Watson Pharmaceuticals’ subsidiary, Watson Laboratories, Inc., has filed an Abbreviated
New Drug Application (ANDA) with the FDA
seeking approval to market rasagiline mesylate 0.5 and 1.0 mg tablets.
Watson’s rasagiline mesylate tablets are generic versions of
Teva Neuroscience, Inc.’s Azilect Tablets, which are indicated for the treatment
of the signs and symptoms of idiopathic Parkinson’s disease as initial
monotherapy and as adjunct therapy to levodopa.
Teva Neuroscience, Inc., Teva Pharmaceuticals USA, Inc. and
Teva Pharmaceutical Industries Ltd. filed suit against Watson on October 1, 2010
in the United States District Court for the District of New Jersey
seeking to prevent Watson from commercializing its product prior to the
expiration of U.S. Patent No. 5,453,446. Teva’s lawsuit was filed under the
provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval
of Watson’s ANDA until November 16, 2013 or until final resolution of the
matter before the court, whichever occurs sooner, subject to any other
Based on available information, Watson believes it may be a
“first applicant” to file an ANDA for the 0.5 and 1.0 mg generic
versions of Azilect and, should its ANDA be approved, may be entitled to 180
days of shared generic market exclusivity with other ANDA applicants that filed
on the same day as Watson. For the twelve months ending June 30, 2010, Azilect
had total U.S.
sales of approximately $108 million according to IMS Health data.