US Patent

US12458635 — Pharmaceutical composition and administrations thereof

Method of Use · Assigned to Vertex Pharmaceuticals Inc · Expires 2029-08-13 · 3y remaining

Vulnerability score 64/100 Moderate — design-around opportunities exist

What this patent protects

This patent protects pharmaceutical compositions and methods of manufacturing and administering a solid dispersion of the active ingredient in Kalydeco.

USPTO Abstract

The present invention relates to pharmaceutical compositions comprising a solid dispersion of N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide, methods of manufacturing pharmaceutical compositions of the present invention, and methods of administering pharmaceutical compositions of the present invention.

Drugs covered by this patent

FDA Patent Use Codes

When a patent is method-of-use, FDA lists it once per applicable indication ("U-code"). Each U-code carves out a specific therapeutic use that generic filers must either license or design around.

CodeDescriptionDrug
U-4335 — Kalydeco
U-4337 — Kalydeco
U-4337 — Kalydeco
U-4338 — Kalydeco
U-4330 —
U-4330 —
U-4333 —
U-4333 —
U-4336 — Kalydeco
U-4335 — Kalydeco
U-4338 — Kalydeco
U-4339 — Kalydeco
U-4336 — Kalydeco
U-4337 — Kalydeco
U-4337 — Kalydeco
U-4337 — Kalydeco
U-4335 — Kalydeco

Patent Metadata

Patent number
US12458635
Jurisdiction
US
Classification
Method of Use
Expires
2029-08-13
Drug substance claim
No
Drug product claim
Yes
Assignee
Vertex Pharmaceuticals Inc
Source
FDA Orange Book + USPTO grounding via Google Patents

Bibliographic data sourced from FDA Orange Book + USPTO public records. Plain-English summary generated by AI grounded in source text. Patent term extensions (PTR, SPC, pediatric) may shift the effective expiry. Not legal advice.

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