Pharmabiz
 

THREAT OF AUTHORISED GENERICS

P A FrancisWednesday, March 14, 2007, 08:00 Hrs  [IST]

Global pharmaceutical giants are increasingly getting desperate with intense generic competition and worsening pipeline crisis. Top companies like Pfizer, GSK, Merck, Novartis and others are struggling to obtain new blockbusters for some years now. That makes these companies to cling on to the monopoly of their patented drugs by resorting to what is known as licensing of authorized generics. Authorized generics are same drug formulations of patented products launched by innovator pharmaceutical companies six months before the expiry of the patent. Brand companies are resorting to this strategy to kill the opportunity of the generic companies who have been usually getting the 180 days market exclusivity with the expiry of a patent. By getting into the market of 180 days exclusive marketing period of the first generic company, what the brand companies are doing is maximizing their profits for another six months. The price of authorized generics is not much lower than the branded products unlike what is offered by generic companies during the 180 days. Pfizer has already launched authorized versions of Zoloft and other blockbuster drugs since 2003. An authorized generic is also being launched through a subsidiary company of the innovator or by tying up with another outfit. The recent case of Merck authorizing Dr Reddy's to manufacture and sell cholesterol lowering drug, Zocor, is a case in point. The impact of such launches of authorized generics is certainly hitting generic players quite badly. And the worst scenario emerges when a host of generic players enter the market after the 180 days period. Margins in generics are already under pressure in the US and to some extend in the European markets. It is important for the generic industry and the patient community to pressurize the governments of the developed world to disallow the practice of launching authorized generics. A move, in this context, is on in the US congress to ban the launch of authorized generics during the 180 days exclusivity period. The move is considered significant now when a large number of blockbuster drugs are expected to lose their patents very soon. During the period from 2007 to 2011, at least 50 major drugs will see the expiry of patent protection in the US which is at the rate of more than ten an year. With 2005 seeing a decline in the number of new molecules approved down to 18 from 23 in 2004, there is a definite indication that the loss of revenue from patented drugs will seriously impact the growth of the global pharmaceutical industry. It is quite likely that generics during the four-year period from 2007 to 2011 could threaten $100 billion in revenues generated in the United States and Europe. And the most dramatic change will happen between 2010 to 2012 when the patents covering Lipitor expire. Of course, the loss of revenues to generic companies is going to be a major threat to the financial status of ethical R&D companies. And one obvious option for them in protecting the bottomline is to get into generic business on fair terms by exploiting the opportunities afforded by patent expirations.

 
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