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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
US Department of Justice
Accenture
Argus Health
Teva
Dow
Citi
McKesson
Baxter

Generated: June 24, 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. Seven suppliers are listed for this compound. Additional details are available on the esomeprazole sodium profile page.
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 ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-002 Oct 20, 2006 RX 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 Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-002 Oct 20, 2006 RX 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-001 Feb 20, 2001 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-003 Dec 15, 2011 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-002 Oct 20, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Pharms NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-002 Feb 20, 2001 ➤ 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
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
8,076,361 Form of S-omeprazole ➤ Try a Free Trial
6,677,455 Potassium salt of S-omeprazole ➤ Try a Free Trial
7,745,466 Form of S-omeprazole ➤ Try a Free Trial
6,747,155 Process ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for NEXIUM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00517 Netherlands ➤ Try a Free Trial PRODUCT NAME: ACETYLSALICYLZUUR EN ESOMEPRAZOLMAGNESIUMTRIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 107516 20110912; FIRST REGISTRATION: 540235954023675402375 2011120812
2012 00035 Denmark ➤ Try a Free Trial
2012000017 Germany ➤ Try a Free Trial PRODUCT NAME: ASPIRIN UND ESOMEPRAZOL - MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 81047.00.00 20110930 FIRST REGISTRATION: PORTUGAL 5402359 5402367 5402375 20110812
12/048 Ireland ➤ Try a Free 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
US Army
Baxter
Dow
Colorcon
Harvard Business School
Julphar
Moodys
AstraZeneca

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