CorePharma to Sell Authorized Generic Skelaxin
King Pharmaceuticals has terminated patent litigation and entered an agreement giving CorePharma rights to an authorized generic version of Skelaxin.
The Jan. 2 agreement dismissed all claims in King’s suit against CorePharma, which was filed in U.S. District Court for the Eastern District of New York, King said in an SEC filing. Under the agreement relating to 800-mg Skelaxin (metaxalone) tablets, CorePharma’s license will go into effect Dec. 1, 2012, or six months after the U.S. launch of the first generic version of the product, provided the launch is not at-risk. CorePharma may begin marketing immediately in the event of an at-risk launch.
CorePharma may launch its 800-mg tablets at the same time another firm launches a generic product without certain labeling information. In 2004, the FDA sent a letter to generic applicants that food-related drug use information covered by an FDA Orange Book patent may be omitted from the labeling of proposed generic Skelaxin products.
King submitted a citizen petition asking the FDA to rescind the letter, explaining that taking the muscle relaxant with a high-fat meal significantly increases the drug’s absorption. The company filed a second petition requesting a stay of approval of any generic Skelaxin products until the FDA responds to its first petition.
King also agreed to grant CorePharma a similar license for authorized generic 400-mg Skelaxin tablets, which will go into effect either Jan. 1, 2021, six months after the launch of the first generic Skelaxin 400 mg or immediately following an at-risk launch.
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