Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Moodys
Julphar
Johnson and Johnson
Medtronic
Cerilliant
Cipla
Harvard Business School
US Army

Generated: January 22, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021606

« Back to Dashboard

NDA 021606 describes ZEMPLAR, which is a drug marketed by Abbvie and is included in two NDAs. It is available from two suppliers. There are two patents protecting this drug and three Paragraph IV challenges. 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. Twenty-one 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)

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 021606-002 May 26, 2005 ➤ Sign Up ➤ Sign Up
Abbvie ZEMPLAR paricalcitol CAPSULE;ORAL 021606-002 May 26, 2005 ➤ Sign Up ➤ Sign Up
Abbvie ZEMPLAR paricalcitol CAPSULE;ORAL 021606-001 May 26, 2005 ➤ Sign Up ➤ Sign Up
Abbvie ZEMPLAR paricalcitol CAPSULE;ORAL 021606-003 May 26, 2005 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

This preview shows a limited data set.
Subscribe to access the full database, or try a Free Trial

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Queensland Health
McKinsey
Express Scripts
Daiichi Sankyo
Boehringer Ingelheim
Dow
Fish and Richardson
Cantor Fitzgerald

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.