Authorized Generics Agreements to Increase

The number of authorized generics (AG) agreements is likely to grow as pharma continues to converge with generics companies, a new report from Datamonitor claims. AG agreements are considered more ‘potent’ in the US market because market exclusivity is awarded to first-to-file generics companies, but detractors among the generics-producing community consider them an ‘irritant’ and have called the US 180-day market exclusivity ruling as anti-competitive.

Datamonitor analyzed 40 AG launches in the US between 2004 and 2008 and found that nearly half (45%) came from only a third of the 14 branded pharma companies under investigation. Cardiovascular (CVD), infectious disease (ID), and central nervous system (CNS) disorder classes were collectively responsible for most (60%) of the AG launches; these three therapy areas represent the top three classes in terms of pre-generic quarterly sales in the US, with an average peak AG market share ranging from 43 percent for CNS brands to 50 percent for ID brands.

Datamonitor healthcare strategy analyst Pam Narang commented: “Although the issue of AGs has come under scrutiny across the board, there have yet to be any definitive conclusions regarding their anticompetitive nature.”