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Solid Dosage Forms And Dosing Regimens Comprising (2R,3S,4S,5R)-4-[[3-(3,4-Difluoro-2-Methoxy-Phenyl)-4,5-Dimethyl-5-(Trifluoromethyl) Tetrahydrofuran-2-Carbonyl]Amino]Pyridine-2-Carboxamide

Patent No. EP4346818 (titled "Solid Dosage Forms And Dosing Regimens Comprising (2R,3S,4S,5R)-4-[[3-(3,4-Difluoro-2-Methoxy-Phenyl)-4,5-Dimethyl-5-(Trifluoromethyl) Tetrahydrofuran-2-Carbonyl]Amino]Pyridine-2-Carboxamide") was filed by Vertex Pharmaceuticals Incorporated on Jun 3, 2022. The application was issued on Dec 3, 2025.

Patent Summary

Compound 1, specifically (2R,3S,4S,5R)-4-[[3-(3,4-difluoro-2-methoxy-phenyl)-4,5-dimethyl-5-(trifluoromethyl)tetrahydrofuran-2-carbonyl]amino]pyridine-2-carboxamide, or its pharmaceutically acceptable salts, is used to treat or reduce the severity of pain. It targets NaV1.8 voltage-gated sodium channels to provide analgesia. The compound is administered at 10 mg to 300 mg per day (optionally 20 mg to 200 mg), including specific once-daily doses ranging from 10 mg to 150 mg. Indications include acute, chronic, neuropathic, inflammatory, cancer, visceral, musculoskeletal, and postsurgical pain (e.g., bunionectomy, herniorrhaphy, abdominoplasty), as well as multiple sclerosis, Charcot-Marie-Tooth syndrome, and Pitt Hopkins Syndrome. Pharmaceutical compositions may include solid dispersions with polymers, fillers, lubricants, and disintegrants. The compound may be administered as a free acid or salt.

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Patent Oppositions (2)

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CompanyOpposition DateRepresentative
BARDEHLE PAGENBERGSep 3, 2026BARDEHLE PAGENBERG SL
DEVASep 2, 2026-

Dossier Documents

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  • Date

    Description

EP4346818

VERTEX PHARMACEUTICALS INCORPORATED
Application Number
EP22741050A
Filing Date
Jun 3, 2022
Status
Granted And Under Opposition
Oct 31, 2025
Publication Date
Dec 3, 2025
External Links
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