Vocinti and Vocinti follow-ons being price talks in Korea

Takeda begins reimbursement negotiations alongside Mothers Pharmaceutical and Kyongbo Pharmaceutical

Price expected to fall below KRW 900… patent dispute may follow market launch

Takeda’s P-CAB class drug that is marketed in Japan (brand name in Korea: Vocinti)

Takeda Pharmaceuticals’ potassium-competitive acid blocker (P-CAB) Vocinti (vonoprazan) has entered reimbursement price negotiations with the National Health Insurance Service (NHIS).

However, with two salt-modified products entering negotiations simultaneously, the road to commercialization is expected to be fraught with legal disputes.

According to industry sources on July 10, the Ministry of Health and Welfare recently ordered the NHIS to begin reimbursement negotiations for Vocinti, Vonokhan (Kyongbo Pharmaceutical), and Vono-M (Mothers Pharmaceutical). Both follow-on products contain vonoprazan tosylate.

In May, the Drug Reimbursement Evaluation Committee (DREC) determined that the three products were eligible for reimbursement for four indications, including gastric ulcer, provided the manufacturers accepted a price below the committee's assessed amount.

In such cases, reimbursement prices are generally negotiated at 90% of the weighted average price of comparator products, meaning the final price is expected to be in the upper KRW 800 range.

It is uncommon for the original drug and salt-modified follow-on products to enter reimbursement negotiations simultaneously. However, a bigger issue lies beyond the negotiations- the lingering possibility of legal disputes after reimbursement listing and commercial launch.

Vocinti's patent is scheduled to remain in force until November 17, 2028 at the latest. However, the salt-modified manufacturers may have concluded that, if they successfully avoid the patent-term extension, the relevant patent protection would instead expire on August 29, 2026.

This is why a legal dispute with Takeda is likely if Kyongbo Pharmaceutical and Mothers Pharmaceutical launch their products in August or September after obtaining reimbursement listing.

Industry sources believe the two companies likely completed their legal assessments before filing for reimbursement and are pursuing early commercialization with full awareness of the associated litigation risks.

Because a legal challenge from Takeda was always a foreseeable scenario, each company is believed to have carefully evaluated the commercialization risks before submitting its reimbursement application.

Although the NHIS typically reaches agreements on stable product supply during reimbursement negotiations, it is not expected to independently assess the products' launchability, given that they have already passed the DREC review and received formal negotiation orders from the MOHW.

Even if the companies successfully list and launch their products, with Takeda expected to pursue litigation or other legal actions, commercialization could still be delayed or halted depending on the outcome of the legal proceedings.