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BALSALAZIDE DISODIUM | N022205 | VALEANT PHARMACEUTICALS INTERNATIONAL

1 strength4 unique patents0 unique exclusivities

Patent Timeline

4 unique patents by expiration date

Expiring < 1yr (3)Active (1)Today

2027

2028

2029

2030

2031

Today

Aug. 24, 2026

Aug. 24, 2026

Jun. 23, 2031

Aug. 2, 2026

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Salix Pharmaceuticals Ltd. et al v. Mylan Pharmaceuticals Inc. 1:2014cv00946 2 patentsANDA 206336balsalazide disodium	D. Del.	2014-07-17	Terminated 2015-08-12	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain3 active DMFs7 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

PHARMAZELL GMBHBALSALAZIDE DISODIUM

DMF 164252003

FORMOSA LABORATORIES INCBALSALAZIDE DISODIUM DIHYDRATE USP

DMF 173262004

SIGNA SA DE CVBALSALAZIDE DISODIUM DIHYDRATE USP

DMF 188942005

SA AJINOMOTO OMNICHEM NVInactiveBALSALAZIDE DISODIUM

DMF 122871996

COURTAULDS CHEMICALSInactiveBALSALAZIDE DISODIUM

DMF 122891996

SA AJINOMOTO OMNICHEM NVInactiveBALSALAZIDE DISODIUM

DMF 162562003

FARCHEMIA SRLInactiveBALSALAZIDE DISODIUM DIHYDRATE

DMF 175002004

IPCA LABORATORIES LTDInactiveBALSALAZIDE DISODIUM DIHYDRATE

DMF 177802004

CHIFENG ARKER PHARMACEUTICAL TECHNOLOGY CO LTDInactiveBALSALAZIDE DISODIUM DIHYDRATE

DMF 185732005

OLON SPAInactiveBALSALAZIDE DISODIUM SALT

DMF 196842006

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Nov 2, 2021	SUPPL -5	View Letter (PDF)
Oct 2, 2020	SUPPL -4	View Letter (PDF)
Jan 8, 2020	SUPPL -3	View Letter (PDF)
Dec 17, 2013	SUPPL -1	View Letter (PDF)
Feb 8, 2012	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

4 patents0 exclusivities▴

TABLET;ORAL | Approved: Feb 3, 2012

Patents (4)

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
7452872	Aug 24, 2026	—	—	—	—
7625884	Aug 24, 2026	—	—	—	—
8497256	Jun 23, 2031	—	—	—	—
9192616	Aug 2, 2026	—	—	—	—