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Last Updated: August 13, 2020

DrugPatentWatch Database Preview

NEXIUM IV Drug Profile

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When do Nexium Iv patents expire, and what generic alternatives are available?

Nexium Iv is a drug marketed by Astrazeneca Pharms and is included in one NDA.

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

US ANDA Litigation and Generic Entry Outlook for Nexium Iv

A generic version of NEXIUM IV was approved as esomeprazole sodium by SUN PHARMA GLOBAL on March 18th, 2013.

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Drug patent expirations by year for NEXIUM IV
Drug Prices for NEXIUM IV

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Recent Clinical Trials for NEXIUM IV

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of AlexandriaPhase 4
Alexandria UniversityPhase 4
Yooyoung Pharmaceutical Co., Ltd.Phase 1

See all NEXIUM IV clinical trials

Pharmacology for NEXIUM IV
Paragraph IV (Patent) Challenges for NEXIUM IV
Tradename Dosage Ingredient NDA Submissiondate
NEXIUM IV INJECTABLE;INTRAVENOUS esomeprazole sodium 021689 2009-11-23

US Patents and Regulatory Information for NEXIUM IV

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Pharms NEXIUM IV esomeprazole sodium INJECTABLE;INTRAVENOUS 021689-001 Mar 31, 2005 DISCN Yes No   Start Trial   Start Trial   Start Trial
Astrazeneca Pharms NEXIUM IV esomeprazole sodium INJECTABLE;INTRAVENOUS 021689-002 Mar 31, 2005 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for NEXIUM IV

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms NEXIUM IV esomeprazole sodium INJECTABLE;INTRAVENOUS 021689-001 Mar 31, 2005   Start Trial   Start Trial
Astrazeneca Pharms NEXIUM IV esomeprazole sodium INJECTABLE;INTRAVENOUS 021689-002 Mar 31, 2005   Start Trial   Start Trial
Astrazeneca Pharms NEXIUM IV esomeprazole sodium INJECTABLE;INTRAVENOUS 021689-001 Mar 31, 2005   Start Trial   Start Trial
Astrazeneca Pharms NEXIUM IV esomeprazole sodium INJECTABLE;INTRAVENOUS 021689-002 Mar 31, 2005   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for NEXIUM IV

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1020461 91870 Luxembourg   Start Trial
0984957 2012/048 Ireland   Start Trial PRODUCT NAME: A COMBINATION PRODUCT COMPRISING ASPIRIN AND ESOMEPRAZOLE MAGNESIUM TRIHYDRATE; NAT REGISTRATION NO/DATE: PA 970/063/001 20120831; FIRST REGISTRATION NO/DATE: 5402359; 5402367 5402375 20110812
1411900 2011/016 Ireland   Start Trial PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
1020461 300482 Netherlands   Start Trial PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMZOUT; NATIONAL REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: GB PL 17091/0263 - 0001 20101105
0984957 SPC/GB11/013 United Kingdom   Start Trial PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
1020461 C300482 Netherlands   Start Trial PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMZOUT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 0001 20101105
0124495 SPC/GB01/006 United Kingdom   Start Trial PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Merck

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