Replies to post #441117 on Amarin Corp Plc (AMRN)

[ProLiberty]

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.

[Number sleven]

JRoon, Can you provide any documentation that shows that a generic version of Vascepa was approved in China?
Sleven,