FDA withdrawal has Lannett, Mallinckrodt flailing to prove Concerta generics' extended release is equal

Nasdaq screens

Generics of Johnson & Johnson’s ADHD pill Concerta are hitting hard times due to an FDA crackdown on their bioequivalence. The agency said six months ago that generics makers Lannett and Mallinckrodt had that much time to confirm their extended-release technology matched that of J&J’s.

Neither of them made the deadline, and the FDA proposed withdrawing the generics, sending Mallinckrodt’s share price down slightly yesterday and Lannett’s, the smaller of the two companies, down almost 13%.

J&J’s Concerta employs an extended-release platform that administers the drug within 10 to 12 hours. Both Lannett’s and Mallinckrodt’s drugs, according to a report from Nasdaq, demonstrated a much wider window, decreasing the lower end to 7 hours, depending on the patient.

Of course, this is good news for J&J. But it’s also a welcome turn of events for Teva, which obtained its own generic through Allergan’s generics arm, which it recently bought. J&J had sold Allergan an authorized generic of Concerta. So, with competitors out of the way, the two can do what they want with the price of the drug.

Lannett and Mallinckrodt may now request a hearing to prevent the withdrawal, but they’ll likely have to improve their drugs’ delivery profiles before any decision goes their way.

Lannett bought Kremers Urban, which makes the generic, back in September last year.