Monday, June 23, 2008


The New York Times ( 19th June ), has just reported that Pfizer ( USA ) has settled her lipitor patency dispute with Ranbaxy in USA. The patency, which was due to expire in 2010 has now been pushed to 2011, meaning that Ranbaxy will not be marketing her generic Lipitor in USA until Nov 2011. As part of the settlement, Pfizer has agreed to allow Ranbaxy to sell her generic Lipitor in ASEAN countries unchallenged. Pfizer's atorvastatin, is in crystalline form. The atorvastatin that Ranbaxy manufactures is in the amorphous form. Well, in a way, this is good news as we should see the cost of Lipitor come down and generic lipitor ( Ranbaxy ) which will cost a fraction of Lipitor. So more patients can afford to take it. Ranbaxy has proven to be one of the better international generic companies and I am quite sure that the Lipitor from Ranbaxy would be almost Lipitor standard. There is however, always the nagging question of lack of medical clinical evidence on "amorphous atorvastatin ". Apparently, this patency settlement also involves Pfizer's fixed combo pill Caduet ( amlodipine + atorvastatin ). So it is really a big settlement. I wonder, who is the winner? Interestingly, the same issue of NY Times also reported that FDA has asked MSD, not to re-apply for the approval of Coradaptive ( combination of Naicin-lapropitrant ) until 2013, when their large trial of Heart Protection study 2, results become available. Coradaptive, is the HDL-C raiser without much flushing, which was not approved the last time ( read earlier posting ). Reading between the lines, it appears that MSD has upset FDA bigtime.

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