Methylene Blue Injection is an oxidation-reduction agent indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia. The drug is the generic version of the reference listed drug (RLD) Provay Blue injection.

The majority of current market usage is still on the ampoule presentation whereas the company is offering a generic version of Methylene Blue injection in vial presentation. From a hospital perspective, vial presentation is an affordable option with significant benefit and advantage. Vial presentation has no risk of glass particulate contamination like in ampoules and provides various benefits like ease of use, handlings and flexible option with reduced dose waste, said the firm.

Dr. Sharvil Patel, managing director of Zydus Lifesciences, “Zydus is pleased to introduce Methylene Blue injection, 10mg/2ml and 50mg/5ml in the U.S., continuing our commitment to supply affordable complex generic medications to patients in need and strengthening the U.S. supply chain of care.

According to IQVIA MAT Oct-2023, Methylene Blue injection had an annual sale of approximately $73.4 million in the United States.

In a separate filing, the drug maker said that Sentynl Therapeutics, Inc. (Sentynl), a U.S.-based biopharmaceutical company, wholly-owned by Zydus Lifesciences announced the execution of an assignment and assumption agreement with Cyprium Therapeutics, Inc. (Cyprium), a Fortress Biotech, Inc subsidiary company.

Under the agreement, Cyprium completed the transfer of its worldwide proprietary rights and U.S. FDA documents pertaining to CUTX-101, the copper histidinate product candidate for the treatment of Menkes disease, to Sentynl.

The firm stated that Sentynl now assumes full responsibility for the development and commercialization of CUTX-101. A rolling submission of the CUTX-101 new drug application (NDA) to the FDA is ongoing, with expected completion in 2024, it added.

Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.

The company consolidated net profit surged 53.2% to Rs 800.7 crore in Q2 FY24 as compared with Rs 522.5 crore posted in Q2 FY23. Revenue from operations rose 9.1% YoY to Rs 4,368.8 crore during the quarter ended 30 September 2023.

Shares of Zydus Lifesciences rose 0.65% to Rs 637.60 on the BSE.