ESOMEPRAZOLE MAGNESIUM | N021153 | ASTRAZENECA PHARMACEUTICALS LP
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2019-04-24 | Terminated 2019-09-26 | — | |
| D. Del. | 2019-03-01 | Terminated 2019-09-26 | — | |
ASTRAZENECA AB et al v. HEC PHARM CO., LTD. et al 3 patentsANDA 207265esomeprazole magnesium | D.N.J. | 2015-08-05 | Terminated 2017-02-28 | — |
ASTRAZENECA AB et al v. ACTAVIS LABORATORIES FL, INC. et al 4 patentsANDA 207079esomeprazole magnesium | D.N.J. | 2014-12-17 | Terminated 2016-10-14 | — |
ASTRAZENECA AB et al v. WATSON LABORATORIES, INC. - FLORIDA et al 5 patentsANDA 204358esomeprazole magnesium | D.N.J. | 2013-03-19 | Terminated 2016-10-14 | — |
ASTRAZENECA AB et al v. MYLAN LABORATORIES LIMITED et al 3 patentsANDA 78936esomeprazole magnesium | D.N.J. | 2012-03-06 | Terminated 2016-09-08 | — |
ASTRAZENECA AB et al v. SUN PHARMA GLOBAL FZE et al 2 patentsANDA 20882esomeprazole sodium | D.N.J. | 2010-02-26 | Terminated 2011-10-12 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Foley & Lardner, LLP FDA-2019-P-5691 · 6 docket documents Foley & Lardner LLP filed this ANDA suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA Commissioner determine that an Abbreviated New Drug Application may be submitted for esomeprazole magnesium delayed-release capsules in 2.5 mg, 5 mg | Suitability | 2019-12-04 | Open | Foley & Lardner, LLP |
Citizen Petition from Jubilant Generics Limited FDA-2017-P-7032 · 6 docket documents Jubilant Generics Limited submitted this petition pursuant to section 505(j)(2)(c) of the Federal Food, Drug and Cosmetic Act requesting that the FDA determine Esomeprazole Magnesium Delayed Release Capsules, USP 10 mg, is suitable for submission as an Abbreviated New Drug Application, with Nexium ( | Other | 2017-12-29 | Granted | Jubilant Generics Limited |
Citizen Petition from Sandoz, Inc. FDA-2012-P-0661 · 4 docket documents Sandoz, Inc. filed this petition requesting that the FDA issue a written decision holding that the first applicant to submit a Paragraph IV ANDA for a generic version of NEXIUM (esomeprazole magnesium) Delayed Release Capsules has forfeited its 180-day exclusivity rights under 21 U.S.C. § 355(j)(5)( | 505(q) | 2012-06-25 | Denied | Sandoz, Inc. |
Pharmaceutical Security Institute, Inc. - Citizen Petition FDA-2011-P-0881 · 3 docket documents The Pharmaceutical Security Institute, Inc. filed this petition on November 30, 2011, requesting that the FDA take regulatory action against BetterThanMedicare.com for promoting and selling unapproved drugs, specifically foreign versions of prescription drugs including Nexium, Lipitor, and Plavix th | Other | 2011-12-09 | Denied | — |
Public Citizens Health Research Group - Citizen Petition FDA-2011-P-0741 · 4 docket documents Public Citizen's Health Research Group filed this citizen petition pursuant to 21 U.S.C. § 352 and 21 C.F.R. §§ 10.30 and 201.56 requesting that the FDA immediately add black box warnings and other enhanced safety labeling to all proton pump inhibitors including Nexium, Dexilant, Prilosec, Zegerid, | Other | 2011-10-20 | Partially Denied | — |
Lupin Pharmaceuticals, Inc. - ANDA Suitability Citizen Petition-[FDA-2008-P-0... FDA-2008-P-0080 · 6 docket documents Lupin Pharmaceuticals, Inc. filed this suitability petition pursuant to 21 CFR 314.93 and Section 505(j)(2)(c) of the Federal Food, Drug and Cosmetic Act requesting FDA approval to submit an abbreviated new drug application for Esomeprazole Delayed-Release Tablets in 20 mg and 40 mg strengths, which | Suitability | 2008-02-07 | Open | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$8.78
per ea
Lowest NADAC/Unit
$8.77
per ea
Brand NDCs
4
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00186504031NEXIUM DR 40 MG CAPSULE | $8.78 | EA | Brand | $0.1266 | 2026-06-17 |
| 00186504054NEXIUM DR 40 MG CAPSULE | $8.78 | EA | Brand | $0.1266 | 2026-06-17 |
| 00186502031NEXIUM DR 20 MG CAPSULE | $8.77 | EA | Brand | $0.1604 | 2026-06-17 |
| 00186502054NEXIUM DR 20 MG CAPSULE | $8.77 | EA | Brand | $0.1604 | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.