Amlodipine besylate tablets are the generic version of Pfizer's Norvasc tablets. The patent on amlodipine besylate was one of two patents covered in the litigation scheduled to begin in November 2006.
The court denied Pfizer's attempt to include the patent in the litigation because the patent has already expired.
The FDA has already granted Mylan final approval for its abbreviated new drug application for amlodipine besylate. The FDA also confirmed that Mylan was the first generic company to file on all strengths of Norvasc Tablets and is therefore eligible for 180 days of market exclusivity.
Pfizer's Norvasc tablets had US sales of approximately $2.7 billion for the 12-month period ended June 30, 2006, according to IMS Health.