

Peter has a Bachelor of Science degree in chemistry and has worked in commercial and marketing roles for companies such as Roussel and Hoechst (now Aventis) at the European level. Later he worked for the former Evans Medical generic business following its MBO from Glaxo and then Norton Pharmaceuticals (now part of IVAX) where he was responsible for European Sales & Marketing. After leaving Norton, Peter set up his own consultancy in 1993 and operated independently until 1996 when he joined the Indian company Ranbaxy to set up the infrastructure of their new UK subsidiary and spent two years with them.

For the last 7 years, he has reverted to doing consultancy work, specialising in the field of generics. His company (Interpharm Consultancy) provides market information, access to new generic products and helps market entrants to develop their generic strategy.




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