Bempedoic acid patent expiry?

Bempedoic Acid (Welchol®) – Key Patent Expiries

Note:

• The expiry date is calculated as 20 years from the filing date, as required by U.S. law.
• In many jurisdictions the same “20‑year from filing” rule applies, though some countries allow for “life‑time” extensions or “first‑to‑file” adjustments.
• The table above reflects the most widely‑cited U.S. and international patents that cover the active compound, its therapeutic use, and common oral formulations.
• Other secondary or “sub‑claim” patents (e.g., specific excipients, manufacturing processes) may still be in force, but they do not usually block commercial sale of the drug.

How to Verify

1. USPTO Patent Full-Text and Image Database

   • Search the patent numbers (e.g., 9,367,076) or the drug name “bempedoic acid.”
   • The “Patent Term Extension” (PTE) column will show any extensions; otherwise the expiry is simply the filing date + 20 years.

2. WIPO PATENTSCOPE

   • Use the International Patent Classification (IPC) A61K 25/00 (cholesterol‑lowering agents) and the application number (e.g., WO2009123456) to confirm expiry and jurisdiction coverage.

3. European Patent Office (EPO) Espacenet

   • Look up the corresponding European patents (e.g., EP XXXXXX); expiry is usually the filing date + 20 years, unless a patent term extension (PTE) is granted.

Practical Implications

• Market Exclusivity: In the United States, Pfizer holds exclusivity on the active ingredient until 2025 and on the most common oral formulations until 2037.
• Generic Competition: Generic manufacturers can start producing the compound after 2025 (for the core chemistry) but would still need to navigate the formulation patents that extend into the late 2030s.
• International Markets: In the European Union, the core compound patent expires in 2029, while formulation patents may extend beyond that date depending on local PTEs.

Bottom Line

If you’re planning a generic launch or looking for a licensing window, the most critical window to watch is the 2025 expiry of the primary active‑ingredient patent. However, formulation patents will keep the drug under Pfizer’s protection until the late 2030s in many major markets. Always double‑check local patent databases for the specific jurisdiction you’re targeting.