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Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
Accenture
Argus Health
Fish and Richardson
Harvard Business School
Teva
Covington
UBS
Cerilliant
Julphar

Generated: September 22, 2017

DrugPatentWatch Database Preview

Details for Patent: ► Subscribe

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Which drugs does patent 8,853,260 protect, and when does it expire?


Patent ► Subscribe protects ABRAXANE and is included in one NDA. There has been one Paragraph IV challenge on Abraxane.

This patent has one hundred and fourteen patent family members in twenty-three countries.

Summary for Patent: ► Subscribe

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;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005RXYesYes► Subscribe► SubscribeY TREATMENT OF LUNG CANCER
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005RXYesYes► Subscribe► SubscribeY TREATMENT OF BREAST CANCER
Abraxis Bioscience
ABRAXANE
paclitaxel
FOR SUSPENSION;IV (INFUSION)021660-001Jan 7, 2005RXYesYes► Subscribe► SubscribeY TREATMENT OF PANCREATIC CANCER
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Non-Orange Book Patents for Patent: ► Subscribe

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
5,665,382 Methods for the preparation of pharmaceutically active agents for in vivo delivery► Subscribe
6,537,579 Compositions and methods for administration of pharmacologically active compounds► Subscribe
5,665,383 Methods for the preparation of immunostimulating agents for in vivo delivery► Subscribe
6,506,405 Methods and formulations of cremophor-free taxanes► Subscribe
5,362,478 Magnetic resonance imaging with fluorocarbons encapsulated in a cross-linked polymeric shell► Subscribe
5,508,021 Non-fluorinated polymeric shells for medical imaging► Subscribe
6,749,868 Protein stabilized pharmacologically active agents, methods for the preparation thereof and methods for the use thereof► Subscribe
8,137,684Formulations of pharmacological agents, methods for the preparation thereof and methods for the use thereof► Subscribe
5,505,932 Method for the preparation of fluorocarbon-containing polymeric shells for medical imaging► Subscribe
5,916,596 Protein stabilized pharmacologically active agents, methods for the preparation thereof and methods for the use thereof► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Patent: ► Subscribe

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria264671► Subscribe
Austria427739► Subscribe
Australia2002303626► Subscribe
Australia2003229084► Subscribe
Australia2006202836► Subscribe
Australia2009217409► Subscribe
Australia4592997► Subscribe
Australia4661097► Subscribe
Australia5035900► Subscribe
Australia6249094► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving 500+ biopharmaceutical companies globally:

Colorcon
Cerilliant
Baxter
Mallinckrodt
Cipla
Novartis
Dow
US Army
Express Scripts
Julphar

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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