Competitive Generic Therapies Designation


Competitive Generic Therapies (CGT) is a designation for products that have inadequate generic competition in the market due to low market potential, less profit margin or complexity in manufacturing the drug product. 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. It is necessary for a generic applicant to understand the criteria and timelines for Competitive Generic Therapies Designation before filing a CGT designation request to the FDA.

The Competitive Generics Therapies Designation provides generic manufacturers with a new approval pathway to expedite the development and review the generic drugs, which lack competition through pre-ANDA meetings that help applicants understand the agency’s expectation and reduce the number of review cycles. Additionally, it also provides the applicant with an opportunity of 180-day CGT exclusivity to incentivize the efforts and investments made by the applicant.

Freyr has vast experience and expertise in compilation, submission and review of ANDAs on-time for Competitive Generic Therapy approvals.

Freyr Expertise

  • 01

    Determination of applicability of CGT designation

  • 02

    Guidance on timing and content for CGT request submission

  • 03

    Preparation of CGT request package for submission

  • 04

    Timely submission of the request form for Competitive Generic Therapies Designation approval

  • 05

    Preparation of content for expedited development meeting

  • 06

    Guidance on scientific questions and necessary guidance to seek FDA’s suggestion

  • 07

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

  • 08

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

  • 09

    Guidance on CGT exclusivity for implementation

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