Ever-greening in Pharmaceuticals: Strategies, Consequences and Provisions for Prevention in USA, EU, India and Other CountriesArun Kumar* and Arun Nanda
Department of Pharmaceutical Sciences, Maharshi Dayanand University, Rohtak, India
- *Corresponding Author:
- Arun Kumar
Department of Pharmaceutical Sciences
Maharshi Dayanand University, Rohtak, India
Tel: +01262 393 596
E-mail: [email protected]
Received Date: September 16, 2016; Accepted Date: April 07, 2017; Published Date: April 18, 2017
Citation: Kumar A, Nanda A (2017) Ever-greening in Pharmaceuticals: Strategies, Consequences and Provisions for Prevention in USA, EU, India and Other Countries. Pharm Regul Aff 6:185. doi: 10.4172/2167-7689.1000185
Copyright: © 2017 Kumar A, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Pharmaceutical research and development is an expensive, time consuming and uncertain process that may take 8-10 years to complete. Patent clock starts much before a new drug is approved for marketing and significant amount of time may be lost in the review and approval process by regulatory bodies. So in order to recoup the considerable time and resources invested in the drug development and approval process the pharmaceutical companies depend on exclusivity provisions granted by the regulatory bodies. There are several official and unofficial methods to extend term of a patent beyond 20 years, Official methods include provisions by some regulatory bodies such as Data exclusivity, Orphan drug exclusivity, Paediatric exclusivity and the 180-day exclusivity (Hatch Waxman Act, U.S. Food and Drug Administration), Supplementary protection certificate (European Medical Agency), whereas unofficial methods include altering or reformulate the existing compound to obtain a new patent by utilising polymorphism, creating combinations, stereo-selective/chiral switches, conversion to NDDS, OTC switching, authorised generics, etc. This article aims at highlighting the strategies used by Pharma giants to extend the term of their patent portfolio in order to maintain their monopoly for extended periods and the regulatory provisions in different countries to check these practices.