Fourteen pharmaceutical companies are likely to roll out generic drugs that copied Stillen 2X Tab., a gastritis treatment, in early February. The companies had won limited exclusive rights last year to sell their generic copies for nine months without any other competitors.
|Dong-A ST’s gastritis drug Stillen 2X Tab.|
Stillen 2X developer Dong-A ST improved the usage of the acute and chronic gastritis drug Stillen by reducing the dosing from three times a day to twice a day.
The fourteen generic drugmakers are preparing to launch the similar products early next month, industry officials said.
The 14 drugs with the exclusive sales license for nine months are Partislen S Tab. (Richwood Trading), Uparon F Tab. (Dongkook Pharmaceutical), Estlen-S Tab. (Samjin Pharm), Asica 2X Tab. (Aju Pharm), Stelin 2X Tab. (Arlico Pharm), Stren 2X Tab. (Il Wha), Estalen 2X Tab. (Hana Pharm), Stoe 2X Tab. (Kolmar Korea), Bitilin 2X Tab. (Binex), Bearen Tab. (Daewoong Bio), NPlen S Tab. (Daehan New Pharm), Sutilen 2X Tab. (Youngil Pharm), Stil U 2X Tab. (Kukje Pharm), and Arcidine F Tab. (Wooridul Pharm).
The 14 companies successfully avoided the patent of Stillen, as the Intellectual Property Trial and Appeal Board (IPTAB) ruled that they did not infringe upon Stillen’s patent on “the sustained oral drug formulation using the pharmacological composition of Artemisia asiatica under the gastro-retentive drug delivery system (GRDDS).”
The 14 firms obtained the limited exclusive rights to sell the drugs as of Dec. 5, 2018. They can sell the products for nine months until Sept. 4, 2019, without any other competitors.
A drug company must release a product after winning the limited exclusive sales rights within two months. Delaying the release without a justifiable reason will nullify the exclusive rights.
However, a company can extend the market release for up to two months if it takes more time to get an insurance benefit.
<© Korea Biomedical Review, All rights reserved.>