Lannett Receives Approval for Esomeprazole Magnesium Delayed-Release Capsules

Lannett has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg and 40 mg, the therapeutic equivalent to the reference listed drug, Nexium Delayed-Release Capsules, 20 mg and 40 mg, a.k.a. "the purple pill," of AstraZeneca Pharmaceuticals. For the 12 months ended July 2017, total U.S. sales of Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg and 40 mg, at Average Wholesale Price (AWP) were approximately $1.4 billion, according to IMS.

"The approval for Esomeprazole Magnesium Delayed-Release Capsules demonstrates our ability to develop high quality, complex formulations," said Arthur Bedrosian, chief executive officer of Lannett. "This approval, our seventh thus far in 2017, comes from our wholly owned subsidiary, Kremers Urban Pharmaceuticals. I commend our regulatory, R&D, legal, production, supply chain and staff for this approval of a Paragraph IV product. Our sales team will now begin to utilize their skills, as they always do, to gain market share. A number of competitors are currently marketing the product; we anticipate launching ours in the next several months."