Wyeth filed suit against Watson on March 12, 2008 in the U.S. District Court, District of Delaware, seeking to prevent Watson from commercializing its product prior to the expiration of U.S. patent number 6,500,814. Wyeth's suit was filed under the provisions of the Hatch Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA for up to 30 months or until final resolution of the matter before the court, whichever occurs sooner. Based on available information, Watson believes it may be the first applicant to file an ANDA for LYBREL(R) and, should its product be approved, may be entitled to 180 days of generic market exclusivity.
Watson Files FDA Application for Generic LYBREL(R)
Wyeth filed suit against Watson on March 12, 2008 in the U.S. District Court, District of Delaware, seeking to prevent Watson from commercializing its product prior to the expiration of U.S. patent number 6,500,814. Wyeth's suit was filed under the provisions of the Hatch Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA for up to 30 months or until final resolution of the matter before the court, whichever occurs sooner. Based on available information, Watson believes it may be the first applicant to file an ANDA for LYBREL(R) and, should its product be approved, may be entitled to 180 days of generic market exclusivity.
Subscribe to:
Post Comments (Atom)
No comments:
Post a Comment