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Post# of 446772
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Re: JRoon71 post# 441117

Friday, 11/14/2025 12:55:02 PM

Friday, November 14, 2025 12:55:02 PM

Post# of 446772
According to Grock: China's regulatory framework for innovative chemical drugs like Vascepa (classified as a Class 1 chemical entity) provides 6 years of data exclusivity for new drugs approved via the New Drug Application (NDA) pathway, starting from the approval date.

The U.S. saw generic icosapent ethyl launches in 2020 after patent challenges, but China's stricter NDA pathway and local trial requirements (e.g., EddingPharm's Phase 3 study) delay such competition.
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