Mylan nifedipine XL
FDA grants final approval to 30 mg generic version of Pfizer's Procardia XL following the expiration of the 30-month stay of approval in extended-release nifedipine patent litigation. Mylan has not yet determined whether it will launch the drug before the patent suit is resolved. The company has been sued by Pfizer and by Bayer, the patent holder and manufacturer of controlled-release nifedipine product Adalat CC. The patent case is pending in Pittsburgh district court, where it is expected to be reviewed in mid-December. Mylan will have 180 days of generic exclusivity after launch
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Mylan will begin selling versions of all three dosage strengths of nifedipine extended-release tablets supplied by Pfizer under a patent litigation settlement. Pfizer is expected to begin shipping the product to Mylan the week of March 20. Mylan received approval in December for a 30 mg dose but launch was delayed pending litigation (1"The Pink Sheet" Dec. 20, 1999, In Brief). Mylan will pay royalties to TIMERx controlled-release technology developer Penwest on sales of the 30 mg dose. Pfizer licenses the hypertension and angina treatment from Bayer. A suit against Mylan by Bayer, which manufactures the product in Europe as Adalat, has yet to be resolved. However, Mylan notes the company will be entitled to market the applicable products supplied by Pfizer "irrespective of the fate of its litigation with Bayer"
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