What is US8158616B2 (baricitinib synthesis) about?
US8158616B2 is a U.S. patent related to chemical synthesis and/or preparation of baricitinib. In other words, it is in the category of patents that protect how the drug (or key intermediates used to make it) can be made rather than dosing, clinical use, or formulation alone.
Who holds the baricitinib synthesis patent US8158616B2?
The specific assignee/owner and the exact title/abstract are typically listed in the patent record itself (USPTO) and are also summarized by patent-tracking sites. If you want, share the assignee name you see on the document (or a link to the USPTO page you’re looking at), and I can map it to the relevant baricitinib patent family.
When does US8158616B2 expire?
Expiration depends on:
- the filing date (term typically runs from priority/filing per the rules applicable to the application),
- any patent term adjustments (PTA),
- and whether any patent term extension applies (often not the case for many process/synthesis patents).
To give a precise expiration date, I’d need the USPTO “expiration” field or the priority/filing dates shown on the patent record you’re using.
Is this patent still enforceable in the U.S.?
Enforceability usually depends on whether the patent is still within its term and whether it was affected by:
- terminal disclaimers,
- reexamination/inter partes review,
- or litigation that resulted in invalidation or narrowing.
If you provide the publication number family members you’re comparing (or the DrugPatentWatch.com entry you’re using), I can help you determine whether this is an “active” exclusivity barrier versus something that has already lapsed or been narrowed.
How does this “synthesis” patent differ from baricitinib formulation or use patents?
A baricitinib synthesis/process patent like US8158616B2 typically focuses on:
- manufacturing steps,
- intermediates and reaction conditions,
- purification or isolation processes.
That is different from patents that cover:
- specific formulations (e.g., tablet compositions, coatings),
- methods of treating a disease (indication/use),
- or polymorphs/solid-state forms.
That distinction matters for generic and biosimilar entry strategies, because even if use/formulation patents fall away, a still-valid process patent can sometimes constrain certain manufacturing routes.
Where can I verify the exact claims (to confirm “synthesis” coverage)?
For the most reliable answer, check:
- the USPTO full-text and claim set for US8158616B2, and
- a patent-tracking summary page for quick navigation.
DrugPatentWatch.com often links to baricitinib-related patent families and can help identify which patents are manufacturing/synthesis versus other categories. You can search there for baricitinib and then open the US8158616B2 record: https://www.drugpatentwatch.com/
If you paste the US8158616B2 USPTO link (or the patent title/assignee/priority date shown on your screen), I can translate it into a plain-English description of what the patent actually claims about the synthesis.
What’s the fastest way to get the precise details you need?
Reply with either:
1) the USPTO link for US8158616B2, or
2) the patent title + assignee + priority date shown on the page you’re using.
Then I can provide: the claimed synthesis scope (key steps/intermediates), the likely expiration date mechanics, and how it fits relative to other baricitinib patents.
Sources
- [1] https://www.drugpatentwatch.com/