DUBLIN--(BUSINESS WIRE)--Altan Pharma Limited (“Altan”), an Irish specialty pharmaceutical company, today announced that the United States Patent and Trademark Office (“USPTO”) has 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. 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 intends to file a 505(b)(2) application for approval of its intravenous formulation of acetaminophen with the FDA in the very near future.
According to IMS, the U.S. market for intravenous formulations of acetaminophen in 2017 was approximately $300 million with only one supplier. “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,” said Guillermo Herrera, CEO of Altan. “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,” continued Herrera. Altan’s unique intravenous formulation of acetaminophen has been commercialized in Europe and numerous other countries over the past 10 years with over 100 million units sold since launch.
Altan already holds patents on its formulation of intravenous acetaminophen in Canada, Japan, Australia, South Africa, France, Germany, Spain, Italy, and the UK as well as most other European countries.
About Altan Pharma Ltd.
Altan Pharma Ltd. is a privately held, specialty pharmaceutical company that develops, manufactures and commercializes injectable drugs for the hospital and other provider segments. Altan has a broad geographic footprint covering many European, Latin American and Asian markets. The company is highly focused on building its pipeline of injectable drugs and expanding its commercial presence to new markets through both organic and inorganic means.
Forward Looking Statements
This press release contains “forward-looking statements” subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict, including the difficulty of predicting FDA approvals, acceptance and demand for pharmaceutical products, the impact of competitive products and pricing, new product development and launch, the regulatory environment, etc. This press release is made only as of the date hereof, and unless otherwise required by applicable securities laws, Altan disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
For more information visit www.altanpharma.com