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Competitive Generic Therapies | FDA Guidance for Industry

FDA recognizes that various factors may influence an applicant’s decision to develop a generic drug. For instance, some drugs may not attract a high level of interest from generic drug applicants if there is a limited market for those products and/or if the products are more difficult to develop.

Nevertheless, these drugs can play an important role in diagnosing, treating, and preventing various types of diseases or conditions, and incentivizing generic competition for these products can help ensure that patients have access to the medicines they need.

The provisions associated with competitive generic therapy (CGTs) are intended to incentivize effective development, efficient review, and timely market entry of drugs for which there is inadequate generic competition.

To facilitate increased competition for these products, FDA may take certain actions to expedite the development and review of an ANDA for a drug that is designated as a CGT.

These actions, may help to clarify the regulatory expectations for a particular drug, assist applicants in developing a more complete submission, and ultimately promote a more efficient and effective ANDA review process in order to help reduce the number of assessment cycles necessary to obtain ANDA approval.

The FDA Reauthorization Act of 2017, or FDARA, created a pathway by which FDA may, at the request of the applicant, designate a drug with “inadequate generic competition” as a competitive generic therapy (CGT).

At the request of the applicant, FDA may also expedite the development and review of an abbreviated new drug application (ANDA) for a drug designated as a CGT.

This 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.

It also includes information on the actions FDA may take to expedite the development and review of ANDAs for drugs designated as CGTs.

Finally, it provides information on how FDA implements the statutory provision for a 180-day exclusivity period for certain first approved applicants that submit ANDAs for CGTs.

In order to be eligible for CGT exclusivity under section 505(j)(5)(B)(v) of the FD&C Act, an ANDA applicant must qualify as a “first approved applicant,” which is defined as an applicant that has submitted an application that:

  • Is for a competitive generic therapy that is approved on the first day on which any application for such designated competitive generic therapy is approved
  • Is not eligible for a 180-day patent challenge exclusivity period under section 505(j)(5)(B)(iv) for the drug that is the subject of the application for the competitive generic therapy (discussed further in section V.F. of this guidance)
  • Is not for a drug for which all drug versions have forfeited eligibility for a 180-day patent challenge exclusivity period under section 505(j)(5)(B)(iv) pursuant to section 505(j)(5)(D)55 (also discussed further in section V.F of this guidance)

This guidance revises the guidance of the same title issued in March 2020. This revision is being issued to incorporate information on the meeting types and performance goals included in the Generic Drug User Fee Amendments (GDUFA) Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027 (GDUFA III commitment letter).

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