Opinion ID: 184920
Heading Depth: 2
Heading Rank: 2

Heading: Pfizer's Claims

Text: 8 The FDA approved Pfizer's new drug application for Procardia XLR in 1989 and listed it in the 1990 Orange Book as having the dosage form tablet, extended release; oral. As mentioned, the extended release mechanism in Procardia XLR is a patented osmotic pump. As fluid from the gastrointestinal tract enters the shell of the tablet, it dissolves the active ingredient, nifedipine, and causes a push layer to swell, thereby gradually expelling the nifedipine into the gastrointestinal tract through a hole in the shell. Compl. p 20. 9 In 1993 Pfizer filed a citizen petition with the FDA, pursuant to 21 C.F.R. § 10.30, asking the agency to recognize Pfizer's oral osmotic pump [as] a distinct dosage form.Pfizer also contended the agency must require a suitability petition if a generic drug uses a different mechanism of release from the reference drug. 10 The FDA had not ruled upon Pfizer's petition when, nearly four years later, Mylan submitted an ANDA for an extended release nifedipine tablet claiming pharmaceutical equivalence to Procardia XLR. The FDA accepted Mylan's application for processing even though its tablet uses a different extended release mechanism than does Procardia XLR. 11 After failing to persuade the agency to stay or to withdraw its acceptance of Mylan's ANDA, Pfizer filed this suit in the district court challenging that acceptance as arbitrary, capricious, and contrary to law. In a second count Pfizer repeated the claim, first made in its still-pending citizen petition, that the FDA was obliged to recognize its osmotic pump as a distinct dosage form. Shortly thereafter the FDA denied Pfizer's citizen petition. 12 The district court held that Pfizer's challenge to the FDA's receipt of Mylan's application was unripe because the agency had not yet decided whether to approve Mylan's generic drug.See Pfizer Inc. v. Shalala, 1 F. Supp. 2d 38, 44 (1998). On the other hand, the court held that the FDA's denial of Pfizer's citizen petition was final agency action, and therefore ripe for review. Id. On the merits of that claim, the district court upheld as rational and consistent with the statute the FDA's refusal to treat Pfizer's osmotic pump as a distinct form of dosage. See id. at 44-48.