Abbott Laboratories announced today that it will sell the new tablet form of its protease inhibitor lopinavir/ritonavir under the name Aluvia at a price of $2200 a year in developing and middle-income countries outside sub-Saharan Africa. In Africa and other least-developed countries Aluvia will continue to be sold at what Abbott describes as a no-profit price of $500 a year.
Forty-five countries will qualify for the reduced price of $2200 a year. The countries include India, Ukraine, Vietnam, Thailand and China but exclude Russia and Brazil. The discounted price will also be available to central American countries, excluding Mexico.
Abbott has been criticised over the past year for the pricing of lopinavir/ritonavir in low income and middle income countries, and also for failure to register the product in all countries eligible for the `access` price of $500 a year. This criticism has grown following the licensing of a heat-stable tablet formulation of lopinavir/ritonavir by the US Food and Drug Administration earlier this year. Medecins sans Frontieres in particular has attacked Abbott for delays in obtaining licenses for the new product in Africa.
Abbott says that the delay is caused by the need to obtain a license from the European Medicines Agency before it can submit its product dossier to licensing authorities in Africa and other least-developed countries. A European license is needed, the company says, because African authorities want approval from the licensing authority of the region in which the product is manufactured.
A further delay has been caused by the fact that the European Medicines Agency has refused to register two separate formulations of lopinavir/ritonavir with the same name but for different markets. Instead, the differentiated product must have a different brand name, requiring a separate approval process for packaging and labelling. This requirement is intended to prevent diversion of products intended for use in developing countries back into the European Union. This is the reason why heat-stable lopinavir/ritonavir tablets will be marketed as Aluvia through the company's access programme.