EP Patent

EP4633614A1 — Stable pharmaceutical composition of an amine drug

Assigned to Sun Pharmaceutical Industries Ltd · Expires 2025-10-22 · 1y expired

What this patent protects

The present disclosure relates to a stable multiparticulate composition comprising coated discrete units of an amine drug or a pharmaceutically acceptable salt thereof, with stabilizing amount of one or more nitrite quencher. The composition provides effective control of the leve…

USPTO Abstract

The present disclosure relates to a stable multiparticulate composition comprising coated discrete units of an amine drug or a pharmaceutically acceptable salt thereof, with stabilizing amount of one or more nitrite quencher. The composition provides effective control of the level of nitrosamine drug substance-related impurities (NDSRIs) in the drug product during shelf life of the product.

Drugs covered by this patent

Patent Metadata

Patent number
EP4633614A1
Jurisdiction
EP
Classification
Expires
2025-10-22
Drug substance claim
No
Drug product claim
No
Assignee
Sun Pharmaceutical Industries 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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