Is there a generic for Omega-3-carboxylic acids?

The FDA Orange Book does not currently list an approved generic (ANDA) for Omega-3-carboxylic acids. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Omega-3-carboxylic acids?

EPANOVA (NDA 205060, ASTRAZENECA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Omega-3-carboxylic acids?

The Orange Book lists 4 patents against Omega-3-carboxylic acids products, with the earliest listed expiry in 2026. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Omega-3-carboxylic acids are approved?

Omega-3-carboxylic acids is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Omega-3-carboxylic acids

Omega-3-carboxylic acids: 1 brand, 0 generics; first approved May 05, 2014; on patent until Dec 20, 2026.

On patentHas discontinued products

Generic status & protection

Protected until Dec 20, 2026 (earliest listed patent expiry).

Earliest patent expiry Dec 20, 2026

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Dec 20, 2026

in 5 mo

Originator applications

Brand (NDA) products

EPANOVARLD

ASTRAZENECANDA 2050602014

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1GM CONTAINS AT LEAST 850MG OF POLYUNSATURATED FATTY ACIDS	CAPSULE	ORAL	Discontinued	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Orange Book patent file

Listed patents

Listed patents (4)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7960370	Dec 20, 2026	in 5 mo	Product
10117844	Jan 04, 2033	in 6 yr 7 mo	U-2447
9050308	Jan 04, 2033	in 6 yr 7 mo	U-1511
9050309	Jan 04, 2033	in 6 yr 7 mo	Substance

FDA approval span

Approval history

First approval

May 05, 2014

12 yr 4 mo ago

Most recent approval

May 05, 2014

12 yr 4 mo ago

All 1 application were approved in 2014.

Brand (NDA) 1100%

Generic (ANDA) 00%

Omega-3-carboxylic acids — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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