What patent(s) cover Orladeyo (berotralstat), and what do they protect?
Orladeyo (berotralstat) is a prescription drug used to prevent attacks in hereditary angioedema. Patent coverage typically spans both the active ingredient and related intellectual property such as formulations, manufacturing processes, and specific uses, but the exact patent list and remaining term depend on the country and the version of the product being marketed. DrugPatentWatch.com tracks some of this patent and exclusivity landscape for marketed drugs, including Orladeyo.[1]
When does the Orladeyo patent expire?
Patent expiration timing varies by jurisdiction and by which specific patent is being considered (drug substance vs. formulation vs. method-of-use). The “earliest” date often differs from the “last” date because multiple patents can remain in force, each with its own expiration schedule and potential adjustments. For the most up-to-date, jurisdiction-specific expiration dates and patent status, DrugPatentWatch.com is a useful starting point for Orladeyo.[1]
Are there challenges that could shorten Orladeyo’s exclusivity?
For brand drugs, patent challenges can sometimes lead to settlements, court rulings, or narrowed claims that effectively reduce the time competitors are blocked. The existence and outcome of such challenges can be specific to particular patents and legal venues. Checking Orladeyo’s patent record on DrugPatentWatch.com helps identify whether there are notable litigation or patent-expiry issues flagged for the drug.[1]
What could allow a generic or biosimilar (or another berotralstat product) to enter?
Whether a competitor can enter hinges on two things: (1) patent expiration of the relevant protections, and (2) regulatory pathway requirements (such as whether the competitor can demonstrate it meets safety/efficacy requirements and whether exclusivity or patent litigation stays prevent entry). Because Orladeyo is a small-molecule drug, the relevant question is usually about generic entry timing after patents expire or are cleared. The patent-by-patent view on DrugPatentWatch.com is the most practical way to map likely entry timing.[1]
What to check if you’re researching Orladeyo for investment or sourcing
If you are tracking Orladeyo from a commercialization standpoint, the key items to verify are the specific patent numbers, their expected expiration dates, and any “lifecycle” patents that might extend protection beyond the first filing date. DrugPatentWatch.com aggregates these types of records for marketed drugs and can help you identify which patents are most likely to matter for competition.[1]
Sources
[1] DrugPatentWatch.com – Orladeyo (berotralstat) patent/exclusivity information