Five (5) & Ten (10) Year Data Exclusivity for New Drugs – When To File Generic Drug Applications
Brand pharma companies invest valuable resources, time, and money in moving drugs from development to FDA approval. The new drug approval may also enjoy some type of FDA exclusivity. Typically, FDA exclusivity falls into two types: (1) data exclusivity; and (2) approval/market exclusivity, both of which are known in the industry but not defined expressly […]
