Regulatory Strategies for API going off-patent

  • Nisha Chaudhary M.Pharm (Drug Regulatory Affairs)
  • Vikesh Kumar Shukla
  • Amrish Chandra

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.

Keywords: Patent, types, norms, submission requirements, exclusivity, strategies

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How to Cite
Chaudhary, N., V. K. Shukla, and A. Chandra. “Regulatory Strategies for API Going off-Patent”. International Journal of Drug Regulatory Affairs, Vol. 8, no. 1, Mar. 2020, pp. 11-14, doi:10.22270/ijdra.v8i1.377.

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