First-to-File Generics

Generic manufacturers face strong competition as soon as the patent expires for the reference innovator drug product. Therefore, the US FDA provides an incentive for generic drug applicants to challenge patent drugs by granting a 180-day period of exclusivity. To be eligible for 180-day exclusivity, generic applicant must be the first to file a substantially complete 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 addresses the client’s business challenges through appropriate commercial and portfolio management strategies, aiming 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 generic drug applications.

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

Latest Resources

  • Blogs

    API Guidance Notes – Decode NPRA Malaysia Guidance

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  • White Papers

    Control of Nitrosamines in Drug Products Regulatory Considerations

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  • Past Webinars

    Competitive Generic Therapies (CGT) - FDA Requirements

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