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
Finland	85216
United Kingdom	2123695	ORALLY ADMINISTRABLE PHARMACEUTICAL COMPOSITIONS
Norway	830948

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ASACOL

Last updated: November 17, 2025

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Introduction

ASACOL, an oral sustained-release formulation of mesalamine (5-aminosalicylic acid), is primarily used in the management of ulcerative colitis (UC), a chronic inflammatory bowel disease. Since its initial approval, ASACOL has become a cornerstone therapy for UC, driven by its targeted anti-inflammatory action. Its market landscape is influenced by evolving pharmaceutical dynamics, regulatory pathways, competitive pressures, and emerging treatment paradigms. This analysis explores ASACOL’s current market environment, growth drivers, challenges, and future financial outlook.

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Market Overview

Therapeutic Importance and Indications

ASACOL is marketed mainly by Bausch Health Companies (previously Salix Pharmaceuticals, acquired by Bausch in 2015) under brand names such as Pentasa and Asacol HD. Its primary indication is for inducing and maintaining remission in UC. The product’s efficacy, safety profile, and ease of oral administration have established its reputation. Additionally, the expanding prevalence of UC globally—estimated at approximately 10-20 million cases worldwide [1]—propels the demand for effective therapies like ASACOL.

Market Size and Revenue Generation

The global inflammatory bowel disease (IBD) therapeutics market, including UC treatments, was valued at USD 4.4 billion in 2022 and is projected to grow at a CAGR of around 4.3% through 2030 [2]. ASACOL holds a significant share within this segment. In North America, the adoption rate remains high due to established healthcare infrastructure, with annual sales exceeding USD 1 billion prior to patent expirations in key markets.

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Market Dynamics Influencing ASACOL

Competitive Landscape

ASACOL faces competition from both brand-name drugs and generics. Biosimilar and small-molecule alternatives—such as balsalazide, olsalazine, and newer multi-mechanistic immunomodulators—are vying for market share. Notably, newer therapies, including biologics like infliximab, adalimumab, and emerging small molecules (e.g., JAK inhibitors), have shifted therapeutic paradigms, especially for moderate to severe UC cases. However, for mild to moderate UC, oral aminosalicylates like ASACOL remain preferred due to their safety and tolerability profile.

Patent Expirations and Generic Entry

The patent landscape has significantly impacted ASACOL’s financial trajectory. The original formulations of Asacol received patent protections lasting until the late 2010s, after which numerous generic versions entered the market, exerting price pressure. The sale of Bausch’s Salix segment, including ASACOL, in 2019 to Mithra Pharmaceuticals and other companies prompted strategic pivots, emphasizing cost-effective formulations and broader geographic expansion [3].

Regulatory and Pricing Policies

In response to mounting healthcare costs, regulatory bodies in North America and Europe have intensified scrutiny over drug pricing. Key policies aim to increase generic adoption post-patent expiry, affecting revenue streams. Moreover, the FDA’s approval of new formulations and delivery mechanisms continues to shape market competitiveness.

Emerging Therapies and Treatment Paradigm Shift

Biologics and small-molecule immunomodulators are increasingly used for moderate-to-severe UC, reducing reliance on traditional aminosalicylates like ASACOL. Nonetheless, ASACOL’s favorable safety in mild cases sustains its relevance, and combination therapy approaches further reinforce its market presence.

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Financial Trajectory

Historical Performance

Prior to patent expiry, ASACOL generated robust revenues—peaking at approximately USD 1.2 billion annually for Bausch’s Salix division. Post-patent, revenue declined sharply due to generic competition, with estimates suggesting a fall of 60-70%, bringing sales down to low hundreds of millions globally.

Post-Patent Strategies

Following the loss of exclusivity, manufacturers introduced multiple generic versions at competitive prices, which curbed profitability. To sustain revenue, companies pursued diversification through:

• Formulation innovations: Enhanced release profiles and combination therapies.
• Geographic expansion: Targeting emerging markets with less generic penetration.
• Remicade of pipeline drugs: Developing biosimilars and novel agents.

Forecasted Growth

Given the ongoing demand in UC management and the aging global population, the market for aminosalicylates like ASACOL is expected to stabilize. However, growth is primarily driven by:

• Market expansion into Asia-Pacific and Latin America where UC prevalence is rising.
• Introduction of new formulations, such as once-daily dosing, enhancing patient adherence.
• Strategic collaborations between innovator and generic manufacturers.

Analysts project ASACOL product revenues to stabilize between USD 300–500 million annually over the next 5-7 years, with potential upticks from new formulations or indications.

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Challenges and Opportunities

Challenges

• Intense Price Competition: Multiple generics dilute profit margins.
• Emergence of Biosimilars and Novel Therapeutics: Threaten traditional aminosalicylate dominance.
• Regulatory Changes: Price regulation policies could further pressure revenues.
• Patient Preference for Biologics: May limit growth in mild cases.

Opportunities

• Formulation Improvements: Extended-release, targeted delivery enhances efficacy and compliance.
• New Indications: Exploring off-label uses or additional UC-related conditions.
• Market Expansion: Focus on underserved markets with rising UC prevalence.
• Leverage Digital Health: Incorporate adherence monitoring tools, improving outcomes.

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Future Outlook

ASACOL's financial trajectory will likely mirror the broader trend observed in the aminosalicylate segment—initial revenue peak, subsequent decline due to patent expiry, followed by stabilization through market expansion and product innovation. Strategic focus on unmet needs, formulation enhancements, and geographic diversification will be critical for sustaining profitability.

The ongoing shift towards biologics and advanced small molecules poses a long-term challenge, yet the relatability and safety profile of ASACOL afford it continued relevance, especially in mild-to-moderate UC. Robust pipeline development and potential combination therapies could further bolster its market position.

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Key Takeaways

• Market Dynamics: The aminosalicylate segment faces intense generic competition, driven by patent expirations, but remains vital for UC management in mild cases.
• Financial Trajectory: Post-patent loss, revenues declined significantly but are projected to stabilize due to market expansion, formulation innovations, and geographic diversification.
• Competitive Pressures: Biologics and novel oral therapies are influencing treatment choices, necessitating strategic adaptation.
• Growth Opportunities: Formulation enhancements, entering emerging markets, and exploring new indications can sustain revenue streams.
• Strategic Focus: Investment in pipeline development, patient adherence technologies, and diversification will be key to preserving ASACOL’s market relevance.

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FAQs

1. How does patent expiration affect ASACOL’s market share?
Patent expirations allow generic manufacturers to produce equivalent formulations, significantly reducing prices and eroding brand-specific sales, often leading to a sharp decline in revenue and market share.

2. What are the main competitors to ASACOL in UC treatment?
Primary competitors include other aminosalicylates like balsalazide and olsalazine, biologics such as infliximab and adalimumab, and novel oral agents like tofacitinib, a JAK inhibitor.

3. Can ASACOL be used for other indications beyond ulcerative colitis?
Currently, ASACOL is primarily approved for UC. Off-label uses are limited and require further clinical validation.

4. What strategies can pharmaceutical companies use to sustain ASACOL’s profitability?
Companies can innovate with new formulations, expand into emerging markets, develop combination therapies, and explore additional indications.

5. What is the outlook for ASACOL in the next decade?
While facing competition, ASACOL’s long-standing safety profile ensures it remains relevant in mild UC cases, with growth opportunities in formulations and international markets shaping its future trajectory.

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References

[1] Molodecky, N. A., & Kaplan, G. G. (2010). The rising burden of inflammatory bowel disease in Europe and North America. Digestive Diseases, 28(4-5): 546–550.
[2] Grand View Research. (2022). Inflammatory Bowel Disease Market Size, Share & Trends Analysis Report.
[3] Bausch Health. (2019). Bausch sells Salix portfolio, including ASACOL, to Mithra Pharmaceuticals.

Note: Data and projections are based on industry reports and market analyses as of early 2023, subject to change with emerging developments.