EP Patent

EP4355734A1 — Novel manufacturing method of daprodustat and precursors thereof

Assigned to GlaxoSmithKline Intellectual Property No 2 Ltd · Expires 2024-04-24 · 2y expired

What this patent protects

The present disclosure relates to a manufacturing process for daprodustat in which the level of an acyl impurity of Formula (II) is kept below 0.15% w/w in isolated daprodustat drug substance. Immediate release formulations of daprodustat containing a composition of daprodustat i…

USPTO Abstract

The present disclosure relates to a manufacturing process for daprodustat in which the level of an acyl impurity of Formula (II) is kept below 0.15% w/w in isolated daprodustat drug substance. Immediate release formulations of daprodustat containing a composition of daprodustat in which the level of the acyl impurity of Formula (II) is kept below 0.15% w/w relative to daprodustat drug substance are also disclosed. Medical uses of the immediate release formulation and dosage regimens are disclosed.

Drugs covered by this patent

Patent Metadata

Patent number
EP4355734A1
Jurisdiction
EP
Classification
Expires
2024-04-24
Drug substance claim
No
Drug product claim
No
Assignee
GlaxoSmithKline Intellectual Property No 2 Ltd
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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