Hanmi Pharmaceutical targets the gastritis treatment market with Esomezol DR SR Cap. 10 mg (esomeprazole magnesium trihydrate), or Esomezol DR 10 mg, released by the company early this month.
Amid the intensifying competition over gastritis treatments among various medicines and components, industry watchers pay attention to which will prevail.
According to the Ministry of Food and Drug Safety, Hanmi Pharm registered its patent related to Esomezol DR 10 mg on the list of pharmaceutical patents last Thursday.
The recently registered patent was about Esomezol DR 10 mg’s raw material and its volume, properties, efficacy, effectiveness, usage, and dose. It expires on Oct. 28, 2036. The industry insiders interpreted it as a strategy to keep their distance from latecomers by applying the drug licensing patent system to it.
In October, Hanmi won approval for Esomezol DR 10 mg, a sustained-release gastritis treatment of a proton pump inhibitor (PPI) series. Following the already launched Esomezol DR SR 20 mg and Esomezol DR SR 40 mg, the company has received the permit for the low-dose product.
Notably, while Hamni’s existing PPI-series gastritis drugs, including Esomezol-family drugs, which won the nod for treating gastroesophageal reflux disease (GERD), Esomezol DR 10 mg got the approval to treat gastritis, drawing the industry’s attention. Hanmi emphasized that it has expanded the indication of the Esomezol-family drugs to gastritis.
The company explained that it had confirmed the effectiveness and safety of Esomezol DR 10 mg in treating gastritis in a large-scale phase 3 clinical trial. It added that as there is no pharmacological difference between patients who eat high-fat foods and those with empty stomachs, patients can take it regardless of meals.
Early this month, Hnmi also came forward to survey the market by conducting an opinion poll of Esomezol DR 10 mg on medical professionals. The opinion poll asked about their preference in prescribing gastritis drugs, whether they intended to prescribe Esomezol DR 10 mg and its expected effectiveness.
Intensifying competition amid strategy to secure indication for gastritis
The reason Hanmi put so much effort into Esomezol DR 10 mg has something to do with the recent moves of its competitors, which have secured indications for similar drugs, according to industry insiders.
For example, Daewon Pharmaceutical received the approval for Escorten Tab (esomeprazole magnesium trihydrate), a PPI-series gastritis treatment, for the first time in Korea in April, opening the door to competition over the PPI-series gastritis treatment. Escorten Tab, like Esomezol DR 10 mg, is a low-dose treatment with an esomeprazole component.
No less fierce are attacks from a new strong rival, drugs based on P-CAB (potassium-competitive acid blockers). Daewoong Pharmaceutical, which started the fire with fexuprazan, a homegrown new drug, followed up with securing the gastritis indication for the low-dose Fexuclue 10 mg in August.
The drug costs of Escorten Tab. And Esomezol DR 10 mg is the same at 189 won (15 U.S. cents) per tablet. The insurance benefits and market release of Fexuclue 10 mg have yet to be decided.
Hanmi maintains that PPI-series drugs are relatively free from drug tolerance compared to the existing H2RA (histamine-2 receptor antagonist)-based gastritis treatments and can maintain the effects of suppressing gastric acid secretion even if administered repeatedly. In the case of H2RA-series drugs, famotidine-based drugs, such as Dong-A ST’s Gaster Tab, take the lion’s share after detecting ranitidine impurities.
Amid the intense competition in the gastritis treatment market, market observers pay keen attention to what results Hanmi will produce, armed with the synergic effects of its Esomezol family products.