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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 Pharmacaps, Dr Reddys Labs Ltd, Rising Pharms Inc, Teva Pharms Usa, Abbvie, Hospira Inc, and Sandoz Canada Inc, and is included in eight NDAs. There are four 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

Tradenames:2
Patents:4
Applicants:7
NDAs:8
Drug Master File Entries: see list10
Suppliers: see list4
Therapeutic Class:Metabolic Bone Disease Agents

Pharmacology for Ingredient: paricalcitol

Ingredient-typeCholecalciferol
Drug ClassVitamin D3 Analog

Tentative approvals for PARICALCITOL

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

Clinical Trials for: paricalcitol

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

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

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

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

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

Paricalcitol, Fluorouracil, and Radiation Therapy in Treating Patients With Rectal Cancer That Can Be Removed in Surgery
Status: Terminated Condition: Mucinous Adenocarcinoma of the Rectum; Stage IIA Rectal Cancer; Stage IIB Rectal Cancer; Stage IIC Rectal Cancer; Stage IIIB Rectal Cancer; Stage IIIC Rectal Cancer

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie
ZEMPLAR
paricalcitol
CAPSULE;ORAL021606May 26, 2005RXYes5,587,497*PED<disabled>Y<disabled>
Abbvie
ZEMPLAR
paricalcitol
CAPSULE;ORAL021606May 26, 2005RXNo5,597,815*PED<disabled>Y<disabled>
Abbvie
ZEMPLAR
paricalcitol
INJECTABLE;INJECTION020819Apr 17, 1998RXYes6,361,758*PED<disabled>Y<disabled>
Abbvie
ZEMPLAR
paricalcitol
CAPSULE;ORAL021606May 26, 2005RXNo5,587,497*PED<disabled>Y<disabled>
Rising Pharms Inc
PARICALCITOL
paricalcitol
CAPSULE;ORAL202124Jun 24, 2014RXNo<disabled><disabled>
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