EpiPen set to lose $800M in sales by 2018, thanks to new rivals, authorized generic: analyst

Months of negative headlines over Mylan’s EpiPen price hikes may catch up to the company in a big way. In new projections, a leading biopharma analyst says the lifesaving epinephrine injector is set for a substantial decline through 2018.

Competition to EpiPen is “coming quickly” via Kaleo’s Auvi-Q, which is set to launch in the first half of this year, according to Bernstein’s Ronny Gal—something that might not have happened without the much-publicized price hikes that put patients on the hunt for lower-cost alternatives.

Plus, Adamis has refiled its own potential rival, after an FDA rejection convinced former partner Teva to abandon the project and transfer away the rights, Gal pointed out.

And so far, “at least one large distributor is apparently not carrying” Mylan’s authorized generic version of EpiPen, Gal wrote in a Monday note. The company introduced that generic product to quell the surge of pricing criticism. Bernstein predicts the key product will reel in $300 million in 2018, down from its $1.1 billion estimate for 2016.

On the upside, however, Mylan has offered distributors “minimal discounts” on its new authorized generic, “presumably discounting primarily to PBMs to get preferred/exclusive position.”

And Mylan could be working on a bigger answer. The company is planning to offer EpiPens through its own pharmacy, according to Bloomberg, which would cut out the pharma middlemen CEO Heather Bresch blames for incentivizing high drug prices. According to Mylan’s website, the company set up Mylan On Location “to help businesses, organizations and institutions offer immediate care in emergency situations.” EpiPen is the first product available on the program.

Mylan is also pushing to expand the product’s reach by lobbying for “entity prescription” legislation around the country that would allow public places such as restaurants and parks to purchase and store EpiPens.

Back in August, lawmakers began taking the company to task over repeated price hikes for the big-selling EpiPen. Since then, Mylan has faced multiple investigations and agreed to pony up $465 million to settle claims that it overcharged Medicaid. Last month, the company announced it would lay off less than 10% of its global workforce, potentially translating to thousands of jobs on the chopping block.

As the criticisms mounted on Mylan in October, privately held kaléo said it planned to resurrect its competing product, Auvi-Q, which was previously taken off the market after a recall when marketing partner Sanofi pulled out.

In response to the pricing firestorm, Mylan boosted its access programs and rolled out an authorized generic at half the price. That hit shelves last month.