Concerta generics in 2005?
Executive Summary
Johnson & Johnson's guidance for earnings per share in 2005 - released in conjunction with the Guidant acquisition - assumes that there will be generic competition for both the transdermal fentanyl patch Duragesic and the methylphenidate formulation Concerta, the company told analysts Dec. 16. Mylan expects to launch a generic version of Duragesic Jan. 23, when J&J's pediatric exclusivity expires (1"The Pink Sheet" Dec. 6, 2004, In Brief). Andrx' ANDA for a generic version of Concerta has been held up by a petition filed by J&J in March, arguing that the agency should apply stricter bioequivalence standards to the product...