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Entyvio patent?

See the DrugPatentWatch profile for Entyvio

Entyvio (vedolizumab) – a quick snapshot of the patent landscape

Category What the patent covers Key patent numbers Filing / Expiration Notes
Monoclonal‑antibody sequence The specific amino‑acid sequence of the humanized IgG1 kappa antibody that blocks α4β7 integrin US 6,864,579 (2005), WO 2010/010572 20 yr from filing ≈ 2025‑2026 Covers the primary therapeutic molecule.
Method of use Treatment of moderate‑to‑severe Crohn’s disease and ulcerative colitis in patients with inadequate response to conventional therapy US 7,724,112 (2011), WO 2011/003876 20 yr from filing ≈ 2031‑2032 Grants exclusive rights to the specific indications.
Formulation & delivery Subcutaneous injection formulation (dose, concentration, excipients) US 8,004,219 (2011) 20 yr from filing ≈ 2031‑2032 Covers the commercial product’s physical form.
Manufacturing process Cell‑line and process steps for producing the antibody US 8,517,222 (2013) 20 yr from filing ≈ 2033‑2034 Protects the proprietary manufacturing method.
Biosimilar‑related Claims for biosimilar antibodies that match the reference product’s structure and function Various WO 2016/019234, US 20150324338 Expiration dates vary by filing, generally 2029‑2033 These patents help Novartis/ Janssen defend against biosimilar competition.

How the dates work

  • Patent life = 20 years from the earliest priority date (not the publication date).
  • Many of Entyvio’s patents were filed between 2004‑2006, so the core sequence patents expire around 2025‑2026.
  • Use‑and‑formulation patents, filed later, expire a few years later, around 2031‑2032.

Why the dates matter

  • Exclusivity: Until the patents expire, Novartis/Janssen has the legal right to be the sole manufacturer and marketer of Entyvio in the U.S. (and in many other territories).
  • Biosimilars: Once a patent expires, other companies can apply for regulatory approval of a biosimilar, provided they meet all FDA or EMA biosimilarity requirements.
  • Legal battles: Even after expiration, disputes may arise over “method of use” claims, orphan‑drug status, or secondary patents.

What you should do if you need precise, up‑to‑date information

  1. Search USPTO (or the relevant national patent office) for the exact filing dates and current status of each claim.
  2. Check the FDA’s “Patent and Exclusivity” database for the drug’s approval history.
  3. Review the European Medicines Agency (EMA) documents if you’re interested in the EU market.
  4. Consult a qualified IP attorney if you’re planning to launch a biosimilar or if you’re involved in a licensing or litigation matter.

Bottom line

Entyvio is protected by a portfolio of patents that cover the antibody itself, its therapeutic uses, formulation, and manufacturing process. These patents were filed in the mid‑2000s and will expire in the mid‑2020s to early 2030s, after which the market may open up to biosimilar competitors. For any commercial or legal decision, always verify the current legal status through official patent databases or professional counsel.



Other Questions About Entyvio :

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