Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Moodys
Baxter
Mallinckrodt
Harvard Business School
Merck

Last Updated: December 12, 2019

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ESOMEPRAZOLE MAGNESIUM Drug Profile

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Which patents cover Esomeprazole Magnesium, and what generic alternatives are available?

Esomeprazole Magnesium is a drug marketed by Alkem Labs Ltd, Amneal Pharms Ny, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Glenmark Pharms, Hec Pharm, Hetero Labs Ltd Iii, Ivax Sub Teva Pharms, Lannett Co Inc, Mylan, Sun Pharm, Torrent, Zydus Pharms, Perrigo R And D, and P And L. and is included in nineteen NDAs.

The generic ingredient in ESOMEPRAZOLE MAGNESIUM is esomeprazole magnesium. There are seventy-four drug master file entries for this compound. Ninety suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium profile page.

US ANDA Litigation and Generic Entry Outlook for Esomeprazole Magnesium

A generic version of ESOMEPRAZOLE MAGNESIUM was launched as esomeprazole magnesium by IVAX SUB TEVA PHARMS on December 12th, 2019.

Drug patent expirations by year for ESOMEPRAZOLE MAGNESIUM
Drug Prices for ESOMEPRAZOLE MAGNESIUM

See drug prices for ESOMEPRAZOLE MAGNESIUM

Drug Sales Revenue Trends for ESOMEPRAZOLE MAGNESIUM

See drug sales revenues for ESOMEPRAZOLE MAGNESIUM

Recent Clinical Trials for ESOMEPRAZOLE MAGNESIUM

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Icahn School of Medicine at Mount SinaiPhase 2
University of Texas Southwestern Medical CenterPhase 3
TakedaPhase 3

See all ESOMEPRAZOLE MAGNESIUM clinical trials

Recent Litigation for ESOMEPRAZOLE MAGNESIUM

Identify potential future generic entrants

District Court Litigation
Case NameDate
DR. REDDY'S LABORATORIES, INC. v. ASTRAZENECA AB2018-11-12
ASTRAZENECA AB v. CIPLA LIMITED2016-12-29
AUROBINDO PHARMA LIMITED v. ASTRAZENECA AB2016-08-18

See all ESOMEPRAZOLE MAGNESIUM litigation

Pharmacology for ESOMEPRAZOLE MAGNESIUM
Synonyms for ESOMEPRAZOLE MAGNESIUM
(s)-omeprazole magnesium trihydrate
161796-78-7
161973-10-0
1H-Benzimidazole, 5-methoxy-2-((S)-((4-methoxy-3,5-dimethyl-2-pyridinyl)methyl)sulfinyl)-, magnesium salt, trihydrate
217087-09-7
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
ACN-036633
AK172773
AKOS015896379
AKOS015967196
AKOS025311414
AKOS025402081
AN-11885
AN-15879
AN-34918
azol-1-ide
BCP05838
CCG-100986
CE0112
CHEBI:94401
CHEMBL1567328
CPD004727568
CS-1024
CTK8E8954
D05259
Esomeprazole (Magnesium trihydrate)
Esomeprazole magnesium (Nexium)
Esomeprazole magnesium trihydrate
ESOMEPRAZOLE Mg
Esomeprazole Sodium
Esomeprazole(magnesium)
FT-0625712
FT-0657297
H 168/68 magnesium
H199/18
HMS2051H21
HMS2235F19
HMS2878H13
HMS3372O13
HMS3393H21
HY-17022
I06-1976
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)
MFCD07698573 (95%)
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
STL455071
SW220306-1
SY108184
UNII-426QFE7XLK
VEVZQDGATGBLIC-UHFFFAOYSA-N
Paragraph IV (Patent) Challenges for ESOMEPRAZOLE MAGNESIUM
Tradename Dosage Ingredient NDA Submissiondate
NEXIUM 24HR TABLET, DELAYED RELEASE;ORAL esomeprazole magnesium 207920 2016-09-09
NEXIUM 24HR CAPSULE, DELAYED RELEASE;ORAL esomeprazole magnesium 204655 2014-04-24
NEXIUM FOR SUSPENSION, DELAYED RELEASE;ORAL esomeprazole magnesium 021957 2013-08-01
NEXIUM CAPSULE, DELAYED REL PELLETS;ORAL esomeprazole magnesium 021153 2005-08-05
NEXIUM FOR SUSPENSION, DELAYED RELEASE;ORAL esomeprazole magnesium 022101

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
P And L ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium TABLET, DELAYED RELEASE;ORAL 209202-001 Mar 5, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 209339-001 Oct 16, 2017 OTC No No   Start Trial   Start Trial   Start Trial
Dr Reddys Labs Ltd ESOMEPRAZOLE MAGNESIUM esomeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 207673-001 May 15, 2018 OTC No No   Start Trial   Start Trial   Start 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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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Dow
Johnson and Johnson
McKesson
Merck
McKinsey

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.