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-eight 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	9,089,492
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	6,893,662
Abbvie	ASACOL HD	mesalamine	TABLET, DELAYED RELEASE;ORAL	021830-001	May 29, 2008	5,541,171

International Patents for ASACOL HD

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

Country	Patent Number	Title	Estimated Expiration
Germany	60133319
Finland	85216
Brazil	0117180
United Kingdom	2123695	ORALLY ADMINISTRABLE PHARMACEUTICAL COMPOSITIONS
Hungary	231030	Pharmaceutical dosage form with multiple coatings
Norway	830948
South Africa	8205384

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Asacol HD

Last updated: July 27, 2025

Introduction

Asacol HD (high-dose mesalamine) is a prescription medication primarily utilized in the management of ulcerative colitis (UC), a chronic inflammatory bowel disease affecting millions globally. Since its FDA approval, Asacol HD has established a significant presence within the therapeutic landscape for inflammatory bowel disease (IBD). This report delineates the market dynamics influencing Asacol HD's trajectory, evaluates its financial outlook, and contextualizes its position amid evolving treatment paradigms.

---

Pharmaceutical Overview

Asacol HD, marketed by Janssen Pharmaceuticals, contains mesalamine (5-aminosalicylic acid), a drug that exerts anti-inflammatory effects on the colonic mucosa. Unlike traditional formulations, Asacol HD employs pH-dependent delayed-release technology, ensuring targeted delivery to the distal ileum and colon. Its formulation offers enhanced tolerability and efficacy, making it a preferred choice for moderate to severe ulcerative colitis.

---

Market Dynamics Influencing Asacol HD

1. Therapeutic Demand and Patient Demographics

The rising prevalence of IBD — estimated at approximately 6.8 million cases globally with a significant rise in Western countries — boosts demand for mesalamine-based therapies like Asacol HD [1]. The chronic nature of UC necessitates long-term maintenance treatment, establishing a recurring revenue model.

Demographic shifts, including aging populations and increasing sedentary lifestyles, contribute further to UC incidence, underscoring sustained market need.

2. Competitive Landscape

The market for mesalamine formulations is saturated with various brands such as Pentasa, Lialda, and Apriso. Generic versions of mesalamine have entered many markets, exerting substantial price competition. For instance, Lialda (by AbbVie) and Apriso (by Takeda) are close competitors within the same segment, often influencing pricing strategies.

Furthermore, newer therapeutic agents, including biologics and Janus kinase inhibitors, are gaining prominence for moderate to severe cases, potentially diminishing reliance on first-line aminosalicylates like Asacol HD.

3. Regulatory Environment & Patent Life

Patent expirations for Asacol HD and its formulation innovations impact its market exclusivity. Patent cliffs, typically occurring 8-12 years post-launch, open avenues for generic entrants, pressuring prices and market share. Currently, Asacol HD's patent protection is approaching expiration in key markets, prompting Janssen to leverage orphan disease designations or combination strategies to sustain revenues.

Additionally, regulatory agencies' accelerated pathways for reformulations or new delivery systems could influence pricing and patent strategies.

4. Pricing and Reimbursement Dynamics

Healthcare cost containment efforts worldwide exert downward pressure on drug prices. Reimbursement policies, particularly in the U.S. where payers negotiate formularies, influence accessibility for Asacol HD. Patients with high-deductible plans or reliance on coverage from entities like Medicaid, Medicare, and private insurers face copay constraints, impacting overall market penetration.

Intensity of formulary placement, prior authorization requirements, and tier status further shape sales.

5. Impact of Biologics and Small Molecule Innovations

The expansion of biologics, such as infliximab, adalimumab, and newer oral small molecules like tofacitinib, impacts the UC treatment paradigm. While these agents are often reserved for refractory or severe cases, their rising efficacy and convenience could replace traditional mesalamine therapy in certain segments.

Nonetheless, Asacol HD maintains a niche in mild to moderate UC, especially for patients seeking less invasive long-term management options, preserving its market relevance.

---

Financial Trajectory

1. Revenue Trends and Market Share

Historically, Asacol HD has generated significant revenues within the IBD segment. However, recent years have seen slight declines attributable to patent expirations and increasing generic competition. In 2022, the drug's sales are estimated to be in the vicinity of several hundred million dollars globally, reflecting its steady demand in its core indications [2].

The introduction of generics has reportedly reduced the average sales price by 30-50%, correlating with a measurable decrease in net revenues for Janssen.

2. Future Revenue Projections

Analysts project a gradual decline in Asacol HD's market share following patent expiry, unless counterbalanced by strategic initiatives such as formulation line extensions, combination therapies, or geographical expansion.

Strategic engagement with emerging markets, where generic penetration is less aggressive, could sustain revenues. Additionally, efforts to innovate delivery mechanisms or develop combination formulations (e.g., with microbiome modulators) could bolster future growth.

3. Cost Structure and Margins

Research and development (R&D) expenses related to formulation improvements and phase trials influence profitability. Manufacturing costs are relatively stable given the established production processes but are impacted by raw material costs and regulatory compliance expenses.

Profit margins are expected to shrink modestly post-patent expiry, unless Janssen implements effective market strategies or premium positioning for reformulated or combination products.

4. Potential Market Expansion

Emerging markets present substantial growth opportunities. Increasing healthcare access and improved diagnostic rates drive demand in Asia-Pacific and Latin America. Negotiations for better reimbursement terms and local manufacturing could enhance profitability.

Moreover, the adoption of digital health solutions and patient adherence programs can facilitate better market penetration in these regions.

---

Strategic Outlook

The future of Asacol HD hinges on balancing patent management, competitive positioning, and innovation. Pivoting toward filling unmet needs—such as targeted delivery systems or combination therapies—may delay obsolescence. Furthermore, data demonstrating superior efficacy or safety profiles in real-world settings will influence prescriber preferences.

Janssen may also focus on expanding indications, possibly exploring Crohn’s disease or pouchitis, to diversify revenue streams.

---

Key Factors to Watch

• Patent status and generic entry timelines
• Emerging therapeutic modalities and market share shifts
• Pricing and reimbursement policy changes
• Global expansion and market-specific regulations
• Innovation pipeline for reformulations or combination products

---

Conclusion

Asacol HD's market dynamics reflect a complex interplay of demographic growth, competitive pressures, patent landscapes, and evolving therapeutic standards. While facing a decline due to patent expiration and generic competition, strategic initiatives—including geographic expansion and formulation innovation—may sustain its financial trajectory. Stakeholders must monitor regulatory developments and shifts in UC treatment algorithms to optimize positioning and market share.

---

Key Takeaways

• Market demand remains robust for UC management, supporting Asacol HD’s continued relevance.
• Patent expiries and generics pose significant revenue challenges; proactive strategies are essential.
• Emerging treatments, especially biologics and small molecules, are reshaping the UC therapeutics landscape, impacting Asacol HD’s market share.
• Global expansion, particularly in underserved markets, offers growth avenues.
• Innovation in drug delivery and combination products can enhance longevity in the competitive environment.

---

FAQs

Q1: How does patent expiration affect Asacol HD's market presence?
A1: Patent expiration permits generic manufacturers to produce lower-cost versions, increasing competition and reducing branded drug revenues.

Q2: Are there upcoming formulations or indications for Asacol HD?
A2: While ongoing research may explore new formulations or indications, current assets focus on UC maintenance. Future pipeline developments could alter this landscape.

Q3: How do biologics influence the demand for mesalamine therapies?
A3: Biologics target refractory or severe UC cases, potentially reducing reliance on first-line aminosalicylates like Asacol HD in advanced disease stages.

Q4: What strategies can Janssen employ to maintain Asacol HD’s competitiveness?
A4: Initiatives include geographic expansion, reformulation, patient adherence programs, and exploring combination therapies.

Q5: What is the outlook for Asacol HD in emerging markets?
A5: Growing healthcare infrastructure and disease awareness in emerging markets present promising opportunities, contingent on favorable pricing and reimbursement negotiations.

---

References

[1] Ng, S.C., et al. "Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: A systematic review." The Lancet 390.10114 (2017): 2769-2778.

[2] MarketWatch. "Asacol HD Sales Data and Market Analysis," 2022.