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NDA

OMEGA-3-CARBOXYLIC ACIDS | N205060 | ASTRAZENECA PHARMACEUTICALS LP

1 strength4 unique patents0 unique exclusivities

Patent Timeline

4 unique patents by expiration date

Expiring < 1yr (1)Active (3)Today

2027

2028

2029

2030

2031

2032

2033

Today

Dec. 20, 2026

Jan. 4, 2033

Jan. 4, 2033

Jan. 4, 2033

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

API Supply Chain0 active DMFs1 inactive

0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDInactiveOMEGA-3-CARBOXYLIC ACIDS

DMF 301032016

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Mar 14, 2017	SUPPL -3	View Letter (PDF)
Jan 23, 2017	SUPPL -4	View Letter (PDF)
Oct 12, 2016	SUPPL -2	View Letter (PDF)
May 6, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1GM CONTAINS AT LEAST 850MG OF POLYUNSATURATED FATTY ACIDS

RLD

4 patents0 exclusivities▴

CAPSULE;ORAL | Approved: May 5, 2014

Patents (4)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7960370	Dec 20, 2026	—	—	Yes	—	—
9050308	Jan 4, 2033	—	—	—		—
9050309	Jan 4, 2033	—	Yes	—	—	—
10117844	Jan 4, 2033	—	—	—		—