Mylan’s flagship EpiPen device is in shortage in the U.S.

Mylan’s (MYL) billion dollar emergency allergy treatment injector EpiPen is now being added to the list of medications in short supply by the U.S. Food and Drug Administrations, after several consumers in the U.S. with allergies found it difficult to find Mylan’s allergy device.

The pharma company that received several criticisms last year for raising the price of EpiPen is back in the spotlight again. Mylan stated that customers in the U.S. will find it difficult to find Epipen as well as the other treatment epinephrine auto-injectors. Before the U.S., the shortage for the device was plaguing other countries like the U.K. and Canada. Mylan has no definite timeline as to when the shortage of the emergency shot would end.

Is it due to the recall of thousands of EpiPen devices last year?

Last year, Mylan recalled its EpiPen devices both in the U.S. as well as other countries (80,000 devices), after the device proved to be ineffective in emergencies. Last September, the FDA slammed Pfizer’s (PFE) that was responsible for manufacturing the EpiPens for Mylan.

FDA had even attacked Mylan for not taking any action against the numerous complaints it received on EpiPen. Though not much known whether the current shortage of the devices is due to the recall made last year, the issue is said to be related to manufacturing problem.

Alternatives to EpiPen

Food Allergy Research and Education (FARE) has urged the FDA to approve more alternatives to EpiPen.

Currently, the cheaper alternative to EpiPen is CVS Health’s (CVS) Adrenaclick, the generic version. Last year, the FDA also approved Symjepi that is manufactured by Adamis Pharmaceuticals Corp. (ADMP). However, the treatment is not available in the market yet. Just this month, there was a new treatment available mainly for infants, Auvi-Q, which was developed by Richmond-based private firm Kaleo. These alternatives will benefit the most as Mylan’s blockbuster treatment is hit by the shortage.

Impact on Mylan

Yesterday, Mylan reported revenues that fell below analysts’ expectations. This was mainly due to the decline in the sales of EpiPen and stiff competition in North America. Shares of Mylan rose 3.5% in today’s morning session despite the weak quarterly results.

There was a time when Mylan’s EpiPen controlled most of the market share. But gradually it lost the market share to much cheaper alternates as Epipen had 500% price hike. The lower demand of EpiPen was one of the reasons for the 19% slump in North American sales during the recently ended quarter.