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Deloitte
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Colorcon
Chinese Patent Office
Federal Trade Commission
Harvard Business School
Covington
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Generated: May 23, 2018

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Esomeprazole magnesium - Generic Drug Details

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What are the generic drug sources for esomeprazole magnesium and what is the scope of esomeprazole magnesium patent protection?

Esomeprazole magnesium
is the generic ingredient in five branded drugs marketed by Alkem Labs Ltd, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Hetero Labs Ltd Iii, Ivax Sub Teva Pharms, Lannett Co Inc, Mylan Pharms Inc, Sun Pharm Inds Ltd, Torrent Pharms Ltd, Astrazeneca Pharms, Perrigo R And D, Astrazeneca Lp, and Horizon Pharma Usa, and is included in nineteen NDAs. There are nineteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Esomeprazole magnesium has one hundred and twenty-eight patent family members in forty-two countries.

There are seventy drug master file entries for esomeprazole magnesium. Sixty-eight suppliers are listed for this compound. There is one tentative approval for this compound.
Pharmacology for esomeprazole magnesium
Synonyms for esomeprazole magnesium
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 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
Nexium
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
Tentative approvals for ESOMEPRAZOLE MAGNESIUM
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial22MGCAPSULE, DELAYED RELEASE;ORAL

US Patents and Regulatory Information for esomeprazole magnesium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-001 Oct 20, 2006 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022101-001 Feb 27, 2008 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-001 Oct 20, 2006 RX Yes No ➤ 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
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 esomeprazole magnesium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-002 Oct 20, 2006 ➤ 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 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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Non-Orange Book US Patents for esomeprazole magnesium

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 ➤ Try a Free Trial
6,677,455 Potassium salt of S-omeprazole ➤ Try a Free Trial
8,076,361 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 esomeprazole magnesium

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2012 00035 Denmark ➤ Try a Free Trial
11/016 Ireland ➤ Try a Free Trial PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
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
0984957/02 Switzerland ➤ Try a Free Trial PRODUCT NAME: ESOMEPRAZOL + ACETYLSALICYLSAEURE ; REGISTRATION NO/DATE: SWISSMEDIC 62119 26.06.2012
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Johnson and Johnson
Farmers Insurance
AstraZeneca
QuintilesIMS
Fish and Richardson
Chinese Patent Office
Cantor Fitzgerald
Chubb

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