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Bempedoic acid - a near term launch opportunity for generic pharma manufacturers

Bempedoic acid (Brand: Nexletol, Innovator: Esperion) is an essentially new, oral treatment option approved for patients needing further LDL-C lowering beyond maximally tolerated statin therapy. Bempedoic acid is the first oral, once-daily, non-statin LDL-C lowering medicine approved since 2002 for indicated patients.

Bempedoic acid was studied in 4 phase 3 trial series (CLEAR trials). Phase 3 randomized clinical trials have shown decreases in LDL-C levels from 17.4% to 28.5% when bempedoic acid was added to stable background lipid-lowering therapy (LLT), ranging from no LLT to high-intensity statin treatment with adjunct non-statin LLT.

There is no product patent in several markets, including India, China, Korea, GCC, and other markets in the Middle East, making the API an interesting near-term portfolio selection opportunity for generic formulators. For generic firms interested in the US market, the NCE-1 ling date is February 2024.

We manufacture an anhydrous non-solvated crystalline form of bempedoic acid, the same as the innovator crystalline form. To know more about our offerings , please read the whitepaper on Bempedoic acid by filling the contact form below.

Preencha o formulário de contato abaixo para visualizar o white paper