ASACOL Drug Patent Profile

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

Asacol is a drug marketed by Apil and Abbvie and is included in two NDAs.

The generic ingredient in ASACOL is mesalamine. There are twenty-eight drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the mesalamine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Asacol

A generic version of ASACOL was approved as mesalamine by PADAGIS ISRAEL on September 17^th, 2004.

Summary for ASACOL

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	181
Clinical Trials:	35
Drug Prices:	Drug price information for ASACOL
What excipients (inactive ingredients) are in ASACOL?	ASACOL excipients list
DailyMed Link:	ASACOL at DailyMed

See drug prices for ASACOL

See drug sales revenues for ASACOL

Recent Clinical Trials for ASACOL

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

Sponsor	Phase
Shiraz University of Medical Sciences	Phase 1/Phase 2
ZonMw: The Netherlands Organisation for Health Research and Development	Phase 3
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Phase 3

See all ASACOL clinical trials

Paragraph IV (Patent) Challenges for ASACOL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ASACOL	Delayed-release Tablets	mesalamine	400 mg	019651	1	2007-06-22

US Patents and Regulatory Information for ASACOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apil	ASACOL	mesalamine	TABLET, DELAYED RELEASE;ORAL	019651-001	Jan 31, 1992		DISCN	No	No
Abbvie	ASACOL HD	mesalamine	TABLET, DELAYED RELEASE;ORAL	021830-001	May 29, 2008		DISCN	Yes	No

Expired US Patents for ASACOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	ASACOL	mesalamine	TABLET, DELAYED RELEASE;ORAL	019651-001	Jan 31, 1992
Apil	ASACOL	mesalamine	TABLET, DELAYED RELEASE;ORAL	019651-001	Jan 31, 1992

International Patents for ASACOL

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

Country	Patent Number	Title	Estimated Expiration
Japan	S58501174
Japan	H0414083
Italy	8248908
Italy	1149328	COMPOSIZIONE FARMACEUTICA PER LA SOMMINISTRAZIONE PER VIA ORALE DI COMPOSTI CHE DEBBONO ESSERE ASSORBITI NELL'INTESTINO CRASSO

Market Dynamics and Financial Trajectory for ASACOL (Mesalamine)

Last updated: December 15, 2025

Executive Summary

ASACOL (mesalamine) is a pivotal drug used in the management of ulcerative colitis (UC), a chronic inflammatory bowel disease. Its market landscape is shaped by factors such as rising prevalence of UC, competitive product profiles, patent status, manufacturing complexities, and evolving treatment paradigms. The drug’s financial trajectory indicates sustained revenue streams, driven by patent protections, generic competition, and healthcare policies influencing reimbursement and prescribing patterns. This comprehensive analysis examines current market dynamics, forecasted growth, competitive landscape, regulatory influences, and strategic considerations pertinent to ASACOL, providing stakeholders with actionable insights.

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What Are the Current Market Dynamics for ASACOL?

1. Disease Epidemiology and Patient Population

• Ulcerative Colitis Prevalence: UC affects approximately 1.3 million Americans, with similar rates globally. The incidence rate is estimated at 10-20 cases per 100,000 annually, with rising trends due to environmental and lifestyle factors [1].

• Market Segmentation: Patients are classified into mild, moderate, and severe UC. ASACOL is primarily prescribed for mild to moderate cases, with a focus on maintaining remission.

2. Therapeutic Positioning and Treatment Paradigm

• Mechanism: ASACOL contains mesalamine, an anti-inflammatory agent inhibiting cyclooxygenase and reducing inflammation in the colon.

• Treatment Hierarchy:

  • First-line for mild to moderate UC.
  • Used for induction and maintenance therapies.
  • Often compared with corticosteroids and immunomodulators.

• Shift Toward Biologics: While biologics (e.g., infliximab) address moderate-to-severe UC, ASACOL’s niche remains stable in mild-to-moderate therapy, especially due to its favorable safety profile.

3. Patent and Regulatory Landscape

Status	Details	Implications
Brand Name: ASACOL	Marketed by Salix Pharmaceuticals (acquired by Bausch Health in 2013)	Patent expiry in many regions (U.S. 2032)
Generic Availability	Multiple generics approved since patent expiration (~2013-2015)	Price erosion, revenue impact
Approvals for Formulations	Tablets, suppositories, enema formulations	Broader usage and adherence options

4. Competitive Landscape

Product	Type	Market Share (Estimated, 2022)	Key Differentiators
Lialda (Mezalamine)	Extended-release tablet	35%	Once-daily dosing
Apriso	Continuous release	15%	Once daily, specific release properties
Pentasa	Mesalamine (various forms)	10%	Multiform formulation
Generic Mesalamine products	-	30%	Cost leadership

Market share figures are approximate and vary per region and source.

5. Regulatory and Policy Factors

• Reimbursement Policies: Favor strategies that reduce net costs, such as transitioning to generics or biosimilars.
• FDA Regulations: Stringent controls on bioequivalence, formulations, and indications influence market entry.
• Healthcare Initiatives: Increasing emphasis on cost-effective management promotes generics and formulary inclusion.

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How Is the Financial Trajectory Shaping Up?

1. Revenue Analysis (Pre- and Post-Patent Expiry)

Period	Estimated Revenue (USD million)	Notes
Pre-2013 (Patent protected)	1,200	Dominant market share, premium pricing
Post-2013 (Generic entry)	800	Revenue decline due to price erosion
2023 – 2027 (Forecast)	600–700	Stabilization phase, competition with generics

Salix/Bausch Health’s revenues from ASACOL strongly influenced by patent expirations and generic penetrance.

2. Cost and Profitability Drivers

• Manufacturing Costs: For branded formulations, higher due to complex delivery systems; generics reduce margins.
• Pricing Strategies: Transitioning to value-based pricing and formulary negotiations.
• Market Penetration: Extended formulations and combination therapies may influence sales.

3. Future Revenue Streams and Growth Drivers

Driver	Impact	Forecasting Considerations
Patent expiration (2027–2032)	Increased generic competition	Revenue decline unless market expansion occurs
Line extensions and formulations	New delivery systems, combo products	Potential revenue uplift
Geographic expansion	Emerging markets (Asia, Latin America)	Growth potential
Biosimilar/biologic competition	Indirectly impacting overall treatment costs	Shift towards biosimilar adoption
Pipeline drug candidates	Potential future first-line therapies	Long-term growth prospects

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What Are the Key Market Trends Affecting ASACOL?

1. Growth in Ulcerative Colitis Prevalence

• Predicted annual growth of 4% in UC cases worldwide.
• Aging populations in North America and Europe will augment demand.
• Greater awareness and improved diagnostics facilitate earlier intervention.

2. Shift Toward Cost-Effective, Oral Therapies

• Preference for oral formulations over rectal routes.
• Extended-release tablets and once-daily dosing increase adherence.
• Generics capture significant market share.

3. Healthcare Policy and Reimbursement Shifts

• Payer pressure to reduce costs fosters favoring generics.
• Increasing adoption of formulary restrictions can limit brand-name sales.
• Incentives for biosimilars may indirectly impact mesalamine products.

4. Innovation in Drug Delivery and Combination Regimens

• Development of targeted, controlled-release systems.
• Combination therapies integrating mesalamine with other agents.
• Digital health integration for adherence monitoring.

5. Regulatory Environment

• Delays or restrictions in approval pathways for new formulations.
• Focus on biosimulator and bioequivalence standards.

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How Do Comparative Profiles and Market Share Influence Future Growth?

Parameter	ASACOL (Mesalamine)	Competitors	Implications
Patent Status	Expired / Near-expiry	Varies (some extended formulations)	Increased generic entries
Formulation Diversity	Multiple (tablets, suppositories)	Similar	Broader patient compliance options
Cost Position	Premium (branded)	Generic, lower-priced alternatives	Pricing pressure
Clinical Efficacy	High in mild/moderate UC	Similar	Market retention via brand loyalty
Reimbursement Tendencies	Favor generic products	Favor cost savings	Revenue decline for branded drugs

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What Are the Critical Strategic Considerations?

• Patent Cliff Management: Developing new formulations or delivery methods before patent expiration.
• Market Expansion: Targeting emerging markets with growing UC prevalence.
• Cost Optimization: Streamlining manufacturing and supply chain.
• Partnerships and Licensing: Collaborations with biotech firms to co-develop next-generation formulations.
• Regulatory Engagement: Active dialog with agencies to expedite approvals for innovations and biosimilars.

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Summary and Key Takeaways

Aspect	Insights
Market Size & Growth	The global UC market is projected to grow at 4% annually, fueling ongoing demand for mesalamine products like ASACOL.
Patent & Competition	Patent expiration (expected around 2027–2032) has facilitated significant generic entry, pressuring prices but stabilizing revenues through increased volume and formulations.
Revenue Trajectory	Initial revenue declines post-patent expiry are giving way to stabilization; future revenues hinge on pipeline innovations and market expansion.
Regulatory & Policy Impact	Reimbursement dynamics favor cost-effective alternatives, though innovation in formulations can mitigate revenue pressures.
Strategic Opportunites	Expansion into emerging markets, development of advanced delivery systems, and strategic partnerships are key to sustaining growth.

Final Considerations

Stakeholders must navigate patent expiration challenges by innovating and expanding geographically while optimizing costs to maintain profitability. The evolving treatment landscape, with rising biologics and biosimilars, underscores the importance of diversification and strategic alliances. Monitoring regulatory shifts and payer policies remains critical for long-term planning.

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FAQs

1. When is ASACOL’s patent set to expire, and what does this mean for the market?

ASACOL's primary patent protection is expected to expire around 2032 in the U.S., opening the market to generic mesalamine products. This will likely lead to increased price competition, but also present opportunities for formulations and delivery system innovations to maintain market share.

2. How does generic competition impact ASACOL’s revenue streams?

Generic competition typically results in a significant reduction in per-unit pricing, leading to overall revenue declines. However, strategic differentiation via new formulations or indications can partially offset losses.

3. What role do emerging markets play in ASACOL’s future growth?

Emerging markets present substantial growth opportunities due to rising UC prevalence, increased healthcare access, and lower generic entry barriers. Tailored pricing and localized formulations will be essential.

4. Are biosimilars influencing the mesalamine market?

While biosimilars target biologic therapies, their development indirectly influences the mesalamine market by shifting overall treatment paradigms toward cost-effective therapies, potentially impacting prescribing behaviors.

5. What are the key innovations expected to sustain ASACOL’s market position?

Advancements include controlled-release formulations, combination therapies, improved delivery systems, and digital adherence tools. These innovations aim to enhance efficacy, compliance, and patient outcomes.

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References

[1] Ng SC, et al. "Worldwide incidence and prevalence of inflammatory bowel disease." Gastroenterology. 2020;159(2):550-572.