Mylan announces U.S. launch of generic Ortho Tri-Cyclen Lo Tablets

Mylan N.V.Jan 5 2016

Mylan N.V. (NASDAQ, TASE: MYL) today announced the U.S. launch of Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, which is the generic version of Janssen's Ortho Tri-Cyclen Lo® Tablets. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the prevention of pregnancy.

Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, had U.S. sales of approximately $488.6 million for the 12 months ending Sept. 30, 2015, according to IMS Health. This product represents Mylan's 14th oral contraceptive launch in the U.S.

Currently, Mylan has 270 ANDAs pending FDA approval representing $101.5 billion in annual brand sales, according to IMS Health. Fifty of these pending ANDAs are potential first-to-file opportunities, representing $35.6 billion in annual brand sales, for the 12 months ending June 30, 2015, according to IMS Health.