US Patent

US9833459 — Fulvestrant formulations

Method of Use · Assigned to Fresenius Kabi USA LLC · Expires 2034-02-14 · 8y remaining

Vulnerability score 62/100 Moderate — design-around opportunities exist

What this patent protects

This patent protects a fulvestrant composition that includes a pharmaceutically acceptable alcohol, polysorbate 80, an antioxidant, and castor oil, with excellent storage stability.

USPTO Abstract

The invention provides a fulvestrant composition comprising a pharmaceutically acceptable alcohol, polysorbate 80, an antioxidant, and castor oil, which is substantially or completely free of a non-aqueous ester solvent and which demonstrates excellent storage stability. The composition may be used to treat hormone receptor positive metastatic breast cancer in a subject.

Drugs covered by this patent

Faslodex (fulvestrant) · AstraZeneca

FDA Patent Use Codes

When a patent is method-of-use, FDA lists it once per applicable indication ("U-code"). Each U-code carves out a specific therapeutic use that generic filers must either license or design around.

Code	Description	Drug
`U-2540`	—	Faslodex

Patent Metadata

Patent number: US9833459
Jurisdiction: US
Classification: Method of Use
Expires: 2034-02-14
Drug substance claim: No
Drug product claim: Yes
Assignee: Fresenius Kabi USA LLC
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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