Empagliflozin 93 casesㆍdapagliflozin 83 cases
Hutecs Korea Pharmaceutical leads with 17 cases followed by Chong Kun Dang Pharmaceutical with 16 cases
[Newsmp] Last year, the number of the Korean version of Orange Book registrations at the Ministry of Food and Drug Safety remained at the lowest level in the past 10 years.
According to the Ministry of Food and Drug Safety’s information platform (https://nedrug.mfds.go.kr/), only 556 cases were listed in the K-Orange Book last year. It is the lowest since 988 cases in 2013.
The number of K-Orange Book registrations increased from 988 in 2013 to 1,369 in 2014, surpassing 1,000, and then steadily exceeding 1,000 until 2021.
In particular, it peaked at 3,496 in 2019, but it decreased by more than 40% for the second consecutive year, including 2,011 in 2020 and 1,201 in 2021, and plunged by more than 50% last year.
Of the 566 cases registered last year, two SGLT-2 inhibitors accounted for a total of 176 cases, or one-third, including 93 cases for empagliflozin and 83 cases for dapagliflozin.
By company, a total of 134 companies registered more than one case, and 15 of them recorded over 10 cases.
Hutecs Korea Pharmaceutical took the lead with 17 cases, followed by Chong Kun Dang Pharmaceutical with 16 cases, DongKoo Bio & Pharma, Genuone Sciences and Hana Pharm with 14 cases.
Shin Poong Pharmaceutical recorded 13 cases, MOTHER’S Pharmaceutical and Jeil Pharmaceutical 12 cases, Boryung Pharmaceutical, Myungmoon Pharmaceutical and Myung In Pharm 11 cases, Green Cross, Daewon Pharmaceutical, Aju Pharm and Ahn-Gook Pharmaceutical 10 cases.
GL Pharma registered nine cases, Kukje Pharma, Daehan New Pharm and Il-Yang Pharmaceutical eight cases, Yuhan Corporation, Theragen Etex, PharmGen Science, Daewoong Bio and Whanin Pharmaceutical seven cases.
Moreover, Nexpharm Korea, MEDICA KOREA, Binex, YooYoung Pharmaceutical, Eden Pharma, White Life Science, Kyung Dong Pharmaceutical, Guju Pharm, Dong Wha Pharm, Samjin Pharmaceutical, Sinil Pharmaceutical, Withus Pharmaceutical and HanAll Biopharma listed six cases, while Daewoong Pharmaceutical, Vivozon Healthcare, Dongkwang Pharm, Samik Pharmaceutical, Korea Arlico Pharm, Aprogen Pharmaceuticals, Youngil Pharm, JW Pharmaceutical, Richwood Trading, Union Korea Pharm. and Korea Prime Pharm registered 5 cases.