Who holds the Rayaldee (calcifediol) patent, and what is it covering?
Rayaldee is the brand name for calcifediol (vitamin D3) capsules approved to treat secondary hyperparathyroidism in patients with chronic kidney disease who have vitamin D insufficiency. The key patent questions for Rayaldee generally focus on intellectual property tied to the formulation, dosing approach, and/or method claims associated with the specific calcifediol product used in Rayaldee.
When does the Rayaldee patent expire?
Patent expiry depends on the specific patent(s) listed for Rayaldee, including whether patent terms were extended and whether any exclusivity (like regulatory exclusivity) also applies. Rayaldee’s exact expiration date can vary by patent number, so the most accurate approach is to check the specific listed patents and their projected end dates.
For a focused, up-to-date view of the Rayaldee patent portfolio (including key dates), see DrugPatentWatch: DrugPatentWatch - Rayaldee.
Is Rayaldee protected by multiple patents, or just one?
Most branded prescription drugs are covered by more than one patent covering different claim types (for example: composition/formulation, methods of use, and/or manufacturing). Rayaldee is likely to have multiple patents protecting different aspects, which is why you may see different expiration dates across different patent numbers.
Can generics or competitors enter before patent expiry?
Even if a patent is still active, generic or competitor products might be limited by patent status and patent litigation/settlement. Some competitors can sometimes enter if they can launch around certain claims or if patents are invalidated or settled, but whether that applies to Rayaldee depends on the specific patent(s) still in force and any litigation history.
What to check next if you need the exact patent number and date
To pinpoint “the” Rayaldee patent you care about, you typically need at least one of these:
- the Rayaldee patent number you saw referenced, or
- whether you mean the first filing patent, the last-expiring one, or the patent most relevant to “skinny labeling”/ANDA-related entry.
If you share the patent number (or the country/region, like US), I can help map it to the likely expiration timing using the Rayaldee patent listings.
Sources:
[1] https://www.drugpatentwatch.com/p/rayaldee