After a several-year delay, Teva received U.S. approval for its EpiPen in August 2018, but Schultz said more “validations” were mandated by the U.S. Food & Drug Administration, which it has completed.

(February 20, 2019 / JNS) Teva Pharmaceutical Industries has projected that its generic version of the Mylan EpiPen will consist of about one-quarter of the U.S. market by the end of 2019, announced CEO Karen Schultz on Tuesday.

“When the device’s approval was announced last year, analysts suggested it could add $250 million to Teva’s annual revenue and 4-6 cents per share in earnings, providing a welcome lift for a company that has fired thousands of employees and worked to reduce its debt load to $27 billion from $35 billion,” reported Reuters.

The EpiPen, short for epinephrine auto-injector, is a medical device that injects doses of adrenaline for those who have severe allergies.

Mylan, which was subjected to backlash for drastically increasing the price of its EpiPen almost a few years ago, also manufactures a generic version of the device that, like Teva’s, costs around $300.

The U.S. EpiPen market is valued at around $750 million annually.

After a several-year delay, Teva received U.S. approval for its EpiPen in August, but Schultz said more “validations” were mandated by the U.S. Food & Drug Administration, which it has completed.

Schultz added that although any pharmacy can acquire Teva’s products, the firm does not have enough of a supply for pharmacies and retailers.

“We will be filling up the supply chain more and more over the coming months,” said Schultz, who estimated that his business could consist of 50 percent of the market share by the end of next year.