<abstract xmlns="http://www.w3.org/1999/xhtml"><bold>Objective</bold>: 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. The aim of the present study is 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.<bold>Methods</bold>: 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 FMECA (Failure mode, Effects and Criticality Analysis).<bold>Results</bold>: 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.<bold>Conclusion</bold>: 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.</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. The aim of the present study is 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 FMECA (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.

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

Department of Regulatory Affairs, JSS College of Pharmacy

Department of Pharmaceutical Analysis, JSS College of Pharmacy

Department of Analytical and Product development. Recipharm Pharmaservices

Acta Marisiensis - Seria Medica

This work is licensed under the Creative Commons Attribution 4.0 International License.

Objective: The United States Food and Drug Administration implemented two exclusivity programs Competitive generic therapy and Patent Challenge exclusivity to...

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

Published Online: Apr 13, 2022

Page range: 28 - 34

Received: Dec 06, 2021

Accepted: Mar 07, 2022

DOI: https://doi.org/10.2478/amma-2022-0004

Keywords
generic drug exclusivity, competitive generic therapy, patent challenge exclusivity

© 2022 M Vivek Reddy et al., published by Sciendo

This work is licensed under the Creative Commons Attribution 4.0 International License.

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

Published Online: Apr 13, 2022

Page range: 28 - 34

Received: Dec 06, 2021

Accepted: Mar 07, 2022

DOI: https://doi.org/10.2478/amma-2022-0004

Keywordsgeneric drug exclusivity, competitive generic therapy, patent challenge exclusivity

© 2022 M Vivek Reddy et al., published by Sciendo

This work is licensed under the Creative Commons Attribution 4.0 International License.

Keywords
generic drug exclusivity, competitive generic therapy, patent challenge exclusivity