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Published on:May 2022
Indian Journal of Pharmaceutical Education and Research, 2022; 56(2s):s347-s355
Original Article | doi:10.5530/ijper.56.2s.105

Research on Pharmaceutical Product Life Cycle Management Challenges Faced by Generic Manufacturers for US Approval


Authors and affiliation (s):

Murthannagari Vivek Reddy1, Gonna Nandhi Krishnan Ganesh1,*, Syed Suhaib Ahmed2, Praharsh Kumar Mandadhi Rajendra2, Eknath Babu3

1Department of Regulatory Affairs, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty, Nilgiris, Tamil Nadu, INDIA.

2Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty, Nilgiris, Tamil Nadu, INDIA.

3Department of Regulatory Affairs, Generic Research and Development, Micro Labs Limited, Bangalore, Karnataka, INDIA.

Abstract:

Introduction: Generic drug approval before patent expiration involves patent infringement petitions due to robust Life Cycle Management (LCM) strategies followed by Branded companies. They will extend the patent period of a product after expiration through Exclusivity rights, which act as a barrier for generic companies to launch the product immediately after patent expiration. This study focused on United States (US) generic market. Materials and Methods: The research was conducted on three major aspects where generic companies are facing major issues they are, Patent and Exclusivities, Paragraph IV certifications and Emerging Therapeutic areas. We performed a case study by statistical analysis on 2633 US-approved generic drugs on 12 pharma companies in India from 2009 to 2020. Results: In patent litigations, we found that Indian companies have the highest number of patent litigations related to secondary patents and new clinical indication exclusivity. In Paragraph IV certifications the Indian companies share was raised to 18%. A parallel study conducted on changes in therapeutic areas of these generic drugs from the past decade revealed that the production of cancer drugs was increased compared to cardiovascular and central nervous system drugs. Conclusion: This study will help in overcoming the above issues, where we explored the knowledge gaps between generic companies and branded companies that are needed to be addressed for successful marketing of generic drugs.

Key words: Life Cycle Management (LCM), Patents, Exclusivity, Abbreviated New Drug Approval (ANDA), New Drug Application (NDA).

 




 

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The Official Journal of Association of Pharmaceutical Teachers of India (APTI)
(Registered under Registration of Societies Act XXI of 1860 No. 122 of 1966-1967, Lucknow)

Indian Journal of Pharmaceutical Education and Research (IJPER) [ISSN-0019-5464] is the official journal of Association of Pharmaceutical Teachers of India (APTI) and is being published since 1967.

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