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BALSALAZIDE DISODIUM - Generic Drug Details

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What are the generic sources for balsalazide disodium and what is the scope of patent protection?

Balsalazide disodium is the generic ingredient in three branded drugs marketed by Apotex Inc, Hikma, Mylan, Valeant Pharms Intl, and Par Pharm Inc, and is included in six 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-seven patent family members in twelve countries.

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

Summary for BALSALAZIDE DISODIUM

International Patents:	47
US Patents:	6
Tradenames:	3
Applicants:	5
NDAs:	6
Drug Master File Entries:	10
Suppliers / Packagers:	7
Bulk Api Vendors:	157
Clinical Trials:	7
Patent Applications:	4,287
Drug Prices:	Drug price trends for BALSALAZIDE DISODIUM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BALSALAZIDE DISODIUM
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
Roxane Laboratories	N/A
Mylan Pharmaceuticals	Phase 1

See all BALSALAZIDE DISODIUM clinical trials

Recent Litigation for BALSALAZIDE DISODIUM

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Salix Pharmaceuticals, Inc. v. Apotex, Inc.	2015-09-30
Salix Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc.	2014-07-17

See all BALSALAZIDE DISODIUM litigation

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	NDA	Submissiondate
GIAZO	TABLET;ORAL	balsalazide disodium	022205	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	GIAZO	balsalazide disodium	TABLET;ORAL	022205-001	Feb 3, 2012		DISCN	Yes	No
Par Pharm Inc	BALSALAZIDE DISODIUM	balsalazide disodium	TABLET;ORAL	206336-001	Sep 8, 2015		DISCN	No	No
Valeant Pharms Intl	COLAZAL	balsalazide disodium	CAPSULE;ORAL	020610-001	Jul 18, 2000	AB	RX	Yes	Yes					Y
Hikma	BALSALAZIDE DISODIUM	balsalazide disodium	CAPSULE;ORAL	077806-001	Dec 28, 2007	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
Apotex Inc	BALSALAZIDE DISODIUM	balsalazide disodium	CAPSULE;ORAL	077883-001	Dec 28, 2007	AB	RX	No	No

Expired US Patents for BALSALAZIDE DISODIUM

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

International Patents for BALSALAZIDE DISODIUM

Country	Patent Number	Estimated Expiration
Israel	189104
Brazil	PI0717859
World Intellectual Property Organization (WIPO)	2008063211
Japan	6067203
Canada	3004028
Japan	2015108021
Brazil	PI0615195