Vonoprazan market braces for fierce competition

Alvogen Korea begins developing an orally disintegrating tablet formulation

‘Two-track’ strategy targeting greater convenience and a higher price

As competition intensifies to launch versions of Takeda Pharmaceuticals’ potassium-competitive acid blocker (P-CAB) Vonoprazan before its patent expiry, Alvogen Korea has begun carving out a differentiated path by developing an ‘orally disintegrating tablet’ formulation designed to improve patient convenience.

The move is seen as the company’s attempt to avoid price cuts from a proliferation of generics and secure a more favorable reimbursement price.

According to the Ministry of Food and Drug Safety on the 27th, Alvogen Korea recently received approval for a Phase I clinical trial protocol evaluating the bioequivalence of an orally disintegrating formulation of its vonoprazan fumarate (codename: AK-R320).

The trial will enroll 36 healthy adult volunteers and use a two-treatment, two-period crossover design to compare the pharmacokinetic profiles and safety of the test drug, AK-R320, and the reference drug, AK-R320-R, administered under fasting conditions.

Although the original product has yet to be launched, the market for follow-on vonoprazan products is already witnessing fierce competition among Korean pharmaceutical companies pursuing an “at-risk launch (launch then suit)” strategy. Salt-modified drug developers, including Kyongbo Pharmaceutical and Mothers Pharmaceutical, and same-ingredient generic manufacturers such as Hanmi Pharmaceutical, JW Pharmaceutical, and Shinpoong Pharm have filed patent invalidation challenges against the original product (Vonsinty), whose patents are scheduled to expire between 2027 and 2028. They are also accelerating preparations to secure reimbursement listings.

Taking advantage of the weakened original drug’s regulatory defense, more than 70 generic products have already received approval.

As the market becomes increasingly crowded with generics in the same conventional tablet formulation, Alvogen Korea has played the orally disintegrating tablet, or ODT, card. ODTs dissolve in the mouth and can be taken without water.

ODTs can significantly improve medication adherence among older patients and those with dysphagia who have difficulty swallowing conventional tablets. Major existing P-CAB products, including HK inno.N’s K-CAB, have previously expanded their prescribing reach by introducing orally disintegrating formulations.

The industry is interpreting Alvogen Korea’s move in particular as part of a ‘drug price defense strategy.’ Under Korea’s current tiered generic pricing system, the listing of large numbers of generics with the same active ingredient reduces the reimbursement ceilings for later entrants, causing their profitability to deteriorate sharply.

However, incrementally modified formulations such as ODTs may be able to avoid direct price-grouping competition with conventional generics or qualify for more favorable pricing criteria, giving them an advantage in securing a relatively higher reimbursement price.

The calculation is ultimately to avoid the bloodletting in the “red ocean” conventional tablet market dominated by major pharmaceutical companies, while simultaneously securing the practical benefits of a differentiated and more convenient formulation and a more stable pricing structure.

An industry official said, “With dozens of vonoprazan generics already approved, competition over prescriptions and prices in the conventional tablet market is likely to reach extreme levels. The development of an orally disintegrating tablet by Alvogen Korea is a highly strategic decision aimed not only at targeting a niche market through greater dosing convenience, but also at maximizing profitability by securing a higher price during the anticipated wave of aggressive generic discounting.”