Viewing data from:

OMTRYG

NDA

OMEGA-3-ACID ETHYL ESTERS TYPE A | N204977 | OSMOTICA PHARMACEUTICAL US LLC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jun 24, 2025	SUPPL -10	View Letter (PDF)
Apr 25, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1.2GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Apr 23, 2014

No patent or exclusivity listings for this strength.