ISSN 0975-3583

Journal of Cardiovascular Disease Research

    Assessment of Regulatory Strategies for ANDA Submissions: Case Studies from Generic Drug Manufacturers

    Mitul Tilala, Abhip Dilip Chawda, Abhishek Pandurang Benke
    JCDR. 2024: 196-206


    Propose: The regulatory regulations of different nations globally differ from one another. As a result, it is difficult for the corporations to create a single medication that can be concurrently filed for approval in every country. The various requirements for registration for generic medicine in the US were presented by the present research. In the United States, approved under the abbreviated new drug application are generic medications. Exclusivity rights, which prevent generic businesses from launching a product right away after patent expiration, are used to prolong a product's patent duration after it has expired. The United States (US) generic marketplace was the study's main objective. Aim: Infringement of patents lawsuits are necessary for the approval of generic drugs prior to patent expiration since brand businesses employ strong Life Cycle Management (LCM) techniques. Method: The study focused on three key areas: patents and exclusivities, paragraph IV of the certificates, and emerging therapeutic areas—all of which provide significant challenges for generic businesses. We conducted a case study using statistical analysis on 12 drug firms in India between 2010 and 2020 which produced 2633 US-approved generic medicines.


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    Volume & Issue

    Volume 15 Issue 5