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Generated: October 23, 2018

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NEXIUM Drug Profile

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When do Nexium patents expire, and when can generic versions of Nexium launch?

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 six Paragraph IV challenges.

The generic ingredient in NEXIUM is esomeprazole sodium. There are seventy-one drug master file entries for this compound. Six 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 ➤ 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
Astrazeneca Pharms NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-001 Feb 20, 2001 AB RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-004 Dec 15, 2011 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-001 Oct 20, 2006 RX Yes No ➤ 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 FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-002 Oct 20, 2006 ➤ Sign Up ➤ Sign Up
Astrazeneca Pharms NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-002 Feb 20, 2001 ➤ Sign Up ➤ Sign Up
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-004 Dec 15, 2011 ➤ Sign Up ➤ Sign Up
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-002 Oct 20, 2006 ➤ Sign Up ➤ Sign Up
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 021957-001 Oct 20, 2006 ➤ Sign Up ➤ Sign Up
Astrazeneca Pharms NEXIUM esomeprazole magnesium CAPSULE, DELAYED REL PELLETS;ORAL 021153-002 Feb 20, 2001 ➤ Sign Up ➤ Sign Up
Astrazeneca Pharms NEXIUM esomeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022101-001 Feb 27, 2008 ➤ 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 Date
➤ Subscribe Delayed-release for Oral Suspension 10 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Delayed-release for Oral Suspension 20 mg and 40 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Delayed-release Tablets 20 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Delayed-release Capsules 20 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe For Injection 20 mg/vial and 40 mg/vial ➤ Subscribe ➤ Sign Up
➤ Subscribe Delayed-release 20 mg and 40 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for NEXIUM

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
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
2012 00008 Denmark ➤ Sign Up
0 Finland ➤ Sign Up
0483 Netherlands ➤ Sign Up PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMTRIHYDRAAT; NATIONAL REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: GB PL 17091/0263 - 0001 20101105
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:

US Army
Argus Health
Chubb
Colorcon
Teva
Medtronic
UBS
AstraZeneca
Farmers Insurance

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.