From Evernote:

Drug Pharma ‘Strategy’ (study): Keep launching new drugs and sue generics to buy time to build your market

Clipped from:

Marketing and Production Strategy

The researchers discuss how Abbott’s successful market dominance can be attributed to 2 factors. The first is the sequential launch of branded reformulations that differed subtly in dose and used only bioequivalence data in their new drug application (NDA) to demonstrate that the new dose had the same pharmacological properties as the original formulation. These reformulated products showed no improvement in surrogate markers or patient outcomes. The slightly different formulation also made substitution with older generic formulations impossible.

The second strategy employed by Abbott, note the study authors, involved taking advantage of current US Food and Drug Administration (FDA) policy. Once a generic drug maker filed an abbreviated NDA (ANDA) and challenged a patent used by Abbott for their branded fenofibrate product, Abbott would respond with a patent infringement lawsuit. By law, the FDA requires a 30-month delay before the approval of an ANDA to allow litigation to be resolved. The researchers discuss how Abbott would then use this time to produce and market their next-generation product before the generic version of the previous-generation drug could be approved. Lacking the extensive sales force of major pharmaceutical companies, generic drug makers could not compete.

Abbott Laboratories has been the target of multiple lawsuits as a result of this marketing strategy. A class action suit on behalf of all pharmacies and wholesalers that purchased branded fenofibrate products was filed in 2005 by the Louisiana Wholesale Drug Company, and various patients and states have also filed antitrust lawsuits against Abbott. All of these lawsuits were ultimately settled out of court and cost Abbott $300 million, a figure that amounts to less than 4% of total sales to date of their fibrate franchise, according to Downing and colleagues.


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