Innovator Eli Lilly sued Impax, Cobalt, Sandoz Inc. and Wockhardt for infringement of product patent. Following patents are listed for this product in Orange Book:
US5023269 (Expiry: Jun 11, 2013): Which covers 3-aryloxy-3-substituted propanamines capable of inhibiting the uptake of serotonin and norepinephrine
US5508276 (Expiry: Jul 18, 2014): which covers an enteric duloxetine pellet comprising a) a core consisting of duloxetine and a pharmaceutically acceptable excipient; b) an optional separating layer; c) an enteric layer comprising hydroxypropylmethylcellulose acetate succinate (HPMCAS) and a pharmaceutically acceptable excipient; d) an optional finishing layer.
US6596756 (Expiry: Sep 10, 2019): which covers a method of treating fibromyalgia comprising administering to a patient in need of treatment an effective amount of duloxetine.
Innovator sued generic players on ‘269 patent in the United States District Court for the Southern District of Indiana for submission of Abbreviated New Drug Application ("ANDA") for Duloxetine hydrochloride delayed-release capsules (20, 30, and 60 mg), generic of Cymbalta®, to the Food and Drug Administration. The all four generic companies filed ANDA on August 4, 2008, and all filers of ANDAs submitted on that date will be entitled to 180 days of exclusivity under the applicable regulations.
Cymbalta® is a selective serotonin and norepinephrine reuptake inhibitor indicated for major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, and fibromyalgia. According to Wolters Kluwer Health, U.S. sales of Cymbalta® were approximately $2.3 billion in the 12 months ended September 30, 2008.
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