Zemplar is a brand name of paricalcitol, approved by the FDA in the following formulation(s):
ZEMPLAR (paricalcitol - capsule; oral)
Manufacturer: ABBOTT
Approval date: May 26, 2005
Strength(s): 1MCG, 2MCG, 4MCG [RLD]
ZEMPLAR (paricalcitol - injectable; injection)
Manufacturer: ABBOTT
Approval date: April 17, 1998
Strength(s): 0.005MG/ML [RLD][AP]
Manufacturer: ABBOTT
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 injectable; injection
Manufacturer: SANDOZ CANADA INC
Approval date: July 27, 2011
Strength(s): 0.002MG/ML [AP], 0.005MG/ML [AP]
Note: No generic formulation of the following product is available.
- paricalcitol - capsule; oral
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 for use in treating hyperparathyroidism
Patent 5,246,925
Issued: September 21, 1993
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.Patent expiration dates:
- April 17, 2012✓
- April 17, 2012✓
- October 17, 2012✓
- April 17, 2012
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✓
- June 24, 2014✓
- December 24, 2013
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✓
- January 13, 2016✓
- July 13, 2015
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✓
- April 8, 2018
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✓
- October 8, 2018✓
- April 8, 2018
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 29, 2012 - PREVENTION AND TREATMENT OF SECONDARY HYPERPARATHYROIDISM ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD) STAGE 5 IN PATIENTS ON HEMODIALYSIS OR PERITONEAL DIALYSIS
See also...
- Zemplar Consumer Information (Drugs.com)
- Zemplar Consumer Information (Wolters Kluwer)
- Zemplar Capsules Consumer Information (Wolters Kluwer)
- Zemplar Consumer Information (Cerner Multum)
- Zemplar Advanced Consumer Information (Micromedex)
- Zemplar Intravenous Advanced Consumer Information (Micromedex)
- Zemplar AHFS DI Monographs (ASHP)
- Paricalcitol Consumer Information (Wolters Kluwer)
- Paricalcitol Capsules Consumer Information (Wolters Kluwer)
- Paricalcitol Consumer Information (Cerner Multum)
- Paricalcitol Advanced Consumer Information (Micromedex)
- Paricalcitol Intravenous Advanced Consumer Information (Micromedex)
- Paricalcitol AHFS DI Monographs (ASHP)
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