US Patent

US7598343 — 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 Angiomax, and methods for preparing them.

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
US7598343
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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