Innovator Cubist Pharma has filed a patent infringement lawsuit against Teva Parenteral Medicines (TPM) for alleged violation of Orange Book listed patents related to antibacterial formulation Daptomycin 500Mg/VIAL injectable IV infusion.
Following patents are listed for this producty in Orange Book:
US6468967 (Expiry: Sep 24, 2019): Which covers a method for administering daptomycin, comprising the step of administering to a human patient in need thereof a therapeutically effective amount of daptomycin in a dose of 3 to 75 mg/kg of daptomycin at a dosage interval that minimizes skeletal muscle toxicity, wherein the daptomycin dose is repeatedly administered at a dosage interval of once every 24 hours to once every 48 hours.
US6852689 (Expiry: Sep 24, 2019): Which covers a method for administering daptomycin, comprising the step of administering to a human patient in need thereof a therapeutically effective amount of daptomycin in a dose of at least 3 mg/kg of daptomycin at a dosage interval that minimizes skeletal muscle toxicity, wherein the daptomycin dose is repeatedly administered at a dosage interval of once every 48 hours to once weekly.
USRE39071 (Expiry: Jun 15, 2016): Which covers cyclic peptide derivatives (including Daptomycin) as product
Innovator has filed patent infringement suit in the U.S. District Court for the District of Delaware against Teva. As reported earlier by IP Pharma Doc Here, Teva sent it's Para IV notice letter to innovator in February, 2009. In it’s complaint, innovator has alleged infringement of ‘071 patent by Teva. Since, innovator has sued Teva within 45 days of Para IV notice receipt, there would be a 30 month stay on Teva's ANDA approval process.
Innovator got final approval from USFDA on Sep 12, 2003 to market this product
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