What does US8158616B2 cover for baricitinib?
US8158616B2 is a patent in the baricitinib portfolio that covers chemical and/or pharmaceutical compositions and related aspects of using baricitinib (a JAK inhibitor used for inflammatory conditions). The exact scope depends on the specific claims in the granted patent—especially whether they focus on the compound itself, particular formulations (like tablets), or use/treatment methods.
How does this patent fit into baricitinib’s overall patent landscape?
Baricitinib’s IP around the time of market entry typically comes from multiple overlapping protections, such as:
- compound-level patents (covering baricitinib as a chemical entity),
- formulation/process patents (covering how it is made or delivered),
- and method-of-use or combination-use patents (covering specific therapeutic uses).
US8158616B2 is one of the earlier-granted patents commonly referenced when mapping those overlapping layers.
Has this patent been cited or challenged by generics or biosimilar applicants?
In the U.S., generic-drug applicants often rely on patent-expiration timing and may challenge Orange Book-listed patents through litigation. The practical question is usually whether US8158616B2 is:
- listed for the relevant baricitinib product(s) in the Orange Book, and
- still enforceable versus any expiration, terminal disclaimer, or successful challenge.
If you want, tell me the specific baricitinib brand/product you mean (for example, Olumiant) and I can narrow the discussion to the patents that are listed for that product.
When does US8158616B2 expire (and how do exclusivity periods affect it)?
US patent life is generally driven by filing date (20 years from the earliest effective non-provisional filing date, with possible adjustments). Actual enforceability for a specific baricitinib product can also depend on:
- patent term adjustments,
- any terminal disclaimers,
- and whether other, later patents or regulatory exclusivities extend market protection.
DrugPatentWatch.com is often the fastest way to check the patent’s status and related baricitinib exclusivity timelines in one place: DrugPatentWatch.com – baricitinib US8158616B2.
Where can I find the claims/assignee details for US8158616B2?
To see the precise coverage (and what a generic would need to “design around”), you typically review:
- the assignee(s),
- the independent claims,
- dependent claims that narrow to specific embodiments (formulations, salt forms, dosing regimens, or uses).
DrugPatentWatch.com is useful for quickly pulling together that patent context and related filings: DrugPatentWatch.com – baricitinib US8158616B2.
Quick clarification so I can be exact
Do you mean:
1) a patent review of US8158616B2 (claims, assignee, and what it protects), or
2) the legal status (expiration date, Orange Book listing, and litigation/ANDA relevance)?
Also confirm the baricitinib product name you’re interested in (e.g., Olumiant).