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# Guide on Competitive Generic Therapies
- URL: https://www.fdaweb.com/guide-on-competitive-generic-therapies/
- Published: 2020-03-13T12:00:00.000Z
- Updated: 2026-09-14T16:07:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146324

FDA has finalized a guidance on “[Competitive Generic Therapies](http://email.prnewswire.com/ls/click?upn=3slWLw94I3jq-2B-2FedjFNgZP9Q8-2FvNLx46yPba7RT8XNZJ6mKpJKVdg76ygj8CeWFGBWLktSvq1ip88p3l8M8TpBF-2FVFuI-2BrfFVdkPmYY-2BSNuiLHRqXNbtAh-2BWns1XKdC-2BIn42H-2BhpNXolOCk4P1vRqA-3D-3DJmW0%5FYT-2BgtM2gIoe0GzKRNjnJV0GfiU11vns8m-2BZpwCt0-2BFBxp0Mttf-2FYcRTcT5Y8GMigFC0vH3FMHmXSKmQ7W9r1Znw6CNZ-2Fhaihp7cSS-2F1Ojd1cVQNgsE7gAthxhAAXIfhauHYi60NZ1wh4HjnKIe58SLwb13AzujWeqxK8yO4Bblota1IiAGmwMgn4KGaaSb-2BjQ5iNIQo4GD5tROw7mTFFuSlY7q0Sy89HobBpYGDXVhWP-2BpkdkpEPojGlK1o5dg8v-2FJpN7uIu567t5Ty9T0lHzR-2F6YWJ0CPuPnbM3DzMMQufIRvJGeKe1b4xWBBTIp7mYcYz1xvZ90xNmGibtAJHeXA-2BsKQIM4Mcwt0oLrzymOjw-3D&ref=fdaweb.com)” which describes the process that generic drug applicants should follow to request designation of such a drug and the criteria for that designation. The document provides information on actions the agency may take to expedite ANDA development and review for drugs designated as competitive generic therapies (CGT). It also explains how FDA implements the statutory provisions providing for a 180-day exclusivity period for certain first-approved CGT applicants. The agency recently published a [new Web page](http://email.prnewswire.com/ls/click?upn=3slWLw94I3jq-2B-2FedjFNgZLJsxjG040N2rwPdqKli79DxqkPgDBFv1L-2Fj22aKOo1omnoVNw-2BmIqmBdUfGWtkRgdB-2FBy4X87MPauLTpYI3iQ1URNiqB6pM-2FhfjYjho5luwGqPk%5FYT-2BgtM2gIoe0GzKRNjnJV0GfiU11vns8m-2BZpwCt0-2BFBxp0Mttf-2FYcRTcT5Y8GMigFC0vH3FMHmXSKmQ7W9r1Znw6CNZ-2Fhaihp7cSS-2F1Ojd1cVQNgsE7gAthxhAAXIfhauHYi60NZ1wh4HjnKIe58SLwb13AzujWeqxK8yO4Bblota1IiAGmwMgn4KGaaSb-2BjQ5iNIQo4GD5tROw7mTFFuVnsUEa6cIF3AYugBh3IeIasTjcMBUcN4ia2tC7c3GNhzgGvxuU0GUZ5RxwNcPfV34fSQbi5sSnfpDCmqvwZKjcEesxZp3ey9GHExPCStj-2B-2F82Vuvlu0XldF8gVOw5upJLoL1jZF8x4pHDjGaxuF7Jk-3D&ref=fdaweb.com) listing all approved ANDAs for products that received a CGT designation. The list is updated on a bi-weekly basis and includes information about the approved application, drug product and any potential CGT exclusivity.