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Oct 19, 2006

Pfizer Can Assert Only One of Two Patents in Litigation Against Mylan

  • Mylan Laboratories reported that the U.S. District Court for the Western District of Pennsylvania granted its motion to dismiss the '909 patent from the pending infringement litigation with Pfizer over the hypertension drug Norvasc®. The other patent involved in this lawsuit, scheduled to begin on November 28, 2006, is U.S. Patent No. 4,879,303, which includes improved pharmaceutical salts of amlodipine, particularly the besylate salt, and pharmaceutical compositions thereof.

    In the decision, the court ruled that "because the '909 patent has now expired, the rights secured by the patent are no longer protectable, and entitlement to injunctive relief becomes moot, because such relief is no longer available."

    Mylan reported final approval to it’s ANDA for Amlodipine Besylate tablets, the generic version of Pfizer's Norvasc tablets , 2.5 mg (base), 5 mg (base), and 10 mg (base), on October 4, 2006. Mylan is eligible for 180 days of market exclusivity, because the FDA found that it was the first generic company to file on all strengths of Norvasc Tablets. The exclusivity will begin with the commercial launch of the Mylan product or a final court decision on this litigation, which ever comes first.

    U.S. sales of Norvasc were approximately $2.7 billion for the 12-month period ended June 30, 2006, according to IMS Health.



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