Balsalazide disodium - Generic Drug Details

What are the generic drug sources for balsalazide disodium and what is the scope of freedom to operate?

Balsalazide disodium is the generic ingredient in three branded drugs marketed by Apotex Inc, Dash Pharms Natco, Hikma, Zydus, Valeant Pharms Intl, and Strides Pharma, and is included in seven NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Balsalazide disodium has forty-five patent family members in twelve countries.

There are ten drug master file entries for balsalazide disodium. Ten suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for balsalazide disodium

International Patents:	45
US Patents:	6
Tradenames:	3
Applicants:	6
NDAs:	7
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	221
Clinical Trials:	7
Patent Applications:	6,049
Drug Prices:	Drug price trends for balsalazide disodium
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for balsalazide disodium
What excipients (inactive ingredients) are in balsalazide disodium?	balsalazide disodium excipients list
DailyMed Link:	balsalazide disodium at DailyMed

See drug prices for balsalazide disodium

Recent Clinical Trials for balsalazide disodium

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Valeant Pharmaceuticals International, Inc.	Phase 3
Bausch Health Americas, Inc.	Phase 3
Roxane Laboratories	N/A

See all balsalazide disodium clinical trials

Generic filers with tentative approvals for BALSALAZIDE DISODIUM

Applicant	Application No.	Strength	Dosage Form
		1.1GM	TABLET;ORAL
		1.1G	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for balsalazide disodium

Drug Class

Aminosalicylate

Paragraph IV (Patent) Challenges for BALSALAZIDE DISODIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
COLAZAL	Capsules	balsalazide disodium	750 mg	020610	1	2022-05-26
GIAZO	Tablets	balsalazide disodium	1.1 g	022205	1	2013-11-05

US Patents and Regulatory Information for balsalazide disodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Valeant Pharms Intl	COLAZAL	balsalazide disodium	CAPSULE;ORAL	020610-001	Jul 18, 2000	AB	RX	Yes	Yes					Y
Zydus	BALSALAZIDE DISODIUM	balsalazide disodium	CAPSULE;ORAL	217592-001	Jun 8, 2023	AB	RX	No	No
Valeant Pharms Intl	GIAZO	balsalazide disodium	TABLET;ORAL	022205-001	Feb 3, 2012		DISCN	Yes	No
Valeant Pharms Intl	COLAZAL	balsalazide disodium	CAPSULE;ORAL	020610-001	Jul 18, 2000	AB	RX	Yes	Yes					Y
Strides Pharma	BALSALAZIDE DISODIUM	balsalazide disodium	TABLET;ORAL	206336-001	Sep 8, 2015		DISCN	No	No

Expired US Patents for balsalazide disodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Pharms Intl	GIAZO	balsalazide disodium	TABLET;ORAL	022205-001	Feb 3, 2012
Valeant Pharms Intl	COLAZAL	balsalazide disodium	CAPSULE;ORAL	020610-001	Jul 18, 2000

International Patents for balsalazide disodium

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2096912	PRÉPARATIONS À BASE DE DÉRIVÉS D'ACIDE 2-HYDROXY-5-PHÉNYLAZOBENZOÏQUE ET LEURS APPLICATIONS (FORMULATIONS AND USES OF 2-HYDROXY-5-PHENYLAZOBENZOIC ACID DERIVATIVES)
China	105267226	Balsalazide formulations, production and application thereof
World Intellectual Property Organization (WIPO)	2011137103
South Korea	20140098863	FORMULATIONS AND USES OF 2-HYDROXY-5-PHENYLAZOBENZOIC ACID DERIVATIVES
Brazil	PI0615195	preparaÇço farmacÊutica, embalagem, uso de balsalazida, e, mÉtodo para fabricar uma cÁpsula e para testar dissoluÇço de cÁpsulas de balsalazida