Glenmark Pharmaceuticals Inc., USA, has announced the launch of Methylene Blue Injection USP, 50 mg/10 mL (5 mg/mL) in a single-dose vial formulation.
The product is bioequivalent and therapeutically equivalent to the reference listed drug, ProvayBlue Injection, 50 mg/10 mL (5 mg/mL), developed by Provepharm.
Methylene Blue Injection is indicated for the treatment of acquired methemoglobinemia — a condition in which the blood is unable to effectively deliver oxygen throughout the body. The condition occurs when methaemoglobin is present in high levels in the blood.
Methaemoglobin is a form of haemoglobin, the protein in red blood cells responsible for carrying oxygen to tissues and organs. Unlike normal haemoglobin, methaemoglobin does not transport oxygen. While methaemoglobin normally exists in small amounts in the blood, elevated levels reduce the blood’s oxygen-carrying capacity, which can cause symptoms such as pale or blue-coloured skin
Acquired methemoglobinemia can develop following exposure to certain drugs or chemicals, including nitrites.
Methylene blue works by converting methaemoglobin back into a functional form of haemoglobin, helping restore oxygen delivery throughout the body.
Marc Kikuchi, President and Business Head, North America, said the launch of Methylene Blue Injection USP reflects Glenmark’s continued focus on improving access to quality and affordable medicines for healthcare institutions and patients across the US.
“This addition further strengthens our institutional portfolio and reinforces our focus on delivering reliable treatment options across the US market,” he added.
According to IQVIA data for the 12 months ending April 2026, the ProvayBlue Injection recorded annual sales of approximately USD 19 million in the US market.
