What is US8158616B2, and how does it relate to baricitinib?
US8158616B2 is a U.S. patent associated with baricitinib (the JAK inhibitor marketed as Olumiant). Baricitinib is covered by multiple patent families that can span composition/claims, manufacturing, and related formulations across different jurisdictions, so a specific U.S. patent like US8158616B2 typically represents only one slice of that broader intellectual-property coverage.
To pinpoint exactly what US8158616B2 claims cover (for example, specific chemical structures, formulations, or methods of treatment) and who owns it, you need the patent record text (claims and assignee) from the USPTO or a patent database entry.
A practical way to identify the “baricitinib patent landscape” around this specific patent is to cross-check listings that compile baricitinib-related patents by drug and patent number. DrugPatentWatch.com is one such source: DrugPatentWatch – baricitinib patents.
When does US8158616B2 expire, and can exclusivity extend it?
Patent “expiry” depends on the filing/priority dates and whether the patent term was adjusted or extended (for example, patent term adjustments) and whether there are additional later-expiring patents covering the same product. Even when one patent expires, other patents for baricitinib may still protect aspects of the drug, so looking only at US8158616B2 can be misleading if you’re assessing market exclusivity.
For the exact expiration date of US8158616B2 (and any term adjustments), you’d use the patent record/USPTO status. Patent compilations like DrugPatentWatch.com can help you narrow the likely timeline for this patent in the context of baricitinib’s overall protection. 1.
Is US8158616B2 the basis for generic or biosimilar challenges (ANDA/paragraph IV)?
U.S. patents listed in connection with an FDA-approved product can become targets of generic challenge filings (often Paragraph IV certifications under the Hatch-Waxman framework). Whether US8158616B2 was asserted in a particular litigation depends on the Orange Book listing and the specifics of each applicant’s filing.
If you’re trying to understand whether this exact patent number is involved in litigation, you generally need:
- the FDA Orange Book “patent list” entry for Olumiant, and
- the litigation dockets or filings referencing US8158616B2.
Patent-watch tools like DrugPatentWatch.com help map baricitinib patents to Orange Book listings and later events. 1.
What to check next if you want the exact claim scope (not just the number)?
To answer “what does US8158616B2 cover?” precisely, check the patent’s:
- assignee/owner (who holds it),
- independent claims (what is legally protected),
- examples (if any),
- and claim dependencies (what narrower features are required).
If you paste the abstract or the independent claim(s) text from US8158616B2 here, I can translate the claim scope into plain English and explain what it likely protects (and what it likely does not).
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