Generic Zemplar Availability

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 [AB], 2MCG [AB], 4MCG [RLD] [AB]

ZEMPLAR (paricalcitol - injectable;injection)

  • Manufacturer: ABBVIE
    Approval date: April 17, 1998
    Strength(s): 0.005MG/ML [RLD] [AP]
  • Manufacturer: ABBVIE
    Approval date: February 1, 2000
    Strength(s): 0.002MG/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: ANCHEN PHARMS
    Approval date: June 24, 2014
    Strength(s): 1MCG [AB], 2MCG [AB], 4MCG [AB]
  • Manufacturer: BANNER PHARMACAPS
    Approval date: March 27, 2014
    Strength(s): 1MCG [AB], 2MCG [AB], 4MCG [AB]
  • Manufacturer: DR REDDYS LABS LTD
    Approval date: June 24, 2014
    Strength(s): 1MCG [AB], 2MCG [AB], 4MCG [AB]
  • Manufacturer: TEVA PHARMS USA
    Approval date: September 27, 2013
    Strength(s): 1MCG [AB], 2MCG [AB], 4MCG [AB]

paricalcitol injectable;injection

  • Manufacturer: SANDOZ CANADA INC
    Approval date: July 27, 2011
    Strength(s): 0.002MG/ML [AP], 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: 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.

  • 19-nor-vitamin D compounds
    Patent 5,587,497
    Issued: December 24, 1996
    Inventor(s): DeLuca; Hector F. & Schnoes; Heinrich K. & Perlman; Kato L. & Sicinski; Rafal R. & Prahl; Jean M.
    Assignee(s): Wisconsin Alumni Research Foundation
    This invention provides a novel class of vitamin D-related compounds, namely the 1.alpha.-hydroxy-19-nor-vitamin D analogs, as well as a general method for their chemical synthesis. The compounds exhibit pronounced activity in arresting the proliferation of undifferentiated cells, including malignant cells, and in inducing their differentiation, and thus represent novel therapeutic agents for the treatment of malignant and other diseases characterized by the proliferative growth of undifferentiated cells. Formulations for therapeutic use and treatment methods are also provided. The 19-nor vitamin D compounds have the formula: ##STR1## where X.sup.1 and X.sup.2 are each hydrogen or a hydroxy protecting group and R is a side chain.
    Patent expiration dates:
    • December 24, 2013
    • December 24, 2013
      ✓ 
      Drug substance
    • June 24, 2014
      ✓ 
      Pediatric exclusivity
  • Prevention of hyperphosphatemia in kidney disorder patients
    Patent 5,597,815
    Issued: January 28, 1997
    Inventor(s): Deluca; Hector F. & Slatopolsky; Eduardo
    Assignee(s): Wisconsin Alumni Research Foundation
    The 19-nor-vitamin D analogs, and particularly 19-nor-1.alpha.,25-dihydroxyvitamin D.sub.2, possess low calcemic and phosphatemic activity while also having the ability to suppress parathyroid hormone (PTH) production. The suppressive effect on PTH secretion of these 19-nor analogs without significant changes in serum calcium or serum phosphorus make them ideal tools for the treatment of secondary hyperparathyroidism in patients having kidney disorders.
    Patent expiration dates:
    • July 13, 2015
      ✓ 
      Patent use: PREVENTION AND TREATMENT OF SECONDARY HYPERPARATHYROIDISM ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD) STAGE 5, WHICH MAY RESULT IN RENAL OSTEODYSTROPHY, WHILE AVOIDING HYPERPHOSPHATEMIA
    • January 13, 2016
      ✓ 
      Pediatric exclusivity
  • Cosolvent formulations
    Patent 6,136,799
    Issued: October 24, 2000
    Inventor(s): Li; Lukchiu & Pec; Edward Anthony & Robinson; Daniel H. & Stephens; Dennis A. & Jantzi; Kathee & May; Thomas Barton & Oberdier; John Paul
    Assignee(s): Abbott Laboratories
    Stable pharmaceutical formulations of a therapeutic agent, a low molecular weight alcohol and a glycol derivative are disclosed. Preferred formulations include 19-nor-1.alpha.,3.beta.,25-trihydroxy-9,10-secoergosta-5,7(E),22(E)-triene .
    Patent expiration dates:
    • April 8, 2018
    • October 8, 2018
      ✓ 
      Pediatric exclusivity
  • Cosolvent formulations
    Patent 6,361,758
    Issued: March 26, 2002
    Inventor(s): Lukchiu; Li & Edward Anthony; Pec & Daniel H.; Robinson & Dennis A.; Stephens & Kathee; Jantzi & Thomas Barton; May & John Paul; Oberdier
    Assignee(s): Abbott Laboratories
    Stable pharmaceutical formulations of a therapeutic agent, a low molecular weight alcohol and a glycol derivative are disclosed. Preferred formulations include 19-nor-1&agr;,3&bgr;,25-trihydroxy-9,10-secoergosta-5,7(E),22(E)-triene.
    Patent expiration dates:
    • April 8, 2018
      ✓ 
      Drug product
    • October 8, 2018
      ✓ 
      Pediatric exclusivity

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.
ABProducts 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.
APInjectable 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.
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