Rayaldee generics — when can they launch?
Rayaldee (CALCIFEDIOL) · · 16 active US patents · 0 expired
Where Rayaldee sits in the generic timeline
Imminent generic cliff: earliest active US patent for Rayaldee expires in 2027 (~1 year from today). ANDA filers are likely already preparing Paragraph IV certifications. Expect first-filer 180-day exclusivity competition imminently.
Under US Hatch-Waxman, a generic enters via an ANDA (Abbreviated New Drug Application) and may file with one of four Paragraph IV certifications attacking the brand's listed patents. If the brand sues within 45 days, a 30-month FDA approval stay is triggered. First Para IV filer typically gets 180-day market exclusivity.
Patent estate by type — active patents
Method-of-use patents only carve out specific indications; generics can launch with a "skinny label" omitting those uses. Composition-of-matter patents block the molecule itself.
- Method of Use — 9 patents
- Formulation — 7 patents
FDA U-codes carved out by Rayaldee patents
Method-of-use patents are listed against specific FDA Patent Use Codes ("U-codes") representing carved-out indications. Generics can launch with a label that omits these uses.
| U-code | Description |
|---|---|
U-2274 | (no description) |
U-1888 | (no description) |
U-1871 | (no description) |
U-3814 | (no description) |
U-3815 | (no description) |
U-1873 | (no description) |
U-2258 | (no description) |
U-1872 | (no description) |
U-3721 | (no description) |
Sample patent estate
Showing 6 of 16 active US patents. View full estate on the Rayaldee drug page →
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This patent protects methods and compositions for treating vitamin D insufficiency and deficiency using delayed, sustained release formulations of 25-hydroxyvitamin D2 and/or 25-hydroxyvitamin D3.USPTO title: Treating vitamin D insufficiency and deficiency with 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3
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This patent protects methods for treating vitamin D insufficiency and deficiency using 25-hydroxyvitamin D2 and/or 25-hydroxyvitamin D3.USPTO title: Treating vitamin D insufficiency and deficiency with 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3
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This patent protects a delayed, sustained release oral dosage form of 25-hydroxyvitamin D.USPTO title: Oral dosage form of 25-hydroxyvitamin D
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This patent protects a method for treating secondary hyperparathyroidism in patients with chronic kidney disease using a controlled release formulation of vitamin D compounds.USPTO title: Method for treating secondary hyperparathyroidism in CKD
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This patent protects a method for treating secondary hyperparathyroidism in patients with chronic kidney disease using a controlled release formulation of vitamin D compounds.USPTO title: Method for treating secondary hyperparathyroidism in CKD
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This patent protects a method for preparing a controlled release oral dosage form of a vitamin D compound by incorporating it into a mixture of waxy materials.USPTO title: Method for controlled release oral dosage of a vitamin D compound
Sources
- FDA Orange Book — patents listed against Rayaldee (NDA filed 1980)
- Rayaldee drug profile — full patent estate, indications, clinical trials, pricing
- Patent cliff 2027 — every drug losing US exclusivity that year
Patent term extensions (PTR, pediatric exclusivity), Hatch-Waxman 30-month stays, and FDA regulatory exclusivity (NCE/ODE/PED) may shift the effective generic entry date. Not legal advice.
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