Teva disclosed in a regulatory filing to the Tel Aviv stock exchange on Tuesday that it expects the US launch of its generic version of Mylan's EpiPen (epinephrine) auto-injector to be "significantly delayed" until at least 2017.
The Israeli company noted that the FDA identified "major deficiencies" in its application, issuing the drugmaker a complete response letter on February 23. Teva indicated that it intends to submit a response to the agency.
According to Evercore ISI analyst Umer Raffat, the delay may boost Mylan's 2017 earnings by $0.20 a share, adding "if there is a longer delay, outer year estimates may need more meaningful revision." Raffat noted that analysts had forecast erosion of $200 million in EpiPen sales in 2017.
Sales in Mylan's specialty drug unit, which includes revenue from EpiPen, rose 5 percent  to $254.1 million in the fourth quarter. The company said that sales of EpiPen grew following Sanofi's recall  of the competing product Auvi-Q (epinephrine) over possible inaccurate dose delivery.