CGT Designations: FDA Explains Process in New Draft Guidance

Regulatory NewsRegulatory News | 15 February 2019 |  By 

The US Food and Drug Administration (FDA) on Friday released draft guidance providing information on how sponsors can apply for competitive generic therapy (CGT) designation and when they may be eligible for CGT exclusivity.

The CGT designation, which was established with the FDA Reauthorization Act of 2017 (FDARA), is meant as an incentive for industry to develop generics for drugs lacking competition.

To date, FDA has granted more than 100 CGT designation requests, and in 2018, between August and December, FDA approved the first five abbreviated new drug applications (ANDAs) for generic drugs designated as CGTs (the first was approved last August), which qualified for 180-day exclusivity.

“This new type of exclusivity provides an incentive and a reward to generic drug applicants that submit, obtain approval of, and promptly market ANDAs for drugs with inadequate generic competition and where the approval of the ANDA would not be blocked by patents or exclusivities,” the guidance says.


Section 803 of FDARA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to add a section, 506H, which established a new process to designate and expedite the development and review of certain drugs either intended for submission or submitted in an ANDA and for which there is inadequate generic competition.

The draft guidance provides a description of the process that applicants should follow to request designation of a drug as a CGT and the criteria for designating a drug as a CGT.

This draft guidance also includes information on the actions FDA may take to expedite the development and review of ANDAs for drugs designated as CGTs, and it provides information on how FDA implements the 180-day exclusivity period for certain first-approved applicants that submit ANDAs for CGTs.

Draft Guidance

FDA may designate a drug as a CGT after determining that there is inadequate generic competition for that drug. The term "inadequate generic competition" is defined by the guidance to mean, "that there is not more than one approved drug in the active section of the Orange Book."

Because each strength of a drug product is a distinct drug product, FDA says that in evaluating whether there is not more than one approved drug in the active section of the Orange Book, the agency considers whether the product(s) in the active section is the same strength(s) as the product for which CGT designation is being sought.

“For example, if multiple strengths of a drug are approved under the new drug application (NDA) for the RLD, and some strengths are available for sale and listed in the active section of the Orange Book, but the particular strength for which CGT designation is sought is withdrawn from sale and thus is in the discontinued section of the Orange Book, FDA would not consider the particular strength of the RLD for which CGT designation is sought to be in the active section of the Orange Book,” the guidance says.

In this instance, an ANDA submitted referencing this particular strength of the RLD as its basis of submission may be eligible for a CGT designation.

FDA also says it generally intends to expedite the review of ANDAs for drugs designated as CGTs when the applicant has participated in the pre-ANDA meeting program prior to the submission (e.g., when the drug is a complex product).

“FDA generally does not intend to expedite the review of ANDAs covering CGTs if, at the time of ANDA submission, unexpired patents or exclusivities were listed in the Orange Book for the RLD,” the guidance notes.
And an expedited review does not result in a shorter user fee goal date, the guidance notes.

“However, priority ANDAs can qualify for review with a shorter 8-month GDUFA goal date by pre-submitting complete, accurate information regarding facilities involved in manufacturing processes and testing of the drug that is the subject of the application,” the guidance explains.

As far as the 180-day exclusivity, FDA will grant such exclusivity to the first-approved applicant that: Obtains approval of an ANDA for a CGT-designate drug and for which there were no unexpired patents or exclusivities listed in the Orange Book for the relevant RLD at the time the applicant submitted the original ANDA to the agency. The other stipulation is that the generic sponsor commercially markets such a drug within 75 calendar days after the approval of the ANDA. The 180-day CGT exclusivity period will be forfeited by a first-approved applicant if the applicant fails to market the competitive generic therapy within 75 days.

The draft guidance also explains the relationship between CGT exclusivity and 180-day patent challenge exclusivity.

Draft Guidance


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Tags: CGT, generic, guidance

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