Innovator Hoffman La Roche filed a third lawsuit in a US court to block an ANDA application by Orchid Chemicals and Pharmaceutical Ltd. seeking marketing approval for a generic version of Boniva (Ibandronate sodium) in 150 mg strength, Roche’s best-selling prescription drug for osteoporosis.
Following patents are listed in Orange Book for this product
US4927814 (Expiry: Mar 17, 2012): Covers Ibandronate sodium as product
US6143326 (Expiry: Apr 21, 2017): Covers method of treating a bone disease in a patient in need thereof, comprising orally administering to the patient a pharmaceutical formulation comprising a tablet core containing about 0.1 to 100 mg of ibandronate and a coating which is free of ibandronate and has the following proportional composition: (a) about 51.425% by weight of methylhydroxypropylcellulose; (b) about 24.650% by weight of titanium dioxide; (c) about 15.000% by weight of polyethylene glycol; and (d) about 8.925% by weight of talc.
US6294196 (Expiry: Oct 7, 2019): A pharmaceutical composition in solid unit dosage form, said dosage form comprising an inner phase containing as the active substance ibandronic acid, or a physiologically compatible salt or hydrate thereof, said active substance being present in the dosage form in an amount of from about 0.2% to 30% by weight of the dosage form, and an outer phase containing stearic acid in an amount of about less than 5% by weight of the dosage form, wherein said inner phase comprises about at least 80% by weight of the dosage form and said outer phase comprises from about. 0.1% to 20% by weight of the dosage form.
US7410957 (Expiry: May 6, 2023): A method for treating osteoporosis comprising commencing treatment by orally administering to a subject in need of such treatment, on a single day, a first dose in the form of a tablet, wherein said tablet comprises an amount of a pharmaceutically acceptable salt of ibandronic acid that is equivalent to about 150 mg of ibandronic acid and continuing said treatment by orally administering, once monthly on a single day, a tablet comprising an amount of a pharmaceutically acceptable salt of ibandronic acid that is equivalent to about 150 mg of ibandronic acid.
The new lawsuit, filed in the district court of New Jersey, claims that Orchid product will infringe recently issued patent '957.
Following patents are listed in Orange Book for this product
US4927814 (Expiry: Mar 17, 2012): Covers Ibandronate sodium as product
US6143326 (Expiry: Apr 21, 2017): Covers method of treating a bone disease in a patient in need thereof, comprising orally administering to the patient a pharmaceutical formulation comprising a tablet core containing about 0.1 to 100 mg of ibandronate and a coating which is free of ibandronate and has the following proportional composition: (a) about 51.425% by weight of methylhydroxypropylcellulose; (b) about 24.650% by weight of titanium dioxide; (c) about 15.000% by weight of polyethylene glycol; and (d) about 8.925% by weight of talc.
US6294196 (Expiry: Oct 7, 2019): A pharmaceutical composition in solid unit dosage form, said dosage form comprising an inner phase containing as the active substance ibandronic acid, or a physiologically compatible salt or hydrate thereof, said active substance being present in the dosage form in an amount of from about 0.2% to 30% by weight of the dosage form, and an outer phase containing stearic acid in an amount of about less than 5% by weight of the dosage form, wherein said inner phase comprises about at least 80% by weight of the dosage form and said outer phase comprises from about. 0.1% to 20% by weight of the dosage form.
US7410957 (Expiry: May 6, 2023): A method for treating osteoporosis comprising commencing treatment by orally administering to a subject in need of such treatment, on a single day, a first dose in the form of a tablet, wherein said tablet comprises an amount of a pharmaceutically acceptable salt of ibandronic acid that is equivalent to about 150 mg of ibandronic acid and continuing said treatment by orally administering, once monthly on a single day, a tablet comprising an amount of a pharmaceutically acceptable salt of ibandronic acid that is equivalent to about 150 mg of ibandronic acid.
The new lawsuit, filed in the district court of New Jersey, claims that Orchid product will infringe recently issued patent '957.
Teva (and Gate), Mutual Pharmaceuticals, Apotex, Dr. Reddy's, Cobalt, Genpharm, Actavis and Orchid are the generic players currently in litigation with innovator.
USFDA has approved two strengths of innovator Hoffman La Roche for Boniva (Ibandronate sodium) 2.5 mg base (approved on May 16, 2003) and 150 mg base (approved on Mar 24, 2005)
Link to livemint news Here
USFDA has approved two strengths of innovator Hoffman La Roche for Boniva (Ibandronate sodium) 2.5 mg base (approved on May 16, 2003) and 150 mg base (approved on Mar 24, 2005)
Link to livemint news Here
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