Generic drugs of Bridion get approval en masse in Korea – Korea Biomedical Review

Korean pharmaceutical companies recently obtained marketing approval for generic drugs of MSD’s Bridion (sugammadex), a muscle relaxation antagonist.
As the original drug’s patent expires in April, local drugmakers are expected to engage in fierce competition to sell generic copies, observers said.
The Ministry of Food and Drug Safety said Friday JW Pharmaceutical, GC Pharma, and Daewoong Pharmaceutical received the permit for generic drugs of Bridion.
Bridion arrived in Korea in February 2013. During surgery, the injection is used to reverse the neuromuscular blockade induced by general anesthetics rocuronium bromide or vecuronium bromide.
The government has been approving generic drugs of Bridion since Dec. 29, when Hanlim Pharm won the permit first.
Nineteen Bridion generics obtained local approval, and half of them are scheduled to be manufactured at Huons’ third plant in Jecheon, North Chungcheong Province.
Industry watchers said the Bridion generic market would heat up in April.
Bridion’s patent, registered in Korea, is titled “6-mercapto-cyclodextrin derivatives: reversal agents for a drug-induced neuromuscular block.” It expires on April 12, 2022.
Korean drugmakers have tried but failed to nullify Bridion’s patent.
CTC Bio filed a suit to invalidate the patent, and Intro Bio Pharma, Hana Pharm, Huons Global, and Chong Kun Dang also filed lawsuits to nullify the patent extension, but the court dismissed all.
No local company successfully invalidated Bridion’s patent, which means that no company obtained exclusive sales right for a generic drug for a certain period.
A company that quickly secures the generic drug market with the patent expiration is expected to have an advantage. Thus, observers said the market competition among Korean pharmaceutical companies would become severe.

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