Successful commercial entries of ‘ODTs’

Will it achieve the expected performance?

Orally disintegrating tablet (ODT) products are entering the blockbuster chronic disease treatment market.

Commercial sales of an amlodipine ODT for hypertension begin this month, and a pitavastatin ODT for hyperlipidemia successfully achieved commercialization late last month.

As chronic disease ODT products are trending in the South Korean pharmaceutical market, attention is focused on whether these products can deliver strong performance.

On July 27, the Ministry of Food and Drug Safety (MFDS) approved two dosage strengths (2mg, 4mg) of GL Pharma's "Pitael ODT," a pitavastatin calcium hydrate ODT.

Subsequently, on July 30, three pharmaceutical companies, Kukje Pharma, Theragen Etex, and Huons, consecutively obtained marketing authorizations for the same active ingredient and dosage form.

Recently, approvals and product launches of waterless ODTs have been expanding rapidly in the South Korean market for chronic disease therapies, including dyslipidemia and hypertension.

In the dyslipidemia segment, following the MFDS approval of the world's first rosuvastatin + ezetimibe combination ODT in June, pitavastatin monotherapy ODTs were consecutively approved in late July.

In the hypertension field, BC World Pharmaceutical expanded its lineup by launching "Ambaro OD Tab." (5mg, 10mg), a calcium channel blocker (CCB) containing amlodipine besylate, on the 1st of this month, signaling that the full-scale commercialization of ODT products across cardiovascular therapeutics is hitting its stride.

BC World Pharmaceutical has fortified its third ODT portfolio entry with "Ambaro OD Tab.", following its telmisartan-based "Telvaro OD Tab." and rosuvastatin-based "Suvaro OD Tab." This strategic expansion of its cardiovascular portfolio specifically targets enhanced convenience for elderly patients, individuals with dysphagia (swallowing difficulties), and polypharmacy patients requiring long-term treatment for hypertension and hyperlipidemia.

The pharmaceutical industry is focusing on developing and launching ODT formulations for chronic conditions because of a practical calculation: improving patient compliance alongside securing favorable drug pricing protection.

The current oral tablet generic market is saturated with dozens of late-entry competitors subject to the "tiered drug pricing system," where prices drop sequentially based on approval order, leaving little room for profitability. In contrast, ODT formulations are recognized as "novel dosage forms" that enhance patient convenience, allowing manufacturers to secure the maximum price tier (53.55% of the original drug price) of the existing tablet market, making them highly attractive commercial targets for pharmaceutical companies.

However, it remains to be seen whether these commercialized ODT drugs can translate their market entry into meaningful prescription sales performance.

Industry insiders who view the commercial outlook for ODTs favorably cite the growing proportion of elderly patients and favorable sales margin structures for pharmaceutical companies as key drivers.

A domestic pharmaceutical representative said, "Chronic diseases such as hypertension and hyperlipidemia account for a very high proportion of patients aged 65 and older. Many of these patients suffer from dysphagia, making it difficult to swallow multiple pills at once, or face significant inconvenience when taking medication on the go without water," and explained, "Sine BC World Pharmaceutical or GL Pharmtech neutralized bitter drug tastes using proprietary taste-masking technologies, dramatically improving patient adherence."

The representative added, "From a manufacturer's perspective, while the existing tablet market makes it difficult to even recover marketing costs due to harsh tiered pricing cuts, ODTs secure top-tier pricing. This provides the financial flexibility needed to execute impactful sales and marketing activities directed at healthcare professionals, enabling rapid market penetration."

Conversely, industry observers who express skepticism regarding the actual commercial success of ODT products point to prescribing habits among physicians and inherent limitations of the ODT dosage form itself.

Another pharmaceutical industry source noted, "The chronic disease therapy market is characterized by strong physician trust and prescribing habits rooted in originators and established solid oral tablets, such as Hanmi Pharm's 'Rosuzet,' and added, "It remains uncertain how many prescribers will switch from established tablets proven safe over time solely for the convenience of 'waterless' administration."

The representative added, "ODT formulations are sensitive to moisture, making packaging management and storage challenging. Furthermore, as the tablet dissolves in the mouth, some patients complain of oral residue or a strange sensation," and noted, "Given that dozens of pharmaceutical companies are jumping into the same active ingredient simultaneously, even with maximum drug pricing guaranteed, it will ultimately lead to fierce sales battles among competitors, making it difficult to generate blockbuster sales as expected."