HERTFORDSHIRE, England and PITTSBURGH — Mylan last week capped off its 2016 by with the launch of three generics. The company on Thursday announced the launch of its generics of Concerta (methylphenidate hydrochloride) extended-release tablets, Zovia (ethynodiol diacetate and ethinyl estradiol, 1 mg/0.05 mg) tablets and Cerebyx (fosphenytoin sodium, 75 mg/mL) injection.
Mylan’s generic of Concerta, a drug indicated to treat attention deficit hyperactivity disorder, will be available in 18-, 27-, 36- and 54-mg dosage strengths. The drug had U.S. sales of about $1.59 billion for the 12 months ended Oct. 31, 2016, according to QuintilesIMS data. The company did not include sales information for its generic of Zovia, an oral contraceptive.
Mylan’s generic Cerebyx, indicated to treat certain types of sever seizures has also been launched and the drug saw U.S. sales of approximately $36.3 million for the 12 months ended Oct. 31, 2016.
Mylan said it currently has 240 abbreviated new drug applications pending before the FDA, which it says represent some $95.6 billion in brand sales, with 41 of the ANDA’s potential first-to-file opportunities.