Abstract

Tularam Barot39616, Bhupendra Prajapati39617*, Jeshika Patel39618, Shruti Barot39619, Nirmal Vashi39620 and Priyadarshini Patel39621

A drug manufacturer applies for a patent to protect their drug from being copied or sold by other companies. A patent is granted for a period of time during which, only the original manufacturer can research, develop and sell the brand name drug. When the patent expires, other manufacturers can submit an Abbreviated New Drug Application (ANDA) to the FDA for approval to market the generic version. A generic drug is equivalent to its brand name, but usually much less expensive. Generic drugs are approved by the U.S. Food and Drug Administration (FDA), and are deemed to be safe and effective as the brand name product. Generic drugs must meet strict FDA requirements with respect to quality, performance, labeling, manufacturing and bioequivalence. Generic drugs must have same active ingredient and expected to have same effect when used in place of brand name drug. This review aims to provide information on the drugs whose patent is going to expire in the coming years, and expecting their generic version in the market.