Patent Term Extension Application for CRENESSITY™ (crinecerfont), Patent No. 11,311,544 | Federal Regulations · Congress.wiki

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FDA-2025-E-0492

Patent Term Extension Application for CRENESSITY™ (crinecerfont), Patent No. 11,311,544

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Comment Period OpensFeb 28, 2025

Comment Period ClosesApr 15, 2026

Type	Title	Posted	Comments	Status
Notice	Determination of Regulatory Review Period for Purposes of Patent Extension; CRENESSITY FR Doc: 2026-02973	Feb 13, 2026	--

CDER

Patent Term Extension Application

Patent No. 11,311,544

CRENESSITY™ (crinecerfont)

Neurocrine Biosciences, Inc.

Finnegan, Henderson, Farabow,

Garrett & Dunner, L.L.P.

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