ALLEGAN — The generic drug and over-the-counter health product manufacturer Perrigo Co. (Nasdaq: PRGO) announced that it has agreed to settle its Hatch-Waxman litigation relating to Acetadote (acetylcysteine) injection brought by Cumberland Pharmaceuticals Inc.
Under the terms of the settlement, Perrigo can launch a generic version of Acetadote injection upon expiration of the patents in May 2026. In addition, Perrigo entered into an agreement with Cumberland wherein Perrigo can distribute Cumberland sourced authorized generic product upon generic market formation.
Acetadote, administered intravenously within 8 to 10 hours after ingestion of a potentially hepatotoxic quantity of acetaminophen, is indicated to prevent or lessen hepatic injury and has annual sales of approximately $41 million, as measured by Wolters Kluwer.
“This settlement is another example of our long-term investment in extended product development,” said Perrigo chairman and CEO Joseph C. Papa. “As always, Perrigo is committed to making quality healthcare more affordable for our customers.”
From its beginnings as a packager of generic home remedies in 1887, Perrigo has grown to become a global provider of over-the-counter and generic prescription pharmaceuticals, nutritional products and active pharmaceutical ingredients and is the world’s largest manufacturer of over-the-counter pharmaceutical products for the store brand market.