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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Fuji
Chubb
Harvard Business School
US Army
Farmers Insurance
Dow
McKinsey
Cerilliant

Generated: June 25, 2018

DrugPatentWatch Database Preview

NEXIUM 24HR Drug Profile

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When do Nexium 24hr patents expire, and what generic alternatives are available?

Nexium 24hr is a drug marketed by Astrazeneca Lp and is included in two NDAs. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and two patent family members in forty-two countries.

The generic ingredient in NEXIUM 24HR is esomeprazole magnesium. There are seventy drug master file entries for this compound. Sixty-nine suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium profile page.
Drug patent expirations by year for NEXIUM 24HR
Synonyms for NEXIUM 24HR
(-)-Omeprazole magnesium
(S)-Omeprazole magnesium
1H-Benzimidazole, 5-methoxy-2-((S)-((4-methoxy-3,5-dimethyl-2-pyridinyl)methyl)sulfinyl)-, magnesium salt, trihydrate
202742-32-3
302841-07-2
320416-93-1
371759-50-1
372519-57-8
376628-34-1
5-Methoxy-2-((S)-((4-methoxy-3,5-dimethyl-2-pyridyl)methyl)sulfinyl)benzimidazole, magnesium salt (2:1), trihydrate
925R0D7W1O
Axagon
bis(5-methoxy-2-{(S)-[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl}benzimidazol-1-ide) magnesium
CHEBI:50309
CHEMBL2146133
D-961H
D01984
DTXSID5044231
Esomeprazole magnesium (USAN)
Esomeprazole magnesium [USAN:INN]
Esomeprazole magnesium [USAN:USP]
Esomeprazole magnesium hydrate
Esomeprazole magnesium hydrate (JAN)
Esopral
H 199/18
H-199/18
H199/18 MAGNESIUM TRIHYDRATE
KWORUUGOSLYAGD-YPPDDXJESA-N
Lucen
Magnesium, bis(5-methoxy-2-(((4-methoxy-3,5-dimethyl-2-pyridinyl)methyl)sulfinyl)-1H-benzimidazolato)-, (T-4-(S),(S))-
Magnesium, bis(5-methoxy-2-((S)-((4-methoxy-3,5-dimethyl-2-pyridinyl)methyl)sulfinyl-kappaO)-1H-benzimidazolato-kappaN1)-, (T-4)-
Magnesium, bis(5-methoxy-2-((S)-((4-methoxy-3,5-dimethyl-2-pyridinyl)methyl)sulfinyl-kappaO)-1H-benzimidazolato-kappaN1)-, trihydrate, (T-4)-
magnesium;5-methoxy-2-[(S)-(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]benzimidazol-1-ide;trihydrate
MolPort-044-560-334
Nexium
Nexium (TN)
Perprazole
R6DXU4WAY9
SCHEMBL144575
UNII-426QFE7XLK component KWORUUGOSLYAGD-YPPDDXJESA-N
UNII-925R0D7W1O
UNII-R6DXU4WAY9

US Patents and Regulatory Information for NEXIUM 24HR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Lp NEXIUM 24HR esomeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 204655-001 Mar 28, 2014 OTC Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Astrazeneca Lp NEXIUM 24HR esomeprazole magnesium TABLET, DELAYED RELEASE;ORAL 207920-001 Nov 23, 2015 OTC Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Astrazeneca Lp NEXIUM 24HR esomeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 204655-001 Mar 28, 2014 OTC Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Astrazeneca Lp NEXIUM 24HR esomeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 204655-001 Mar 28, 2014 OTC Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for NEXIUM 24HR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Lp NEXIUM 24HR esomeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 204655-001 Mar 28, 2014 ➤ Sign Up ➤ Sign Up
Astrazeneca Lp NEXIUM 24HR esomeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 204655-001 Mar 28, 2014 ➤ Sign Up ➤ Sign Up
Astrazeneca Lp NEXIUM 24HR esomeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 204655-001 Mar 28, 2014 ➤ Sign Up ➤ Sign Up
Astrazeneca Lp NEXIUM 24HR esomeprazole magnesium TABLET, DELAYED RELEASE;ORAL 207920-001 Nov 23, 2015 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for NEXIUM 24HR
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Delayed-release Tablets 20 mg ➤ Subscribe 2016-09-09

Non-Orange Book US Patents for NEXIUM 24HR

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,076,361 Form of S-omeprazole ➤ Sign Up
6,677,455 Potassium salt of S-omeprazole ➤ Sign Up
7,745,466 Form of S-omeprazole ➤ Sign Up
8,466,175 Form of S-omeprazole ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for NEXIUM 24HR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
12/048 Ireland ➤ Sign Up 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
2012 00035 Denmark ➤ Sign Up PRODUCT NAME: ET KOMBINATIONSPRODUKT AF NAPROXEN OG ESOMEPRAZOL MAGNESIUM TRIHYDRAT; NAT. REG. NO/DATE: 49583 20120327; FIRST REG. NO/DATE: GB PL 17901/0263-001 20101105
2012 00035 Denmark ➤ Sign Up
017 Luxembourg ➤ Sign Up 92017, EXPIRES: 20230525
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Cipla
Cantor Fitzgerald
Boehringer Ingelheim
Covington
Chinese Patent Office
Cerilliant
Accenture
US Army

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