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Details for Patent: 5,965,156

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Patent 5,965,156 protects AMBISOME and is included in one NDA.

This patent has eighteen patent family members in thirteen countries.

Summary for Patent: 5,965,156

Title: Amphotericin B liposome preparation
Abstract:A novel composition and method for solubilizing amphiphilic drugs in a small amount of organic solvent for use in improved liposomes is disclosed. A phosphatidylglycerol is acidified in a small amount of organic solvent. The amphiphilic drug, such as Amphotericin B, suspended in organic solvent is then added to the acidified phosphatidylycerol and a soluble complex is formed between the phosphatidylglycerol and the amphiphilic drug. When the liposome composition incorporating the soluble complex is hydrated, the final pH of the hydrating aqueous buffer is carefully controlled. The Amphotericin B liposomes formed have markedly reduced toxicity.
Inventor(s): Proffitt; Richard T. (Arcadia, CA), Adler-Moore; Jill (Altadena, CA), Chiang; Su-Ming (Canoga Park, CA)
Assignee: NeXstar Pharmaceuticals, Inc. (Boulder, CO)
Application Number:08/469,251
Patent Claim Types:
see list of patent claims
Compound; Process; Dosage form; Use;

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Astellas
AMBISOME
amphotericin b
INJECTABLE, LIPOSOMAL;INJECTION050740-001Aug 11, 1997RXYes5,965,156► subscribeY FOR THE TREATMENT OF FUNGAL INFECTIONS
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Non-Orange Book Patents for Patent: 5,965,156

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
6,770,290 Amphotericin B liposome preparation► 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: 5,965,156

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria66598► subscribe
Australia2416188► subscribe
Australia598958► 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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