GSK Pulls Back Inhaler Patents After US FTC Warning Letter (1)

December 20, 2023, 8:04 PM UTC

GlaxoSmithKline Plc and an Amneal Pharmaceuticals Inc. unit agreed to delist patents on some older inhalers and injectors from a US Food and Drug Administration registry, potentially accelerating the approval of generic versions.

The delistings from the FDA’s Orange Book of drug patents came in response to the Federal Trade Commission, which sent warning letters to 10 pharmaceutical entities last month. The agency argued that the targeted patents don’t cover actual inventions or aren’t valid and gave the companies 30 days to delist or recertify them.

In response, GSK agreed to withdraw patents related to three of its asthma inhalers ...

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