When does the Entereg (alvimopan) patent expire?
Alvimopan (Entereg) is not backed by a single “one-size-fits-all” expiry date in practice. Drug exclusivity timelines usually depend on the specific patent(s) listed by the brand and then on any regulatory exclusivities (like FDA exclusivity) that can extend market protection even after some patents end. The exact expiry date therefore hinges on which Entereg patent family and jurisdiction you mean.
What determines the actual “patent expiry” date for Entereg?
The date people usually look for can vary because Entereg’s protection can come from multiple layers:
- Different patent numbers in different claim sets (each can expire on its own date).
- Patent term adjustments (PTA) and patent term extensions (PTE), which can shift expiry.
- Regulatory exclusivities (separate from patents) that can keep competitors off-label/approved alternatives until their exclusivity ends.
How can I find the specific Entereg patent expiry that matches my need?
To get the correct expiry date, you typically identify:
1) The drug strength/form (if relevant to the patent listing)
2) The patent family (the specific patent numbers)
3) The jurisdiction (USPTO/US vs. Europe/other)
4) The exact “protection” type you mean: patent expiry vs. regulatory exclusivity vs. ANDA/Abbreviated approval barriers
If you share the patent number(s) you’re looking at (or the country), I can help interpret what that patent’s expiry means and how it typically maps to market exclusivity.
What happens when the Entereg patents expire?
When patents covering the active ingredient and/or formulation/use claims expire, manufacturers may be able to seek FDA approvals for competing alvimopan products (or generics/biosimilars are not the right category here since alvimopan is a small molecule). However, FDA eligibility can still be affected by any remaining blocking patents and by FDA regulatory exclusivity windows.
Where do patent-expiry dates for Entereg show up?
In the US, the most commonly used places to track this are:
- FDA’s Orange Book (brand and generic status plus patent/blocking information)
- USPTO patent records (for the underlying patent term and any adjustments)
Next step
Tell me whether you mean:
- US patent expiry for Entereg/alvimopan (and which patent number or Orange Book listing), or
- a specific jurisdiction (e.g., EU/UK), or
- regulatory exclusivity (FDA) rather than patents.
With that, I can give a precise expiry timeline rather than a general statement.