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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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Mylan effectively amended its patent certification for its 30 mg extended-release nifedipine from paragraph IV to paragraph III by entering into an agreement with Pfizer to market "authorized generic" variants of Procardia XL and failing to launch its own approved version of the drug, FDA said Feb. 6.

Mylan Nifedipine Settlement Revised Certification To Paragraph III, FDA Says

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Mylan Nifedipine XL Exclusivity Forfeited By Settling With Pfizer, Teva Says

Mylan's generic nifedipine extended-release tablets should no longer be eligible for 180-day exclusivity because of the company's patent litigation settlement with Pfizer, Teva told FDA in a citizen petition.

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