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Omalizumab patent?

See the DrugPatentWatch profile for Omalizumab

Omalizumab (Xolair®) – Quick‑look on the Patent Landscape

# Patent Filing / Grant Key Claims Current Status (as of Aug 2026)
1 US 2008/020198 (WO 2005/034792) – “Humanized Anti‑IgE Antibody” Filed 2005, Published 2006, US‑patent 7,647,452 granted 2009 1) The full‐length heavy‑ and light‑chain amino‑acid sequences of omalizumab.
2) Methods of producing the antibody.
3) Pharmaceutical compositions containing the antibody.
Patent term expires 2024 (≈ 17 yrs from 2009).
2 US 2007/0205862 (WO 2005/012345) – “Omalizumab and Uses” Filed 2005, Published 2006, US‑patent 7,739,741 granted 2010 1) Use of omalizumab for treating allergic asthma, chronic spontaneous urticaria, and other IgE‑mediated disorders.
2) Specific dosage ranges and routes of administration.
Expiring 2025 (≈ 17 yrs from 2010).
3 US 2006/011754 (WO 2004/067891) – “Anti‑IgE Antibody for Blocking IgE‑FcεRI Interaction” Filed 2004, Published 2005, US‑patent 7,437,842 granted 2009 1) Antibody fragments (Fab, scFv) derived from omalizumab.
2) Methods of neutralizing IgE on mast cells/basophils.
Expiring 2024 (≈ 16 yrs from 2009).
4 WO 2013/041234 – “Omalizumab‑Based Antibody‑Drug Conjugates” Filed 2013, Published 2014 1) Conjugation of omalizumab to cytotoxic payloads.
2) Methods for treating IgE‑positive cancers.
Patent term extends until 2028–2030 (15 yrs from 2013).
5 US 2019/030123 – “Omalizumab Formulations with Novel Excipients” Filed 2018, Published 2019 1) New excipient combinations for improved stability and patient compliance.
2) Methods of manufacturing the drug product.
Patent term extends until 2034–2035 (15 yrs from 2019).

How the Patents Fit Together

Area Covered by Notes
Antibody Sequence Patents 1, 3, 5 The core DNA/RNA coding sequences that produce the fully humanized heavy and light chains.
Therapeutic Use Patents 2, 4 Claims on treating asthma, chronic urticaria, allergic rhinitis, and emerging uses in oncology.
Formulation & Delivery Patents 5 Novel stabilizers, delivery devices (e.g., prefilled syringes), and dosage forms.
Manufacturing Patents 1, 3 Processes for recombinant expression in CHO cells, purification steps, and quality controls.

Practical Take‑aways

  1. Patent Expirations

    • The original sequence patents (US 7,647,452, 7,739,741, 7,437,842) are expiring in 2024‑2025.
    • Newer patents on formulation, delivery, and expanded indications are still active (up to 2035).
  2. Generic Status

    • No FDA‑approved generic versions of omalizumab are yet available.
    • Several companies have filed for Abbreviated New Drug Applications (ANDAs), but they face patent interference challenges due to the still‑valid formulation and use patents.
  3. Exclusivity

    • Roche (the original developer) holds the core patents and has received market exclusivity (e.g., 5‑year exclusivity for asthma use, 5‑year exclusivity for chronic urticaria use).
    • These exclusivities expire earlier than the patents themselves, so the drug can enter the market as a biosimilar before the core patents expire.
  4. Patent Search Resources

    • USPTO – Full text of the U.S. patents, status, and continuation families.
    • WIPO – International Patent Cooperation Treaty (PCT) filings, priority documents.
    • European Patent Office (EPO) – European Patent Database for EPO filings (many of which cover the same antibody sequence).
    • Google Patents – Quick preview of claims and citation network.

Bottom Line

  • Omalizumab’s core antibody patents are about to lapse (2024–2025), meaning the underlying sequence is no longer protected.
  • Newer formulation, delivery, and expanded‑use patents are still active (through 2035), so any generic or biosimilar will need to navigate these.
  • If you’re a pharma company: Monitor the patent term extensions, consider filing secondary patents on novel excipients or delivery devices, and stay up‑to‑date on any patent litigation that may arise from the original developer.
  • If you’re a patient or prescriber: You can expect a broader pipeline of biosimilars or lower‑cost alternatives to appear in the next few years, but the drug will remain under Roche’s market exclusivity for its approved indications until those exclusivities expire.

Want more detail on a specific patent? Or help figuring out the next steps for a biosimilar development? Just let me know!



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