ESOMEPRAZOLE MAGNESIUM | N021153 | ASTRAZENECA PHARMACEUTICALS LP
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
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 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 |
Citizen Petition from Jubilant Generics Limited FDA-2017-P-7032 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 | Open | Jubilant Generics Limited |
Citizen Petition from Sandoz, Inc. FDA-2012-P-0661 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 |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.