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Generated: December 14, 2017

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 three 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. Nineteen suppliers are listed for this compound. Additional details are available on the paricalcitol profile page.

Summary for 021606

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 021606

Ingredient-typeCholecalciferol

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. 0074-4317 0074-4317-30 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (0074-4317-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength1MCG
Approval Date:May 26, 2005TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Oct 18, 2019
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Oct 18, 2023
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength2MCG
Approval Date:May 26, 2005TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Oct 18, 2019
Regulatory Exclusivity Use:NEW PATIENT POPULATION

Expired Orange Book Patents for NDA: 021606

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
AbbvieZEMPLARparicalcitolCAPSULE;ORAL021606-003May 26, 2005► Subscribe► Subscribe
AbbvieZEMPLARparicalcitolCAPSULE;ORAL021606-003May 26, 2005► Subscribe► Subscribe
AbbvieZEMPLARparicalcitolCAPSULE;ORAL021606-002May 26, 2005► Subscribe► Subscribe
AbbvieZEMPLARparicalcitolCAPSULE;ORAL021606-001May 26, 2005► Subscribe► Subscribe
AbbvieZEMPLARparicalcitolCAPSULE;ORAL021606-002May 26, 2005► Subscribe► Subscribe
AbbvieZEMPLARparicalcitolCAPSULE;ORAL021606-003May 26, 2005► Subscribe► Subscribe
AbbvieZEMPLARparicalcitolCAPSULE;ORAL021606-002May 26, 2005► Subscribe► Subscribe
AbbvieZEMPLARparicalcitolCAPSULE;ORAL021606-001May 26, 2005► Subscribe► Subscribe
AbbvieZEMPLARparicalcitolCAPSULE;ORAL021606-001May 26, 2005► Subscribe► Subscribe
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Queensland Health
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Dow

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.

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