FDA Orange Book
Is there a generic for Rayaldee?
Rayaldee contains calcifediol. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Rayaldee (calcifediol). The Orange Book shows its last listed patent expires March 14, 2034.
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Rayaldee products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, extended release, oral | 0.03MG | Marketed (Rx) | None | 0 | None |
NDA 208010, held by EIRGEN PHARMA LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Rayaldee patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9943530 | February 2, 2027 | Method of use | U-2274 | 208010 |
| 10213442 | February 2, 2027 | Drug product | None | 208010 |
| 8906410 | February 2, 2027 | Drug product | None | 208010 |
| 8778373 | April 25, 2028 | Method of use | U-1873 | 208010 |
| 9408858 | April 25, 2028 | Method of use | U-1888 | 208010 |
| 9925147 | April 25, 2028 | Drug product | U-2258 | 208010 |
| 8207149 | April 25, 2028 | Method of use | U-1871 | 208010 |
| 9925147 | April 25, 2028 | Drug product | U-2255 | 208010 |
| 9925147 | April 25, 2028 | Drug product | U-2256 | 208010 |
| 9925147 | April 25, 2028 | Drug product | U-2257 | 208010 |
| 9925147 | April 25, 2028 | Drug product | U-2259 | 208010 |
| 9498486 | April 25, 2028 | Method of use | U-3814 | 208010 |
| 11154509 | April 25, 2028 | Method of use | U-3815 | 208010 |
| 8361488 | July 19, 2028 | Drug product | None | 208010 |
| 8426391 | August 27, 2028 | Method of use | U-1872 | 208010 |
| 11801253 | September 7, 2030 | Drug product | U-3721 | 208010 |
| 11801253 | September 7, 2030 | Drug product | U-3722 | 208010 |
| 11801253 | September 7, 2030 | Drug product | U-3723 | 208010 |
| 9861644 | March 14, 2034 | Drug product | None | 208010 |
| 10300078 | March 14, 2034 | Drug product | None | 208010 |
| 10357502 | March 14, 2034 | Drug product | None | 208010 |
| 11253528 | March 14, 2034 | Drug product | None | 208010 |
Rayaldee NDC codes
Questions
Is there a generic for Rayaldee?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Rayaldee (calcifediol). The Orange Book shows its last listed patent expires March 14, 2034.
What is the generic name for Rayaldee?
The active ingredient in Rayaldee is calcifediol, per the FDA Orange Book.
When does the Rayaldee patent expire?
The last patent listed for Rayaldee in the Orange Book expires March 14, 2034. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.