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Profile for Tradename: ZEMPLAR

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Zemplar is a drug marketed by Abbvie and is included in two NDAs. It is available from three suppliers. There are three patents protecting this drug and three Paragraph IV challenges.

The generic ingredient in ZEMPLAR is paricalcitol. There are ten drug master file entries for this compound. Five suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the paricalcitol profile page.

Summary for Tradename: ZEMPLAR

Suppliers / Packagers: see list11

Pharmacology for Tradename: ZEMPLAR

Drug ClassVitamin D3 Analog

Clinical Trials for: ZEMPLAR

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

Oral Paricalcitol in Kidney Transplant Recipients
Status: Completed Condition: Transplant; Failure, Kidney; Renal Disease, End Stage; Hyperparathyroidism, Secondary

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

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

Effect Of Paricalcitol (Zemplar) On Endothelial Function And Inflammation In Type 2 Diabetes And Chronic Kidney Disease
Status: Active, not recruiting Condition: Type 2 Diabetes; Chronic Kidney Disease

Study of Zemplar iv in Patients With End Stage Chronic Kidney Disease, Undergoing Haemodialysis
Status: Completed Condition: Parathyroid Hormone

Paricalcitol Effect on Anemia in CKD
Status: Completed Condition: Anemia; Chronic Kidney Disease

The PRIMO II Study: Paricalcitol Injection Benefits in Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease (CKD) Stage 5
Status: Terminated Condition: Chronic Kidney Disease (CKD) Stage 5; Hypertrophy, Left Ventricular

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
CAPSULE;ORAL021606-001May 26, 2005RXNo5,597,815*PED<disabled>Y<disabled>
SOLUTION;INTRAVENOUS020819-001Apr 17, 1998RXYes6,361,758*PED<disabled>Y<disabled>
SOLUTION;INTRAVENOUS020819-002Feb 1, 2000RXYes6,361,758*PED<disabled>Y<disabled>
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Expired Patents for Tradename: ZEMPLAR

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
SOLUTION;INTRAVENOUS020819-003Feb 1, 20005,597,815*PED<disabled>
CAPSULE;ORAL021606-001May 26, 20055,246,925*PED<disabled>
CAPSULE;ORAL021606-003May 26, 20055,587,497*PED<disabled>
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Paragraph IV activity for: ZEMPLAR

Drugname Dosage Strength RLD Submissiondate
paricalcitolInjection0.002 mg per mL in 1 mL vial and 0.005 mg per mL in 1 mL and 2 mL vialsZemplar11/28/2008
paricalcitolCapsules1 mcg and 2 mcgZemplar10/14/2008
paricalcitolCapsules4 mcgZemplar8/25/2008
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ISSN: 2162-2639

Preferred citation:

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

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