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Details for Generic Name: paricalcitol

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Paricalcitol is the generic ingredient in two branded drugs marketed by Banner Life Sciences, Dr Reddys Labs Ltd, Rising Pharms Inc, Teva Pharms Usa, Abbvie, Hikma Pharms, Hospira Inc, and Sandoz Canada Inc, and is included in nine NDAs. There are three patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for paricalcitol. Four suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: paricalcitol

Drug Master File Entries: see list10
Suppliers: see list4
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: paricalcitol

Drug ClassVitamin D3 Analog

Tentative approvals for PARICALCITOL

Applicant Application No. Form Dosage
<disabled><disabled>INJECTABLE; INJECTION2MCG/ML
<disabled><disabled>INJECTABLE; INJECTION5MCG/ML
<disabled><disabled>INJECTABLE; INJECTION10MCG/ML

Clinical Trials for: paricalcitol

The Effect of Paricalcitol Capsules on Reducing Albuminuria in Patients With Type 2 Diabetic Nephropathy Being Treated With Renin-angiotensin System Inhibitors
Status: Completed Condition: Diabetic Nephropathy; Chronic Kidney Disease

Efficacy and Safety of 6 Months Treatment With Paricalcitol Injection or Oral in Patients With Secondary Hyperparathyroidism on Dialysis
Status: Completed Condition: Secondary Hyperparathyroidism; Dialysis

Evaluation of the Effectiveness of Paricalcitol Versus Cinacalcet With Low-Dose Vitamin D
Status: Completed Condition: Chronic Kidney Disease; Secondary Hyperparathyroidism; Hemodialysis

The Effect of Paricalcitol on Creatinine Filtration, Secretion and Glomerular Filtration Rate
Status: Completed Condition: Chronic Kidney Disease

Study of Protective Effects of Paricalcitol on Inner Layer of Vessels and Its Protective Effect on Inflammation
Status: Completed Condition: Chronic Kidney Disease; Endothelial Dysfunction; Inflammation; Hypertension

Dose-response Study of Paricalcitol Injection in Chronic Kidney Disease Patients Receiving Hemodialysis
Status: Completed Condition: Chronic Kidney Disease on Hemodialysis; Secondary Hyperparathyroidism

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira Inc
SOLUTION;INTRAVENOUS201657-003Oct 21, 2014RXNo<disabled><disabled>
CAPSULE;ORAL021606-002May 26, 2005RXNo5,597,815*PED<disabled>Y<disabled>
SOLUTION;INTRAVENOUS020819-002Feb 1, 2000RXYes5,597,815*PED<disabled>Y<disabled>
Dr Reddys Labs Ltd
CAPSULE;ORAL091412-002Jun 24, 2014RXNo<disabled><disabled>
Banner Life Sciences
CAPSULE;ORAL202539-002Mar 27, 2014RXNo<disabled><disabled>
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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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