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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 freedom to operate?
Esomeprazole magnesium
is the generic ingredient in four branded drugs 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, Astrazeneca Pharms, Perrigo R And D, Astrazeneca Lp, P And L, and Horizon, and is included in twenty-five NDAs. There are fifteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Esomeprazole magnesium has forty-nine patent family members in nineteen countries.
There are seventy-four drug master file entries for esomeprazole magnesium. Ninety suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for ESOMEPRAZOLE MAGNESIUM
| International Patents: | 49 |
| US Patents: | 15 |
| Tradenames: | 4 |
| Applicants: | 18 |
| NDAs: | 25 |
| Drug Master File Entries: | 74 |
| Suppliers / Packagers: | 90 |
| Bulk Api Vendors: | 43 |
| Clinical Trials: | 16 |
| Patent Applications: | 1,333 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for ESOMEPRAZOLE MAGNESIUM |
| Drug Sales Revenues: | Drug sales revenues for ESOMEPRAZOLE MAGNESIUM |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ESOMEPRAZOLE MAGNESIUM |
| DailyMed Link: | ESOMEPRAZOLE MAGNESIUM at DailyMed |
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 |
Generic filers with tentative approvals for ESOMEPRAZOLE MAGNESIUM
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE;ORAL |
| Start Trial | Start Trial | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE;ORAL |
| Start Trial | Start Trial | EQ 20MG BASE;500MG | Tablet, Delayed Release; Oral |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan | ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 078936-001 | Aug 2, 2015 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Horizon | VIMOVO | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 022511-002 | Apr 30, 2010 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Horizon | VIMOVO | esomeprazole magnesium; naproxen | TABLET, DELAYED RELEASE;ORAL | 022511-001 | Apr 30, 2010 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Astrazeneca Pharms | NEXIUM | esomeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 021957-004 | Dec 15, 2011 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for ESOMEPRAZOLE MAGNESIUM
| 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 | Start Trial | Start Trial |
| Astrazeneca Pharms | NEXIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 021153-001 | Feb 20, 2001 | Start Trial | Start Trial |
| Astrazeneca Lp | NEXIUM 24HR | esomeprazole magnesium | CAPSULE, DELAYED RELEASE;ORAL | 204655-001 | Mar 28, 2014 | Start Trial | Start Trial |
| Astrazeneca Pharms | NEXIUM | esomeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 021957-002 | Oct 20, 2006 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ESOMEPRAZOLE MAGNESIUM
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Hong Kong | 1034510 | Start Trial |
| Portugal | 1104417 | Start Trial |
| Canada | 2393366 | Start Trial |
| World Intellectual Property Organization (WIPO) | 0009497 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ESOMEPRAZOLE MAGNESIUM
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0984957 | 2012/048 | Ireland | Start 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 |
| 1411900 | 2011/016 | Ireland | Start 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 |
| 0984957 | SPC/GB11/013 | United Kingdom | Start Trial | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 |
| 1411900 | SPC/GB11/015 | United Kingdom | Start Trial | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.