- Expect synergic effect with products of different capacity
Daewoong Bio and Hanall BioPharma have won exclusive rights to sell the generic product of Glucophage XR Tab. 1,000mg, an antidiabetics developed by Merck, officials said.
The Ministry of Food and Drug Safety (MFDS) said Thursday it gave priority distribution right to Hanall Biopharma of its generic Glucodown OR Tab. 1,000mg, and to Daewoong Bio, of its generic, Daewoongbio Metformin SR Tab. 1,000mg, from March 21 to Dec. 20, 2017.
The substance patent of the original medicine Glucophage XR Tab expired a long time ago, and the patent of XR Tab. will expire on March 10, 2019. BMS has imported and sold Glucophage XR Tab. in Korea.
As the patent period had not ended, Hanall and Daewoong Bio filed a patent right scope declaration trial with Intellectual Property Trial and Appeal Board (IPTAB) against BMS last year, claiming they didn’t infringe on the patent about “biphasic- controlled release delivery system for high solubility pharmaceuticals and method.” The board delivered a verdict in January 2017 that they had not infringed on the patent, opening the way for the two firms to win the exclusive selling rights.
Currently, Hanall Biopharma and Daewoong Bio are selling Glucodown OR Tab. 500mg and Daewoongbio Metformin SR Tab. 500mg, respectively. The acquisition of the exclusive right to sell 1000-mg tablets will likely allow them to make synergy effect in the XR Tab. market, industry watchers said.