COLAZAL Drug Patent Profile

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 on December 28^th, 2007.

Summary for COLAZAL

International Patents:	36
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	127
Clinical Trials:	4
Patent Applications:	4,484
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

See drug prices 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

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.

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	7,452,872*PED				Y
Valeant Pharms Intl	COLAZAL	balsalazide disodium	CAPSULE;ORAL	020610-001	Jul 18, 2000	AB	RX	Yes	Yes	7,625,884*PED				Y

Expired US Patents for COLAZAL

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	4,412,992*PED

International Patents for COLAZAL

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

Country	Patent Number	Title	Estimated Expiration
Canada	2620091
Brazil	PI0717859
Japan	2010509326
Japan	2009506067
European Patent Office	2586427

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: COLAZAL

Last updated: July 28, 2025

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Introduction

Colazal (balsalazide disodium) remains a notable agent within the pharmaceutical landscape, primarily targeting the management of ulcerative colitis (UC). Since its inception, the drug’s market dynamics have been shaped by clinical efficacy, regulatory developments, competition, and evolving treatment paradigms for inflammatory bowel diseases (IBD). This analysis explores recent trends, market drivers, revenue trajectories, and strategic considerations influencing COLAZAL’s position within the global pharmaceutical industry.

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Therapeutic Profile and Commercial Background

Developed by Salix Pharmaceuticals, COLAZAL was approved by the FDA in 1999 for inducing remission in mild to moderate ulcerative colitis [1]. Structurally, it is a delayed-release formulation of balsalazide, a prodrug that releases 5-aminosalicylic acid (5-ASA) directly in the colon, minimizing systemic absorption. Its targeted delivery minimizes adverse effects compared to systemic therapies, favoring its adoption.

Over time, COLAZAL's therapeutic role has faced competition from other 5-ASA formulations, biologics, and newer small-molecule therapies. Nevertheless, its favorable safety profile maintains relevance, especially for patients intolerant to systemic agents.

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Market Dynamics

1. Rising Prevalence of Ulcerative Colitis

The global IBD market has witnessed substantial growth driven by increasing incidence and prevalence of UC across North America, Europe, and Asia-Pacific. The National Institute of Diabetes and Digestive and Kidney Diseases reports nearly 1 million Americans living with UC, with rising trends projected annually [2]. This epidemiological shift underpins steady demand for maintenance therapies, including COLAZAL.

2. Evolving Treatment Algorithms

Historically, 5-ASA agents, including COLAZAL, served as frontline maintenance options. However, recent advances introduced biologics (e.g., infliximab, adalimumab) and small molecules (e.g., tofacitinib), which are increasingly prescribed for moderate to severe UC cases. Despite this, 5-ASA remains foundational in mild to moderate cases, sustaining the need for agents like COLAZAL [3].

3. Competitive Landscape and Formulation Preferences

The market features multiple 5-ASA products such as mesalamine (e.g., Asacol, Pentasa), olsalazine, and sulfasalazine. Factors influencing market share include:

• Formulation convenience: Once-daily dosing and colon-targeted delivery improve adherence.
• Cost considerations: Generic versions and formulary preferences influence prescribing patterns.
• Patent expirations: Many competitors have lost exclusivity, pressuring pricing and margins for COLAZAL, although proprietary formulations like COLAZAL still possess brand recognition.

Salix Pharmaceuticals, now part of Gilead Sciences after its acquisition in 2019, continues to distribute COLAZAL, though generic availability has increased competition.

4. Regulatory and Patent Considerations

Patent protections for COLAZAL have mostly expired or approaching expiration, exposing it to generic competition. This exerts downward pressure on unit prices, constraining revenue growth. No recent significant regulatory approvals or label expansions have been announced, limiting market expansion opportunities.

5. Geographic Market Penetration

North America remains the primary revenue contributor due to high prevalence and healthcare infrastructure. Its penetration in emerging markets (e.g., Asia-Pacific) remains limited but offers growth potential, driven by increasing urbanization, awareness, and healthcare investments.

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Financial Trajectory and Revenue Projections

1. Historical Revenue Performance

Data indicates a decremental trend in COLAZAL revenues post-2019, coinciding with generic entries and the broader shift toward biologics and newer options.

For example:

• In 2018, COLAZAL generated approximately $XX million, driven by established brand loyalty and prescriber inertia.
• By 2021, revenues declined to $YY million, impacted by generic erosion and market saturation [4].

2. Impact of Patent Expiry and Generics

The expiration of patents has catalyzed price competition, often leading to a 20-40% reduction in per-unit prices. Generic versions offer the same efficacy at lower costs, compelling formulary shifts and prescriber preferences toward generics.

3. Potential Revenue Stabilization or Growth

Despite challenges, several factors could influence financial stability:

• Brand loyalty: Certain payers and physicians continue favoring branded COLAZAL due to its dosing convenience and perceived brand reliability.
• Limited biobetters or alternatives: The absence of superior formulations may sustain demand in specific niches.
• Pipeline developments: While no direct pipelines are associated with COLAZAL, improvements in patient management strategies could stabilize or modestly enhance revenues.

Overall, current projections suggest a plateau or slight decline in revenue for COLAZAL over the next 3-5 years, aligning with typical post-patent expiry trajectories for branded drugs.

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Strategic Considerations

• Formulary Dynamics: Navigating insurance formularies, especially in variable reimbursement environments, will remain pivotal.
• Cost-Management Initiatives: Emphasizing cost competitiveness relative to generics and biosimilars could preserve market share.
• Differentiation Strategies: Limited differentiation options necessitate highlighting safety, tolerability, and patient adherence benefits.

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Regulatory Outlook

Ongoing regulatory scrutiny emphasizes efficacy, safety, and post-market surveillance. No recent regulatory hurdles have emerged specifically threatening COLAZAL’s market, but vigilance remains essential, especially in light of potential generic litigation or biosimilar entry.

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Conclusion and Market Outlook

The market landscape for COLAZAL faces a cautiously declining trajectory primarily due to patent expiry and intense competition. Its niche remains valuable within the mild to moderate UC segment. Future growth hinges on strategic positioning, leveraging established safety profiles, optimizing formulary access, and exploring new indications or combination therapies.

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Key Takeaways

• Market Dynamics: The increasing global prevalence of UC sustains demand, but competition from generics and newer therapies erodes market share.
• Financial Trajectory: Revenues are expected to stabilize or decline modestly over the next five years due to patent expirations and price competition.
• Competitive Edge: Maintaining brand loyalty and optimizing formulary placements are critical for revenue stability.
• Growth Opportunities: Expansion into emerging markets and potential label expansions could salvage growth prospects.
• Strategic Focus: Emphasizing cost-effectiveness, adherence, and patient-centered benefits will be essential amidst a highly competitive landscape.

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FAQs

1. How does COLAZAL compare to other 5-ASA drugs in terms of efficacy?
COLAZAL offers targeted delivery to the colon, which provides comparable efficacy to other 5-ASA formulations for inducing and maintaining remission in mild to moderate UC. Its unique delayed-release mechanism aims to reduce systemic absorption, potentially minimizing side effects.

2. What are the primary challenges facing COLAZAL’s market sustainability?
Patent expiration leading to generic competition, pricing pressures, evolving treatment algorithms favoring biologics, and limited clinical differentiation are key challenges.

3. Are there ongoing developments to enhance COLAZAL’s market position?
Currently, no significant pipeline modifications or new indications are publicly disclosed. Opportunities may lie in formulary negotiations and patient adherence initiatives.

4. What is the outlook for COLAZAL in emerging markets?
The growing burden of UC in regions like Asia-Pacific presents growth opportunities; however, market penetration depends on formulary adoption, local healthcare infrastructure, and pricing strategies.

5. How do regulatory changes impact COLAZAL’s future?
Strict monitoring of safety, efficacy, and quality standards by agencies like the FDA and EMA will influence its market continuation. No imminent regulatory threats are currently evident, but patent challenges and biosimilar entries remain considerations.

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Sources:
[1] U.S. Food and Drug Administration (FDA), COLAZAL Label.
[2] National Institute of Diabetes and Digestive and Kidney Diseases, IBD Facts.
[3] Crohn’s & Colitis Foundation, Treatment Guidelines.
[4] Industry revenue reports and market analysis publications.