US Patent

US8716338 — Dosage units of 3-(6-(1-(2,2-difluorobenzo[D] [1,3] dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid

Method of Use · Assigned to Vertex Pharmaceuticals Inc · Expires 2030-09-20 · 4y remaining

Vulnerability score 59/100 Moderate — design-around opportunities exist

What this patent protects

This patent protects formulations of a specific compound in Form I, used in pharmaceutical packs or kits, for methods of treatment.

USPTO Abstract

The present invention relates to formulations of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid in Form I, pharmaceutical packs or kits thereof, and methods of treatment therewith.

Drugs covered by this patent

Kalydeco (IVACAFTOR) · Vertex Pharms Inc

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.

Code	Description	Drug
`U-3426`	—	Kalydeco
`U-2396`	—	Kalydeco
`U-1910`	—	Kalydeco
`U-1718`	—	Kalydeco
`U-2396`	—	Kalydeco

Patent Metadata

Patent number: US8716338
Jurisdiction: US
Classification: Method of Use
Expires: 2030-09-20
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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