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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.
Summary for ESOMEPRAZOLE MAGNESIUM
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Recent Clinical Trials for ESOMEPRAZOLE MAGNESIUM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Icahn School of Medicine at Mount Sinai | Phase 2 |
| University of Texas Southwestern Medical Center | Phase 3 |
| Takeda | Phase 3 |
Recent Litigation for ESOMEPRAZOLE MAGNESIUM
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| DR. REDDY'S LABORATORIES, INC. v. ASTRAZENECA AB | 2018-11-12 |
| ASTRAZENECA AB v. CIPLA LIMITED | 2016-12-29 |
| AUROBINDO PHARMA LIMITED v. ASTRAZENECA AB | 2016-08-18 |
Pharmacology for ESOMEPRAZOLE MAGNESIUM
| Drug Class | Proton Pump Inhibitor |
| Mechanism of Action | Proton Pump Inhibitors Cytochrome P450 2C19 Inhibitors |
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 |
