.

BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Uncover prior art in expired and abandoned patents
  • Drug patents in 130+ countries

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Fish and Richardson
Chinese Patent Office
Medtronic
Accenture
Cantor Fitzgerald
Novartis
Cerilliant
McKinsey
Healthtrust
UBS

Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021689

« Back to Dashboard

NDA 021689 describes NEXIUM IV, which is a drug marketed by Astrazeneca Pharms and is included in one NDA. It is available from two suppliers. Additional details are available on the NEXIUM IV profile page.

The generic ingredient in NEXIUM IV is esomeprazole sodium. There are sixty-nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the esomeprazole sodium profile page.

Summary for 021689

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 021689

Suppliers and Packaging for NDA: 021689

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEXIUM IV esomeprazole sodium INJECTABLE;INTRAVENOUS 021689 NDA AstraZeneca Pharmaceuticals LP 0186-6020 0186-6020-01 10 VIAL in 1 CARTON (0186-6020-01) > 5 mL in 1 VIAL
NEXIUM IV esomeprazole sodium INJECTABLE;INTRAVENOUS 021689 NDA AstraZeneca Pharmaceuticals LP 0186-6040 0186-6040-01 10 VIAL in 1 CARTON (0186-6040-01) > 5 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INTRAVENOUSStrengthEQ 20MG BASE/VIAL
Approval Date:Mar 31, 2005TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 4, 2017
Regulatory Exclusivity Use:80 MG DOSING REGIMEN FOR THE RISK REDUCTION OF REBLEEDING OF GASTRIC AND DUODENAL ULCERS IN THE FIRST 72 HOURS FOLLOWING THERAPEUTIC ENDOSCOPY IN ADULTS
Regulatory Exclusivity Expiration:Mar 4, 2017
Regulatory Exclusivity Use:RISK REDUCTION OF REBLEEDING OF GASTRIC OR DUODENAL ULCERS FOLLOWING THERAPEUTIC ENDOSCOPY IN ADULTS

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 40MG BASE/VIAL
Approval Date:Mar 31, 2005TE:APRLD:Yes
Regulatory Exclusivity Expiration:Mar 4, 2017
Regulatory Exclusivity Use:80 MG DOSING REGIMEN FOR THE RISK REDUCTION OF REBLEEDING OF GASTRIC AND DUODENAL ULCERS IN THE FIRST 72 HOURS FOLLOWING THERAPEUTIC ENDOSCOPY IN ADULTS

Expired Orange Book Patents for NDA: 021689

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca PharmsNEXIUM IVesomeprazole sodiumINJECTABLE;INTRAVENOUS021689-002Mar 31, 2005► Subscribe► Subscribe
Astrazeneca PharmsNEXIUM IVesomeprazole sodiumINJECTABLE;INTRAVENOUS021689-001Mar 31, 2005► Subscribe► Subscribe
Astrazeneca PharmsNEXIUM IVesomeprazole sodiumINJECTABLE;INTRAVENOUS021689-002Mar 31, 2005► Subscribe► Subscribe
Astrazeneca PharmsNEXIUM IVesomeprazole sodiumINJECTABLE;INTRAVENOUS021689-001Mar 31, 2005► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.



Complete Access Available with Subscription
« Back to Dashboard

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

Serving leading biopharmaceutical companies globally:

Moodys
Accenture
Harvard Business School
US Department of Justice
Cantor Fitzgerald
Cerilliant
Cipla
McKinsey
Queensland Health
Mallinckrodt

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot