Blocking generics by adding a second score

A Wall Street Journal article (Oct 6, 2011) describes a decision by the firm Warner Chilcott, which sells tables for its drug Doryx, which was scheduled to go off patent, to add a second score on the tablet so it can be divided into thirds.  As a result, generics planning to sell the original tablet, which could be divided into halves, could be asked by the FDA to match the tablet, as per the company’s request. The delay may enable the firm to retain its monopoly of the $ 3000 per 180 count bottle market for severe acne.  Should cosmetic changes that do not impact the chemical composition be permitted to be used to block generics ? If dosage is the constraint, should nonscoring packaging solutions that enable dosage control be considered equivalent by the FDA ? What supply chain strategies by the patent holder should be accepted as reasonable in their attempts to deter competition for off patent drugs ?

About aviyer2010

Professor
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