Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Methylene Blue Injection, 10mg/2ml and 50mg/5ml. Zydus’ Methylene Blue Injection, 10mg/2ml and 50mg/5ml. is the generic version of the Reference Listed Drug (RLD) ProvayBlue Injection.
The majority of current market usage is still on the ampoule presentation whereas Zydus is offering a generic version of Methylene Blue injection in vial presentation.
Methylene Blue Injection is an oxidation-reduction agent indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia. Methylene Blue Injection, 10mg/2ml and 50mg/5ml had an annual sale of approximately $73.4 million in the United States (IQVIA MAT Oct-2023).