Mallinckrodt Launches Generic Version of CONCERTA in U.S.

Mallinckrodt, the Pharmaceuticals business of Covidien (NYSE: COV), todayannounced that it has received approval from the U.S. Food and DrugAdministration (FDA) to manufacture and market a generic version of CONCERTA^®(methylphenidate HCl) Extended-Release (ER) Tablets USP (CII) in 27, 36 and 54mg dosage strengths. The company will launch Methylphenidate HCl ER Tablets inthe 27 mg dosage strength immediately.Methylphenidate HCl ER Tablets are indicated for the treatment of AttentionDeficit Hyperactivity Disorder (ADHD) in children 6 years of age and older,adolescents and adults up to the age of 65 as an integral part of a totaltreatment program for ADHD that may include other measures (psychological,educational, social). Mallinckrodt believes it holds a separate 180-dayexclusivity period for each of the 27, 36 and 54 mg dosage strengths, whichbegins upon commercial launch of each respective dosage strength.Mallinckrodt's current plan is to have the 36 mg and 54 mg dosage strengthscommercially available in the first calendar quarter of 2013. Mallinckrodtplans to submit a supplement to its approved abbreviated new drug applicationfor the 18 mg dosage strength in the first calendar quarter of 2013.“This approval represents an important addition to our line of genericpharmaceutical products, and we look forward to providing an affordabletreatment option to patients coping with ADHD,” said Mark Trudeau, President,Mallinckrodt. “We are pleased the FDA found that our long-acting technologydelivers a dose which is therapeutically equivalent to what is currently onthe market."Mallinckrodt is the largest U.S. supplier of opioid pain medications and amongthe top 10 generic pharmaceuticals manufacturers in the U.S., based onprescriptions. Covidien announced in December 2011 that it plans to spin offMallinckrodt into a stand-alone company, a process expected to be completed inmid-2013.