Altan Pharma Limited said the USPTO granted two patents to Altan covering its intravenous formulation of acetaminophen (paracetamol).
“U.S. Patent No. 9,943,479 covers Altan’s unique formulation, which allows the product to be packaged in a flexible plastic container and maintain stability throughout its approved shelf life,” said Altan Pharma.
“U.S. Patent No. 9,943,492 covers the process for manufacturing the product. These patents will provide U.S. patent protection for Altan’s intravenous formulation of acetaminophen until July 18, 2026.
“Traditional intravenous formulations of acetaminophen are extremely sensitive to oxygen, requiring them to be deoxygenated in the manufacturing process and to be packaged in glass vials to maintain stability throughout their approved shelf life.
“Altan has developed a unique formulation that does not need to be deoxygenated and can be packaged in flexible plastic containers, which are preferred by hospitals due to breakage and inventory management concerns of glass vials.”
Altan said it intends to file a 505(b)(2) application for approval of its intravenous formulation of acetaminophen with the FDA in the very near future.
Altan CEO Guillermo Herrera said: “We are very pleased that the USPTO has placed its stamp of approval on our unique IV formulation, and we look forward to registering and launching our first product in the U.S. market in the near future.
“U.S. hospitals and patients have been forced to pay inflated prices for intravenous acetaminophen compared to their European counterparts due to the exclusive supply situation in the U.S. Our goal is to bring a superior product to the U.S. market and to offer it to hospitals, patients and payors at a fair price.”