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Generated: January 16, 2019

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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-one drug master file entries for this compound. Seventy-three 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
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 TABLET, DELAYED RELEASE;ORAL 207920-001 Nov 23, 2015 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 TABLET, DELAYED RELEASE;ORAL 207920-001 Nov 23, 2015 ➤ Sign Up ➤ Sign Up
Astrazeneca Lp NEXIUM 24HR esomeprazole magnesium TABLET, DELAYED RELEASE;ORAL 207920-001 Nov 23, 2015 ➤ 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 CAPSULE, DELAYED RELEASE;ORAL 204655-001 Mar 28, 2014 ➤ 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 Date
➤ Subscribe Delayed-release Tablets 20 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for NEXIUM 24HR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00517 Netherlands ➤ Sign Up PRODUCT NAME: ACETYLSALICYLZUUR EN ESOMEPRAZOLMAGNESIUMTRIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 107516 20110912; FIRST REGISTRATION: 540235954023675402375 2011120812
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
017 Luxembourg ➤ Sign Up 92017, EXPIRES: 20230525
2012000051 Germany ➤ Sign Up PRODUCT NAME: KOMBINATIONSPRODUKT UMFASSEND NAPROXEN UND ESOMEPRAZOL-MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105
11/016 Ireland ➤ Sign Up PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
2012 00035 Denmark ➤ Sign Up
00483 Netherlands ➤ Sign Up PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMTRIHYFRAAT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 0001 20110524
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Cantor Fitzgerald
Cerilliant
Julphar
Citi
Federal Trade Commission
McKinsey
Colorcon
Baxter

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