Generics Surge the Market Save

Generics are being approved at a record-setting pace. Thanks to the 2012 FDA Safety and Innovation Act, there are new funds generated by manufacturers' fees for drug applications to hasten the approval of generics. 

Prior to 2012, there were 2,866 “backlogged” applications pending FDA approval. Since, 84% have been acted upon and 609 have been approved. In 2015 alone, the FDA has approved 580 generic drugs – the highest number on record – while another 146 were granted tentative approval. This growth is partly due to legislation and also the number of drug patents due to expire.

Generics make up about 90% of prescriptions in the US, a market share that has grown steadily since 1984 Hatch Waxman Act fostering generics for the public. Faster approval of generics, in general, carries less safety risk compared to new drug development. 

Since January 2016 new approvals have been granted for generic versions of Savella, Crestor, to name a few.