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FOREST's PROPRANOLOL SR GAINS 180-DAY EXCLUSIVITY

Executive Summary

FOREST's PROPRANOLOL SR GAINS 180-DAY EXCLUSIVITY until Oct. 24 under a May 12 ruling by the District of Columbia federal court. Forest's generic marketing arm Inwood sued FDA April 11 after Forest became the first firm to receive ANDA approval to market the sustained release generic of Ayerst's Inderal LA. Forest challenged the Inderal LA patent but was not sued by Ayerst for infringement. FDA denied Forest generic exclusivity, asserting that under the exclusivity statute a company must have been sued for patent infringement in order to obtain exclusivity, in addition to being the first applicant to submit a paragraph IV certification of noninfringement. However, the court decided that Forest deserved the exclusivity award despite not being sued by Ayerst. FDA's interpretation of the patent/ANDA law "ignores the contribution that manufacturers such as Inwood make by submitting documentation to a patent holder which is so detailed and persuasive that the patent holder decides not to file a lawsuit," the opinion states. The court added that "such a contribution is equally valuable in terms of opening up the market to generic competition." The District of Columbia federal court's finding stands in direct opposition to a decision handed down by the Clarksburg, West Virginia federal court May 5 on Mylan's prazosin approval. The West Virginia court upheld FDA's interpretation that a company must be sued for patent infringement to obtain exclusivity. Mylan was denied exclusivity, however, because it was not the first applicant to file an ANDA and certify that its proposed product would not infringe the patent of the reference product ("The Pink Sheet" May 15, T&G-8). The D.C. court also objected to FDA's reading of the statute because requiring a patent infringement suit "places the decision as to whether a generic manufacturer will be entitled to exclusivity entirely in the hands of the patent holder." Furthermore, the opinion explains, "if the patent holder chooses to sue only the second, the third or the fifth applicant, the rather bizarre result will be that no one is entitled to exclusivity," as in the Mylan case. The court conceded that the ruling may delay the entry of subsequent generics to the market, but said "this potential problem . . . does not give the FDA or this court a license to read into the present, clear language of [the statute] a requirement of a suit for patent infringement that is simply not there." Forest said it will begin shipping propranolol "within the next one to two weeks." The company will sell its drug in 60, 80, 120 and 160 mg doses. Although the firm has not released prices for the generic, it estimates that the drug will cost roughly 60% of the current price of Inderal LA, which generates approximately $ 100 mil. in annual sales, according to Forest.
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