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 As drug patents expire on small molecule and biological compounds, the originators of these drugs lose the exclusive right (a patent conferred by law) to make and market that drug, thus opening the possibility for competitors to sell the same product either under its chemical generic name or under the competitor's own, newly-invented brand name. In recent years, a number of high-profile drugs such as Glaxo's Zantac (ranitidine) and Eli Lillyâs Prozac (Fluoxetine) have come to the end of their patent lives, creating considerable marketing and financial opportunities for generic drug competitors. Thus, the Generic (GX) Drug Industry has boomed, accounting for approximately $11.1 billion in revenues worldwide last year. Furthermore, total ethically prescribed drugs with current total US revenues of a further $40 billion will be coming off patent in the next five years. Many Generic Drug companies have taken advantage of new drug delivery technologies to offer so-called "Super GX" products with, for example, slow release capabilities -- thereby differentiating their generic product from others and achieving premium pricing. Another feature of the Generic Drug Industry is the rise of companies producing single-isomer (chiral) versions of drugs coming off patent, in many cases achieving a new patented product with similar (or greater) therapeutic efficacy than the original (racemic) drug, together with reduced or eliminated side-effects. On the horizon are biogenerics, along with their special set of manufacturing, clinical and regulatory problems. FPG has made a particular specialty of the GX industry, having advised on a number of transactions that have occurred within this sector. The major pharmaceutical companies have had to choose either to build up a GX capability or else consciously to de-emphasize that field. Hence, FPG has been in a very good position to offer transactional and strategic advice based on its knowledge of the GX orientation of the major pharma companies as well as its awareness of most of the new entrepreneurial GX companies that have come into being and flourished in the US, Europe and elsewhere (such as Eastern Europe, India and Israel). FPG covers these elements of the global GX sector: > Independent GX Companies > "Super GX" Companies (featuring Drug Delivery Technologies) > Chiral Companies (Single Isomer, Metabolites) > Major Pharmaceutical Companies with GX Capabilities > Biogenerics Companies |
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