(Health Korea News / Lee Chung-man) As the gastric acid secretion blocking (P-CAB) drug has been selling like hotcakes since its launch, interest in the generic version of Takeda Pharmaceutical’s P-CAB drug ‘Vocinti’ (ingredient name: vonoprazan), which had been neglected until then, is exploding.
According to our investigation, a total of 17 companies have received approval for bioequivalence test plans (INDs) for generic ‘Bosinti’ from the Ministry of Food and Drug Safety in 2024.
In order of approval, they are ▲Dongkwang Pharmaceutical ▲Dongkook Pharmaceutical ▲Yooyoung Pharmaceutical ▲Aju Pharmaceutical ▲Dongkoo Biopharmaceutical ▲Anguk Pharmaceutical ▲Bibon Pharmaceutical ▲Samik Pharmaceutical ▲Unimed Pharmaceutical ▲Nova M Healthcare ▲Yuhan Corporation ▲KS Pharmaceutical ▲Alvogen Korea ▲Saehan Pharmaceutical ▲Korea Pharmaceutical ▲Kyungbo Pharmaceutical ▲Daehwa Pharmaceutical.
Daehwa Pharmaceutical received approval for bioequivalence IND on the 12th. The test will evaluate the bioequivalence of its generic ‘DHP2824’ and ‘Bosinti’ on 32 healthy adults, and will be conducted at Gimpo Our Hospital.
The main treatment indication of P-CAB preparations including ‘Bosinti’ is gastroesophageal reflux disease. This disease is a chronic recurrent disease in which stomach contents or stomach acid reflux into the esophagus, causing symptoms and complications. The main symptoms include heartburn, a feeling of water coming up, and a feeling of stuffiness.
Previously, proton pump inhibitors (PPIs) were used to treat gastroesophageal reflux disease. PPI drugs work by inhibiting the proton pump involved in the final stage of gastric acid secretion, thereby reducing gastric acid secretion. However, PPI drugs have the disadvantage of increasing the risk of infectious diseases due to decreased gastric acidity, and side effects such as gastrointestinal malignancy and osteoporosis.
To improve this, a new drug that has emerged is the P-CAB drug. The P-CAB drug binds to the proton pump without activation by gastric acid, thereby inhibiting gastric acid secretion quickly and stably. It also improves the shortcomings of existing PPI drugs, such as slow onset of action, dietary influence, and drug interaction problems.
Representative P-CAB drugs are HK inno.N’s ‘K-Cap’ (ingredient name: tegoprazan) and Daewoong Pharmaceutical’s ‘Pexuclu’ (ingredient name: fexuprazan). The two drugs have surpassed PPI drugs and become blockbuster drugs in one fell swoop. Among them, ‘K-Cap’ is recording prescription sales of 100 billion won.
Accordingly, pharmaceutical companies are salivating over the P-CAB market and are starting to develop generics. Initially, the companies were weighing whether to attack the patents of ‘K-Cap’ and ‘Pexuclu’, but HK inno.N and Daewoong Pharmaceutical are showing a strong stance in defending their patents, and the fact that there are more than 10 years left until the patent expiration period is a burden.
The material patent for ‘K-Cap’ is valid until August 2031, the crystal patent until March 2036, and ‘Pexuclu’ until February and March 2036, respectively.
This is why ‘Bosinti’ has become popular recently. ‘Bosinti’ is the first P-CAB formulation to appear in the world, and was first approved in Japan in 2015. In Korea, it received product approval in March 2019 through its domestic branch, Takeda Pharmaceutical Korea.
‘Bosinti’ has not been released yet in Korea, although it has been approved. It is said that insurance coverage is an obstacle. Nevertheless, the fact that domestic companies are targeting generic versions of ‘Bosinti’ is interpreted as the patent period expiring soon.
‘Bosinti’, which currently holds two domestic patents, has patent expiration dates of December 20, 2027 (material patent) and November 17, 2028 (crystal patent), respectively.
The generic version of ‘Bosinti’ could be released after 2028. Therefore, companies appear to be attempting to develop generic versions of ‘Bosinti’, whose patent is about to expire, in order to quickly enter the P-CAB formulation market.
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Source: www.hkn24.com
