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Details for Patent: 6,406,713

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Patent 6,406,713 protects ABELCET and is included in one NDA.

This patent has forty-six patent family members in twenty-four countries.

Summary for Patent: 6,406,713

Title: Methods of preparing low-toxicity drug-lipid complexes
Abstract:Methods and compositions are described for nonliposomal lipid complexes in association with toxic hydrophobic drugs such as the polyene antibiotic amphotericin B. Lipid compositions are preferably a combination of the phospholipids dimyristoylphosphatidylcholine (DMPC) and dimyristoylphosphatidylglycerol (DMPG) in about a 7:3 mole ratio. The lipid complexes contain a bioactive agent, and may be made by a number of procedures, at high drug:lipid ratios. These compositions of high drug:lipid complexes (HDLCs) may be administered to mammals such as humans for the treatment of infections, with substantially equivalent or greater efficacy and reduced drug toxicities as compared to the drugs in their free form. Also disclosed is a novel liposome-loading procedure, which may also be used in the formation of the HDLCs.
Inventor(s): Janoff; Andrew S. (Yardley, PA), Madden; Thomas D. (Vancouver, CA), Cullis; Pieter R. (Vancouver, CA), Kearns; John J. (Princeton, NJ), Durning; Anthony G. (Yardley, PA)
Assignee: The Liposome Company, Inc. (Princeton, NJ)
Application Number:08/430,661
Patent Claim Types:
see list of patent claims
Use; Formulation; Dosage form;

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Sigma Tau
ABELCET
amphotericin b
INJECTABLE, LIPID COMPLEX;INJECTION050724-001Nov 20, 1995RXYes6,406,713► subscribeY
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Non-Orange Book Patents for Patent: 6,406,713

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
5,948,441 Method for size separation of particles► subscribe
4,963,297 Spontaneous vesticulation of multilamellar liposomes► subscribe
5,616,334 Low toxicity drug-lipid systems► 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: 6,406,713

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria113468► subscribe
Austria118169► subscribe
Australia1799088► 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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