South Korean pharmaceutical companies are stepping into the limelight with their groundbreaking drugs. HK inno.N's K-CAB, featuring the active ingredient Tegoprazan, and Daewoong Pharmaceuticals' Fexuclue, containing Fexuprazan, have become blockbuster pharmaceuticals. K-CAB achieved impressive sales revenue of $79.3 million in the previous year, while Fexuclue demonstrated outstanding performance, exceeding $7.6 million upon its release. Industry insiders anticipate that Fexuclue may reach $75.6 million in sales this year, creating a buzz in the industry.

On November 1st, industry sources revealed a notable drug in the spotlight as treatments for gastroesophageal reflux disease (GERD) make significant advancements. Takeda Pharmaceutical's Vocinti, which contains the active ingredient Vonoprazan, takes center stage. With expectations of further growth in the competitive proton pump inhibitor (P-CAB) market, South Korean pharmaceutical companies are actively involved in developing follow-up drugs to Vocinti.

Vocinti obtained product approval from the Ministry of Food and Drug Safety (MFDS) in March 2019 but has not yet been included in the National Health Insurance Service (NHIS) coverage. Multiple evaluations for its inclusion in the coverage were conducted, but due to its low cost, it was reportedly abandoned for South Korean distribution. Consequently, Korean pharmaceutical companies developing follow-up generic drugs have the potential to become the first products included in the national insurance coverage.

The challenge lies in determining the appropriate timeline from development to pricing among pharmaceutical companies. Companies such as Genuone Sciences, GL Pharma, and Rex Pharm Tech have formulated plans to release Vocinti generics and have recruited collaborative development partners. Industry expectations suggest that more than ten companies, and potentially even over 40 companies, could consider product development if a "1+3" collaborative approach is implemented.

The reevaluation period (PMS) for Vocinti is set to expire on March 28, 2025, with substance patents persisting until December 20, 2027, and November 17, 2028. Substance patents typically have low chances of being successfully challenged, leading to the expectation that generic versions of Vocinti may only be released after November 2028. This timeline is not directly related to the "priority sale item approval".

Some companies that have not yet made preparations have the flexibility for development, and determining the exact development timing is not straightforward. However, if an unregistered composition patent is granted during this period (before the substance patent expires), the situation may change. If a composition patent is granted, pharmaceutical companies will have to initiate passive rights scope confirmation judgment to avoid it, and generic developers will have to file for priority sale item approval within 14 days. While this largely depends on the patent holder, Takeda Pharmaceutical, there is a prevailing opinion that early development should be considered as a precautionary measure.

A representative from a domestic pharmaceutical company stated, "There is a viewpoint that even though it's an original product and has not been included in the national insurance coverage so far, they may consider registering the composition patent now. However, it is advisable to proceed with preparation and clinical development in advance to be prepared for any contingency."

Another pharmaceutical company representative mentioned, "There is still plenty of time until the patent expiration, but many pharmaceutical companies are getting ready for development or reviewing their options. Obtaining approval is one thing, but as the first registered product, the timing for pricing approval needs to be carefully determined. We are planning to proceed while considering various scenarios."