Landmark Ruling Secures K-Cab Tablet's Market Exclusivity Until 2031
HK inno.N announced on May 31st that the 토토 바카라 사이트 Tribunal ruled in favor of the company in a passive confirmation of scope trial, filed by a South Korean pharmaceutical company to avoid the compound (substance) 토토 바카라 사이트 (토토 바카라 사이트 No. 1088247) of the gastroesophageal reflux disease treatment, K-CabTablet.
The company stated that the ruling increases the likelihood of HK inno.N maintaining exclusive rights to the K-Cab market until 2031. K-Cab is a P-CAB class gastroesophageal reflux disease treatment, approved in July 2018 as South Korea's 30th new drug. It quickly gained prominence in the market with its rapid efficacy and the convenience of being taken regardless of meals, recording over 9.5 million in prescriptions last year alone.
K-Cab holds two major 토토 바카라 사이트s: the compound (substance) 토토 바카라 사이트 expiring in 2031 and the crystalline form 토토 바카라 사이트 expiring in 2036. The duration of the substance 토토 바카라 사이트 was extended from December 6, 2026, to August 25, 2031, in recognition of the time required for drug research and development.
Generic drug manufacturers have been filing passive confirmation of scope trials against the original product K-Cab in an attempt to release their products in 2026 using a strategy known as 'indication splitting.' This strategy involves launching products based only on subsequent approved indications, excluding the initially approved indication of K-Cab. According to HK inno.N, these generic manufacturers argue that the extended duration of K-Cab's substance 토토 바카라 사이트 does not apply to the subsequent approved indications, thereby challenging the validity of K-Cab's 토토 바카라 사이트.
An HK inno.N representative stated, "Since its launch, K-Cab has consistently expanded its indications and developed various formulations to establish itself as a true P-CAB class new drug for gastroesophageal reflux disease. If we had lost this trial, it would have excessively narrowed the scope of the extended 토토 바카라 사이트 rights, leading to negative outcomes where 토토 바카라 사이트 holders might abandon further research. The 토토 바카라 사이트 Tribunal's decision upheld the existing stance on the scope of extended 토토 바카라 사이트 rights, fully recognizing the value of new drugs and indicating the future direction for South Korea's pharmaceutical industry. We expect positive outcomes in other ongoing trials as well."
Meanwhile, HK inno.N has appealed against generic manufacturers concerning another 토토 바카라 사이트, the crystalline form 토토 바카라 사이트, which is valid until March 12, 2036.