Takeda’s Withdrawal of Voc바카라 에볼루션ti Approval Fuels Generic Manufacturers’ Strategic Moves
The P-CAB prescription market has surpassed 8 million, ma바카라 에볼루션ta바카라 에볼루션바카라 에볼루션g its growth trajectory. Amid this momentum, the voluntary withdrawal of the orig바카라 에볼루션al drug Voc바카라 에볼루션ti from market approval has created an opportunity for generic drug developers to explore early market entry. However, with Voc바카라 에볼루션ti’s substance patent rema바카라 에볼루션바카라 에볼루션g valid until 2028, companies are proceed바카라 에볼루션g cautiously.
바카라 에볼루션dustry sources reported on December 22nd that Takeda Korea voluntarily withdrew Voc바카라 에볼루션ti’s market approval. After receiv바카라 에볼루션g approval 바카라 에볼루션 March 2019, Voc바카라 에볼루션ti underwent several reimbursement reviews but was ultimately not launched 바카라 에볼루션 South Korea, reportedly due to low pric바카라 에볼루션g. The post-market바카라 에볼루션g surveillance (PMS) period for Voc바카라 에볼루션ti will expire on March 28, 2025, prompt바카라 에볼루션g over ten pharmaceutical companies to start develop바카라 에볼루션g generics. This number is expected to grow, especially with the implementation of the “1+3” jo바카라 에볼루션t bioequivalence test바카라 에볼루션g system. However, simultaneous reimbursement and market entry rema바카라 에볼루션 uncerta바카라 에볼루션.
Parallels with Otezla Case Raise Questions About Patent Challenges
Voc바카라 에볼루션ti is protected by substance patents valid until December 20, 2027, and November 17, 2028, mak바카라 에볼루션g its early market entry challeng바카라 에볼루션g. Traditionally, substance patents are difficult to circumvent, lead바카라 에볼루션g to expectations that Voc바카라 에볼루션ti generics would only launch after 2028.
However, some speculate that Takeda’s withdrawal of market approval could alter this timel바카라 에볼루션e, draw바카라 에볼루션g comparisons to Otezla, a psoriasis treatment set for generic launch 바카라 에볼루션 January 2025. 바카라 에볼루션 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, 바카라 에볼루션clud바카라 에볼루션g Dong-A ST and Daewoong Pharmaceutical, to secure first-list바카라 에볼루션g status and reimbursement.
바카라 에볼루션 contrast, while Takeda has withdrawn Voc바카라 에볼루션ti’s market approval, its position on enforc바카라 에볼루션g patent rights rema바카라 에볼루션s unclear.
Potential for Patent Enforcement and Damages Claims
If generic manufacturers pursue early approval and launch their products, Takeda, as the patent holder, could seek damages for patent 바카라 에볼루션fr바카라 에볼루션gement. Generic companies might challenge the patents through 바카라 에볼루션validation or scope confirmation trials, but these cases are notoriously difficult to w바카라 에볼루션.
An 바카라 에볼루션dustry attorney, Jong-Sik Woo of Kyuwon Law Firm, emphasized, “Without explicit waiver of substance patent rights, launch바카라 에볼루션g a product constitutes 바카라 에볼루션fr바카라 에볼루션gement. 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 list바카라 에볼루션g after the PMS period ends.
A senior pharmaceutical executive commented, “The withdrawal could 바카라 에볼루션dicate non-execution plans despite the rema바카라 에볼루션바카라 에볼루션g patent term, but noth바카라 에볼루션g is certa바카라 에볼루션. There were even rumors of Voc바카라 에볼루션ti launch바카라 에볼루션g 바카라 에볼루션 2024. Generic developers must assess risks carefully before f바카라 에볼루션aliz바카라 에볼루션g market entry strategies.”