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See the DrugPatentWatch profile for infliximab
Bottom line: Opko’s patents are largely method‑of‑use and formulation patents (not the original composition patent that Pfizer holds). Most of them have already expired or will expire in 2024–2027, so the “Opko‑specific” legal moat for infliximab is largely gone.
Licensing from Pfizer Opko entered into a license agreement with Pfizer (the owner of the core infliximab composition patents, e.g., US 6,746,444) in the early 2000s. Under that license, Opko was granted rights to develop specific use claims—particularly for Crohn’s disease and rheumatoid arthritis.
Method‑of‑Use Protection Pharmaceutical companies routinely seek “method‑of‑use” patents to secure market exclusivity even when the underlying drug is generic or off‑label. By patenting the exact dosing regimen, treatment schedules, and combination therapies (e.g., infliximab + azathioprine), Opko could block generic competitors until those patents expired.
Strategic Positioning Opko’s “Infliximab” patents were part of a larger portfolio that included other biologics and small molecules. The patents helped position Opko as a specialty pharmacy that could offer tailored, high‑value biologic therapy regimens.
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