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Generic Zemplar Availability

Last updated on Sep 6, 2023.

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

ZEMPLAR (paricalcitol - capsule;oral)

  • Manufacturer: ABBVIE
    Approval date: May 26, 2005
    Strength(s): 1MCG [RLD] [AB], 2MCG [RLD] [AB], 4MCG (discontinued) [RLD]

ZEMPLAR (paricalcitol - solution;intravenous)

  • Manufacturer: ABBVIE
    Approval date: April 17, 1998
    Strength(s): 0.005MG/ML (0.005MG/ML) [RLD] [AP]
  • Manufacturer: ABBVIE
    Approval date: February 1, 2000
    Strength(s): 0.002MG/ML (0.002MG/ML) [RLD] [AP], 0.01MG/2ML (0.005MG/ML) [RLD] [AP]

Has a generic version of Zemplar been approved?

A generic version of Zemplar 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 Zemplar and have been approved by the FDA:

paricalcitol capsule;oral

  • Manufacturer: AMNEAL PHARMS
    Approval date: January 13, 2016
    Strength(s): 1MCG [AB], 2MCG [AB]
  • Manufacturer: AUROBINDO PHARMA LTD
    Approval date: January 14, 2016
    Strength(s): 1MCG [AB], 2MCG [AB]
  • Manufacturer: BIONPHARMA
    Approval date: March 27, 2014
    Strength(s): 1MCG [AB], 2MCG [AB]
  • Manufacturer: DR REDDYS
    Approval date: June 24, 2014
    Strength(s): 1MCG [AB], 2MCG [AB]
  • Manufacturer: MARKSANS PHARMA
    Approval date: October 7, 2016
    Strength(s): 1MCG [AB], 2MCG [AB]
  • Manufacturer: RISING
    Approval date: June 24, 2014
    Strength(s): 1MCG [AB], 2MCG [AB]
  • Manufacturer: TEVA PHARMS USA
    Approval date: September 27, 2013
    Strength(s): 1MCG [AB], 2MCG [AB]

paricalcitol solution;intravenous

  • Manufacturer: ACCORD HLTHCARE
    Approval date: February 4, 2016
    Strength(s): 0.002MG/ML (0.002MG/ML) [AP], 0.005MG/ML (0.005MG/ML) [AP], 0.01MG/2ML (0.005MG/ML) [AP]
  • Manufacturer: AMNEAL PHARMS CO
    Approval date: March 9, 2017
    Strength(s): 0.002MG/ML (0.002MG/ML) [AP], 0.005MG/ML (0.005MG/ML) [AP], 0.01MG/2ML (0.005MG/ML) [AP]
  • Manufacturer: DR REDDYS
    Approval date: August 17, 2016
    Strength(s): 0.002MG/ML (0.002MG/ML) [AP], 0.005MG/ML (0.005MG/ML) [AP], 0.01MG/2ML (0.005MG/ML) [AP]
  • Manufacturer: EUGIA PHARMA
    Approval date: October 9, 2018
    Strength(s): 0.002MG/ML (0.002MG/ML) [AP], 0.005MG/ML (0.005MG/ML) [AP], 0.01MG/2ML (0.005MG/ML) [AP]
  • Manufacturer: HIKMA PHARMS
    Approval date: November 18, 2014
    Strength(s): 0.002MG/ML (0.002MG/ML) [AP], 0.005MG/ML (0.005MG/ML) [AP], 0.01MG/2ML (0.005MG/ML) [AP]
  • Manufacturer: HOSPIRA
    Approval date: October 21, 2014
    Strength(s): 0.002MG/ML (0.002MG/ML) [AP], 0.005MG/ML (0.005MG/ML) [AP], 0.01MG/2ML (0.005MG/ML) [AP]
  • Manufacturer: RISING
    Approval date: November 2, 2017
    Strength(s): 0.005MG/ML (0.005MG/ML) [AP], 0.01MG/2ML (0.005MG/ML) [AP]
  • Manufacturer: SANDOZ
    Approval date: July 27, 2011
    Strength(s): 0.002MG/ML (0.002MG/ML) [AP], 0.005MG/ML (0.005MG/ML) [AP], 0.01MG/2ML (0.005MG/ML) [AP]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Zemplar. 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: Generic Drug FAQ.

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:

    • October 18, 2023 - FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION S
    • October 18, 2023 - INDICATED IN PEDIATRIC PATIENTS 10 YEARS AND OLDER FOR THE PREVENTION AND TREATMENT OF SECONDARY HYPERPARATHYROIDISM ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD) STAGES 3 AND 4 AND CKD STAGE 5 IN PATIENTS ON HEMODIALYSIS OR PERITONEAL DIALYSIS

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 (e.g. identical active ingredients, dosage form, and routes 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 (e.g. AB1, AB2, AB7). 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.
AP Injectable aqueous solutions and, in certain instances, intravenous non-aqueous solutions. It should be noted that even though injectable (parenteral) products under a specific listing may be evaluated as therapeutically equivalent, there may be important differences among the products in the general category, Injectable; Injection. For example, some injectable products that are rated therapeutically equivalent are labeled for different routes of administration. In addition, some products evaluated as therapeutically equivalent may have different preservatives or no preservatives at all. Injectable products available as dry powders for reconstitution, concentrated sterile solutions for dilution, or sterile solutions ready for injection are pharmaceutical alternative drug products. They are not rated as therapeutically equivalent (AP) to each other even if these pharmaceutical alternative drug products are designed to produce the same concentration prior to injection and are similarly labeled. Consistent with accepted professional practice, it is the responsibility of the prescriber, dispenser, or individual administering the product to be familiar with a product's labeling to assure that it is given only by the route(s) of administration stated in the labeling.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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