ESOMEPRAZOLE MAGNESIUM Drug Patent Profile
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When do Esomeprazole Magnesium patents expire, and when can generic versions of Esomeprazole Magnesium launch?
Esomeprazole Magnesium is a drug marketed by Alkem Labs Ltd, Amneal Pharms Ny, Aurobindo Pharma Ltd, Cisen, Cspc Ouyi, Dr Reddys, Ethypharm, Glenmark Speclt, Granules, Graviti Pharms, Guangzhou Novaken, Hec Pharm, Hetero Labs Ltd Iii, Indchemie Health, Ivax Sub Teva Pharms, Lannett Co Inc, Mylan, Prinston Inc, Sun Pharm, Torrent, Zhejiang Yongtai, Zydus Pharms, Anda Repository, Aurobindo Pharma, Marksans Pharma, Norvium Bioscience, Perrigo R And D, Cipla, P And L, and Dexcel. and is included in forty-four NDAs. There are two patents protecting this drug.
This drug has four patent family members in three countries.
The generic ingredient in ESOMEPRAZOLE MAGNESIUM is esomeprazole magnesium. There are seventy-four drug master file entries for this compound. One hundred and eleven suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Esomeprazole Magnesium
A generic version of ESOMEPRAZOLE MAGNESIUM was approved as esomeprazole magnesium by IVAX SUB TEVA PHARMS on January 26th, 2015.
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Summary for ESOMEPRAZOLE MAGNESIUM
| International Patents: | 4 |
| US Patents: | 2 |
| Applicants: | 30 |
| NDAs: | 44 |
| Finished Product Suppliers / Packagers: | 109 |
| Raw Ingredient (Bulk) Api Vendors: | 64 |
| Clinical Trials: | 19 |
| Patent Applications: | 3,620 |
| Drug Prices: | Drug price information 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 |
| What excipients (inactive ingredients) are in ESOMEPRAZOLE MAGNESIUM? | ESOMEPRAZOLE MAGNESIUM excipients list |
| DailyMed Link: | ESOMEPRAZOLE MAGNESIUM at DailyMed |
See drug prices for ESOMEPRAZOLE MAGNESIUM
Recent Clinical Trials for ESOMEPRAZOLE MAGNESIUM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Daewoong Pharmaceutical Co. LTD. | Phase 3 |
| Icahn School of Medicine at Mount Sinai | Phase 2 |
| University of Texas Southwestern Medical Center | Phase 3 |
Pharmacology for ESOMEPRAZOLE MAGNESIUM
| Drug Class | Proton Pump Inhibitor |
| Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for ESOMEPRAZOLE MAGNESIUM
Paragraph IV (Patent) Challenges for ESOMEPRAZOLE MAGNESIUM
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| NEXIUM | Delayed-release for Oral Suspension | esomeprazole magnesium | 2.5 mg and 5 mg | 021957 | 1 | 2018-09-24 |
| NEXIUM | Delayed-release for Oral Suspension | esomeprazole magnesium | 10 mg | 022101 | 1 | 2018-07-06 |
| NEXIUM 24HR | Delayed-release Capsules | esomeprazole magnesium | 20 mg | 204655 | 2014-04-24 | |
| NEXIUM | Delayed-release for Oral Suspension | esomeprazole magnesium | 20 mg and 40 mg | 021957 | 1 | 2013-08-01 |
| NEXIUM | Delayed-release Capsules | esomeprazole magnesium | 20 mg and 40 mg | 021153 | 1 | 2005-08-05 |
US Patents and Regulatory Information for ESOMEPRAZOLE MAGNESIUM
ESOMEPRAZOLE MAGNESIUM is protected by two US patents.
Patents protecting ESOMEPRAZOLE MAGNESIUM
Stable orally disintegrating pharmaceutical compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Stable orally disintegrating pharmaceutical compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Torrent | ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 203636-001 | Oct 19, 2015 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Ivax Sub Teva Pharms | ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 078003-002 | Jan 26, 2015 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Aurobindo Pharma | ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium | CAPSULE, DELAYED RELEASE;ORAL | 209339-001 | Oct 16, 2017 | OTC | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for ESOMEPRAZOLE MAGNESIUM
See the table below for patents covering ESOMEPRAZOLE MAGNESIUM around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2017216789 | ⤷ Sign Up | |
| European Patent Office | 3471708 | COMPOSITIONS PHARMACEUTIQUES STABLES À DÉSINTÉGRATION ORALE (STABLE ORALLY DISINTEGRATING PHARMACEUTICAL COMPOSITIONS) | ⤷ Sign Up |
| Australia | 2017285390 | Stable orally disintegrating pharmaceutical compositions | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ESOMEPRAZOLE MAGNESIUM
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1411900 | 2011C/016 | Belgium | ⤷ Sign Up | PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214 |
| 1411900 | 2011/016 | 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 |
| 1411900 | SPC/GB11/015 | United Kingdom | ⤷ Sign Up | 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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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 verification 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.
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