Radius Health and Ipsen Pharma S.A.S. accuse Orbicular of infringing U.S. Patents 7,803,770, 8,148,333, 8,748,382, 10,996,208 and 11.255,842 by the filing of an Abbreviated New Drug Application (“ANDA”) with the FDA. The asserted patents relate to Radius’ Tymlos® pharmaceutical product, used for treating postmenopausal women with osteoporosis who are at high risk for fractures. Tymlos was the first new bone building drug approved for postmenopausal women in nearly fifteen years in the United States. Orbicular, an Indian corporation with no place of business in the United States, submitted an ANDA seeking approval to manufacture and sell the ANDA generic that is the basis for the infringement claim before the expiration of the patents listed in the Orange Book as covering Tymlos. The ANDA asserted that the patents are invalid, unenforceable, or would not be infringed by the manufacture and sale of the ANDA product.
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