Replies to post #441118 on Amarin Corp Plc (AMRN)

[lizzy241]

ProLiberty
According to Copilot, no Chinese companies sell generic Vascepa in China, except for Branded Vascepa, which has exclusive rights to sell through Edding.

🔎 Current Situation in China
Regulatory Approval:

China’s National Medical Products Administration (NMPA) approved Vascepa in June 2023 for severe hypertriglyceridemia (≥500 mg/dL).

In July 2024, approval expanded to cardiovascular risk reduction (CVRR) as an adjunct to statin therapy.

Commercial Rights:

Amarin Corporation (the U.S. developer of Vascepa) granted exclusive rights to Eddingpharm to commercialize Vascepa in mainland China.

Eddingpharm is preparing for national reimbursement listing (NRDL) and broader commercial rollout.

Generic Status:

While generic versions of Vascepa exist in the U.S. (e.g., Dr. Reddy’s, Apotex, Camber Pharmaceuticals), these approvals are under the FDA.

In China, no generics are approved or sold. Patent protection and exclusivity agreements prevent local companies from marketing icosapent ethyl generics at this stage.

📌 Key Takeaways
Only branded Vascepa® is available in China, through Eddingpharm.

Generic Vascepa is not sold in China — despite FDA-approved generics in the U.S.

Future generics in China may appear once patents expire or if local manufacturers pursue approvals, but that has not happened yet.