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EpiPen Shortage Could Give New Generic Rival a Boost

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Mylan NV’s EpiPen is still hard to find at many pharmacies, three months after U.S. authorities declared that the lifesaving allergy device was in shortage, a survey by Wells Fargo & Co. showed.

The finding comes a day after Teva Pharmaceutical Industries Ltd. gained Food and Drug Administration approval to sell a generic version of Mylan’s epinephrine autoinjector.

Wells Fargo analysts reached out to 53 pharmacies across the country on Thursday and found that 66% were out of stock of Mylan’s EpiPens, not including EpiPen Jr., analyst Davis Maris said in a note Friday. Fifty-five percent of the pharmacies were out of all types of Mylan EpiPen and EpiPen Jr, which is meant for kids who weigh 33 pounds (15 kilograms) to 66 pounds.

(Related: Patients Can’t Find EpiPen at Pharmacy Amid Supply Shortage)

Teva hasn’t said when it will begin shipping generic EpiPens. Antares Pharma Inc., which has a deal with Teva to make the devices for the generic shot, has sent $22 million worth of the autoinjectors to the Israeli drugmaker for launch, Jack Howarth, a spokesman for Antares said in an email. Teva must supply the active ingredient ephinephrine to go into the device. Teva hasn’t said how much it will charge for its generic EpiPen.

Mylan’s autoinjector was placed on the FDA’s shortage list in May after more than 400 patients in 45 states reported difficulty filling prescriptions. What Mylan has characterized as “intermittent supply constraints” were due to manufacturing issues at Pfizer Inc.’s Meridian unit after it was warned by the FDA for failing to investigate hundreds of complaints about defective EpiPens, including cases where patients were hurt or died due to faulty injectors.

Pfizer has said it is confident in the safety of the product.

Antares works with a third-party to supply the autoinjectors to Teva, Howarth said. He declined to name the third-party but said it isn’t Meridian.

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“There is an EpiPen shortage – we believe this works in Teva’s favor,” Maris wrote.

Mylan and Pfizer didn’t immediately respond to requests for comment on the Wells Fargo report.

Mylan has faced competition from other similar autoinjectors — Impax Laboratories LLC’s Adrenaclick and Kaleo Inc.’s Auvi-Q. However, neither are considered generics for EpiPen, which meant that pharmacists couldn’t substitute them for the brand-name version. The two rivals haven’t sold nearly as well as EpiPen. Adrenaclick is also on FDA’s shortage list.

In July, Mylan’s products accounted for almost 75% of U.S. prescriptions for epinephrine autoinjectors — similar to its market share in 2017, according to data compiled by Bloomberg Intelligence. Maris said there is pent-up demand for the autoinjectors due to the shortage.

Mylan bought the rights to EpiPen in 2007, when it cost about $57 a shot. The Canonsburg, Pennsylvania-based drugmaker came under fire two years ago from patients and U.S. lawmakers for raising the price of EpiPen to $600 for a two-pack of the autoinjecting pens. Mylan then introduced an authorized generic version of its own device at $300 for a two-pack.

— Read U.S. to Make More Drugs Easily Available, Cutting Role Docs Playon ThinkAdvisor.

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