The march of the authorized generic deal continues with two new pacts between brand-name drugmakers and their copycats. In both cases, the generics makers will be able launch their versions of the branded drugs before they officially go off patent.
First, there's Novartis and Mylan, which have inked an agreement on the breast cancer treatment Femara. Mylan will be able to sell versions of the drug before the patents begin to expire in 2011. Mylan says it was the first to ask the FDA to OK its copy of Femara, which would give it 180 days of marketing exclusivity on the generic form. That's worth a substantial amount of moolah, because that first generic usually carries a higher price tag than the copies do once several companies are competing. Femara brought in about
$470 million in U.S. sales over the 12 months ended Sept. 30, Mylan said.
Next, there's Medicis Pharmaceutical and Impax Laboratories, which have cut a deal on a generic version of the acne drug Solodyn. Impax had filed for FDA approval on a copycat version, prompting a patent fight, but under this settlement, Impax gets the right to sell a copycat drug by November 2011.
Impax will pay royalties to Medicis on Solodyn sales. Plus – and this is the innovative part of the deal–Medicis and Impax will work together to develop five dermatology products, including a new-and-improved Solodyn. Impax will get $40 million up front and $23 million in milestone pay6ments, plus royalties on Solodyn II.