Orange Book product · Brand (NDA)

EPANOVA

OMEGA-3-CARBOXYLIC ACIDS

Brand (NDA)NDA 205060DISCN ASTRAZENECA

May 05, 2014

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
May 05, 2014
12 yr 4 mo ago
Today
Patent 7960370 expires
Listed drug product patent expiration.
Dec 20, 2026
in 6 mo
Patent 10117844 expires
Listed method-of-use patent (U-2447) expiration.
Jan 04, 2033
in 6 yr 8 mo
Patent 9050308 expires
Listed method-of-use patent (U-1511) expiration.
Jan 04, 2033
in 6 yr 8 mo
Patent 9050309 expires
Listed drug substance patent expiration.
Jan 04, 2033
in 6 yr 8 mo

Active ingredient

OMEGA-3-CARBOXYLIC ACIDS

Strength

1GM CONTAINS AT LEAST 850MG OF POLYUNSATURATED FATTY ACIDS

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 205060

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

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 6 mo	Product
10117844	Jan 04, 2033	in 6 yr 8 mo	U-2447
9050308	Jan 04, 2033	in 6 yr 8 mo	U-1511
9050309	Jan 04, 2033	in 6 yr 8 mo	Substance