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

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.