In case of defects dolutegravir ChemRar Group is ready to meet the needs of Russian patients

Over the past year, patient organizations have repeatedly reported that Russian HIV patients do not have enough dolutegravir . The original drug under the Tivicay brand is supplied to Russia by the British GSK. Initially, the active substance was protected by a patent until 2026, but then its validity was extended until 2029.

As Kommersant writes , the expert community turned to the FAS with a request to assist in issuing a compulsory license for the drug, the acquisition of which “costs the state several times more” than in other EAEU countries. The Civil Code of the Russian Federation allows for the issuance of a compulsory license “in case of extreme necessity” related to “ensuring the defense and security of the state, protecting the life and health of citizens.”

ChemRar Group has developed a generic version of Tivicaya, conducted bioequivalence studies and is currently at the stage of obtaining a marketing authorization. The company’s production capacity allows us to completely cover the need of Russian patients for this vital drug.

ChemRar Group especially emphasizes that it respects the patent rights of the originator, and compulsory licensing is a legal tool that can and should be used only as a last resort.

The manufacturer intends to act exclusively in the interests of Russian patients and is ready to apply to the government to obtain a compulsory license only if there is a shortage of the drug on the market and a corresponding request from the state.