FDA balks on generic Concerta as Mallinckrodt, Actavis meds gobble up market

Back in November, the FDA set a deadline for drugmakers producing cheap knockoffs of Johnson & Johnson's ($JNJ) ADHD med Concerta after determining that generics made by Mallinckrodt Pharmaceuticals ($MNK) and UCB wore off more quickly and could not be substituted for the brand. The agency gave companies 6 months to prove that their copycat versions were equivalent to the brand-name drug, or remove their product from the market. But that time has come and gone, and the FDA has yet to issue a final word on the meds.

As The New York Times reports, generics from UCB and Mallinckrodt command about 30% of the market and major pharmacies like CVS ($CVS) and Rite Aid ($RAD) are still stocking the drugs. UCB claims it submitted new information last week that will prove its generic is equivalent to Concerta, but isn't revealing that information just yet, the company told the newspaper. And Mallinckrodt is planning to battle it out with the FDA in court, suing the agency instead of offering proof of that its drug works as well as Concerta.

Regulators deemed a third Concerta generic, sold by Actavis--the U.S. generics arm of Allergan ($AGN)--but manufactured by J&J, as equivalent to the brand. Now Actavis is jacking up the prices for its med while snatching up market share. In November, Actavis held about 50% of the market for generic Concerta, according to an analysis from Sanford C. Bernstein & Company analyst Ronny Gal seen by the NYT. And that number jumped to 70% in May.

The agency's lack of action comes as a surprise to many analysts, who expected a much different outcome for Mallinckrodt and UCB after the FDA's November announcement. Some saw the companies as taking a similar path as Teva Pharmaceutical Industries ($TEVA), which was forced to pull its version of Wellbutrin XL after the FDA found that Teva's generic wasn't equivalent to the branded drug.

"It's the first time we're seeing something exactly like this," Ronny Gal, an analyst with Sanford C. Bernstein & Company, told the NYT. "I kind of thought the FDA would tell them to go away. They haven't."

But the agency maintains that it's looking into the issue. The discovery that the drugs didn't match up stemmed from an effort last year to expand testing of generic drugs. Regulators said they would focus on generic antidepressants, seizure drugs, ADHD meds and immunosuppressants, checking on knockoffs of Pfizer's ($PFE) Lipitor and AstraZeneca's ($AZN) Toprol XL. But the FDA's current lack of action on generic Concerta in the face of its own disclosure they came up short, leaves doctors uncertain about what to do for their patients, particularly when pressured by payers to prescribe the generics in question.

"This has gone on for months," Dr. Louis Kraus, a chief of child psychiatry at a Chicago-based hospital who used to prescribe generic Concerta, told the NYT. "We're as much in the black as the patients are. And then we find this out, and it's really frightening."

- read the NYT story (sub. req.)

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