US Patent

US12257342 — Phenylephrine hydrochloride ready-to-use solution

Formulation · Assigned to Hikma Pharmaceuticals USA Inc · Expires 2036-09-26 · 10y remaining

Vulnerability score 55/100 Moderate — design-around opportunities exist

What this patent protects

This patent protects a ready-to-use solution of phenylephrine hydrochloride with improved stability, specifically an injectable form with edetate disodium chelating agent.

USPTO Abstract

This invention relates to a dilute, ready-to-use solution of phenylephrine hydrochloride having improved stability and utility. In a particular embodiment, the formulation consists of an injectable form of phenylephrine hydrochloride with edetate disodium chelating agent in place of any sodium metabisulfite antioxidants to improve the solution's ability to remain stable and active in a dilute state after prolonged storage. This invention also relates to a form for injection of the solution that includes packaging the solution in a single-use container, as well as a form for containing the ready-to-use solution in a sterile, sealed container. Lastly this invention relates to methods of making the injectable solution for use in a single-use container, as well as for containment in a sterile, sealed container.

Drugs covered by this patent

Patent Metadata

Patent number
US12257342
Jurisdiction
US
Classification
Formulation
Expires
2036-09-26
Drug substance claim
No
Drug product claim
Yes
Assignee
Hikma Pharmaceuticals USA 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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