FDA Grants Hearing on Generic Concerta After a Decade

A regulatory dispute that started under a different presidential administration finally has a hearing date. On 13 August 2026, FDA published a Federal Register notice granting Kremers Urban Pharmaceuticals' request for a formal evidentiary public hearing on CDER's decade-old proposal to withdraw approval of its generic version of Concerta, the extended-release ADHD drug. A prehearing conference is scheduled for 28 September 2026.

What FDA found, starting in 2013

The dispute traces back to FDA's adverse event reporting system, FAERS. In September 2013, FDA received reports describing insufficient therapeutic effect later in the day from patients on Kremers Urban's generic methylphenidate extended-release tablets; similar reports about Mallinckrodt's version followed in November 2014. Extended-release methylphenidate is supposed to release the drug on a specific curve over roughly twelve hours, and Concerta's clinical profile depends on that curve holding through the school or work day — a generic that releases differently can look bioequivalent on paper and still under-treat patients by afternoon. In June 2014, CDER concluded that Kremers Urban's own data were insufficient to establish that its product was bioequivalent to Concerta under FDA's revised bioequivalence recommendations for the drug. FDA gave both manufacturers roughly six months to either confirm bioequivalence under the new standard or voluntarily pull their products. Neither did.

Why this took nine years to get a hearing date

CDER published notices of opportunity for a hearing on both ANDAs on 18 October 2016. Kremers Urban requested its hearing within the month, on 10 November 2016, and filed its supporting summary of data and analyses on 4 December 2017 — and there the docket largely sat. Formal evidentiary hearings under 21 CFR Part 12 are a rarely used, litigation-like process, and FDA and industry more often resolve these disputes through settlement, additional bioequivalence studies, or a quiet voluntary withdrawal long before a hearing is actually convened. This one did none of those. CDER filed a narrative position statement on 24 February 2026 narrowing the dispute to specific sub-issues — principally, whether the Kremers Urban product is bioequivalent to Concerta across the drug's full twelve-hour labeled therapeutic window, not just at isolated measurement points — and the 13 August grant of hearing sets the case moving toward an actual evidentiary proceeding, with a prehearing conference on 28 September.

What's still on pharmacy shelves

Both generics remain approved and marketed. FDA's proposal to withdraw approval is exactly that — a proposal, still contested through the hearing process a decade after it was filed. Mallinckrodt's parallel ANDA proceeding, covering its own generic (now associated with Kudco), is a separate docket and is not resolved by this notice. For prescribers and pharmacists, the practical guidance FDA has given since 2014 has not changed: patients switched to a generic methylphenidate ER product who report reduced effectiveness, particularly later in the day, should have that reported through FDA's MedWatch program, and prescribers who want to avoid a substitution question altogether can specify no generic substitution on the prescription. Whatever the hearing eventually decides, it will turn on data these two companies were first asked to produce more than a decade ago.