The "authorized generic" half-price version of Mylan NV's allergy shot EpiPen will be available "by the end of the year," Mylan spokesman Nina Devlin said in an email Monday, months later than a timeline the company gave in August.
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."
Congress has targeted Mylan for increasing the list price of the EpiPen more than sixfold since 2007, to over $600 for a package of two. In response, Mylan announced the cheaper generic version.
Devlin declined to be any more specific about when the $300 generic version would be available.
Drugmakers don't need the formal approval of the U.S. Food and Drug Administration to take an authorized generic product to market, according to the agency's website, though they do have to notify the agency. An authorized generic drug is identical to the original version, though without the brand name on the label, according to the FDA.
Sandy Walsh, an FDA spokesman, didn't immediately respond to a request for comment on the status of Mylan's generic.
Pfizer Inc., which manufacturers the brand version of EpiPen for Mylan, has not announced any manufacturing difficulty that could delay production of an authorized generic.
Last month, at a hearing of the House Committee on Oversight and Government Reform, lawmakers grilled Mylan Chief Executive Officer Heather Bresch 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 underrepresented Mylan's profits.
The stock fell 23 cents to close Tuesday at $37.97 in New York.
Information for this article was contributed by Anna Edney of Bloomberg News.
Business on 10/05/2016