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Generic Rayaldee Availability

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

RAYALDEE (calcifediol - capsule, extended release;oral)

  • Manufacturer: OPKO IRELAND GLOBAL
    Approval date: June 17, 2016
    Strength(s): 0.03MG [RLD]

Has a generic version of Rayaldee been approved?

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.

See also: About generic drugs.

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.

  • Film forming compositions comprising modified starches and iota-carrageenan and methods for manufacturing soft capsules using same
    Patent 6,582,727
    Issued: June 24, 2003
    Inventor(s): Keith Edward; Tanner & John J.; Getz & Stephen W.; Burnett & Elizabeth; Youngblood & Peter Robert; Draper
    Assignee(s): R. P. Scherer Technologies, Inc.
    Disclosed herein are composition comprising a modified starch and a carrageenan, especially iota-carrageenan, where the compositions are suitable for use in manufacturing soft capsules.
    Patent expiration dates:
    • August 22, 2020
      ✓ 
      Drug product
  • Method for treating secondary hyperparathyroidism in CKD
    Patent 8,207,149
    Issued: June 26, 2012
    Inventor(s): Tabash; Samir P. & White; Jay A. & Bishop; Charles W. & Agudoawu; Sammy A. & Messner; Eric J. & Petkovich; P. Martin
    Assignee(s): Cytochroma, Inc. Proventiv Therapeutics, LLC
    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
    Assignee(s): Cytochroma Inc. Proventiv Therapeutics, LLC
    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 D2 and 25-hydroxyvitamin D3
    Patent 8,426,391
    Issued: April 23, 2013
    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 D2, 25-hydroxyvitamin D3, or a combination of 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3, or it includes gradually administering to the patient a sterile intravenous formulation including a first ingredient selected from the group consisting of 25-hydroxyvitamin D2, 25-hydroxyvitamin D3, or a combination of 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3.
    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
      ✓ 
      Drug product
  • Methods for controlled release oral dosage of a vitamin D compound
    Patent 8,778,373
    Issued: July 15, 2014
    Assignee(s): Opko IP Holdings II, Inc. Opko Renal, LLC
    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: ADMINISTRATION OF 25-HYDROXYVITAMIN D3 BY CONTROLLED RELEASE
  • Oral dosage form of 25-hydroxyvitamin D
    Patent 8,906,410
    Issued: December 9, 2014
    Assignee(s): Opko Health, Inc.
    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 D2, 25-hydroxyvitamin D3, or a combination of 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3, or it includes gradually administering to the patient a sterile intravenous formulation including a first ingredient selected from the group consisting of 25-hydroxyvitamin D2, 25-hydroxyvitamin D3, or a combination of 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3.
    Patent expiration dates:
    • February 2, 2027
      ✓ 
      Drug product
  • Method for treating secondary hyperparathyroidism in CKD
    Patent 9,408,858
    Issued: August 9, 2016
    Assignee(s): OPKO RENAL, LLC OPKO IRELAND GLOBAL HOLDINGS, LTD.
    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

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • June 17, 2019 - NEW PRODUCT

Glossary

TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
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