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Details for New Drug Application (NDA): 021689

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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-five drug master file entries for this compound. Six suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the esomeprazole sodium profile page.

Summary for NDA: 021689

Tradename:
NEXIUM IV
Applicant:
Astrazeneca Pharms
Ingredient:
esomeprazole sodium
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:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 20MG 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
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

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms
NEXIUM IV
esomeprazole sodium
INJECTABLE;INTRAVENOUS021689-001Mar 31, 20055,877,192*PED► subscribe
Astrazeneca Pharms
NEXIUM IV
esomeprazole sodium
INJECTABLE;INTRAVENOUS021689-002Mar 31, 20056,143,771► subscribe
Astrazeneca Pharms
NEXIUM IV
esomeprazole sodium
INJECTABLE;INTRAVENOUS021689-002Mar 31, 20055,877,192*PED► subscribe
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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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