Generic Rayaldee Availability

Last updated on Apr 10, 2025.

Rayaldee is a brand name of calcifediol, approved by the FDA in the following formulation(s):

RAYALDEE (calcifediol - capsule, extended release;oral)

Manufacturer: EIRGEN
Approval date: June 17, 2016
Strength(s): 0.03MG ^[RLD]

Is there a generic version of Rayaldee available?

No. There is currently no therapeutically equivalent version of Rayaldee available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Rayaldee. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

Related patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

Treating vitamin D insufficiency and deficiency with 25-hydroxyvitamin Dand 25-hydroxyvitamin D
Patent 10,213,442
Issued: February 26, 2019
Inventor(s): Bishop Charles W. & Crawford Keith H. & Messner Eric J.
Assignee(s): OPKO RENAL, LLC
Methods and compositions for treating 25-hydroxyvitamin D insufficiency and deficiency in a patient are described herein. The method includes orally administering to the patient a delayed, sustained release formulation including a first ingredient selected from the group consisting of 25-hydroxyvitamin D, 25-hydroxyvitamin D, or a combination of 25-hydroxyvitamin Dand 25-hydroxyvitamin D, or it includes gradually administering to the patient a sterile intravenous formulation including a first ingredient selected from the group consisting of 25-hydroxyvitamin D, 25-hydroxyvitamin D, or a combination of 25-hydroxyvitamin Dand 25-hydroxyvitamin D.
Patent expiration dates:
- February 2, 2027
  ✓
  Drug product
Stabilized modified release vitamin D formulation and method of administering same
Patent 10,300,078
Issued: May 28, 2019
Inventor(s): White Jay A. & Tabash Samir P. & Agudoawu Sammy A. & Melnick Joel Z.
Assignee(s): OPKO IRELAND GLOBAL HOLDINGS, LTD.
A stabilized formulation for controlled release of a vitamin D compound is disclosed. The formulation comprises one or both of 25-hydroxyvitamin Dand 25-hydroxyvitamin Dand a cellulosic compound. The stabilized formulations exhibit a stable dissolution profile following exposure to storage conditions and demonstrate improved pharmacokinetic parameters compared to unstabilized formulations.
Patent expiration dates:
- March 14, 2034
  ✓
  Drug product
Stabilized modified release vitamin D formulation and method of administering same
Patent 10,357,502
Issued: July 23, 2019
Inventor(s): White Jay A. & Tabash Samir P. & Agudoawu Sammy A. & Melnick Joel Z.
Assignee(s): OPKO IRELAND GLOBAL HOLDINGS, LTD.
A stabilized formulation for controlled release of a vitamin D compound is disclosed. The formulation comprises one or both of 25-hydroxyvitamin Dand 25-hydroxyvitamin Dand a cellulosic compound. The stabilized formulations exhibit a stable dissolution profile following exposure to storage conditions and demonstrate improved pharmacokinetic parameters compared to unstabilized formulations.
Patent expiration dates:
- March 14, 2034
  ✓
  Drug product
Methods for controlled release oral dosage of a vitamin D compound
Patent 11,154,509
Issued: October 26, 2021
Inventor(s): Bishop; Charles W. et al.
Assignee(s): EIRGEN PHARMA LTD. (Waterford, IE); OPKO RENAL, LLC (Miami, FL)
A stable, controlled release formulation for oral dosing of vitamin D compounds is disclosed. The formulation is prepared by incorporating one or more vitamin D compounds into a solid or semi-solid mixture of waxy materials. Oral dosage forms can be prepared by melt-blending the components described herein and filling gelatin capsules with the formulation.
Patent expiration dates:
- April 25, 2028
  ✓
  Patent use: TREATING SECONDARY HYPERPARATHYROIDISM IN STAGE 3 OR 4 CKD WITH SUSTAINED RELEASE 25-HYDROXYVITAMIN D TO REDUCE THE PATIENT'S SERUM PARATHYROID HORMONE LEVEL WHILE AVOIDING PTH OVERSUPPRESSION
Stabilized modified release Vitamin D formulation and method of administering same
Patent 11,253,528
Issued: February 22, 2022
Inventor(s): White Jay A. & Tabash Samir P. & Agudoawu Sammy A. & Melnick Joel Z.
Assignee(s): EIRGEN PHARMA LTD.
A stabilized formulation for controlled release of a vitamin D compound is disclosed. The formulation comprises one or both of 25-hydroxyvitamin Dand 25-hydroxyvitamin Dand a cellulosic compound. The stabilized formulations exhibit a stable dissolution profile following exposure to storage conditions and demonstrate improved pharmacokinetic parameters compared to unstabilized formulations.
Patent expiration dates:
- March 14, 2034
  ✓
  Drug product
Method of safely and effectively treating and preventing secondary hyperparathyroidism in chronic kidney disease
Patent 11,801,253
Issued: October 31, 2023
Inventor(s): Bishop; Charles W. et al.
Assignee(s): OPKO RENAL, LLC (Miami, FL)
A method of treating and preventing secondary hyperparathyroidism in CKD by increasing or maintaining blood concentrations of both 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D in a patient by administering 25-hydroxyvitamin D.sub.3 with or without 25-hydroxyvitamin D.sub.2 and, as necessary, 1,25-dihydroxyvitamin D.sub.2 as a Vitamin D hormone replacement therapy.
Patent expiration dates:
- September 7, 2030
  ✓
  Patent use: TREATMENT OF SECONDARY HYPERPARATHYROIDISM WITH SUSTAINED RELEASE 25-HYDROXYVITAMIN D IN CHRONIC KIDNEY DISEASE PATIENTS RECEIVING CHOLESTYRAMINE
  ✓
  Drug product
- September 7, 2030
  ✓
  Patent use: TREATMENT OF SECONDARY HYPERPARATHYROIDISM WITH SUSTAINED RELEASE 25-HYDROXYVITAMIN D IN CHRONIC KIDNEY DISEASE PATIENTS RECEIVING PHENOBARBITAL OR OTHER ANTICONVULSANTS
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  Drug product
- September 7, 2030
  ✓
  Patent use: TREATMENT OF SECONDARY HYPERPARATHYROIDISM WITH SUSTAINED RELEASE 25-HYDROXYVITAMIN D IN CHRONIC KIDNEY DISEASE PATIENTS RECEIVING CYP3A INHIBITORS
  ✓
  Drug product
Method for treating secondary hyperparathyroidism in CKD
Patent 8,207,149
Issued: June 26, 2012
Inventor(s): Tabash; Samir P. et al.
Assignee(s): Cytochroma, Inc. (Markham, CA); Proventiv Therapeutics, LLC (Bannockburn, IL)
A stable, controlled release formulation for oral dosing of vitamin D compounds is disclosed. The formulation is prepared by incorporating one or more vitamin D compounds into a solid or semi-solid mixture of waxy materials. Oral dosage forms can be prepared by melt-blending the components described herein and filling gelatin capsules with the formulation.
Patent expiration dates:
- April 25, 2028
  ✓
  Patent use: TREATMENT OF SECONDARY HYPERPARATHYROIDISM IN PATIENTS WITH STAGE 3 OR 4 CHRONIC KIDNEY DISEASE USING CONTROLLED RELEASE, ORAL 25-HYDROXYVITAMIN D
Methods and compositions for controlled release oral dosage of a vitamin D compound
Patent 8,361,488
Issued: January 29, 2013
Inventor(s): Bishop; Charles W. et al.
Assignee(s): Cytochroma Inc. (Markham, CA); Proventiv Therapeutics, LLC (Bannockburn, IL)
A stable, controlled release formulation for oral dosing of vitamin D compounds is disclosed. The formulation is prepared by incorporating one or more vitamin D compounds into a solid or semi-solid mixture of waxy materials. Oral dosage forms can be prepared by melt-blending the components described herein and filling gelatin capsules with the formulation.
Patent expiration dates:
- July 19, 2028
  ✓
  Drug product
Treating vitamin D insufficiency and deficiency with 25-hydroxyvitamin Dand 25-hydroxyvitamin D
Patent 8,426,391
Issued: April 23, 2013
Inventor(s): Bishop Charles W. & Crawford Keith H. & Messner Eric J.
Assignee(s): Proventiv Therapeutics, LLC
Methods and compositions for treating 25-hydroxyvitamin D insufficiency and deficiency in a patient are described herein. The method includes orally administering to the patient a delayed, sustained release formulation including a first ingredient selected from the group consisting of 25-hydroxyvitamin D, 25-hydroxyvitamin D, or a combination of 25-hydroxyvitamin Dand 25-hydroxyvitamin D, or it includes gradually administering to the patient a sterile intravenous formulation including a first ingredient selected from the group consisting of 25-hydroxyvitamin D, 25-hydroxyvitamin D, or a combination of 25-hydroxyvitamin Dand 25-hydroxyvitamin D.
Patent expiration dates:
- August 27, 2028
  ✓
  Patent use: USE OF SUSTAINED RELEASE 25-HYDROXYVITAMIN D IN TREATING PATIENTS HAVING 25-HYDROXYVITAMIN D INSUFFICIENCY OR DEFICIENCY
Methods for controlled release oral dosage of a vitamin D compound
Patent 8,778,373
Issued: July 15, 2014
Inventor(s): Bishop; Charles W. et al.
Assignee(s): Opko IP Holdings II, Inc. (Grand Cayman, KY); Opko Renal, LLC (Miami, FL)
A stable, controlled release formulation for oral dosing of vitamin D compounds is disclosed. The formulation is prepared by incorporating one or more vitamin D compounds into a solid or semi-solid mixture of waxy materials. Oral dosage forms can be prepared by melt-blending the components described herein and filling gelatin capsules with the formulation.
Patent expiration dates:
- April 25, 2028
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  Patent use: ADMINISTRATION OF 25-HYDROXYVITAMIN D3 BY CONTROLLED RELEASE
Oral dosage form of 25-hydroxyvitamin D
Patent 8,906,410
Issued: December 9, 2014
Inventor(s): Bishop; Charles W. et al.
Assignee(s): Opko Health, Inc. (N/A, N/A)
Methods and compositions for treating 25-hydroxyvitamin D insufficiency and deficiency in a patient are described herein. The method includes orally administering to the patient a delayed, sustained release formulation including a first ingredient selected from the group consisting of 25-hydroxyvitamin D.sub.2, 25-hydroxyvitamin D.sub.3, or a combination of 25-hydroxyvitamin D.sub.2 and 25-hydroxyvitamin D.sub.3, or it includes gradually administering to the patient a sterile intravenous formulation including a first ingredient selected from the group consisting of 25-hydroxyvitamin D.sub.2, 25-hydroxyvitamin D.sub.3, or a combination of 25-hydroxyvitamin D.sub.2 and 25-hydroxyvitamin D.sub.3.
Patent expiration dates:
- February 2, 2027
  ✓
  Drug product
Method for treating secondary hyperparathyroidism in CKD
Patent 9,408,858
Issued: August 9, 2016
Inventor(s): Bishop; Charles W. et al.
Assignee(s): OPKO RENAL, LLC (Miami, FL); OPKO IRELAND GLOBAL HOLDINGS, LTD. (Grand Cayman, KY)
A stable, controlled release formulation for oral dosing of vitamin D compounds is disclosed. The formulation is prepared by incorporating one or more vitamin D compounds into a solid or semi-solid mixture of waxy materials. Oral dosage forms can be prepared by melt-blending the components described herein and filling gelatin capsules with the formulation.
Patent expiration dates:
- April 25, 2028
  ✓
  Patent use: USE OF CONTROLLED RELEASE 25-HYDROXYVITAMIN D IN TREATING SECONDARY HYPERPARATHYROIDISM IN PATIENTS HAVING CHRONIC KIDNEY DISEASE
Method for controlled release oral dosage of a vitamin D compound
Patent 9,498,486
Issued: November 22, 2016
Inventor(s): Bishop; Charles W. et al.
Assignee(s): OPKO RENAL, LLC (Miami, FL); OPKO IRELAND GLOBAL HOLDINGS, LTD. (Grand Cayman, KY)
A stable, controlled release formulation for oral dosing of vitamin D compounds is disclosed. The formulation is prepared by incorporating one or more vitamin D compounds into a solid or semi-solid mixture of waxy materials. Oral dosage forms can be prepared by melt-blending the components described herein and filling gelatin capsules with the formulation.
Patent expiration dates:
- April 25, 2028
  ✓
  Patent use: USE OF SUSTAINED OR EXTENDED RELEASE ORAL 25-HYDROXYVITAMIN D3 IN TREATING SECONDARY HYPERPARATHROIDISM IN ADULT PATIENTS HAVING CHRONIC KIDNEY DISEASE STAGE 3 OR 4
Stabilized modified release vitamin D formulation and method of administering same
Patent 9,861,644
Issued: January 9, 2018
Inventor(s): White Jay A. & Tabash Samir P. & Agudoawu Sammy A. & Melnick Joel Z.
Assignee(s): OPKO IRELAND GLOBAL HOLDINGS, LTD.
A stabilized formulation for controlled release of a vitamin D compound is disclosed. The formulation comprises one or both of 25-hydroxyvitamin Dand 25-hydroxyvitamin Dand a cellulosic compound. The stabilized formulations exhibit a stable dissolution profile following exposure to storage conditions and demonstrate improved pharmacokinetic parameters compared to unstabilized formulations.
Patent expiration dates:
- March 14, 2034
  ✓
  Drug product
Method for treating secondary hyperparathyroidism in CKD
Patent 9,925,147
Issued: March 27, 2018
Inventor(s): Bishop; Charles W. et al.
Assignee(s): OPKO RENAL, LLC (Miami, FL); OPKO IRELAND GLOBAL HOLDINGS, LIMITED (Grand Cayman, KY)
A stable, controlled release formulation for oral dosing of vitamin D compounds is disclosed. The formulation is prepared by incorporating one or more vitamin D compounds into a solid or semi-solid mixture of waxy materials. Oral dosage forms can be prepared by melt-blending the components described herein and filling gelatin capsules with the formulation.
Patent expiration dates:
- April 25, 2028
  ✓
  Patent use: TREATING SECONDARY HYPERPARATHYROIDISM IN CHRONIC KIDNEY DISEASE WITH SUSTAINED RELEASE 25-HYDROXYVITAMIN D TO REDUCE THE PATIENT'S SERUM PARATHYROID HORMONE LEVEL AND THE SUSTAINED RELEASE IS OVER AT LEAST 10 HOURS
  ✓
  Drug product
- April 25, 2028
  ✓
  Patent use: TREATING SECONDARY HYPERPARATHYROIDISM IN CHRONIC KIDNEY DISEASE WITH SUSTAINED RELEASE 25-HYDROXYVITAMIN D TO REDUCE THE PATIENT'S SERUM PARATHYROID HORMONE LEVEL AND CMAX IS REDUCED COMPARED TO BOLUS IV INJECTION AND IMMEDIATE-RELEASE, ORAL DOSING
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  Drug product
- April 25, 2028
  ✓
  Patent use: TREATING SHPT IN CKD WITH SUSTAINED RELEASE CALCIFEDIOL TO REDUCE SERUM PARATHYROID HORMONE LEVEL AND CHANGE IN SERUM CONCENTRATION OF CALCIFEDIOL IN DOSE INTERVAL IS REDUCED COMPARED TO BOLUS IV INJECTION AND IMMEDIATE-RELEASE, ORAL DOSING
  ✓
  Drug product
- April 25, 2028
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  Patent use: TREATING SECONDARY HYPERPARATHYROIDISM IN CKD WITH SUSTAINED RELEASE CALCIFEDIOL TO REDUCE THE PATIENT'S SERUM PARATHYROID HORMONE LEVEL AND CMAX24HR/C24HR IS REDUCED COMPARED TO BOLUS IV INJECTION AND IMMEDIATE-RELEASE, ORAL DOSING
  ✓
  Drug product
- April 25, 2028
  ✓
  Patent use: TREATING SECONDARY HYPERPARATHYROIDISM IN CKD WITH SUSTAINED RELEASE CALCIFEDIOL TO REDUCE THE PATIENT'S SERUM PARATHYROID HORMONE LEVEL AND TMAX IS INCREASED COMPARED TO BOLUS IV INJECTION AND IMMEDIATE-RELEASE, ORAL DOSING
  ✓
  Drug product
Treating vitamin D insufficiency and deficiency with 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3
Patent 9,943,530
Issued: April 17, 2018
Inventor(s): Bishop Charles W. & Crawford Keith H. & Messner Eric J.
Assignee(s): OPKO RENAL, LLC
Methods and compositions for treating 25-hydroxyvitamin D insufficiency and deficiency in a patient are described herein. The method includes orally administering to the patient a delayed, sustained release formulation including a first ingredient selected from the group consisting of 25-hydroxyvitamin D, 25-hydroxyvitamin D, or a combination of 25-hydroxyvitamin Dand 25-hydroxyvitamin D, or it includes gradually administering to the patient a sterile intravenous formulation including a first ingredient selected from the group consisting of 25-hydroxyvitamin D, 25-hydroxyvitamin D, or a combination of 25-hydroxyvitamin Dand 25-hydroxyvitamin D.
Patent expiration dates:
- February 2, 2027
  ✓
  Patent use: MAINTAINING SERUM 25-HYDROXYVITAMIN D AT A LEVEL OF AT LEAST 30 NG/ML WITH ORAL, SUSTAINED RELEASE 25-HYDROXYVITAMIN D

More about Rayaldee (calcifediol)

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Professional resources

Related treatment guides

Hyperparathyroidism Secondary to Renal Impairment

Glossary

Term	Definition
Drug Patent	A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity	Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD	A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

Further information

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Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

User Reviews & Ratings

7 Reviews

Images

Pill O 30 is Rayaldee 30 mcg — Rayaldee 30 mcg (O 30)