It is the first FDA approval of a generic version of Dolutegravir. Through a tie up with ViiV and the Clinton Health Access Initiative, Inc., the product is expected to be launched in sub-Saharan Africa in late 2016.
“This is a one-of-its-kind agreement between innovator and generic company where the generic version of the drug will be launched in around three years from the originator product. Further, we are also developing a fixed dose combination of DTG,” said N. Govindarajan, Managing Director of Aurobindo Pharma Limited.
Tentative approvals are given for generic versions of drugs that continue to enjoy patent protection and cannot be marketed purely on the basis of these approvals.
Dolutegravir is indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents.
The drud is an integrase strand transfer inhibitor recommended for use in treatment-naïve patients by the US Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO).
ViiV Healthcare and Aurobindo Pharma signed a licensing agreement in 2014 that allows Aurobindo Pharma to supply Dolutegravir in 92 licensed countries, following completion of required local regulatory approval processes.
“Dolutegravir is a critical new tool that will help us achieve the UNAIDS 90-90-90 goals and an AIDS-free generation. The WHO included Dolutegravir in its recommendations for first-line therapy in 2015, and we expect rapid growth in demand now that a cost-effective generic product is available. Dolutegravir, taken with other HIV treatments, has the potential to improve the lives of millions of patients,” said David Ripin, Executive Vice President of the Clinton Health Access Initiative, Inc.
The approved Abbreviated New Drug Application (ANDA) is bio equivalent and therapeutically equivalent to the reference listed drug product Tivicay, of ViiV Healthcare.
Aurobindo Pharma Limited, headquartered at Hyderabad, manufactures generic pharmaceuticals and active pharmaceutical ingredients.
Aurobindo now has close to 230 ANDA approvals (199 Final approvals including 10 from Aurolife Pharma LLC) from USFDA.
The company’s product portfolio is spread over 6 major therapeutic areas such as Antibiotics, Anti-Retrovirals, CVS, CNS, Gastroenterologicals, and Anti-Allergies, supported by an outstanding R&D set-up.
It sells in over 150 countries.
The Clinton Health Access Initiative, Inc. focuses on improving market dynamics for medicines and diagnostics; lowering prices for treatment; accelerating access to lifesaving technologies; and helping governments build the capacity required for high-quality care and treatment programs.