US Patent

US7582727 — Pharmaceutical formulations of bivalirudin and processes of making the same

Formulation · Assigned to Medicines Co · Expires 2028-07-27 · 2y remaining

Vulnerability score 60/100 Moderate — design-around opportunities exist

What this patent protects

This patent protects pharmaceutical formulations of bivalirudin, including a specific method of preparing them, with certain quality control standards.

USPTO Abstract

Pharmaceutical batch(es) or pharmaceutical formulation(s) comprising bivalirudin as the active ingredient, and a method of preparing the pharmaceutical batch(es) or pharmaceutical formulation(s). The pharmaceutical batch(es) or pharmaceutical formulation(s) may have a maximum impurity level of Asp 9 -bivalirudin that does not exceed about 0.6%. Also, the pharmaceutical batch(es) or pharmaceutical formulation(s) may have a reconstitution time that does not exceed about 42 seconds. The method of preparing the pharmaceutical batch(es) or pharmaceutical formulation(s) may comprise dissolving bivalirudin in a solvent to form a first solution, efficiently mixing a pH-adjusting solution with the first solution to form a second solution in which the pH-adjusting solution may comprise a pH-adjusting solution solvent, and removing the solvent and the pH-adjusting solution solvent from the second solution.

Drugs covered by this patent

Patent Metadata

Patent number
US7582727
Jurisdiction
US
Classification
Formulation
Expires
2028-07-27
Drug substance claim
No
Drug product claim
Yes
Assignee
Medicines Co
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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