Regulatory strategies for api going off-patent Chaudhary Nisha*, Shukla Vikesh Kumar, Chandra Amrish Department of Drug Regulatory Affairs, Amity Institute of Pharmacy, Amity University, Sector-125, Noida, (UP), India *Corresponding author Tel.: +91-7895804557, E-mail address: nisha.chaudhary014@gmail.com (Nisha Chaudhary)
Online published on 24 May, 2021. Abstract Pharmaceutical industries are one of the most developing industries having enormous profit margins. Today the pharmaceutical companies are challenged with increased costs of drug discovery and development and intrusive competition from generic drug companies. The pharmaceutical companies have begun the process of drug development and in the same period also begin to espouse the various schemes to expand the duration of patent-holding. So, increasing patent term for the already patented products is an effective strategy for withstanding generic competition. Pharmaceutical industries can use various ways to optimize the patent protection on large products, optimizing the market lifecycles and the strategies for API going off-patent in pharmaceutical industries in India are outlined below to provide the significant pharmaceutical patenting information. Top Keywords Patent, Types, Norms, Submission requirements, Exclusivity, Strategies. Top |