OMEPRAZOLE | N022032 | DEXCEL PHARMA TECHNOLOGIES LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
DEXCEL PHARMA TECHNOLOGIES LTD. et al v. SUN PHARMA GLOBAL FZE et al 2 patentsANDA 207891omeprazole | D.N.J. | 2015-11-11 | Terminated 2018-08-07 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Lupin Pharmaceuticals, Inc. - ANDA Suitability Citizen Petition-[FDA-2008-P-0... FDA-2008-P-0080 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.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 12599565 | Jan 31, 2030 | — | — | Yes | — | — |
Dexcel Pharma added patent 12599565 to the Orange Book for omeprazole (NDA 022032).
New: New record