Innovator Endo and Penwest has sued generic player Impax for patent infringement related to the pain treatment Oxymorphone Hydrochloride (Opana ER), after Impax has applied to make a generic form of recently approved strengths. Innovator sued Impax based on an amendment to ANDA application. The amendment added new dosages of the drug 7.5 mg, 15 mg and 30 mg.
Impax had already submitted ANDA for dosages of 5, 10, 20 and 40 mg. Both the companies are alredy in litigation on this product as reported earlier by Ippharmadoc Here and here. 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.
Earlier, on Feb 29, 2008 Innovator got approval to market new strengths 7.5 mg, 15 mg and 30 mg doses of Opana ER.
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