Teva Says Its Generic EpiPen Will Be 'Significantly Delayed'

Teva Pharmaceutical Industries Ltd (ADR) (NYSE: TEVA) announced in a regulatory filing on Monday that it has received notice from the U.S. Food and Drug Administration (FDA) related to its epinephrine.

Teva said that the FDA identified "certain major deficiencies" and now expects its epinephrine product to be "significantly delayed." Any launch will not take place prior to 2017.

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Bloomberg, citing a research report by Evercore ISI's Umer Raffat, stated that Mylan NV (NASDAQ: MYL) could see its earnings boosted by 20 cents a share as Teva's FDA announcement implies Mylan's EpiPen injector won't see any competition.

Bloomberg added that EpiPen is Mylan's specialty division's "main product," and Wall Street analysts were forecasting an erosion of $200 million in EpiPen sales in 2017 from Teva.

"If there is a longer delay, outer year estimates may need more meaningful revision," Bloomberg quoted Raffat as saying.

Shares of Mylan were trading higher by 1.09 percent at $45.56 Tuesday afternoon.