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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Citi
Fuji
QuintilesIMS
AstraZeneca
Cantor Fitzgerald
Julphar
Mallinckrodt
Baxter

Generated: April 20, 2018

DrugPatentWatch Database Preview

NEXIUM Drug Profile

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Which patents cover Nexium, and what generic alternatives are available?

Nexium is a drug marketed by Astrazeneca Pharms and Astrazeneca Lp and is included in six NDAs. There are seven patents protecting this drug and five Paragraph IV challenges.

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

The generic ingredient in NEXIUM is esomeprazole sodium. There are seventy drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the esomeprazole sodium profile page.
Summary for NEXIUM
Drug patent expirations by year for NEXIUM
Pharmacology for NEXIUM
Synonyms for NEXIUM
161973-10-0
1H-Benzimidazole, 5-methoxy-2-((S)-((4-methoxy-3,5-dimethyl-2-pyridinyl)methyl)sulfinyl)-, magnesium salt, trihydrate
217087-09-7
217087-10-0
382E335
5-methoxy-1H-1,3-benzimidazol-2-yl (4-methoxy-3,5-dimethyl-2-pyridinyl)methyl sulfoxide
5-Methoxy-2-(((4-methoxy-3,5-dimethyl-2-pyridyl)methyl)sulfinyl)benzimidazole, magnesium salt (2:1)
5-Methoxy-2-((S)-((4-methoxy-3,5-dimethyl-2-pyridyl)methyl)sulfinyl)benzimidazole, magnesium salt (2:1), trihydrate
95382-33-5
A810316
AB00698386-07
AB2000267
AC-402
AC-4540
AC1L2XM7
AC1L2XMA
AC1NSJYQ
AKOS015896379
AKOS015967196
AKOS025311414
AKOS025402081
AN-11885
AN-15879
AN-34918
azol-1-ide
CCG-100986
CE0112
CHEBI:94401
CHEMBL1567328
CPD004727568
CS-1024
CTK8E8954
D05259
Esomeprazole (Magnesium trihydrate)
Esomeprazole magnesium
Esomeprazole magnesium dihydrate
Esomeprazole magnesium trihydrate
ESOMEPRAZOLE Mg
Esomeprazole(magnesium)
FT-0625712
FT-0657297
H 168/68 magnesium
H199/18
HE073137
HE073437
HE316079
HMS2051H21
HMS2235F19
HMS2878H13
HMS3372O13
HMS3393H21
HY-17022
I06-1976
IN2364
J-014249
KS-1054
KWORUUGOSLYAGD-UHFFFAOYSA-N
LS-181810
magnesium 5-methoxy-2-(((4-methoxy-3,5-dimethylpyridin-2-yl)methyl)sulfinyl)benzo[d]imidazol-1-ide 6-methoxy-2-(((4-methoxy-3,5-dimethylpyridin-2-yl)methyl)sulfinyl)benzo[d]imid
magnesium 5-methoxy-2-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methylsulfinyl]benzimidazol-1-ide
magnesium 5-methoxy-2-[(4-methoxy-3,5-dimethyl-2-pyridyl)methylsulfinyl]benzimidazol-1-ide
magnesium 5-methoxy-2-[(4-methoxy-3,5-dimethyl-2-pyridyl)methylsulfinyl]benzimidazol-1-ide trihydrate
magnesium 5-methoxy-2-[(4-methoxy-3,5-dimethyl-pyridin-2-yl)methylsulfinyl]benzimidazol-1-ide
magnesium 5-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]benzimidazol-1-ide
magnesium 5-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]benzimidazol-1-ide trihydrate
magnesium bis(5-methoxy-2-{[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl}benzimidazol-1-ide)
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-[(R)-(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]benzimidazol-1-ide;tri
magnesium(2+) bis(5-methoxy-2-[(4-methoxy-3,5-dimethylpyridin-2-yl)methanesulfinyl]-1H-1,3-benzodiazol-1-ide)
MAGNESIUM(2+) ION 5-METHOXY-2-[(4-METHOXY-3,5-DIMETHYLPYRIDIN-2-YL)METHANESULFINYL]-1H-1,3-BENZODIAZOL-1-IDE 6-METHOXY-2-[(4-METHOXY-3,5-DIMETHYLPYRIDIN-2-YL)METHANESULFINYL]-1H-1,3-BENZODIAZOL-1-IDE
MAGNESIUM(2+) ION BIS(5-METHOXY-2-[(4-METHOXY-3,5-DIMETHYLPYRIDIN-2-YL)METHANESULFINYL]-1H-1,3-BENZODIAZOL-1-IDE) TRIHYDRATE
MFCD06798050
MFCD07698573
MLS001165732
MLS001401413
MolPort-005-940-841
MolPort-016-633-260
MRF-0000267
N Bis (1H-Benzimidazole,5-methoxy-2-[(S)-[4-methoxy-3,5-dimethyl-2-pyridinyl)methyl)sulfinyl]-)
NC00236
Omeprazole magnesium
omeprazole magnesium (10 mg)
Omeprazole magnesium (USAN)
Omeprazole magnesium [USAN:USP]
Omeprazole magnesium [USAN]
omeprazole magnesium, ep
omeprazole mg
Prilosec OTC (TN)
Q-100195
RT-012496
SAM001246538
SC-72064
SCHEMBL665194
SCHEMBL722792
SMR000469280
SMR000550477
ST24046692
ST51053319
STL455071
UNII-426QFE7XLK
VEVZQDGATGBLIC-UHFFFAOYSA-N

US Patents and Regulatory Information for NEXIUM

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 Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-002 Oct 20, 2006 RX 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 Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-002 Oct 20, 2006 RX 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-002 Feb 20, 2001 ➤ Sign Up ➤ Sign Up
Astrazeneca Pharms NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-001 Feb 20, 2001 ➤ Sign Up ➤ Sign Up
Astrazeneca Pharms NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-001 Feb 20, 2001 ➤ Sign Up ➤ Sign Up
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-002 Oct 20, 2006 ➤ 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
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Delayed-release for Oral Suspension 20 mg and 40 mg ➤ Subscribe 2013-08-01
➤ Subscribe Delayed-release Tablets 20 mg ➤ Subscribe 2016-09-09
➤ Subscribe Delayed-release Capsules 20 mg ➤ Subscribe 2014-04-24
➤ Subscribe For Injection 20 mg/vial and 40 mg/vial ➤ Subscribe 2009-11-23
➤ Subscribe Delayed-release 20 mg and 40 mg ➤ Subscribe 2005-08-05

Non-Orange Book US Patents for NEXIUM

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
7,745,466 Form of S-omeprazole ➤ Sign Up
8,076,361 Form of S-omeprazole ➤ Sign Up
6,677,455 Potassium salt of S-omeprazole ➤ Sign Up
6,747,155 Process ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for NEXIUM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
C/GB11/013 United Kingdom ➤ Sign Up PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
C/GB01/006 United Kingdom ➤ Sign Up PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Teva
AstraZeneca
McKinsey
Cerilliant
Mallinckrodt
Cantor Fitzgerald
Fish and Richardson
US Army

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