The P-CAB prescription market has surpassed $138 million, maintaining its growth trajectory. Amid this momentum, the voluntary withdrawal of the original drug Vocinti from market approval has created an opportunity for generic drug developers to explore early market entry. However, with Vocinti’s substance patent remaining valid until 2028, companies are proceeding cautiously.

Industry sources reported on December 22nd that Takeda Korea voluntarily withdrew Vocinti’s market approval. After receiving approval in March 2019, Vocinti underwent several reimbursement reviews but was ultimately not launched in South Korea, reportedly due to low pricing. The post-marketing surveillance (PMS) period for Vocinti will expire on March 28, 2025, prompting over ten pharmaceutical companies to start developing generics. This number is expected to grow, especially with the implementation of the “1+3” joint bioequivalence testing system. However, simultaneous reimbursement and market entry remain uncertain.

Vocinti is protected by substance patents valid until December 20, 2027, and November 17, 2028, making its early market entry challenging. Traditionally, substance patents are difficult to circumvent, leading to expectations that Vocinti generics would only launch after 2028.

However, some speculate that Takeda’s withdrawal of market approval could alter this timeline, drawing comparisons to Otezla, a psoriasis treatment set for generic launch in January 2025. In Otezla’s case, Amgen voluntarily withdrew its market approval and chose not to enforce its use patent (valid until March 2028). This enabled several companies, including Dong-A ST and Daewoong Pharmaceutical, to secure first-listing status and reimbursement.

In contrast, while Takeda has withdrawn Vocinti’s market approval, its position on enforcing patent rights remains unclear.

If generic manufacturers pursue early approval and launch their products, Takeda, as the patent holder, could seek damages for patent infringement. Generic companies might challenge the patents through invalidation or scope confirmation trials, but these cases are notoriously difficult to win.

An industry attorney, Jong-Sik Woo of Kyuwon Law Firm, emphasized, “Without explicit waiver of substance patent rights, launching a product constitutes infringement. Careful evaluation of patent issues is essential.”

Additionally, Takeda’s withdrawal could be tied to unmet PMS requirements. Speculation suggests Takeda might reacquire approval and secure reimbursement listing after the PMS period ends.

A senior pharmaceutical executive commented, “The withdrawal could indicate non-execution plans despite the remaining patent term, but nothing is certain. There were even rumors of Vocinti launching in 2024. Generic developers must assess risks carefully before finalizing market entry strategies.”