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					Y
Valeant Pharms Intl	COLAZAL	balsalazide disodium	CAPSULE;ORAL	020610-001	Jul 18, 2000	AB	RX	Yes	Yes					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

International Patents for COLAZAL

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

Country	Patent Number	Title	Estimated Expiration
Japan	2012246322
Canada	2620091
New Zealand	565974	Balsalazide formulations and manufacture and use thereof
South Korea	20090118906	FORMULATIONS AND USES OF 2-HYDROXY-5-PHENYLAZOBENZOIC ACID DERIVATIVES
World Intellectual Property Organization (WIPO)	2007025146
Japan	2018145202

Market Dynamics and Financial Trajectory for COLAZAL

Last updated: January 13, 2026

Executive Summary

COLAZAL (balsalazide disodium) is an oral prodrug used primarily for the remission of ulcerative colitis in adult patients. Introduced in 1999 by Salix Pharmaceuticals, it has maintained a niche market segment focused on inflammatory bowel diseases (IBD). This analysis elucidates the market landscape, drivers, barriers, competitors, and financial outlook for COLAZAL. Despite its longstanding presence, the drug faces both considerations and challenges that influence its growth trajectory amid evolving therapeutic paradigms.

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What Are the Market Dynamics Influencing COLAZAL?

1. Therapeutic Indications and Patient Demographics

Parameter	Details
Primary Indication	Ulcerative colitis, especially for remission maintenance
Patient Demographics	Adults aged 18-65 with mild to moderate ulcerative colitis
Market Penetration	Limited to specialized gastroenterology clinics

2. Treatment Alternatives and Competitive Landscape

Competitors	Product Names	Mechanism	Market Share (est.)
Mesalamine Derivatives (5-ASA)	Rowasa, Asacol HD, Apriso	Local anti-inflammatory agents	50-60%
Corticosteroids	Prednisone, Budesonide	Systemic anti-inflammatory	20-30%
Biological Agents	Infliximab, Adalimumab	Immunomodulation	10-15%
Other 5-ASA formulations	Pentasa, Lialda	Mix of systemic and local	Remaining 5-10%

3. Pricing and Reimbursement Environment

Aspect	Details
Average Wholesale Price (AWP)	Approx. $1.20 - $2.00 per capsule (varies by region)
Insurance Reimbursement	Generally favorable; some restrictions for generic use
Out-of-Pocket Cost	Varies; typically $20-$50/month for insured patients

4. Regulatory and Patent Status

Status	Details
Patent Protection	Expired in the U.S. since ~2010
Generic Entry	Multiple generics available (e.g., generic balsalazide disodium)
FDA Approval	Original approval under NDA 21-085 (1999)

5. Market Drivers and Barriers

Drivers	Impact
Increasing prevalence of IBD	Global rise; approximately 6.8 million cases worldwide[1]
Focus on remission maintenance	High value in chronic disease management
Favorable safety profile	Well tolerated; fewer systemic side effects
Barriers	Patent expiry; generic competition; formulary preferences shifting towards biologics; side effect/trial limitations

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What Is the Financial Trajectory for COLAZAL?

1. Revenue Estimates and Trends

Year	Estimated Global Sales (USD millions)	Notes
2018	$25	Steady but plateauing growth
2020	$23	Slight decline; generic impact begins
2022	$20	Further decline; competitive market pressures
2025 (Forecast)	$15-$18	Continued erosion expected; possible stabilization

2. Factors Affecting Revenue

• Patent Expiry & Generics: Post-patent expiration (~2010) led to entry of generics, compelling prices downward.
• Market Shrinkage: Shift toward biologic agents (e.g., infliximab, vedolizumab) for moderate to severe disease alters prescribing trends.
• Reimbursement Policies: Variability impacts prescription volumes—favorability in developed markets cushions decline but does not halt it.
• Pipeline and Formulation Innovation: Limited pipeline; no notable new formulations or indications to reverse decline.

3. Cost Structure and Profitability

Cost Component	Approximate % of Revenue	Implication
Manufacturing & Distribution	10-15%	Marginally decreasing with generics
Marketing & Sales	20-25%	Concentrated on specialty clinics
R&D Expenses	Minimal (leading to no new indications)	Limited new investments
Gross Margin	~70% (pre-generic era), now ~50-60%	Declining margins due to price competition

4. Strategic Considerations

Strategy Shift	Rationale
Focus on niche markets	Patients intolerant to biologics or 5-ASA
Diversification	Partnering or development pipelines for IBD treatments
Cost Optimization	Reduce manufacturing and marketing overheads

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How Does COLAZAL Compare with Similar Drugs?

Parameter	COLAZAL	Pentasa	Lialda	Asacol HD
Mechanism	5-ASA prodrug (balsalazide)	5-ASA controlled-release	5-ASA in a delayed-release	5-ASA delayed-release
Indications	Ulcerative colitis remission	Mild to moderate UC	Mild to moderate UC	Mild to moderate UC
Patent Status	Expired (~2010)	Patent expired (~2018)	Patent expired (~2018)	Patent expired (~2012)
Market Share	Niche, declining	Broader due to dosing flexibility	Similar niche, declining	Similar, declining
Pricing	~$1.50/capsule (brand)	~$2.00/capsule	~$2.00/capsule	~$2.00/capsule
Formulation	Powder in capsules	Tableted, delayed-release	Tablet, delayed-release	Tablet, delayed-release

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What Are the Regulatory and Market Entry Barriers?

Barrier	Details
Patent Expiry	Opens market to generics, reducing pricing power
Regulatory Approvals	Well-established; no recent hurdles for approvals
Market Saturation	High competition from generics and biologics
Prescribing Behavior	Preference for newer agents in severe cases
Reimbursement Policies	Favor biologics for moderate/severe cases; generic preferences for mild disease

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Future Outlook and Investment Considerations

Outlook Aspect	Insights
Market Growth	Expected to decline modestly, primarily due to competition and patent expiration[2]
Personalized Medicine	Limited scope; potential for niche use but unlikely to reverse decline
Pipeline and Innovation	No substantial pipeline; potential for repositioned formulations or combination therapies
Potential Growth Areas	Narrow; perhaps in specific markets or in combination with other IBD treatments

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Key Takeaways

• Market Position: COLAZAL remains a niche player, primarily used for maintenance therapy in ulcerative colitis.
• Revenue Decline: Since patent expiry, sales have steadily declined due to generic competition and shifting treatment paradigms toward biologics.
• Competitive Landscape: Dominated by other 5-ASA formulations and biologic agents, with biologics increasingly capturing severe and refractory cases.
• Financial Outlook: Continued decline expected, with margins squeezed by price erosion and market saturation.
• Strategic Focus: To maintain relevance, stakeholders may pursue niche applications, formulation innovations, or combination therapies.

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FAQs

1. Why has COLAZAL's market share declined over the past decade?

Patent expiration in 2010 allowed multiple generics to enter, causing price competition and erosion of market share. Additionally, the increasing use of biologics for moderate to severe ulcerative colitis has shifted market demand away from 5-ASA drugs like COLAZAL.

2. Are there new formulations or indications for COLAZAL?

Currently, no significant new formulations or indications are under development or regulatory review for COLAZAL. The drug continues serving its original role with minimal innovation.

3. How do the costs of COLAZAL compare with other ulcerative colitis treatments?

Generic versions have reduced costs compared to brand-name formulations. Its price per capsule (~$1.50–$2.00) remains lower than biologics, which can cost upwards of $3,000–$6,000 per infusion or injection.

4. Will COLAZAL regain market share in the future?

Unlikely, unless it is repositioned with new formulations, biosimilars, or combination therapies. The trend favors biologics and newer agents, making a significant market comeback improbable.

5. What are the key factors that could influence COLAZAL's future value?

Emerging trends like personalized medicine, new combination regimens, or regulatory changes could impact its value. However, current factors predict a gradual decline in market relevance.

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References

[1] Ng, S.C., et al. (2017). "Worldwide incidence and prevalence of inflammatory bowel disease." Lancet Gastroenterol Hepatol. 2(1): 55–64.

[2] Salix Pharmaceuticals. (2010). "Annual Report." Market data and patent expiry timelines.

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Disclaimer: This article provides a strategic analysis based on current available data and market trends as of 2023. Changes in regulatory policies, clinical guidelines, or innovation pipelines may alter projections. Business decisions should incorporate detailed due diligence and consider regional market nuances.