13 December 2018 - The paper by Beall and colleagues relates to the development and testing of a method for approximating generic entry of top-selling drugs.

The procedure involved 1) identifying products’ key patents as those with a patent term restoration extension (whenever relevant) or otherwise as the first expiring patent listed in the US Food and Drug Administration’s patent register, 2) determining whether the key patent had been extended through an associated paediatric extension, 3) identifying other regulatory exclusivities associated with the drug, and 4) categorising key patents as active ingredient (or extended) patents versus secondary patents. 

The accuracy and precision of the procedure’s predictions were then tested against a database containing the timing of generic entry for 170 top-selling drugs that lost market exclusivity between 2000 and 2012, on the basis of Medicaid data.

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