Risk Assessment of Failures in Generic Drug Development and Approval Procedure under Competitive Generic Drug Therapy and Patent Challenge Exclusivities Provided by the United States Food and Drug Administration

Risk assessment of CGT and PC Exclusivity drugs

  • Vivek Reddy M JSS College of Pharmacy Ooty, JSS AHER Mysuru.
  • Ganesh Gnk Department of Regulatory Affairs, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty, Nilgiris, Tamil Nadu-643001, India.
  • Babu B Department of Pharmaceutical Analysis, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty, Nilgiris, Tamil Nadu-643001, India.
  • Ramesh Jagadeesan Assistant Vice President, Department of Analytical and Product development. Recipharm Pharmaservices, Bangalore, Karnataka-560002, India.
  • Praharsh Kumar M R Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty, Nilgiris, Tamil Nadu-643001, India.
Keywords: Generic drug exclusivity, Competitive generic therapy, Patent Challenge exclusivity.

Abstract

Objective: The United States Food and Drug Administration implemented two exclusivity programs Competitive generic therapy and Patent Challenge exclusivity to develop generic drugs, which provide a 180-day monopoly market for first generic applicants in the United States of America. To find the root cause of failures in developing and filing the first generic drugs under these exclusivities and to compare both the exclusivities to find the merits and demerits.  

Methods: We used descriptive statistics for data analysis of both the exclusivities and Risk assessment was conducted on 14 industries to find the root cause of failures in every stage of the approval procedure by FECA (Failure mode, Effects and Criticality Analysis).

Results: We found 44% of rejections in competitive generic therapy drugs and 30% of rejections in patent challenge exclusivity drugs. The risk analysis conducted on failures found that, in drug selection, 6% of failures are occurred due to rare diseases. In drug development, 9% of failures are occurred due to formulation failures. In pre-approval, 10% of failures are occurred due to secondary patents. In post-approval, 6% of failures are occurred due to product changes after approval. 

Conclusion: We hope this study can give an idea for small and medium companies in developing countries for the early development of generic drugs for life-threatening diseases.

Author Biographies

Ganesh Gnk, Department of Regulatory Affairs, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty, Nilgiris, Tamil Nadu-643001, India.

Dr. GNK Ganesh, M. Pharma, PhD. Associate Professor

Babu B, Department of Pharmaceutical Analysis, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty, Nilgiris, Tamil Nadu-643001, India.

Dr. B Babu, Assistant Professor.

Ramesh Jagadeesan, Assistant Vice President, Department of Analytical and Product development. Recipharm Pharmaservices, Bangalore, Karnataka-560002, India.

Dr. Ramesh Jagadeesan, M. Pharma, PhD. Assistant Vice President.

Praharsh Kumar M R, Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty, Nilgiris, Tamil Nadu-643001, India.

Praharsh Kumar M R, M.Pharmacy. Research Scholar

Published
2022-03-09
How to Cite
1.
M V, Gnk G, B B, Jagadeesan R, M R PK. Risk Assessment of Failures in Generic Drug Development and Approval Procedure under Competitive Generic Drug Therapy and Patent Challenge Exclusivities Provided by the United States Food and Drug Administration. amm [Internet]. 9Mar.2022 [cited 3Dec.2024];68(1). Available from: https://ojs.actamedicamarisiensis.ro/index.php/amm/article/view/126
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Original article