proportion to the plaintiffs operations that the loss of the amount of money involved would ... cause extreme hardship to the business, or even threaten destruction of the business”). In the instant case, although the plaintiff has indicated that sales of Prograf® account for a sizable percentage of its U.S. revenues, Pl.’s Mot. at 26, it has failed to demonstrate how the introduction of generic tacrolimus would cause extreme hardship to the business or threaten its very existence, see Gulf Oil, 514 F.Supp. at 1026. The plaintiff has not indicated to what extent it predicts its revenues will decline following the introduction of generic tacrolimus or how such a decline would affect its overall business operations. See Mead Johnson Pharm. Group v. Bowen, 655 F.Supp. 53, 56 (D.D.C.1986) (<HOLDING>); see also Mylan Pharm,., 81 F.Supp.2d at 42-43
holding that the district court erred when it failed to consider the presumption of irreparable harm holding that a movant for a preliminary injunction must first demonstrate that it is likely to suffer irreparable harm in the absence of the requested relief holding that a drug manufacturer failed to demonstrate irreparable harm because its claim that it will suffer a loss of sales should an anda be approved and drug product marketed before this case is disposed of on the merits is pure speculation as it had failed to provide any proof of economic loss and merely states that it would probably lose 20 to 30 percent of its market during the first year holding that the plaintiff failed to establish irreparable harm because there is nothing before the court which would lead it to conclude that the competing drug will cause any harmful health effects holding that proof of loss is not evidence of extent of loss and insured is not precluded from showing his damages were greater than shown in proof of loss