New FDA Approved Generic EpiPen to Hit the Market: What That Means for Mylan

New FDA Approved Generic EpiPen to Hit the Market: What That Means for Mylan

The first generic version of the EpiPen, a lifesaving treatment for use during severe allergic reactions, was approved by the Food and Drug Administration in August of 2018. This means that Mylan, the maker of the brand-name version, now faces serious competition from Teva Pharmaceuticals, the generic device’s manufacturer.

In 2016, Mylan came under fire for a series of price hikes on its EpiPen. It didn’t take long before the company released its generic version of the medication to deliver an emergency dose of epinephrine to counteract anaphylaxis during a severe allergic reaction. It wasn’t enough to silence the outrage of patients, the government, and its watchdogs.

It was during this time, between 2010 and 2016, that Mylan had to defend its motives repeatedly when it raised EpiPen prices by 400% between those years, according to federal investigators. In 2009, the price of a two-pack of injection pens was about $100; in 2016, it had increased to $600 for the same two-pack of pens. The generic version Mylan released in December of 2016 still was set at a wholesale cost of $300.

Mylan also eventually settled to repay $465 million after a lawsuit by the government stated that the company overcharged for treatment. The company also cut its earnings outlook thereafter and is reportedly considering “alternatives.”

Mylan had also been criticized for incorrectly classifying its EpiPen as a generic treatment for the Medicaid Drug Rebate program, which meant that the company supplied lower rebates to state health programs than it should have.

“Americans are rightfully concerned about rising drug prices, and now more than ever patients and families across this country are standing at the pharmacy counter struggling to pay for their medications,” Mylan CEO Heather Bresch said in a statement back in 2016.

The new generic EpiPen by Teva, however, is the first approved by the FDA not made by Mylan. The Trump administration describes the approval as being reflective of its commitment to increasing the speed of FDA medication approvals.

FDA Commissioner Scott Gottlieb said, “This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages.”

Teva said the treatment’s approval “marks an important step forward in bringing our patients additional prescription medications that have met the FDA’s rigorous standards. We’re applying our full resources to this important launch in the coming months and eager to begin supplying the market.”

Critics have pointed the finger at Mylan for years for exorbitant price gouging, one of many giant price increases that are becoming “the norm” in the pharmaceutical industry. While a spokesperson for Mylan has not been available for comment on the competitor’s generic EpiPen rival, the company did announce last year that it is considering a significant shift in corporate strategy – could that ultimately lead to a sale?


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By |2019-06-20T20:51:19+00:00May 10th, 2019|

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Byron Mignanelli

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