SEOUL, KOREA- Hanmi Pharm acquired permission for its drug as an incrementally modified drug from the U.S. Food and Drug Administration, first in Korea. Given that the number of companies that can enter a market is limited, Hanmi Pharm is expected to be able to take a virtual monopoly position in the area.
The Ministry of Health and Welfare announced on August 7 that Hanmi Pharm’s Esomezol, a medicine for gastro-oesophageal reflux conditions, acquired the FDA’s permission for sales. Prior to this, LG Life Sciences’ Factive and growth hormone Valtropin had acquired FDA permissions for sales. However, this is the first time among domestic modified drugs to acquire FDA permission.
Esomezol is a new medicine that is created by modifying AstraZeneca’s Nexium heartburn tablet which created earnings of $6 billion in the U.S. market alone. After two years of litigation with AstraZeneca, Hanmi Pharm drew a consensus opinion that Esomezol did not infringe on the patents of Nexium tab
