The New Approval Pathway for Generic Drugs: Competitive Generic Therapy

August 29, 2018 Suzanne Konigsberg

By Yuexia Li and Robert Iser, PAREXEL® Consulting

Under new authorities provided to the agency in the FDA Reauthorization Act of 2017 (FDARA), a drug can be designated as a Competitive Generic Therapy (CGT) if there is inadequate generic competition for that drug, meaning there is not more than one approved drug in the active section of the Orange Book.  In other words, there is no more than one (1) Reference Listed Drug (RLD) drug or not more than one (1) generic drug with the same RLD.  This new approval pathway was created to expedite the development and review of a generic drug for products that lack competition.

The applicant requests the CGT designation either prior to ANDA submission or with the ANDA submission, but CGT designation can’t be requested after the ANDA submission.  FDA must grant or deny the CGT designation request within 60 calendar days of receiving the request. 

Applicants for generic drug that receives a CGT designation may receive review enhancements and expedited review of their Abbreviated New Drug Application (ANDA).  FDA implemented the following measures for CGT designated ANDAs, so that the chance of first cycle approval for such ANDAs is more likely.

  • FDA review team will hold meetings with the applicant throughout the development of the drug prior to submission of the ANDA
  • FDA will provide timely advice to, and interactive communication with, the applicant regarding the development of the drug to ensure that the development program to gather the data necessary for approval is as efficient as practicable 
  • FDA will involve senior managers and experienced review staff as appropriate, in a collaborative, coordinated review of such application, including with respect to drug-device combination products and other complex products
  • FDA will assign a cross-disciplinary project lead who will facilitate an efficient review of the development program and application, including manufacturing inspections; and serve as a scientific liaison between the review team and the ANDA applicant

Applicants receiving a CGT designation are also eligible for a 180-day period of marketing exclusivity if they are the first approved applicant under CGT designation and there is no blocking patents or exclusivities identified in the Orange Book for that drug.  Under a special forfeiture rule for CGTs, the applicant must commercially market the CGT within 75 calendar days after the date of approval of its ANDA or it will forfeit its 180-day CGT exclusivity.

For the generic companies submitting CGT designated ANDAs, they should make sure the following are considered:

  • Avail themselves of pre-ANDA submission, development discussions with FDA
  • Submit high quality ANDAs (leveraging all the current FDA generic drug submission expectations) for ensure successful filing and technical review
  • Be responsive to any information requests from FDA and provide quality responses to all questions
  • Make sure that their supply chain is inspection ready, so that there are no CGMP compliance related “snags” during the review process
  • Be ready to commercially market the product, as soon as possible after approval, to not only maximize their period of exclusivity, but more importantly to meet the intent of the pathway – providing the U.S. public additional low-cost alternatives

PAREXEL Consulting’s team of subject-matter experts can provide key advice to generic drug companies on how to strategize your submission, to assist in preparation of your facilities to be “inspection ready” to meet the CGMP regulations and expectations from the FDA, to help companies effectively communicate with the FDA throughout the submission life-cycle, and to maximize your 180-day exclusivity once your CGT generic drug is approved. 


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FDA Guidance for Industry: ANDA Submissions