Competitive Generic Therapies Designation

Our comprehensive expertise in Competitive Generic Therapies (CGT) designations guides manufacturers through the FDA's expedited approval pathway. Our services cover CGT applicability assessment, request preparation, and strategic guidance throughout the development and review process.

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 that 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 - Expertise

  • Determination of the applicability of the CGT designation.
  • Guidance on the timing and content for the competitive generic therapies’ request submission.
  • Preparation of CGT request package for submission.
  • Timely submission of the request form for CGT designation approval.
  • Preparation of content for expedited development meeting.
  • Guidance on scientific questions to seek the FDA’s suggestions.
  • Guidance on interpreting the FDA’s feedback for study designs and data generation.
  • Participate in mid-review cycles and expedited development meetings on behalf of the manufacturer/sponsor.
  • CGT guidance exclusivity for implementation.
Competitive Generic Therapies Designation

Celebrating Customers Success

 

Medicinal Products

Regulatory Affairs

India

Thank you for the timely support over the weekend, which allowed us to resubmit quickly after being notified. This continuously demonstrates Freyr's commitment towards our company’s milestones.

Director - Global Regulatory Affairs – Operations

India-based, Global Top Generic Pharma Company

 

Medicinal Products

Publishing

UK

I am sure you have heard by now that we have received our first-ever approval from the FDA for our Brands division. This is a major milestone for us as well as for my team here in Reg Ops. I would be remiss if I didn’t point out that we would not have been able to do this without the help of your dedicated team. From the original filing, then the following year of responses, all helped get us to final approval.

Thank you Freyr team for a job well done!

Sr. Director, Head of Regulatory Operations

Ireland-based, Global Specialty Pharmaceutical Company

 

Medicinal Products

Regulatory Affairs

USA

Please relate to the team the excellent job they have done on the IND reactivation. Specifically, the high-quality module 3, written by Freyr. It was very comprehensive, very few revisions were required, and we had no questions from Health Canada or FDA. No CMC questions: that was a first for me. So very responsive to my many requests, which I am sure can be frustrating but always helpful while producing excellent work.

Thank you for always being available and responding quickly and comprehensively to all my requests.

What a great team you have, Freyr.

Lynne McGrath

Regulatory Consultant

 

Medicinal Products

Regulatory Affairs

USA

Congratulations!!! ​

Thanks for your great support for a successful ANDA filing, especially to the publishing team. Heartfully appreciate their last hours of hard work.

Assistant Manager​

US-based, Leading, Complex Generic Pharmaceutical Products Company​

 

Medicinal Products

Regulatory Affairs

USA

Thank you all for the great support!​

CEO

US-based, Leading Innovative Pharmaceuticals Company​

 

Medicinal Products

Regulatory Affairs

USA

The ANDA receipt has been received! Thank you very much for your hard work, patience, and support for our work over the last couple of months. We are delighted that we were able to meet the timeline and hit an important corporate goal of our young company. ​

Thank you again, and we look forward to working with your team on the next project!

Senior Director of Business and Product Development​

US-based, Leading Innovator Pharmaceuticals Company​