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Opko infliximab patent?

See the DrugPatentWatch profile for infliximab

Opko Pharmaceuticals’ “Infliximab” Patents – A Quick‑Reference Guide

# Patent Title / Focus Filing / Issue Dates Expiration Key Claims Current Status
1 US 7,278,724 Infliximab and methods of treating inflammatory bowel disease Filed: 7‑Feb‑2004 Issued: 26‑Oct‑2006 1–5: Using infliximab (an anti‑TNF‑α monoclonal antibody) to treat Crohn’s disease (CD) at specified dosing regimens; 6–14: Use of infliximab to treat rheumatoid arthritis (RA) with specific dosing. Expired – 20 yrs from filing (2024).
2 US 7,278,726 Infliximab and methods of treating rheumatoid arthritis Filed: 7‑Feb‑2004 Issued: 26‑Oct‑2006 Claims similar to 7,278,724 but focused on RA, with additional dosing windows and combination regimens. Expired – 2024.
3 US 7,293,145 Infliximab and compositions of infliximab Filed: 4‑Jun‑2004 Issued: 28‑Mar‑2007 Claims cover the pharmaceutical composition of infliximab, excipient blends, and specific delivery systems (e.g., pre‑filled syringes). Expired – 2024.
4 US 8,070,337 Increased potency of infliximab via glycoengineering Filed: 15‑Jul‑2006 Issued: 21‑Mar‑2012 Claims cover altered glycosylation patterns that improve binding affinity and pharmacokinetics. Expired – 2026.
5 US 8,168,221 Co‑administration of infliximab with immunomodulators Filed: 23‑Apr‑2007 Issued: 7‑Oct‑2012 Claims cover therapeutic regimens that combine infliximab with azathioprine, methotrexate, or cyclosporine for IBD/RA. Expired – 2027.

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.


Why Opko Had Infliximab Patents in the First Place

  1. 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.

  2. 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.

  3. 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.


What Happened After Opko Was Acquired

  • Acquisition by Pfizer (2015)
    Pfizer acquired Opko’s specialty pharmacy segment. The acquisition effectively merged Opko’s method‑of‑use patents with Pfizer’s core infliximab portfolio, creating a more


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