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Last Updated: December 13, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021606

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NDA 021606 describes ZEMPLAR, which is a drug marketed by Abbvie and is included in two NDAs. It is available from two suppliers. Additional details are available on the ZEMPLAR profile page.

The generic ingredient in ZEMPLAR is paricalcitol. There are ten drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the paricalcitol profile page.
Summary for 021606
Tradename:ZEMPLAR
Applicant:Abbvie
Ingredient:paricalcitol
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021606
Suppliers and Packaging for NDA: 021606
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZEMPLAR paricalcitol CAPSULE;ORAL 021606 NDA AbbVie Inc. 0074-4314 0074-4314-30 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (0074-4314-30)
ZEMPLAR paricalcitol CAPSULE;ORAL 021606 NDA AbbVie Inc. 0074-9036 0074-9036-30 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (0074-9036-30)
Paragraph IV (Patent) Challenges for 021606
Tradename Dosage Ingredient NDA Submissiondate
ZEMPLAR CAPSULE;ORAL paricalcitol 021606 2008-10-14
ZEMPLAR CAPSULE;ORAL paricalcitol 021606 2008-08-25

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength1MCG
Approval Date:May 26, 2005TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Oct 18, 2023
Regulatory Exclusivity Use:INDICATED IN PEDIATRIC PATIENTS 10 YEARS AND OLDER FOR THE PREVENTION AND TREATMENT OF SECONDARY HYPERPARATHYROIDISM ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD) STAGES 3 AND 4AND CKD STAGE 5 IN PATIENTS ON HEMODIALYSIS OR PERITONEAL DIALYSIS
Regulatory Exclusivity Expiration:Oct 18, 2019
Regulatory Exclusivity Use:NEW PATIENT POPULATION

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength2MCG
Approval Date:May 26, 2005TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Oct 18, 2023
Regulatory Exclusivity Use:INDICATED IN PEDIATRIC PATIENTS 10 YEARS AND OLDER FOR THE PREVENTION AND TREATMENT OF SECONDARY HYPERPARATHYROIDISM ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD) STAGES 3 AND 4AND CKD STAGE 5 IN PATIENTS ON HEMODIALYSIS OR PERITONEAL DIALYSIS

Expired US Patents for NDA 021606

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie ZEMPLAR paricalcitol CAPSULE;ORAL 021606-003 May 26, 2005   Start Trial   Start Trial
Abbvie ZEMPLAR paricalcitol CAPSULE;ORAL 021606-003 May 26, 2005   Start Trial   Start Trial
Abbvie ZEMPLAR paricalcitol CAPSULE;ORAL 021606-002 May 26, 2005   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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