The patent badge is an abbreviated version of the USPTO patent document. The patent badge does contain a link to the full patent document.

The patent badge is an abbreviated version of the USPTO patent document. The patent badge covers the following: Patent number, Date patent was issued, Date patent was filed, Title of the patent, Applicant, Inventor, Assignee, Attorney firm, Primary examiner, Assistant examiner, CPCs, and Abstract. The patent badge does contain a link to the full patent document (in Adobe Acrobat format, aka pdf). To download or print any patent click here.

Date of Patent:
Nov. 23, 2021

Filed:

Apr. 08, 2013
Applicant:

Eagle Pharmaceuticals, Inc., Woodcliff Lake, NJ (US);

Inventors:

Bulusu Bhanu Teja, Hyderabad, IN;

Nagesh R. Palepu, Southampton, PA (US);

Assignee:

Eagle Pharmaceuticals, Inc., Woodcliff Lake, NJ (US);

Attorney:
Primary Examiner:
Assistant Examiner:
Int. Cl.
CPC ...
A61K 47/22 (2006.01); A61K 47/20 (2006.01); A61K 47/14 (2017.01); A61K 31/565 (2006.01); A61K 47/10 (2017.01); A61K 9/00 (2006.01);
U.S. Cl.
CPC ...
A61K 47/22 (2013.01); A61K 9/0019 (2013.01); A61K 31/565 (2013.01); A61K 47/10 (2013.01); A61K 47/14 (2013.01); A61K 47/20 (2013.01);
Abstract

Long term storage stable fulvestrant-containing compositions are disclosed. The compositions can include fulvestrant; a solvent selected from dimethyl sulfoxide (DMSO), glycofurol, N-methyl pyrrolidone, and mixtures thereof; an oil mixture selected from a mixture of caprylic and capric triglycerides, a mixture of caprylic, capric and linoleic triglycerides, a mixture of caprylic, capric and succinic triglycerides, and a mixture of propylene glycol dicaprylate and propylene glycol dicaprate; and a sustained release member selected from benzyl benzoate, dihydrolipoic acid, benzyl alcohol and lipoic acid. The fulvestrant-containing compositions have less than about 5% total impurities, on a normalized peak area response ('PAR') basis as determined by high performance liquid chromatography ('HPLC') at a wavelength of 223 nm, after at least about 24 months of storage at a temperature of from about 5° C. to about 25° C.


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