BALSALAZIDE DISODIUM
FDA Orange Book ingredient view

What this means

BALSALAZIDE DISODIUM is the active ingredient in COLAZAL / GIAZO (marketed by VALEANT PHARMACEUTICALS INTERNATIONAL). Available as capsule;oral, tablet;oral. First approved 2000 — 25 years on market. Currently protected by 6 patents. The earliest market opportunity is 2026-08-01 — only 50 days away. Urgent. 6 ANDAs already filed — competitive space. Bottom line: near-term opportunity worth evaluating against your portfolio.

NDA products2
ANDA generics filed6
Blocking patents6
Exclusivities0
Blocking patents
6 patents associated
PatentTypeExpiryVerdict
US 9192616US 9192616U-12292026-08-01
Test patent linked to FDA Orange Book — US 7625884US 7625884U-12292026-08-23Medium 65
US 7452872US 7452872U-12292026-08-23
US 7452872*PEDUS 7452872*PED2027-02-23
US 7625884*PEDUS 7625884*PED2027-02-23
US 8497256US 8497256U-12292031-06-22
NDA products
2 approved
COLAZALNDA 020610

750MG · CAPSULE;ORAL · approved 2000-07-17 · VALEANT PHARMACEUTICALS INTERNATIONAL

GIAZONDA 022205

1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET;ORAL · approved 2012-02-02 · VALEANT PHARMACEUTICALS INTERNATIONAL

ANDA generics
6 filed
APOTEX INCANDA 077883

750MG · approved 2007-12-27

750MG · approved 2025-04-02

750MG · approved 2007-12-27

750MG · approved 2007-12-27

750MG · approved 2023-06-07

1.1GM · approved 2015-09-07