Hanmi Pharmaceutical said Tuesday it will release Tefovir Tab (compound: tenofovir disoproxilphosphate) in early October and jump into the chronic hepatitis B therapy market, as it recently obtained a preferential right to sell the drug.
Hanmi한미약품(CEO Woo Jong-soo우종수 and Kwon Se-Chang권세창) said it earned the approval from the Ministry of Food and Drug Safety(MFDS) to exclusively sell Tefovir until June 30, 2018, under the ministry’s preferential sales approval system.
The system provides a company with an exclusive right for nine months, in case the company wins a lawsuit against the original maker of the drug and first applies for an approval.
Tefovir by Hanmi got approval as it was considered equivalent to the incrementally modified drug by changing the compound of the original drug tenofovir disoproxil fumarate to phosphate. Because Hanmi avoided the salt patent, it can release the drug 13 months earlier than other generics.
“Our drug secured an advantageous position in the market and its price is competitive against the original drug. It will be useful to doctors and patients,” said Park Myung-hee박명희, managing director of Hanmi’s marketing division.
“Tefovir was manufactured under a globally-competitive quality control system of Hanmi Fine Chemical한미정밀화학. It has superb quality.”
Only available through prescriptions, those aged 12 or older can take one pill of Teforvir a day, regardless of meals.