- In June 2024, Indoco Remedies received tentative approval from the USFDA for its Abbreviated New Drug Application (ANDA) for canagliflozin and Metformin Hydrochloride Tablets, a generic version of Invokamet in various dosages. This approval will enable the company to expand its product portfolio and tap into the growing demand for affordable diabetes treatments in the U.S. market
- In November 2023, Lupin Limited has received tentative approval from the U.S. FDA for its Abbreviated New Drug Application for canagliflozin and Metformin Hydrochloride Extended-Release Tablets, a generic version of Janssen’s Invokamet XR Tablets in various dosages. This approval will enable Lupin to enter the competitive U.S. market for diabetes treatments, boosting its revenue from generics and expanding its product portfolio
- In July 2023, Menarini has become the exclusive distributor of INVOKANA (canagliflozin) and VOKANAMET (canagliflozin and metformin) in the UK and Northern Ireland, following a distribution agreement with Janssen, effective January 2, 2023, with physical distribution beginning July 1, 2023. This partnership allows Menarini to strengthen its market position in the UK and expand its portfolio of diabetes treatments, increasing revenue opportunities
- In February 2023, Zydus Lifesciences Limited has received tentative USFDA approval for its generic canagliflozin and Metformin Hydrochloride Tablets (50 mg/500 mg, 50 mg/1,000 mg, 150 mg/500 mg, and 150 mg/1,000 mg), equivalent to Janssen's Invokamet Tablets. This approval will enable Zydus to expand its presence in the U.S. diabetes market, offering a cost-effective alternative to the branded product
