Orange Book product · Brand (NDA)

TIVORBEX

INDOMETHACIN

Brand (NDA)NDA 204768DISCN GENUS

Feb 24, 2014

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Feb 24, 2014
12 yr 6 mo ago
Today
Patent 8734847 expires
Listed drug product patent expiration.
Apr 23, 2030
in 3 yr 11 mo
Patent 8992982 expires
Listed drug product patent expiration.
Apr 23, 2030
in 3 yr 11 mo
Patent 9089471 expires
Listed method-of-use patent (U-55) expiration.
Apr 23, 2030
in 3 yr 11 mo

Active ingredient

INDOMETHACIN

Strength

40MG

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 204768

Product number

002

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
8734847	Apr 23, 2030	in 3 yr 11 mo	Product
8992982	Apr 23, 2030	in 3 yr 11 mo	Product
9089471	Apr 23, 2030	in 3 yr 11 mo	U-55