Orange Book product · Brand (NDA)

DUEXIS

FAMOTIDINE; IBUPROFEN

Brand (NDA)NDA 022519DISCN HORIZON

Apr 23, 2011

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Apr 23, 2011
15 yr 5 mo ago
Today
Patent 8067451 expires
Listed drug product patent expiration.
Jul 18, 2026
in 29 d
Patent 8309127 expires
Listed drug product patent expiration.
Jul 18, 2026
in 29 d
Patent 8318202 expires
Listed drug product patent expiration.
Jul 18, 2026
in 29 d
Patent 8449910 expires
Listed drug product patent expiration.
Jul 18, 2026
in 29 d
Patent 8501228 expires
Listed method-of-use patent (U-1196) expiration.
Jul 18, 2026
in 29 d

Active ingredient

FAMOTIDINE; IBUPROFEN

Strength

26.6MG;800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 022519

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
8067451	Jul 18, 2026	in 29 d	ProductU-1196
8309127	Jul 18, 2026	in 29 d	Product
8318202	Jul 18, 2026	in 29 d	Product
8449910	Jul 18, 2026	in 29 d	Product
8501228	Jul 18, 2026	in 29 d	U-1196