Product Launch Details

Glenmark Pharmaceuticals Inc., USA (Glenmark) announced the launch of Methylene Blue Injection USP, 50 mg/10 mL (5 mg/mL) Single-Dose Vial. The product is bioequivalent and therapeutically equivalent to the reference listed drug, ProvayBlue® Injection, 50 mg/10 mL (5 mg/mL), of Provepharm SAS [NDA 204630].

Market Size and Financial Context

According to IQVIA® sales data for the 12-month period ending April 2026, the ProvayBlue® Injection, 50 mg/10 mL (5 mg/mL) market achieved annual sales of approximately $19.0 million. This market data includes both brand and all available therapeutic equivalents.

Strategic Commentary

Marc Kikuchi, President & Business Head, North America, commented: "The launch of Methylene Blue Injection USP reflects Glenmark's ongoing commitment to expanding access to quality, affordable medicines for healthcare institutions and the patients they serve. This addition further strengthens our institutional portfolio and reinforces our focus on delivering reliable treatment options across the U.S. market."

Important Qualifications

  • Glenmark's Methylene Blue Injection USP is only approved for the indication(s) listed in Glenmark's approved label
  • The product may have different approved indications than the reference listed drug
  • IQVIA® data was obtained for all approved RLD indications, but Glenmark's product will only be marketed for its approved label indications
  • Market data includes both retail and non-retail channels as per IQVIA® National Sales Perspectives

Company Background

Glenmark Pharmaceuticals Ltd. is a global, research-led pharmaceutical company with 11 world-class manufacturing facilities across four continents, supported by six cutting-edge R&D centres, and a commercial footprint in 80+ countries. The company delivers a diversified portfolio across branded, innovative, generics, and consumer health products, with a focus on respiratory, dermatology, and oncology. Scrip 100 positions Glenmark among the Top 100 biopharmaceutical companies globally by pharmaceutical sales for 2024.