The Federal Circuit Court of Appeals in Washington DC, USA, has affirmedthe Pharmaceutical Resources' summary judgement victory in its case against Bristol-Myers Squibb over megestrol oral suspension, leading the generics firm to suggest that it will be able to begin marketing the product "very shortly." However, it also notes that B-MS has the option of requesting a rehearing of the case.
"Launch is anticipated to begin sometime in the third quarter, depending upon the ruling of the appellate court on any rehearing petition," said Pharmaceutical Resources.
Megestrol oral suspension, which B-MS markets as Megace, had sales in 2000 of $180 million, an increase of 58% over the prior year, according to Pharmaceutical Resources. The product is indicated for the treatment of anorexia, cachexia, or an unexplained significant weight loss in patients with a diagnosis of AIDS. The generics firm believes it is the first to file for approval of megestrol oral suspension, entitling it to 180 days of exclusivity on the US market following the drug's full approval.
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