Competitive Pressure for First-in-Class Drugs is Intensifying


Applied Clinical Trials

Applied Clinical TrialsApplied Clinical Trials-02-01-2016
Volume 25
Issue 2

Study shows sharp reduction in market exclusivity periods for first-in-class treatment entrants.

Competition between drugs within a given class has intensified, according to a new study recently published by the Tufts Center for the Study of Drug Development (Tufts CSDD). Newly approved first-in-class prescription drugs face substantially shorter periods of exclusivity within which to recoup the high and rising cost of drug development.

Tufts CSDD reviewed 40 multiple-entrant pharmacologic classes that produced 108 new drug approvals in which the first-in-class agent received approval between 1998 and 2011. Comparing market exclusivity periods for drugs approved between 1998-2004 and those approved between 2005-2011, the results show a 51% reduction in the median time-from 4.7 years down to 2.3 years-from when the first-in-class drug was approved to when the first competitor entered the market. Three-out-of-four second entrants in a given drug class were approved within 3.7 years and 25% were approved in less than six months. Tufts CSDD also found that nearly half (49%) of the 40 classes examined eventually had three or more competitors. 

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