The patent wall protecting Eisai‘s (TYO:4523) blockbuster Alzheimer’s disease drug Aricept is crumbling fast with two more generics companies receiving U.S. Food and Drug Administration approval this week to take on the drug that Eisai manufactures at its Research Triangle Park, North Carolina facility.
Teva Pharmaceutical Industries (NASDAQ:TEVA) and Actavis have both received FDA approval on their products, which they said would begin shipping immediately. Aricept generates about $2.3 billion in U.S. sales, according to IMS Health data.
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Aricept’s patents expired last November and the first drugs company to market an Aricept generic was Ranbaxy, which had 180 days of marketing exclusivity. With those six months passed, generics competitors are now aggressively rolling out their own products to snatch a piece of the market.
Eisai had attempted to extend the Aricept’s patent life with a new formulation that delivered the drug through a skin patch. But in April, Eisai’s drug partner Teikoki Pharma was told by the FDA that the agency could not approve the companies’ skin patch application.
Eisai has taken other steps to fend off generics companies. Last September, the company entered into an agreement with Pfizer (NYSE:PFE) subsidiary Greenstone to sell an “authorized generic.” While generics companies must file an abbreviated new drug application with the FDA and get approval before marketing their drugs, authorized generics are made under the already approved new drug application. These drugs are essentially the same as the branded product, but a drug company typically reaches an arrangement with another company to sell them under a generic name.
With its authorized generic of Aricept, Eisai will be able to take some of the sales that would have gone to its generic competitors. But it won’t make nearly as much money as it did selling branded Aricept. Alzheimer’s disease patient advocates purchasing the Greenstone generic Aricept have reported savings up to 66 percent off of the branded drug.