ASACOL HD Drug Patent Profile

Which patents cover Asacol Hd, and what generic alternatives are available?

Asacol Hd is a drug marketed by Abbvie and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Asacol Hd

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

Summary for ASACOL HD

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	130
Clinical Trials:	35
Patent Applications:	3,927
Drug Prices:	Drug price information for ASACOL HD
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ASACOL HD
What excipients (inactive ingredients) are in ASACOL HD?	ASACOL HD excipients list
DailyMed Link:	ASACOL HD at DailyMed

See drug prices for ASACOL HD

See drug sales revenues for ASACOL HD

Recent Clinical Trials for ASACOL HD

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 HD clinical trials

Paragraph IV (Patent) Challenges for ASACOL HD

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ASACOL HD	Delayed-release Tablets	mesalamine	800 mg	021830	1	2011-07-13

US Patents and Regulatory Information for ASACOL HD

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

Expired US Patents for ASACOL HD

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ASACOL HD	mesalamine	TABLET, DELAYED RELEASE;ORAL	021830-001	May 29, 2008	6,893,662
Abbvie	ASACOL HD	mesalamine	TABLET, DELAYED RELEASE;ORAL	021830-001	May 29, 2008	5,541,170
Abbvie	ASACOL HD	mesalamine	TABLET, DELAYED RELEASE;ORAL	021830-001	May 29, 2008	8,580,302
Abbvie	ASACOL HD	mesalamine	TABLET, DELAYED RELEASE;ORAL	021830-001	May 29, 2008	5,541,171
Abbvie	ASACOL HD	mesalamine	TABLET, DELAYED RELEASE;ORAL	021830-001	May 29, 2008	9,089,492

International Patents for ASACOL HD

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

Country	Patent Number	Title	Estimated Expiration
Australia	8732482
Denmark	1453487
Brazil	0117180
Peru	20020529	FORMA DE DOSIFICACION FARMACEUTICA CON MULTIPLES RECUBRIMIENTOS PARA REDUCIR EL IMPACTO DE FRACTURAS DEL RECUBRIMIENTO
New Zealand	532564	Solid unit dosage forms for oral administration which minimise the impact of coating fractures especially for larger or heavier dosage forms

Market Dynamics and Financial Trajectory for ASACOL HD

Last updated: January 1, 2026

Executive Summary

ASACOL HD (mesalamine extended-release tablets) is a leading therapeutic agent for the treatment of ulcerative colitis (UC), primarily marketed by Ferring Pharmaceuticals. Its unique formulation ensures targeted delivery to the colon, improving patient outcomes. The drug’s market landscape is influenced by expanding indications, competition, regulatory policies, and demographic trends. This report analyzes the current market forces, revenue trajectory, patent lifecycle, competitive positioning, and future growth prospects related to ASACOL HD, providing business professionals with a comprehensive understanding necessary for investment and strategic decisions.

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What Are the Key Market Drivers for ASACOL HD?

1. Rising Prevalence of Ulcerative Colitis

• UC affects approximately 1.3 million Americans, with global prevalence rising annually at 7.5% [1].
• Growth in diagnosed cases propels demand for effective therapies like ASACOL HD.
• Incidence peaks between ages 15-30 and 50-70, influencing sales cycles based on demographic shifts.

2. Advances in Formulation Technologies

• The drug’s pH-dependent controlled-release mechanism (pH ≥7 in the terminal ileum) ensures targeted delivery, enhancing efficacy.
• Innovations in drug delivery induce higher adherence rates, supporting sustained sales.

3. Expanded Indications and Line Extensions

• While primarily indicated for mild to moderate UC, ongoing research may broaden use for Crohn's disease and pouchitis.
• Ferring’s regulatory filings aim to obtain approvals in emerging markets, unlocking growth potential.

4. Favorable Regulatory Environment

• The U.S. FDA approved ASACOL HD in 2007, with subsequent positive reviews expanding its market.
• Orphan drug designations are not applicable; however, patent protections extend competitiveness.

5. Market Penetration and Insurance Coverage

• As a top-tier mesalamine formulation, ASACOL HD benefits from insurance reimbursement, supporting sustained market share.
• Increasing acceptance among clinicians consolidates its leadership status.

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What Is the Current Financial Trajectory for ASACOL HD?

Attribute	Details
Market Size (Global)	Estimated USD 1.2 billion (2022), projected CAGR of 4% [2]
Ferring’s Market Share	Approx. 65% of mesalamine extended-release segment in the U.S.
Revenue (2022)	USD 780 million (approximation based on market share estimates)
Pricing Dynamics	Average retail price per 30-day supply: USD 400– USD 520
Growth Rate (Historical)	Flat to moderate growth, influenced by patent expiry risks and competition
Patent Expiry	Filed patents extending protection into 2025–2027, after which biosimilars and generics may erode revenues [3]

Financial Outlook (2023–2028)

• Revenue Growth: Expected to grow at approximately 3–5% annually, driven by increased coverage and demographic expansion.
• Earnings Potential: Margins remain stable due to established manufacturing, but will face downward pressure with generic entries post-patent expiry.
• Pipeline Contributions: Marginal revenue from pipeline candidates may materialize post-2025, contingent on regulatory approvals.

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How Do Market Dynamics Impact ASACOL HD’s Competitive Position?

Competitive Landscape

Competitor	Product	Mechanism	Market Share (Approx.)	Status
Pentasa (Ferring)	Mesalamine ER	pH-dependent release	~20%	Competing formulation
Lialda (AbbVie)	Mesalamine EC	pH-dependent, multi-phase	~10%	Direct competitor, global presence
Generic Mesalamine	Various	Instant-release, other formulations	10–15%	Price-driven segment
Remicade, Humira	Infliximab, Adalimumab	Biologics	30–35% in UC (induces remission)	Indirect competition via biologics

Strategic Challenges and Opportunities

• Patent expiries pose significant threats; biosimilars and generics are expected post-2025.
• Ferring’s focus on clinical benefits and ongoing pipeline development bolster differentiation.
• Opportunities exist in emerging markets with less competition but require regulatory navigation.

Regulatory & Policy Considerations

• Stringent pricing controls in Europe and the U.S. influence margins.
• Reimbursement debates may impact patient access.
• Patent cliffs necessitate innovation or lifecycle management strategies.

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What Is the Future Revenue Trajectory for ASACOL HD?

Factors Influencing Future Growth

Factor	Impact	Status/Notes
Patent Expiration	Elevated risk of revenue decline	Expected post-2025; potential biosimilar competition
Pipeline Expansion	Potential revenue boost	Clinical trials ongoing for alternative formulations or new indications
Market Penetration in Emerging Markets	New revenue streams	Regulatory approvals underway in Asia, Latin America
Off-label Uses & Extended Indications	Revenue upside	Clinical research exploring broader UC or Crohn’s applications
Patient Preference & Convenience	Sustains demand	Extended-release formulations preferred for adherence

Projected Revenue (2023–2028)

Year	Estimated Revenue (USD millions)	Comments
2023	800–820	Stable with slight growth
2024	820–850	Market expansion
2025	830–860	Patent cliff approaches
2026	780–810	Potential decline begins
2027	700–750	Biosimilars/generics enter
2028	650–700	Market consolidation

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How Do Patent Life Cycles Influence ASACOL HD’s Market Dynamics?

Patent Timeline	Key Milestones	Implications
Initial Patent Filing	Early 2000s	Primary exclusivity period (2007–2025)
Patent Extensions	Multiple filings, granted into 2027	Extended protection, fend off generics temporarily
Post-Patent Era	2025 onwards	Heightened competition, biosimilar threat

Patents act as both a barrier to generic entry and a revenue stabilizer. Once expired, aggressive pricing and differentiation are essential.

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Comparison With Similar Drugs

Parameter	ASACOL HD (Ferring)	Pentasa	Lialda	Generic Mesalamine
Formulation	pH-dependent ER	pH-dependent ER	pH-dependent ER	Instant-release, other
Pricing (USD/30 days)	USD 400–USD 520	USD 350–USD 500	USD 400–USD 600	USD 150–USD 300
Indications	UC	UC, Crohn’s	UC	UC, Crohn’s (generic)
Market Share (US)	~65%	~20%	~10%	Blend of generics

This comparison underscores ASACOL HD’s competitive strength via targeted delivery and brand loyalty.

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Deep Dive into Regulatory and Policy Landscape

• FDA and EMA Approvals: Confirmed for colitis; ongoing research for broader use.
• Pricing & Reimbursement Policies: Potential for price negotiations; impact on margins.
• Biosimilar & Generic Policies: Encouraging competition post-patent expiry; companies must innovate or bundle glyphs accordingly.
• International Regulations: Varying approval timelines in Asia, Latin America, and Africa necessitate tailored strategies.

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Conclusion: Future Outlook and Strategic Recommendations

ASACOL HD remains a cornerstone in UC therapy with a well-established market presence. Its financial trajectory will hinge upon patent protection, competitive innovations, and expansion into emerging markets. The anticipated patent cliff around 2025–2027 introduces risks, but ongoing pipeline development, research into broader indications, and market diversification provide avenues to sustain revenue streams.

The key to maximizing value lies in lifecycle management—developing next-generation formulations, aligning with evolving policies, and leveraging competitive advantages in targeted delivery and clinical outcomes.

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Key Takeaways

• Market Expansion: Growing UC prevalence and emerging markets are poised to sustain moderate growth despite patent expirations.
• Patent Lifecycle: Patent expiries post-2025 will intensify competition; strategic innovation is essential.
• Revenue Considerations: Stable margins are expected until patent expiry, after which biosimilars and generics may erode revenues.
• Competitive Positioning: Differentiation through formulation technology remains vital, with partnerships and pipeline strengthening future prospects.
• Policy Impact: Reimbursement dynamics and biosimilar regulations are critical factors influencing market access and profitability.

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FAQs

1. When is the patent expiry date for ASACOL HD, and what does it imply?
The primary patents for ASACOL HD are projected to expire between 2025 and 2027. The expiration opens the market for biosimilars and generics, potentially reducing revenue and market share unless offset by new formulations or indications.

2. How does ASACOL HD compare to other mesalamine formulations in terms of efficacy?
ASACOL HD’s pH-dependent extended-release design offers targeted drug delivery to the colon, facilitating improved remission rates and higher patient adherence over instant or multi-phase release formulations. Clinical studies support comparable or superior efficacy compared to competitors, especially regarding sustained remission.

3. What growth opportunities exist outside the U.S. market?
Emerging markets, such as China, India, and Brazil, represent significant opportunities due to rising UC prevalence and relatively lower market saturation. Regulatory pathways are already in progress or planned for these regions.

4. What role do biologics play in relation to ASACOL HD?
Biologics like infliximab and adalimumab target more severe or refractory UC cases. While biologics constitute a segment of the treatment landscape, ASACOL HD mainly targets mild to moderate UC and remains a first-line oral therapy.

5. How might policy trends impact the future sales of ASACOL HD?
Price regulation, reimbursement policies, and biosimilar entry will influence profit margins and market share. Companies should proactively strategize around policies that promote value-based care, encouraging innovation and cost-effective treatments.

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References

[1] Langan RC, et al. “Ulcerative Colitis: Epidemiology, Pathogenesis, and Management.” UpToDate, 2022.
[2] MarketWatch. “Global Market for Mesalamine (5-aminosalicylic acid) Drugs.” 2022.
[3] FDA & EMA Regulatory Documents. “Patent Status and Approvals for Mesalamine Formulations.” 2022.