LIALDA Drug Patent Profile

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

Lialda is a drug marketed by Takeda Pharms Usa and is included in one NDA.

The generic ingredient in LIALDA 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 Lialda

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

Summary for LIALDA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	13
Patent Applications:	4,400
Drug Prices:	Drug price information for LIALDA
Drug Sales Revenues:	Drug sales revenues for LIALDA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LIALDA
What excipients (inactive ingredients) are in LIALDA?	LIALDA excipients list
DailyMed Link:	LIALDA at DailyMed

See drug prices for LIALDA

See drug sales revenues for LIALDA

Recent Clinical Trials for LIALDA

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

Sponsor	Phase
NorthShore University HealthSystem	Phase 2
Food and Drug Administration (FDA)	N/A
University of Michigan	N/A

See all LIALDA clinical trials

Pharmacology for LIALDA

Drug Class

Aminosalicylate

Paragraph IV (Patent) Challenges for LIALDA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LIALDA	Delayed-release Tablets	mesalamine	1.2 g	022000	1	2009-12-16

US Patents and Regulatory Information for LIALDA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Usa	LIALDA	mesalamine	TABLET, DELAYED RELEASE;ORAL	022000-001	Jan 16, 2007	AB	RX	Yes	Yes

Expired US Patents for LIALDA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	LIALDA	mesalamine	TABLET, DELAYED RELEASE;ORAL	022000-001	Jan 16, 2007

International Patents for LIALDA

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

Country	Patent Number	Title	Estimated Expiration
Denmark	1287822
Hong Kong	1085669
China	1355694
Austria	235234
Italy	MI991316
European Patent Office	1287822	Compositions pharmaceutiques orales à liberation régulée à base de mésalazine (Mesalazine controlled release oral pharmaceutical compositions)
Hong Kong	1046247

Market Dynamics and Financial Trajectory for LIALDA

Last updated: November 20, 2025

Introduction

LIALDA (brand name for mesalamine), marketed by Alnylam Pharmaceuticals in certain regions, is a prescription drug primarily used for the treatment of ulcerative colitis — a chronic inflammatory bowel disease. Its market trajectory, influenced heavily by clinical efficacy, regulatory status, competitive landscape, and shifting healthcare priorities, exemplifies broader trends shaping chronic gastrointestinal therapies. As the pharmaceutical industry continues to evolve, understanding the nuanced dynamics affecting LIALDA offers critical insight into its current and future financial prospects.

Pharmacological Profile and Therapeutic Standing

LIALDA (mesalamine or 5-aminosalicylic acid) is a locally acting anti-inflammatory agent designed for targeted delivery within the colon through controlled-release formulations. The drug’s efficacy in inducing and maintaining remission of ulcerative colitis, supported by extensive clinical trials [1], positions it as a cornerstone in the inflammatory bowel disease (IBD) treatment arsenal.

Its formulation as a once-daily oral therapy enhances patient adherence, addressing one of the key challenges in chronic disease management. However, the market faces competition from other mesalamine formulations (e.g., Asacol, Pentasa) and biologic agents (e.g., infliximab, adalimumab) that serve similar or adjunctive roles [2].

Market Dynamics

Market Size and Growth Potential

The global IBD market is projected to witness robust growth, driven by increasing prevalence, rising awareness, and expanding diagnostic capabilities. The Global IBD therapeutics market alone is forecasted to reach approximately USD 16 billion by 2026, growing at a CAGR of 5-7% [3]. Mesalamine drugs like LIALDA capture a significant share within this landscape, primarily impacting ulcerative colitis management.

Factors such as escalating incidence in North America and Europe and developing nations’ rising healthcare expenditure bolster demand. Notably, the advent of biosimilar and generic alternatives could influence prices and market share, necessitating strategic positioning for LIALDA.

Regulatory Environment and Patent Indicators

LIALDA’s market exclusivity hinges on patent protections and regulatory approvals. While certain patents have provided market exclusivity, patent cliffs loom as generic versions of mesalamine products emerge, eliciting price competition [4].

Regulatory agencies also influence market dynamics through approval pathways for novel formulations and biosimilars, potentially expanding or constraining LIALDA’s market share. Ongoing patent litigations and exclusivity provisions must be closely monitored to forecast revenue streams accurately.

Competitive Landscape

LIALDA competes with multiple mesalamine formulations differing in delivery mechanisms, dosing, and pricing strategies. Generic versions of mesalamine have entered several markets, often at a substantially lower cost, exerting downward pressure on LIALDA's pricing and sales volumes.

Biologics, while used primarily for more severe cases, further fragment the treatment landscape. Non-pharmacological innovations and emerging therapies targeting different pathways suggest that LIALDA’s market share will be contended by multiple avenues, underscoring the importance of differentiation through formulation innovation or combination therapies.

Market Penetration and Adoption Barriers

Physician prescribing behavior, patient adherence, and healthcare reimbursement policies significantly impact market penetration. Although LIALDA’s once-daily dosing enhances compliance, high drug costs and insurance coverage hurdles can limit prescriptions. Additionally, practitioners may prefer switching to biosimilars or alternative therapies based on cost-benefit analyses, especially as healthcare reforms emphasize affordability.

Financial Trajectory

Revenue Projections

LIALDA’s revenue stream hinges on factors such as global demand, competitive pricing, and market exclusivity periods. Currently, it commands a significant share within the mesalamine segment, with estimated sales reaching upwards of USD 1 billion annually in leading markets [5].

However, revenue trajectories are sensitive to patent expiration timelines, the entry of generics, and regional market access regulations. As patents expire or face legal challenges, anticipated sales could decline unless offset by new formulations or indications.

R&D and Lifecycle Management

To sustain growth, incumbent companies typically invest in R&D to develop second-generation formulations, combination therapies, or novel delivery systems. For LIALDA, such innovations could mitigate generic competition or expand indications, thereby augmenting revenue.

The potential for approval of new formulations or adjunct therapies would reshape the drug's financial landscape, emphasizing the importance of pipeline development.

Pricing Trends and Reimbursement

Pricing strategies are critical to revenue. High-brand pricing, combined with barriers to generic substitution in certain regions, initially sustains profitability. Yet, increasing pressure for price reductions and reimbursement negotiations necessitate strategic alignment with payers and healthcare systems to preserve margins.

Key Market Trends Influencing LIALDA’s Financial Future

• Patent Expiry Milestones: Projected patent cliffs over the next 3-5 years could see a significant decline in LIALDA’s market share unless countered by new formulations or indications.

• Biosimilar and Generic Entry: Entry of cost-effective alternatives is likely to reduce drug prices and sales volumes, as seen with other mesalamine products.

• Emerging Therapies: The rise of biologic and small molecule agents targeting different inflammatory pathways could reduce reliance on traditional mesalamine treatments.

• Patient-Centered Approaches: Emphasis on personalized medicine and adherence programs may influence prescribing patterns and thereby impact sales.

Strategic Considerations

To sustain its economic viability, companies managing LIALDA should focus on:

• Extending Market Exclusivity: Through formulation patents or combination product strategies.

• Innovating Delivery Systems: Developing formulations with improved efficacy or convenience.

• Expanding Indications: Investigating additional inflammatory or gastrointestinal conditions.

• Engaging Healthcare Stakeholders: To optimize reimbursement and support formulary inclusion.

Conclusion

LIALDA occupies a pivotal position in ulcerative colitis therapy, buoyed by its efficacy, dosing convenience, and established market presence. Nonetheless, its future financial trajectory depends heavily on navigating patent expiries, competitive pressures from generics and biologics, and evolving healthcare policies that emphasize cost containment.

Strategic portfolio management, continuous innovation, and proactive regulatory engagement are paramount to sustaining its revenue streams amid a dynamic landscape. As the global IBD market expands, LIALDA’s ability to adapt will be decisive in maintaining its market share and financial health.

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Key Takeaways

• Market growth is driven by rising incidence of ulcerative colitis and healthcare expenditure, but faces headwinds from patent expiries and generic competition.
• Maintaining market share requires innovation in formulations and exploring new indications, as well as strategic patent protections.
• Pricing pressures and reimbursement policies significantly influence revenue, emphasizing the importance of stakeholder engagement.
• Monitoring regulatory developments and competitive moves, including biosimilar entries, is critical for revenue forecasting.
• Diversification into novel delivery systems and combination therapies can safeguard long-term market positioning.

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FAQs

1. What is the patent outlook for LIALDA, and how might it affect market share?
Patent protections for LIALDA's key formulations are nearing expiration, opening the door for generic competitors. This typically leads to price erosion and reduced market share unless offset by new formulations or indications.

2. How does competition from biologics impact LIALDA’s market?
Biologics target more severe or refractory ulcerative colitis cases, often replacing mesalamine in advanced disease. While biologics do not directly compete in the same niche, their increasing use can influence overall IBD treatment paradigms and patient management, potentially affecting LIALDA’s demand.

3. What emerging trends could improve LIALDA’s long-term prospects?
Innovations in drug delivery, such as targeted or sustained-release systems, and expanding indications to other inflammatory diseases could enhance longevity. Additionally, strategic patenting and lifecycle management support sustained market presence.

4. How do healthcare reimbursement policies influence LIALDA sales?
Reimbursement determines patient access and prescribing patterns. Favorable coverage encourages use, while restrictive policies or high out-of-pocket costs can restrict sales.

5. What role does patient adherence play in LIALDA’s market performance?
Once-daily dosing improves adherence, which directly influences clinical outcomes and ongoing demand. Conversely, affordability and coverage issues can hinder consistent medication use, impacting sales.

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Sources:

1. Clinical efficacy data from published phase III trials in ulcerative colitis treatments.
2. Competitive landscape evaluations from industry reports and market analyses.
3. Global IBD therapeutics market projections from Market Research Future (MRFR).
4. Patent expiry timelines and legal filings from patent databases and legal analyses.
5. Sales data estimates from IQVIA and industry reports focusing on mesalamine medications.