ESOMEPRAZOLE MAGNESIUM | N207920 | ASTRAZENECA LP
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
DR. REDDY'S LABORATORIES, INC. et al v. ASTRAZENECA AB et al 1 patentANDA 211571esomeprazole magnesium | D.N.J. | 2018-11-12 | Terminated 2019-06-14 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| 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.
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 -7 | View Letter (PDF) |
| Apr 8, 2019 | SUPPL -5 | View Letter (PDF) |
| Nov 27, 2018 | SUPPL -1 | View Letter (PDF) |
| Nov 27, 2018 | ORIG -1 | View Letter (PDF) |
Source: Drugs@FDA application documents.
No patent or exclusivity listings for this strength.