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Harvard Business School
Queensland Health
Moodys
Fuji
Baxter
Fish and Richardson
Colorcon
Covington
Johnson and Johnson

Generated: September 18, 2018

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NEXIUM 24HR Drug Profile

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Which patents cover Nexium 24hr, and when can generic versions of Nexium 24hr launch?

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.

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 ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Astrazeneca Lp NEXIUM 24HR esomeprazole magnesium TABLET, DELAYED RELEASE;ORAL 207920-001 Nov 23, 2015 OTC Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Astrazeneca Lp NEXIUM 24HR esomeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 204655-001 Mar 28, 2014 OTC Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Astrazeneca Lp NEXIUM 24HR esomeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 204655-001 Mar 28, 2014 OTC Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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 TABLET, DELAYED RELEASE;ORAL 207920-001 Nov 23, 2015 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Lp NEXIUM 24HR esomeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 204655-001 Mar 28, 2014 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Lp NEXIUM 24HR esomeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 204655-001 Mar 28, 2014 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Lp NEXIUM 24HR esomeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 204655-001 Mar 28, 2014 ➤ Try a Free Trial ➤ Try a Free Trial
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 ➤ Try a Free Trial

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
6,677,455 Potassium salt of S-omeprazole ➤ Try a Free Trial
8,466,175 Form of S-omeprazole ➤ Try a Free Trial
8,076,361 Form of S-omeprazole ➤ Try a Free Trial
7,745,466 Form of S-omeprazole ➤ Try a Free Trial
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
871 Luxembourg ➤ Try a Free Trial 91871, EXPIRES: 20230525
0483 Netherlands ➤ Try a Free Trial PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMTRIHYDRAAT; NATIONAL REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: GB PL 17091/0263 - 0001 20101105
00517 Netherlands ➤ Try a Free Trial PRODUCT NAME: ACETYLSALICYLZUUR EN ESOMEPRAZOLMAGNESIUMTRIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 107516 20110912; FIRST REGISTRATION: 540235954023675402375 2011120812
90006-4 Sweden ➤ Try a Free Trial PRODUCT NAME: ACETYLSALICYLSYRA OCH ESOMEPRAZOLMAGNESIUMTRIHYDRAT; NAT. REG. NO/DATE: MTNR 44371 20110930; FIRST REG.: PT 5402359MFL 20110812
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Queensland Health
Moodys
Fuji
Baxter
Fish and Richardson
Colorcon
Covington
Johnson and Johnson

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