In July 2024, the UK's MHRA approved the first generic versions of raltegravir for both adult and pediatric patients, granted to Lupin Healthcare (UK) Limited and Zentiva Pharma UK Limited. (gov.uk) This approval is expected to enhance the accessibility of HIV treatments in the UK.
In May 2025, the FDA approved Lupin Ltd.'s ANDA for a 600 mg tablet formulation of raltegravir potassium. This approval marks a significant step towards increasing the availability of generic raltegravir in the U.S. market.
In February 2023, Viatris withdrew its application for marketing authorization of Raltegravir Viatris in the European Union. (ema.europa.eu) The reasons for this withdrawal were not specified but may impact the availability of generic raltegravir in the EU market.
In February 2015, Merck announced a collaboration with the Medicines Patent Pool to expand access to pediatric formulations of raltegravir in developing countries. This agreement aims to improve access to raltegravir for HIV-infected children in regions with high disease burden.
In 2023, the WHO updated its Model List of Essential Medicines, reaffirming the inclusion of raltegravir as a critical component in the treatment of HIV-1 infection. (test-cms.who.int) This inclusion underscores the global recognition of raltegravir's importance in HIV therapy.
These developments reflect the dynamic nature of the pharmaceutical industry and the ongoing efforts to enhance the accessibility and affordability of essential medicines like raltegravir worldwide.
