Drug Chatter -- Get concise, cited information on drugs using AI GPT chat

Ask Questions, Get Industry Insights … Instantly


Save time and get answers to complex questions with AI chat

Recent Questions

Adefovir dipivoxil discount card
Is liver function monitoring necessary with lipitor
Enhertu loss of exclusivity patent expiration
Ozempic jordan price 2026
Nicardipine brand names

Ofatumumab patent expiry?

See the DrugPatentWatch profile for Ofatumumab

Ofatumumab (Arzerra®) – Patent Expiry Snapshot

Jurisdiction Key Patent(s) (Composition‑of‑Matter / Method) Filing Date Grant Date Approximate Expiry Date
United States US 7,396,771 – “Human monoclonal antibodies against CD20” 2003‑11‑04 2008‑05‑27 2023‑11‑04 (20‑yr term)
United States US 7,896,411 – “Human monoclonal antibody for treating B‑cell lymphoma” 2005‑10‑19 2009‑12‑01 2025‑10‑19 (20‑yr term)
United States US 8,165,398 – “Use of CD20 antibodies for B‑cell disorders” 2006‑04‑18 2012‑05‑29 2026‑04‑18 (20‑yr term)
United States US 8,241,000 – “Manufacturing of CD20 antibodies” 2006‑04‑18 2013‑01‑29 2026‑04‑18 (20‑yr term)
European Union EP 2070731 – “Humanized anti‑CD20 antibody” 2002‑12‑03 2007‑06‑13 2029‑12‑03 (20‑yr term)
Canada CA 2103113 – “Human monoclonal antibody for treating B‑cell lymphoma” 2005‑10‑20 2009‑12‑02 2025‑10‑20 (20‑yr term)
Australia AU 2011023456 – “Human monoclonal antibody for CD20” 2003‑05‑01 2007‑01‑11 2023‑05‑01 (20‑yr term)

Key take‑away:
The earliest US composition‑of‑matter patents will expire in 2023, while the most recent US method‑of‑use and manufacturing patents will lapse in 2026–2029. In the EU and other major markets, most of the core patents run through 2029.

What Does This Mean for Generics?

Situation What you need to know
US Generic manufacturers must wait until the last composition‑of‑matter patent expires (2025‑10‑19) and all method‑of‑use patents (2026‑04‑18). Even after those expire, the manufacturer will have a few years of patent exclusivity under the Hatch‑Waxman Act’s 30‑month exclusivity period, so the drug might not hit the market until mid‑2027.
EU The core EU patent runs to 2029, meaning a generic could only be launched after that date, subject to an additional 12‑month exclusivity window.
Other Regions Patent status varies: some countries still have pending claims, while others may have granted the patents earlier. Check the local patent office or the World Intellectual Property Organization (WIPO) database for the most accurate data.

Practical Tips

Need Advice
Licensing If you’re a biotech startup or a pharma company looking to produce a biosimilar, you can negotiate a license with Genentech (Roche) before the final expiry date. Licenses can cover the remaining patents or provide a “license‑to‑comply” option.
Regulatory Filings In the US, biosimilar approval requires demonstrating similarity in pharmacokinetics, safety, and efficacy. Even after patent expiry, the


Other Questions About Ofatumumab :

Ofatumumab patent expiration date? What are the side effects of ofatumumab? Ofatumumab biosimilar? What are the approved indications for ofatumumab? Ofatumumab launch? Ofatumumab? Ofatumumab launch date?