Patent Term Extension Application for ALYFTREK™ (vanzacaftor/tezacaftor/deutivacaftor), Patent No. 8,865,902 | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2025-E-0483

Patent Term Extension Application for ALYFTREK™ (vanzacaftor/tezacaftor/deutivacaftor), Patent No. 8,865,902

Documents

Comments

Description

Open

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; ALYFTREK FR Doc: 2026-02968	Feb 13, 2026	--

CDER

Patent Term Extension Application

Patent No. 8,865,902

ALYFTREK (vanzacaftor/tezacaftor/deutivacaftor)

Vertex Pharmaceuticals (Europe) Limited

Finnegan, Henderson, Farabow,

Garrett & Dunner, L.L.P.

Open