Innovator Endo Pharma and Penwest Pharma have accused Sandoz of patent infringement in their third suit to keep a generic version of painkiller Opana ER (Oxymorphone Hydrochloride) off the market. Following patents are listed in orange book for this product
US5128143 (Expiry: Sep 19, 2008): Covers a slow release pharmaceutical excipient of an inert diluent and a hydrodrophilic material including xanthan gum and a galactomannan gum capable of cross-linking the xanthan gum in the presence of aqueous solutions.
US5662933 (Expiry: Sep 9, 2013) which covers a sustained release pharmaceutical formulation and methods of making and using the same. The sustained release pharmaceutical formulation includes a sustained release excipient including a gelling agent, an inert pharmaceutical diluent, an optional hydrophobic material and/or hydrophobic coating, and a medicament for sustained oral administration.
US5958456 (Expiry: Sep 9, 2013) which covers a controlled release solid dosage form for oral administration of a therapeutically active medicament to a patient in need thereof, comprising: a pharmaceutically effective amount of a medicament to be administered to a patient in need of said medicament; a sustained release excipient comprising a gelling agent; a pharmaceutically acceptable hydrophobic material; and an inert pharmaceutical diluent wherein the ratio of said inert diluent to said gelling agent is from about 1:8 to about 8:1, said dosage form providing a sustained release of said medicament when exposed to an environmental fluid.
US7276250 (Expiry: Jul 3, 2022) which covers an oral sustained release formulation comprising from about 5 mg to about 80 mg oxymorphone hydrochloride and from about 80 mg to about 360 mg of a granulated sustained release delivery system, wherein the granulated sustained release delivery system comprises from about 8.3% to about 41.7% by weight locust bean gum, from about 8.3% to about 41.7% by weight xanthan gum, from about 20% to about 55% by weight dextrose, from about 5% to about 20% by weight calcium sulfate dihydrate, and from about 2% to about 10% ethyl cellulose.
Innovator is already in litigation with Actavis and Impax on this product as reported earlier by IPPHARMADOC Here
US5128143 (Expiry: Sep 19, 2008): Covers a slow release pharmaceutical excipient of an inert diluent and a hydrodrophilic material including xanthan gum and a galactomannan gum capable of cross-linking the xanthan gum in the presence of aqueous solutions.
US5662933 (Expiry: Sep 9, 2013) which covers a sustained release pharmaceutical formulation and methods of making and using the same. The sustained release pharmaceutical formulation includes a sustained release excipient including a gelling agent, an inert pharmaceutical diluent, an optional hydrophobic material and/or hydrophobic coating, and a medicament for sustained oral administration.
US5958456 (Expiry: Sep 9, 2013) which covers a controlled release solid dosage form for oral administration of a therapeutically active medicament to a patient in need thereof, comprising: a pharmaceutically effective amount of a medicament to be administered to a patient in need of said medicament; a sustained release excipient comprising a gelling agent; a pharmaceutically acceptable hydrophobic material; and an inert pharmaceutical diluent wherein the ratio of said inert diluent to said gelling agent is from about 1:8 to about 8:1, said dosage form providing a sustained release of said medicament when exposed to an environmental fluid.
US7276250 (Expiry: Jul 3, 2022) which covers an oral sustained release formulation comprising from about 5 mg to about 80 mg oxymorphone hydrochloride and from about 80 mg to about 360 mg of a granulated sustained release delivery system, wherein the granulated sustained release delivery system comprises from about 8.3% to about 41.7% by weight locust bean gum, from about 8.3% to about 41.7% by weight xanthan gum, from about 20% to about 55% by weight dextrose, from about 5% to about 20% by weight calcium sulfate dihydrate, and from about 2% to about 10% ethyl cellulose.
Innovator is already in litigation with Actavis and Impax on this product as reported earlier by IPPHARMADOC Here
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