Development of pharmaceutical medicine is an expensive process and approval from drug authority takes a lot of time because of this time consuming process very often patents protection related to pharmaceutical medicine are expired before approval or launch of medicines in the market. As a result, most pharmaceutical industries rely on the exclusivity granted under the FDA- Food and Drug Authority or EMEA-European Medicines Agency.
Regulatory exclusivity is exclusive marketing rights granted by FDA or EMEA upon approval of a drug. It may run simultaneously with a patent protection or not. It prevents submission or final approval of ANDAs or 505(b)(2) applications and therefore it is design in such way to balance between new drug innovation and generic drug competition.
Pharmaceutical companies generally file patent application in respective countries at the time of innovation of product. Approval of product will take almost 10 years or more from respective drug authority. This is because the requirement of conducting clinical trials to prove safety and efficacy of any new drug molecule is very tedious, costly and without any guarantee of favourable results. At the time of launch of product in a market, patent protection left on the product is very little. To provide pharmaceutical companies chance to recoup their investment on drug research & development and to give