US Patent

US9855335 — Tigecycline composition for injection

Formulation · Assigned to Galenicum Health SL · Expires 2033-04-07 · 7y remaining

Vulnerability score 42/100 Strong — defensible against typical IPR challenges

What this patent protects

This patent protects a tigecycline composition for injection that includes a propping agent and a stabilization agent.

USPTO Abstract

Disclosed is a tigecycline composition for injection, comprising the active component, tigecycline, and a propping agent. Also included is a stabilization agent. Also disclosed is a stable, pharmaceutically acceptable reconstitution liquid having freeze-dried tigecycline. The tigecycline composition for injection of the present invention has good redissolution, and can dissolve without intense shaking, thereby avoiding foams caused by intense shaking. Upon testing, the tigecycline composition and the tigecycline composition-diluted reconstitution liquid prepared in the present invention prove to have substantially lowered oxidation degradation and epimer generation and increased stability of the tigecycline preparation. Compared to the compositions currently in clinical use, the composition of the present invention can increase the treatment effect of tigecycline, avoid safety risks caused by lactose, is easy to produce and store, and has a clinical usage stability, satisfying the requirements for clinical medicine.

Drugs covered by this patent

Patent Metadata

Patent number
US9855335
Jurisdiction
US
Classification
Formulation
Expires
2033-04-07
Drug substance claim
No
Drug product claim
Yes
Assignee
Galenicum Health SL
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.

Track this patent

Get a daily-checked alert when vulnerability score, expiry, classification, or assignee changes. Email, Slack, or Teams delivery. Pro: 50 watches, Free: 3.