ESOMEPRAZOLE MAGNESIUM | N204655 | ASTRAZENECA LP
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
ASTRAZENECA AB et al v. PERRIGO COMPANY PLC et al 2 patentsANDA 207193esomeprazole magnesium | D.N.J. | 2015-02-04 | Terminated 2017-06-09 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Hyman Phelps and McNamara PC FDA-2015-P-2230 · 5 docket documents Hyman, Phelps & McNamara, P.C. submitted this petition pursuant to FDC Act section 505(j)(2)(C) requesting that FDA determine that Esomeprazole Magnesium Delayed-Release Tablets, 20 mg (OTC), is suitable for submission in an ANDA, with the reference listed drug being AstraZeneca's NEXIUM 24HR Delaye | Other | 2015-08-18 | WithdrawnUnverified summary | Hyman Phelps and McNamara PC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| N/A | Not Yet Recruiting | University of Medicine and Pharmacy at Ho Chi Minh City | 600 | 2026-07-27 → 2027-12-27 | |
| N/A | Not Yet Recruiting | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | 45 | 2026-11-01 → 2028-12-01 | |
| N/A | Recruiting | Seoul National University Bundang Hospital | 600 | 2014-08 → 2027-12 | |
| Phase 2 | Recruiting | Stanford University | 25 | 2019-05-29 → 2028-12 | |
| Phase 1 | Recruiting | Basilea Pharmaceutica | 96 | 2025-01-07 → 2026-12-30 | |
| Phase 3 | Completed | AstraZeneca | 343 | 2014-07 → 2016-02 | |
| Phase 1 | Completed | Nurix Therapeutics, Inc. | 223 | 2024-11-30 → 2026-05-01 | |
| Phase 4 | Completed | Elpen Pharmaceutical Co. Inc. | 364 | 2017-01-30 → 2017-12-30 | |
| Phase 4 | Completed | King Saud University | 1,920 | 2012-01 → 2015-12 | |
| Phase 4 | Completed | Seoul National University Bundang Hospital | 648 | 2003-01 → 2010-12 |
Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.
Lowest Price
$23.01
Highest Price
$23.01
FSS NDCs
1
Big4 NDCs
0
| Description | Price | Type | Vendor | Contract End |
|---|---|---|---|---|
| 00573-2450-42NEXIUM 24HR 20MG (BASE) CAP,EC | $23.01 | FSS | Haleon US LP | 09/30/2027 |
Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.
30 active API suppliers hold Drug Master Files for this ingredient.
Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.
| Date | Submission | Document |
|---|---|---|
| Sep 7, 2022 | SUPPL -18 | View Letter (PDF) |
| Dec 8, 2020 | SUPPL -14 | View Letter (PDF) |
| Apr 8, 2019 | SUPPL -11 | View Letter (PDF) |
| Jan 26, 2018 | SUPPL -9 | View Letter (PDF) |
| Feb 6, 2017 | SUPPL -7 | View Letter (PDF) |
| Jan 17, 2017 | SUPPL -6 | View Letter (PDF) |
| Oct 6, 2014 | SUPPL -1 | View Letter (PDF) |
| Apr 2, 2014 | ORIG -1 | View Letter (PDF) |
Source: Drugs@FDA application documents.
No patent or exclusivity listings for this strength.