First-to-File Generics

Generic manufacturers face fierce competition as soon as the patent expires for the reference innovator drug product. Therefore, the US FDA provides an incentive for the first-to-file generic drug applicants challenging patent drugs, by granting a one hundred and eighty (180)-day period of exclusivity. To be eligible for this exclusivity, the generic applicant must be the first to file a complete Abbreviate New Drug Application (ANDA) containing a paragraph IV certification to a patent listed in the Orange Book.

Freyr has a broad range of cost-effective services and solutions that address the client’s business challenges through appropriate commercial and portfolio management strategies. This is aimed at providing ‘First-to-File’ and ‘First-to-Market’ opportunities for generic pharmaceutical companies along with the preparation of risk mitigation plans to accelerate drug approvals by minimizing the Refuse-to-Receive (RTR) from Health Authorities and preventing any unexpected delays in review cycles of first-to-file generic drug applications.

Our professionals have extensive knowledge and experience in registration activities, offering end-to-end ANDA services for manufacturers/sponsors/ANDA applicants and thus, can be a preferred Regulatory partner to ensure ANDA approval right at the first time.


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  • Past Webinars

    The Regulatory Pathway for Expedited Access to Malaysian Pharma Industry

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