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Details for Patent: 8,129,342

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Patent 8,129,342 protects CUBICIN and is included in one NDA. There has been one Paragraph IV challenge on Cubicin. There is one tentative approval for the compound protected by this patent. Additional details are available via the generic ingredient links below.

This patent has fifty-three patent family members in twenty-five countries.

Summary for Patent: 8,129,342

Title:High purity lipopeptides
Abstract: The invention discloses highly purified daptomycin and to pharmaceutical compositions comprising this compound. The invention discloses a method of purifying daptomycin comprising the sequential steps of anion exchange chromatography, hydrophobic interaction chromatography and anion exchange chromatography. The invention also discloses a method of purifying daptomycin by modified buffer enhanced anion exchange chromatography. The invention also discloses an improved method for producing daptomycin by fermentation of Streptomyces roseosporus. The invention also discloses high pressure liquid chromatography methods for analysis of daptomycin purity. The invention also discloses lipopeptide micelles and methods of making the micelles. The invention also discloses methods of using lipopeptide micelles for purifying lipopeptide antibiotics, such as daptomycin. The invention also discloses using lipopeptide micelles therapeutically.
Inventor(s): Kelleher; Thomas J. (Thousand Oaks, CA), Lai; Jan-Ji (Westborough, MA), DeCourcey; Joseph P. (Boston, MA), Lynch; Paul D. (Arlington, MA), Zenoni; Maurizio (Ferentino Frosinone, IT), Tagliani; Auro R. (Pavia, IT)
Assignee: Cubist Pharmaceuticals, Inc. (Lexington, MA)
Application Number:12/888,233
Patent Claim Types:
see list of patent claims
Composition; Process; Use; Formulation;
Patent Metrics:
Source: PatentQuant.com
Field: Biotechnology
Back Citations: 35th percentile
Forward Citations: 7th percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Cubist Pharms Llc
CUBICIN
daptomycin
POWDER;INTRAVENOUS021572-002Sep 12, 2003RXYes8,129,342► subscribeYY
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Non-Orange Book Patents for Patent: 8,129,342

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
8,853,357High purity lipopeptides► subscribe
9,358,267High purity lipopeptides► subscribe
6,696,412 High purity lipopeptides, Lipopeptide micelles and processes for preparing same► 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: 8,129,342

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria311405► subscribe
Austria449785► subscribe
Australia3097801► 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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