ESOMEPRAZOLE MAGNESIUM - Generic Drug Details
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What are the generic drug sources for esomeprazole magnesium and what is the scope of patent protection?
Esomeprazole magnesium
is the generic ingredient in five branded drugs 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, Astrazeneca, Aurobindo Pharma, Guardian Drug, Marksans Pharma, Norvium Bioscience, Perrigo R And D, Astrazeneca Lp, Cipla, P And L, Dexcel, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Sciegen Pharms Inc, and Horizon, and is included in fifty-five NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Esomeprazole magnesium has four patent family members in three countries.
There are fifty-nine drug master file entries for esomeprazole magnesium. One hundred and twelve suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for ESOMEPRAZOLE MAGNESIUM
International Patents: | 4 |
US Patents: | 2 |
Tradenames: | 5 |
Applicants: | 36 |
NDAs: | 55 |
Drug Master File Entries: | 59 |
Finished Product Suppliers / Packagers: | 112 |
Raw Ingredient (Bulk) Api Vendors: | 64 |
Clinical Trials: | 19 |
Patent Applications: | 6,066 |
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 |
What excipients (inactive ingredients) are in ESOMEPRAZOLE MAGNESIUM? | ESOMEPRAZOLE MAGNESIUM excipients list |
DailyMed Link: | ESOMEPRAZOLE MAGNESIUM at DailyMed |
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 |
Generic filers with tentative approvals for ESOMEPRAZOLE MAGNESIUM
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE;ORAL |
⤷ Sign Up | ⤷ Sign Up | EQ 20MG BASE;375MG | 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 | 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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dexcel | ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 214278-001 | Oct 20, 2020 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Ethypharm | ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 090841-002 | Mar 31, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Glenmark Speclt | ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 209495-002 | May 10, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Lannett Co Inc | ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 205563-001 | Sep 1, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Prinston Inc | ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 214920-001 | Mar 28, 2023 | AB | RX | 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 |
Expired US Patents for ESOMEPRAZOLE MAGNESIUM
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Astrazeneca | NEXIUM | esomeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 021957-002 | Oct 20, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca | NEXIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 021153-002 | Feb 20, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca | NEXIUM | esomeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 021957-001 | Oct 20, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca | NEXIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 021153-001 | Feb 20, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Astrazeneca | NEXIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 021153-002 | Feb 20, 2001 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ESOMEPRAZOLE MAGNESIUM
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 |
European Patent Office | 3932396 | COMPOSITIONS PHARMACEUTIQUES STABLES À DÉSINTÉGRATION ORALE (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 | 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 | 2011C/016 | Belgium | ⤷ Sign Up | PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214 |
1411900 | SPC/GB11/015 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 |
0124495 | SPC/GB01/006 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727 |
0984957 | 2012/048 | Ireland | ⤷ Sign Up | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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