Regulatory Strategies for API going off-patent

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


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


Download data is not yet available.


1. Ghai D. Patent protection and the Indian pharmaceutical industry. Int. J. Phar. Sci. Rev & Dev [Internet]. 2010 [cited in 2020 Jan 2]. Available from:
2. Mathur V."Patenting of pharmaceuticals. An Indian perspective", Int. J. Drug. Dev. and Res [Internet].2012 Jul-Sept [cited in 2020 Jan 02]; 4(3)27-34. Available from:
3. Ducray. P. Compounds of formula I and a process for their preparation. Indian patent IN 202989; 2006.
4. Mukherjee S. The new Indian patent law: a challenge for India. Int. J. Prop Manage. 2006; 1(1/2):131-49.
5. FDA/CDER/SBIA Chronicles [Internet]. 2015 May 19 [cited in 2020 Jan 03]. Available from:
6. Drugs coming off-patent by 2022.International Journal of Pharmaceutical Sciences Review and Research [Internet]. [cited in 2020 Jan 04]. Available from:
7. Gupta H, Kumar S, R S.K, and Gaud R.S. Patent protection strategies. J Pharm Bioallied Sci. [Internet]. 2010 Jan -Mar [cited in 2020 Jan 06]; 2(1):2-7. Available from:
8. Pharmagenerics: Emerging from the shadows of brand power [Internet]. [cited in 2020 Jan 03]. Available from:
9. Kinjal Suchak, Lisa J. Murray." Patent Centric Strategies for Drug Re-innovation", Journal of Pharmaceutical Innovation [Internet].2018. [cited in 2020 Jan 04]. Available from:
608 Views | 251 Downloads
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.

Most read articles by the same author(s)

1 2 > >>