Korean pharmas race for generic P-CAB market amid Takeda's uncertain future for Vocinti

More than 20 Korean pharmaceutical companies are getting ready to grab the generic potassium-competitive acid blocker (P-CAB) market in response to a potential void left by Takeda Pharmaceutical's once-promising P-CAB, Vocinti (ingredient: vonoprozan).

Vocinti, approved by Korea's Ministry of Food and Drug Safety (MFDS) in 2019, has yet to hit the market, with news reports citing pricing issues and its failure to secure insurance coverage. Industry insiders attribute the Takeda drug's postponed release to the Korean government's low reimbursement offer.

While Takeda has not completely ruled out a future launch of Vocinti, an official stated that the company is "considering it in broad terms," referring to its overall strategy and market conditions, suggesting that a release is unlikely in the near term.

Meanwhile, competition in the Korean P-CAB generic market is intensifying. 

Korean pharmaceutical giants HK inno.N and Daewoong Pharmaceutical have achieved significant success with their P-CAB drugs, K-CAB (ingredient: tegoprazan) and Fexuclue (ingredient: fexuprazan), respectively. Both have stormed the market, establishing dominance in treating acid-related disorders, with K-CAB achieving a prescription value of 761.1 billion won ($570 million) since its 2019 launch and Fexuclue reaching 101.6 billion won in just two years since its 2022 launch.

With patents for K-CAB and Fexuclue set to last until 2036, other Korean drugmakers have to wait for too long. However, Vocinti’s earlier patent expiration makes it the only potential alternative for those eager to enter the market quickly.

Vocinti's future in Korea is uncertain, with its re-evaluation period set to expire on March 28, 2025. Without patient treatment data, which requires actual sales, Takeda will be unable to submit the necessary documents to maintain approval. As a result, the drug’s approval could be automatically withdrawn from the Korean market.

This looming expiration has Korean firms rushing to secure generic approvals. However, even after Vocinti’s approval is withdrawn, patent protections will delay the entry of generics into the market. The chemical patent for vonoprozan extends until December 2027, while the crystalline form patent lasts until November 2028, indicating that generic versions may not enter the market for another four years.

However, Korean pharmaceutical companies are preparing well in advance as the P-CAB sector is booming, particularly in the treatment of gastroesophageal reflux disease (GERD).

Industry forecasts suggest that the domestic anti-ulcer drug market will grow by over 5 percent annually. Proton pump inhibitors (PPI) currently hold around 53 percent of the market, while P-CAB drugs are estimated to account for around 20 percent. By 2027, however, the market share of PPI drugs is expected to drop to 43 percent, while P-CAB drugs are projected to grow to around 36 percent.

The race to dominate the vonoprazan market is intensifying, with over 20 Korean pharmaceutical companies racing to conduct bioequivalence tests on the drug’s main ingredient, according to the Ministry of Food and Drug Safety (MFDS) on Thursday. 

Kyongbo Pharmaceutical has recently received MFDS approval to conduct a phase 1 clinical trial for its Vonokhan 20mg tablets, using Takeda’s Vocinti as the reference drug. The trial will assess the pharmacokinetics and safety of both drugs in healthy adult volunteers at H+ Yangji Hospital.

Last month, Korean Drug Co. received approval for a bioequivalence trial against Vocinti, a randomized, single-dose study expected to conclude by January. Other pharmaceutical firms including Hutecs Korea, Dongkook, Vivozon, Unimed, and Theragen Etex are also advancing their generic development efforts.

With companies like Dongwha Pharm and Daewon Pharm finalizing their trials and preparing for generic approval, news reports indicate that the momentum is significant, positioning the market for the upcoming entry of generics into the Korean pharmaceutical landscape.