This is the first ANDA for a generic version of dolutegravir, and comes less than two years after the FDA approval of GlaxoSmithKline’s originator product Tivicay (dolutegravir) gained approval in August 2013 in the US.

The announcement on 26 May 2015 comes as a result of a collaboration between ViiV Healthcare, Aurobindo Pharma and the Clinton Health Access Initiative (CHAI). CHAI was founded in 2002 with the goal of helping save the lives of millions of people living with HIV/AIDS in the developing world by dramatically scaling up antiretroviral treatment. ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline and Pfizer dedicated to delivering advances in treatment and care for people living with HIV.

Upon receiving tentative approval from FDA, Aurobindo Pharma will be able to supply dolutegravir at a dosage of 50 mg via the President’s Emergency Plan for AIDS Relief (PEPFAR) programme, following completion of required local regulatory approval process, in the licensed countries outside of the US, as per the agreement signed between Aurobindo Pharma and ViiV Healthcare in 2014.

This submission comes less than five years after ViiV Healthcare and CHAI signed an agreement to collaborate with the goal of bringing innovative formulations of medicines for the treatment and prevention of HIV/AIDS to people living with HIV in developing countries, on an affordable yet sustainable basis.

Under the PEPFAR, FDA allows for an expedited review process and can issue tentative approval for generic drug products. Tentative approval by FDA enables generics access to poor nations under a US initiative, which allows sale of generics to treat conditions where there is a significant public health impact, even though the originator drugs are still under patent protection in the US.

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