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FDA updates its list of drugs without generics Posted 12/01/2018

The US Food and Drug Administration (FDA) announced in December 2017 that it had updated its list of drugs without generics.

The update is part of the agency’s continuing efforts to increase competition and bring down the price of prescription drugs.

FDA first published the list of brand-name drugs that no longer have patent protection or exclusivity in the US and that do not have approved generics in June 2017 [1]. This list includes approved new drug applications (NDA) drug products that are no longer protected by patents or exclusivities, and for which FDA has not approved an abbreviated new drug application (ANDA) referencing that NDA product.

List of off-patent, off-exclusivity drugs without an approved generic
Date: December 2017

The list is divided into two parts. Part I contains drug products for which FDA could immediately accept an ANDA without prior discussion. Part II identifies drug products involving potential legal, regulatory, or scientific issues which should be addressed with the agency prior to submission of an ANDA.

For this updated list FDA used different methodology. Under the updated methodology, the list is organized based on drug products, not active ingredients. This means that an active and approved NDA for a particular active ingredient and dosage form will be included on the list if there are no approved ANDAs for at least one drug product for that active ingredient and dosage form approved in the NDA, even if there are approved ANDAs that reference a drug product in a different NDA with the same active ingredient and dosage form.

FDA says that it ‘maintains this list to improve transparency and encourage the development and submission of ANDAs in markets with little competition’. The list is updated every six months and is available in both PDF and Excel format.

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1. GaBI Online - Generics and Biosimilars Initiative. FDA lists drugs without generics to increase competition [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 12]. Available from: www.gabionline.net/Generics/General/FDA-lists-drugs-without-generics-to-increase-competition

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Source: US FDA

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