Cheaper EpiPen May Not Come Until End of Year, Mylan Saysby
In August, company said $300 two-pack could be out in ‘weeks’
Company says it needs to assure inventory, create packaging
Mylan NV’s half-price version of its EpiPen allergy shot may not be available until the end of the year, the drugmaker said in an e-mail, potentially months after a timeline the company gave in August.
The “authorized generic” version of EpiPen will be available “by the end of the year,” Mylan spokeswoman Nina Devlin said in an e-mail Monday. Five weeks ago, in a statement on Aug. 29, the company had said it expected to introduce the generic version “in several weeks.” Mylan’s generic version will cost $300 for a two-pack, about half the brand-version price.
“We expect to launch this year once we have assured that sufficient inventory will be available to meet anticipated orders, created the necessary packaging for the product, and created the necessary labeling for the product,” Devlin said. “We are diligently working to complete these efforts in order to provide the generic as soon as possible.”
Mylan has attracted the opprobrium of Congress by increasing the list price of the EpiPen more than six-fold since 2007, to over $600 for a package of two. To quell the growing furor over EpiPen’s price, it announced the cheaper authorized generic version.
Devlin declined to be any more specific about when the $300 generic version would be available.
Drugmakers don’t need advance approval by the U.S. Food and Drug Administration to bring an authorized generic product to market, Theresa Eisenman, an FDA spokeswoman, though do have to notify the agency in an annual report.
Pfizer Inc., which manufacturers the brand version of EpiPen for Mylan, has not announced any manufacturing issue that could delay production of an authorized generic.
Last month, at a hearing of the House Committee on Oversight and Government Reform, Mylan Chief Executive Officer Heather Bresch faced skeptical lawmakers who grilled her over the drugmaker’s profits and executive pay. At the hearing, she said Mylan makes $100 in profit on each pair of EpiPens. But in a Sept. 30 letter demanding more detailed information from Mylan, lawmakers said that figure included tax assumptions that may have under-represented Mylan’s profits.
As of Monday’s close, Mylan’s shares were down 21 percent since Aug. 19, the last day of trading before lawmakers began questioning the drugmaker’s EpiPen pricing. The stock fell less than 1 percent to $37.88 at 1:56 a.m. in New York on Tuesday.