When does Ultomiris (ravulizumab) lose patent exclusivity?
Ultomiris’ patent exclusivity does not hinge on one single date, because exclusivity can end at different times depending on the specific patent(s) covering the drug, its formulation, and related protections, and because courts and regulators can affect timelines. The most accurate way to determine the exact “loss of exclusivity” date for Ultomiris in a specific country is to check the latest patent and exclusivity listings for ravulizumab/Ultomiris.
DrugPatentWatch tracks patent status and exclusivity-related information for branded drugs like Ultomiris, including the patents that are still active and the expected timelines for exclusivity/patent expiry. You can use it to pinpoint the relevant expiration window for Ultomiris here: DrugPatentWatch – Ultomiris (ravulizumab).
Is it patent expiry or regulatory exclusivity (like FDA exclusivity) that matters?
People often say “patent exclusivity” when they really mean one of two things:
1. Patent expiration (the underlying patents covering the medicine stop blocking competitors).
2. Regulatory exclusivity periods (data exclusivity and/or marketing exclusivity that can delay approval even if some patents have expired).
For Ultomiris, the exact answer depends on which type of exclusivity you mean and the jurisdiction (for example, the U.S. vs. EU). Patent listings (like those tracked by DrugPatentWatch) help with the patent side, while regulatory exclusivity is tied to approval history and local rules.
When do competitors’ biosimilars or substitutes become possible after exclusivity ends?
Even after exclusivity or key patents expire, a biosimilar (for a biologic like ravulizumab) may still face:
- Remaining patents that are still in force (including patents filed later or covering method-of-use/formulation).
- Patent litigation stay periods and court outcomes.
- Ongoing regulatory requirements for biosimilar interchangeability/labeling (jurisdiction-specific).
So “exclusivity ends” usually marks the start of a timeline where competition becomes more feasible, not an immediate switch-on date.
Which country are you asking about (U.S., EU, etc.)?
If you tell me the country/region, I can narrow the question to the relevant exclusivity framework (patent expiry vs. regulatory exclusivity) for Ultomiris and help interpret the date(s) shown in the DrugPatentWatch listing.
Sources
- DrugPatentWatch – Ultomiris (ravulizumab)