COLAZAL Drug Patent Profile

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When do Colazal patents expire, and when can generic versions of Colazal launch?

Colazal is a drug marketed by Valeant Pharms Intl and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-six patent family members in twelve countries.

The generic ingredient in COLAZAL is balsalazide disodium. There are ten drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the balsalazide disodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Colazal

A generic version of COLAZAL was approved as balsalazide disodium by APOTEX INC on December 28^th, 2007.

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Summary for COLAZAL

International Patents:	36
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	221
Clinical Trials:	4
Patent Applications:	4,031
Drug Prices:	Drug price information for COLAZAL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for COLAZAL
What excipients (inactive ingredients) are in COLAZAL?	COLAZAL excipients list
DailyMed Link:	COLAZAL at DailyMed

Drug patent expirations by year for COLAZAL

Recent Clinical Trials for COLAZAL

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

Sponsor	Phase
Roxane Laboratories	N/A
Mylan Pharmaceuticals	Phase 1

See all COLAZAL clinical trials

Pharmacology for COLAZAL

Drug Class	Aminosalicylate

Paragraph IV (Patent) Challenges for COLAZAL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
COLAZAL	Capsules	balsalazide disodium	750 mg	020610	1	2022-05-26

US Patents and Regulatory Information for COLAZAL

COLAZAL is protected by two US patents.

Patents protecting COLAZAL

Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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Glossary

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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	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Valeant Pharms Intl	COLAZAL	balsalazide disodium	CAPSULE;ORAL	020610-001	Jul 18, 2000	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for COLAZAL

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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	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for COLAZAL

See the table below for patents covering COLAZAL around the world.

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Country	Patent Number	Title	Estimated Expiration
Japan	S5753449	2-HYDROXY-5-PHENYLAZOBENZOIC ACID DERIVATIVE, MANUFACTURE AND MEDICINAL COMPOSITION	⤷ Sign Up
Japan	2009506067		⤷ Sign Up
Israel	198513	הרכבים ושימושים בתולדות חומצה 2-הידרוקסי-5-פנילאזובנזואית (Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives)	⤷ Sign Up
New Zealand	565974	Balsalazide formulations and manufacture and use thereof	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration