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Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for Patent: 8,853,260

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Summary for Patent: 8,853,260
Title:Formulations of pharmacological agents, methods for the preparation thereof and methods for the use thereof
Abstract: In accordance with the present invention, there are provided compositions and methods useful for the in vivo delivery of substantially water insoluble pharmacologically active agents (such as the anticancer drug paclitaxel) in which the pharmacologically active agent is delivered in the form of suspended particles coated with protein (which acts as a stabilizing agent). In particular, protein and pharmacologically active agent in a biocompatible dispersing medium are subjected to high shear, in the absence of any conventional surfactants, and also in the absence of any polymeric core material for the particles. The procedure yields particles with a diameter of less than about 1 micron. The use of specific composition and preparation conditions (e.g., addition of a polar solvent to the organic phase), and careful selection of the proper organic phase and phase fraction, enables the reproducible production of unusually small nanoparticles of less than 200 nm diameter, which can be sterile-filtered. The particulate system produced according to the invention can be converted into a redispersible dry powder comprising nanoparticles of water-insoluble drug coated with a protein, and free protein to which molecules of the pharmacological agent are bound. This results in a unique delivery system, in which part of the pharmacologically active agent is readily bioavailable (in the form of molecules bound to the protein), and part of the agent is present within particles without any polymeric matrix therein.
Inventor(s): Desai; Neil P. (Santa Monica, CA), Soon-Shiong; Patrick (Los Angeles, CA)
Assignee: Abraxis BioScience, LLC (Los Angeles, CA)
Application Number:11/520,479
Patent Claim Types:
see list of patent claims
Formulation; Use; Composition; Delivery;

Drugs Protected by US Patent 8,853,260

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Patent Submitted
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 RX Yes Yes ➤ Sign Up ➤ Sign Up Y TREATMENT OF PANCREATIC CANCER ➤ Sign Up
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 RX Yes Yes ➤ Sign Up ➤ Sign Up Y TREATMENT OF BREAST CANCER ➤ Sign Up
Abraxis Bioscience ABRAXANE paclitaxel FOR SUSPENSION;IV (INFUSION) 021660-001 Jan 7, 2005 RX Yes Yes ➤ Sign Up ➤ Sign Up Y TREATMENT OF LUNG CANCER ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Patent Submitted

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Non-Orange Book US Patents Family Members for Patent 8,853,260

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,639,473 Methods for the preparation of nucleic acids for in vivo delivery ➤ Sign Up
5,560,933 Methods for in vivo delivery of substantially water insoluble pharmacologically active agents and compositions useful therefor ➤ Sign Up
5,498,421 Composition useful for in vivo delivery of biologics and methods employing same ➤ Sign Up
6,096,331 Methods and compositions useful for administration of chemotherapeutic agents ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Covington
UBS
Dow
Express Scripts
US Department of Justice
Cantor Fitzgerald
Citi
QuintilesIMS

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