Janssen R&D Ireland (formerly Tibotec Pharmaceuticals) granted multiple non-exclusive licenses to Hetero Drugs, Emcure Pharmaceuticals, Strides ArcoLab and Matrix Laboratories of India, and Aspen Pharmacare of South Africa to manufacture, market and distribute generic versions of its non-nucleoside reverse transcriptase inhibitor rilpivirine hydrochloride (TMC 278), subject to its approval for use with other antiretroviral agents in the treatment of treatment-naïve HIV-1 infected adults. The Indian companies have rights to market the product in 112 lower-middle-income countries (LMICs). Aspen has rights to market the product in SSA, including South Africa. These agreements offer licensees the technical information and knowledge (“tech transfer”) to manufacture the active pharmaceutical ingredients (API) and finished product. They also enable the development of appropriate fixed-dose combinations (FDCs) of rilpivirine with other HIV medicines within the licensing territories. The generic manufacturers will be responsible for timely regulatory filing for generic rilpivirine and for seeking pre-qualification from the World Health Organization (WHO) and FDA ANDA generic drug approvals.