Hanmi Pharmaceutical obtained approval for Esomezol Plus, a combination drug mixing a proton-pump inhibitor (PPI) with an antacid, heating the competition in the combo treatment market.
On Friday, the Ministry of Food and Drug Safety granted the marketing license for Esomezol Plus Tab. 40/350mg as a prescription drug.
Esomesol Plus added magnesium hydroxide, an antacid, to Esomesol (s-omeprazole magnesium trihydrate), an incrementally modified drug to treat gastroesophageal reflux disease.
The combo drug treats erosive reflux esophagitis.
Chong Kun Dang’s Eso Duo Tab. (esomeprazole magnesium trihydrate), released in 2018, is the leading PPI plus antacid combo therapy. Eso Duo recorded 13.9 billion won outpatient prescriptions in 2020, according to UBIST data. However, generic copies came out in the second half of 2021.
Other combo drugs include Yuhan Corp.’s Esopid Tab. (esomeprazole magnesium trihydrate/calcium carbonate), GC Pharma’s Esoca Tab. (esomeprazole magnesium trihydrate/calcium carbonate), and Kyungdong Pharm’s Esocarbo Tab. (esomeprazole magnesium trihydrate/calcium carbonate).
In February, Korea United Pharm won the nod for a phase 1 trial of a new combined drug, mixing rabeprazole sodium and sodium bicarbonate.
Hanmi is soon to roll out a new combo of a PPI and an antacid.
While existing drugs such as Eso Duo and Esopid obtained approval for both a high dose and a low dose, Hanmi’s Esomesol Plus won the permit for a single dose.
Esomesol Plus will be different from existing PPIs such as Nexium Tab. (esomeprazole magnesium) and help diversify Esomesol products, Hanmi said.
Hanmi’s Esomesol items include Esomesol Tab. and Esomesol Cap. (s-omeprozole strontium tetrahydrate).
Early this year, Hanmi rolled out Esomezole DR SR Cap. 20mg, a double-delayed release treatment.
The company emphasized that it extended the duration of the drug to improve the symptoms of nocturnal acid secretion in gastroesophageal reflux disease patients taking PPIs.
After the recall of ranitidine and nizatidine due to impurity in 2019, prescriptions of H2 receptor antagonists have dropped, and those of PPIs have grown.
How the arrival of Hanmi’s Esomesol Plus will affect the PPI and antacid market is drawing attention.