On October 26, 2010, the FDA issued a letter decision addressing whether submission of a second PIV certification could give rise to a second, or superseding, 30-month stay. The FDA issued its letter decision in response to Genzyme's citizen petition regarding ANDA No. 90-040 (filed by Pentech and subsequently acquired by Cobrek), which seeks approval for a generic version of Hectorol® (doxercalciferol injection). The FDA granted Genzyme's request for a second, or superseding, 30-month stay.
Genzyme's NDA No. 21-207 for Hectorol® was first approved on April 6, 2000. The original NDA specified that the injection would be packaged in ampules. Genzyme later submitted a supplemental application that identified minor changes to the inactive ingredients and also proposed a change in packaging from ampules to stoppered vials.
Cobrek's ANDA originally cited Genzyme's ampule NDA formulation as the RLD and contained a PIV certification. Genzyme timely filed suit after receiving notice of Cobrek's first patent certification, which triggered the first 30-month stay in the case. Then, shortly after the FDA approved Genzyme's sNDA, it notified Cobrek that its ANDA could not be approved because the formulation was not Q1/Q2 the same as Genzyme's reformulated RLD in vials. The FDA recommended that Cobrek reformulate and informed Cobrek that it would not accept its amendment without additional patent certifications. Cobrek chose to reformulate and submitted new patent certifications with its amendment. Genzyme filed suit within 45 days of receiving notice of the new patent certifications, and then submitted its petition for a second 30-month stay.
According to FDA's letter decision, the re-submission of the patent certifications and subsequent timely filing of suit by the NDA holder did trigger a superseding 30-month stay. The FDA determined that the plain language of the statute required an additional 30-month stay regardless of whether the 30-month stay provisions of the MMA, which generally prohibit successive 30-month stays, were implicated.