Pfizer Inc v. Shalala, Donna E.
Court of Appeals for the D.C. Circuit
1Opinion of the Court
Opinion for the Court filed by Circuit Judge GINSBURG.
GINSBURG, Circuit Judge:
Pfizer, Inc. manufactures and sells the pioneer drug Procardia XL®, which contains the active ingredient nifedipine, a calcium-blocker used to treat angina and hypertension. Procardia XL® uses a patented “osmotic pump” to control the extended release of nifedipine. Mylan Pharmaceuticals, Inc. filed an abbreviated new drug application (ANDA) with the Food and Drug Administration seeking approval of its own extended release nifedipine product as a generic “pharmaceutical equivalent” to Procardia XL®; Mylan’s product,…
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