Local pharmaceutical companies are quickly releasing medicines containing famotidine to fill the void of ranitidine, a stomach drug recalled in September last year due to carcinogen risk.
Companies won the local license for 13 famotidine products during the last two months of 2019, and another 25 drugs, this year.
The Ministry of Food and Drug Safety granted the nod for 25 famotidine drugs from Jan. 1 to Feb. 17. The companies that won approval include Daewoong Bio, Union Korea Pharm, Theragen Etex, SamChunDang Pharm, Jeil Pharm, Cho-A Pharm, Sinil Pharm, and Ildong Pharmaceutical.
Last year, pharmaceuticals, including Yuhan Corp. Daewoong Pharmaceutical, Boryung Biopharma, and Kyungdong Pharm obtained a permit for seven famotidine products in November, and six in December.
Drug companies moved fast to release famotidine because the agent is the most competitive drug to replace ranitidine.
After the health authorities detected N-Nitrosodimethylamine (NDMA), a substance likely to cause cancer, in ranitidine-containing drugs in September, they ordered the recall of all ranitidine products. The ranitidine market was estimated to be around 200 billion won ($168.2 million) a year. Ranitidine used to be widely prescribed for various gastrointestinal diseases such as reflux esophagitis, gastritis, and indigestion.
The government also banned the sale of some drugs containing nizatidine, which is also in the H2 blockers’ class as ranitidine, due to the same carcinogen risk.
Other H2 blockers that can replace ranitidine or nizatidine are lafutidine, famotidine, roxatidine, and cimetidine.
Proton pump inhibitor (PPI) drug families and potassium-competitive acid blockers (P-CABs) also offer the same indication. Among them, H2 blockers that are most similar to ranitidine in structure, use, and price have become substitutes.
Among H2 blockers, companies are choosing lafutidine and famotidine the most.
Roxatidine has a small share of the H2 blocker market, and cimetidine’s raw material supply is unstable. As raw materials imported from China became unavailable due to environmental problems, they are being supplied from Spain. Because cimetidine imports are low, domestic companies take turns to receive the supply. The supply of raw material problem could be resolved in the second half if local firms develop their own raw materials and the supply from China resumes.
Most pharmaceutical firms chose famotidine over lafutidine. The government granted the license to 10 lafutidine drugs, versus 38 famotidine drugs, from November to early February.
Boryung Pharmaceutical’s Stogar dominates the lafutidine market. U-BIST data showed that annual prescriptions of Stogar recorded 13.9 billion won in 2019, while rival drugs posted less than 2 billion won of annual sales each.
On the other hand, the famotidine market has no leading product. Dong-A ST (Dong-A Gaster), Hanmi Pharmaceutical (Famotidine), and Hutecs (Hutecs Famotidine) have a neck-and-neck market share.
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