Generic Hectorol Availability
Hectorol is a brand name of doxercalciferol, approved by the FDA in the following formulation(s):
HECTOROL (doxercalciferol - capsule; oral)
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Manufacturer: GENZYME CORP
Approval date: June 9, 1999
Strength(s): 2.5MCG [RLD] -
Manufacturer: GENZYME CORP
Approval date: April 23, 2004
Strength(s): 0.5MCG [AB] -
Manufacturer: GENZYME CORP
Approval date: July 13, 2009
Strength(s): 1MCG
HECTOROL (doxercalciferol - injectable; injection)
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Manufacturer: GENZYME CORP
Approval date: April 6, 2000
Strength(s): 2MCG/ML (2MCG/ML), 4MCG/2ML (2MCG/ML) [RLD]
Has a generic version of Hectorol been approved?
A generic version of Hectorol has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Hectorol and have been approved by the FDA:
doxercalciferol capsule; oral
Note: No generic formulation of the following product is available.
- doxercalciferol - injectable; injection
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Hectorol. 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.
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Method for treating and preventing secondary hyperparathyroidism
Patent 5,602,116
Issued: February 11, 1997
Inventor(s): Knutson; Joyce C. & Bishop; Charles W. & Mazess; Richard B.
Assignee(s): Bone Care International, Inc.
A method for preventing loss of bone mass or bone mineral content in a human being suffering from secondary hyperparathyroidism by administering a sufficient amount of 1.alpha.-OH vitamin D.sub.2, 1.alpha.,24(S)-(OH).sub.2 vitamin D.sub.2, 1.alpha.-OH vitamin D.sub.4 or 1.alpha.,24(R)-(OH).sub.2 vitamin D.sub.4.Patent expiration dates:- February 11, 2014✓
- February 11, 2014✓
- February 11, 2014✓
- February 11, 2014
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Stabilized hydroxyvitamin D
Patent 6,903,083
Issued: June 7, 2005
Inventor(s): Knutson; Joyce C. & Mazess; Richard B. & Bishop; Charles W.
Assignee(s): Bone Care International, Inc.
The invention provides a stabilized 1α-hydroxyvitamin D (“SHVD”) which is particularly well suited for pharmaceutical formulations.Patent expiration dates:- July 18, 2021✓✓✓
- July 18, 2021
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Formulation for lipophilic agents
Patent 7,148,211
Issued: December 12, 2006
Inventor(s): Mazess; Richard B. & Driscoll; Jeffrey W. & Goldensoph; Creighton Reed & LeVan; Leon W.
Assignee(s): Genzyme Corporation
The invention relates to pharmaceutical formulations of lipophilic therapeutic agents in which such agents are solubilized in largely aqueous vehicles, and processes for preparing and using the same.Patent expiration dates:- September 14, 2023✓✓
- September 14, 2023
See also...
- Hectorol Consumer Information (Wolters Kluwer)
- Hectorol capsules Consumer Information (Wolters Kluwer)
- Hectorol Consumer Information (Cerner Multum)
- Hectorol AHFS DI Monographs (ASHP)
- Doxercalciferol Consumer Information (Wolters Kluwer)
- Doxercalciferol capsules Consumer Information (Wolters Kluwer)
- Doxercalciferol Consumer Information (Cerner Multum)
- Doxercalciferol AHFS DI Monographs (ASHP)
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. |
| AB | Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against. |
