Competitive Generic Therapies Designation

Competitive Generic Therapies Designation - Overview

Competitive Generic Therapies (CGTs) are designations for products that have inadequate generic competition in the market due to low market potential, less profit margin, or complexity in manufacturing. Inadequate competition, as defined by the FDA, means that there is not more than one approved drug in the active section of the orange book. A generic applicant must understand the criteria and timelines for competitive generic therapies before filing a CGT designation request to the FDA.

The CGT designation provides manufacturers with a new approval pathway to expedite the development and review of generic drugs which lack competition. The process includes pre-ANDA meetings that help applicants understand the agency’s expectations and reduce the number of review cycles. Additionally, it provides the applicant with an opportunity of the one hundred and eighty (180)-day competitive generic therapies’ exclusivity to incentivize the efforts and investments made by the applicant.

Freyr has vast experience and expertise in the timely compilation, submission, and review of ANDAs for competitive generic therapy approvals.

Competitive Generic Therapies Designation - Freyr Expertise

  • 01

    Determination of the applicability of the CGT designation.

  • 02

    Guidance on the timing and content for the competitive generic therapies’ request submission.

  • 03

    Preparation of CGT request package for submission.

  • 04

    Timely submission of the request form for CGT designation approval.

  • 05

    Preparation of content for expedited development meeting.

  • 06

    Guidance on scientific questions to seek the FDA’s suggestions.

  • 07

    Guidance on interpreting the FDA’s feedback for study designs and data generation.

  • 08

    Participate in mid-review cycles and expedited development meetings on behalf of the manufacturer/sponsor.

  • 09

    CGT guidance exclusivity for implementation.

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