Teva/Biovail nifedipine XL
Executive Summary
ANDA is approved for 60 mg dosage of the antihypertensive. Teva has exclusive license to market Biovail's nifedipine in the U.S., and plans to launch the drug immediately with 180-day exclusivity. The Sept. 27 approval follows the expiration of the 30-month Waxman/Hatch stay associated with the patent infringement lawsuit filed against Biovail by Procardia XL marketer Pfizer; the suit is still pending in U.S. Federal District Court in Puerto Rico. Mylan currently markets the 30 mg, 60 mg, and 90 mg doses of nifedipine as an "authorized" generic as part of a patent litigation settlement with Pfizer. Teva recently sent a citizen petition to FDA arguing that the settlement negates Mylan's right to 180-day exclusivity for the 30 mg dose (1"The Pink Sheet" Sept. 4, p. 23)
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