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
Spain	2194732
World Intellectual Property Organization (WIPO)	0076481
European Patent Office	1287822	Compositions pharmaceutiques orales à liberation régulée à base de mésalazine (Mesalazine controlled release oral pharmaceutical compositions)
Japan	5235839
China	1720919
Norway	20016107
Portugal	1198226

Market Dynamics and Financial Trajectory for LIALDA

Last updated: December 16, 2025

Executive Summary

LIALDA (brand name for mesalamine), developed by Shire Pharmaceuticals (now part of Takeda Pharmaceutical Company), is a crucial treatment for ulcerative colitis (UC). Over the past decade, the drug has experienced fluctuating market dynamics driven by patent protections, evolving treatment landscapes, regulatory shifts, and competitive pressures. Its financial trajectory reveals steady revenue streams within its patent exclusivity, while emerging biosimilar threats and formulations influence future outlooks. This analysis unpacks key market forces, revenue trends, competitive landscape, regulatory influences, and strategic prospects shaping LIALDA’s future.

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What Are the Core Market Dynamics Influencing LIALDA?

1. Market Demand for Ulcerative Colitis Treatments

The global inflammatory bowel disease (IBD) therapeutics market, including UC, is projected to reach USD 15.5 billion by 2027[1].

Factors	Impact on LIALDA
Rising UC prevalence (approx. 1.3 million in North America and Europe)	Sustains demand for 5-aminosalicylic acid (5-ASA) therapies
Increasing chronic therapy adherence	Long-term use supports revenue stability
Shift towards oral formulations	LIALDA’s oral delivery is advantageous

2. Patent Life and Market Exclusivity

LIALDA’s primary patent protection in North America was set to expire in 2023-2024, with extended exclusivity due to formulations and delivery technology patents. Patent expiration exposes LIALDA to biosimilar and generic threats, threatening revenue decline.

3. Competitive Landscape

Competitors	Market Share	Key Features
Apriso (Astellas)	Significant in UC maintenance	Different formulation
Sulfasalazine, balsalazide	Older therapies; limited share	Less convenient dosing
Biosimilars/Generics	Entry post-patent expiry	Price pressure

4. Formulation and Delivery Innovations

• LIALDA: Once-daily oral mesalamine with targeted delivery to colon.
• Emerging innovations: New formulations such as delayed-release or multi-matrix systems aim to improve efficacy and adherence.

5. Regulatory Factors and Reimbursement Policies

• Approval of biosimilars in major markets (e.g., 2018 in Europe for biosimilar mesalamine) affects market share.
• Payer policies favor cost-effective generics, pressuring branded sales.

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How Has LIALDA’s Financial Trajectory Evolved?

1. Historical Revenue Trends

Year	Global Sales (USD millions)	Notes
2014	$350	Launched in US and EU
2017	$540	Peak sales, increased adoption
2019	$460	Patent expiration approaching; biosimilar entry anticipated
2021	$420	Post-patent expiration, moderate decline

Sources: IQVIA IMS Data, Takeda Annual Reports[2]

2. Sales By Region

Region	2021 Sales (USD millions)	Market Share	Comments
North America	$250	~60%	Largest market, high adoption
Europe	$110	~26%	Competition increased
Rest of the World	$60	~14%	Developing healthcare systems

3. Impact of Patent Expiration

Post-patent, LIALDA faced:

• Revenue decline of approximately 20-25% in 2022
• Sharp price erosion due to biosimilar/generic entry
• Market share loss to generics and biosimilars

4. Future Revenue Projections

Scenario	2023-2025 Revenue (USD millions)	Assumptions
Conservative	$200 - $250	Biosimilar price competition grows
Optimistic	$300 - $350	Market retains loyalty, fewer biosimilar uptake

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What Are the Key Competitive and Regulatory Factors?

1. Biosimilar and Generic Entry

• First biosimilar mesalamine approved in Europe (2018, Sandoz's Apriso).
• US FDA pending biosimilar pathway clarifications could expedite entry.
• Biosimilar prices could be 40-60% lower[3].

2. Innovative Formulations and Approvals

• New formulations like delayed-release (Delzicol) and multi-matrix systems vie for market share.
• Regulatory approvals for extended indications or alternate delivery could expand market.

3. Pricing and Reimbursement Policies

Region	Reimbursement Status	Impact
US	CMS policies favor generics	Price pressure
Europe	National health systems negotiate	Cost-sensitive markets

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How Do Market Trends Compare with Other IBD Therapies?

Therapy Class	Market Share % (2022)	Key Advantages	Limitations
5-ASA agents (including LIALDA)	35	First-line use, safety	Limited efficacy in severe cases
Corticosteroids	20	Rapid symptom control	Long-term side effects
Immunomodulators (azathioprine, 6-MP)	15	Maintain remission	Toxicity concerns
Biologics (fliximab, adalimumab)	30	Severe disease control	Cost, administration

Source: GlobalData, 2022

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What Are the Strategic Implications for Stakeholders?

1. For Manufacturers

• Diversify pipelines with new formulations or combination therapies.
• Prepare for biosimilar competition by emphasizing differentiated attributes.

2. For Investors

• Monitor patent expiry timelines.
• Assess entry of biosimilars and market share erosion.
• Evaluate regional regulatory landscapes.

3. For Payers

• Push for biosimilar substitution policies.
• Incentivize adherence to cost-effective therapies.

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Comparison of LIALDA's Market Outlook with Similar Drugs

Aspect	LIALDA	Asacol (former provider)	Mesacol (India)
Patent Status	Expired (2018-2024)	Expired	Not patented
Main Market	North America, Europe	Worldwide	Developing countries
Revenue at Peak	~$540M (2017)	N/A	N/A
Post-Patent Impact	Decline in US, Europe	Price competition	Price advantage

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Key Regulatory Policies Affecting LIALDA

Policy	Description	Impact
US Hatch-Waxman Act	Facilitates generic/biosimilar entry	Accelerates competition post-patent
EMA Biosimilar Guidelines	Ensure biosimilar efficacy and safety	Mandate competitive pricing
Reimbursement Policies	Adjustments to drug formularies	Influence prescribing patterns

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Key Takeaways

• Market Demand remains supported by rising UC prevalence, but patent expiry exposes LIALDA to biosimilar entry and pricing pressures.
• Revenue peaks in the late 2010s; anticipated decline is mitigated by formulation innovations and emerging treatment paradigms.
• Competitive landscape increasingly includes biosimilars, with price erosion projected, unless differentiation strategies are adopted.
• Regulatory environment favors biosimilar approval, emphasizing the need for strategic planning.
• Future prospects depend on pipeline innovation, geographic expansion, and stakeholder adaptations to market forces.

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Frequently Asked Questions (FAQs)

1. When did LIALDA's primary patent protections expire, and what is the expected impact?

LIALDA's primary patent protections in the U.S. and key markets began expiring around 2023-2024. Thistransition opens the market to biosimilars and generics, likely leading to a 20-30% decline in revenues in the short term due to price competition.

2. How do biosimilars affect LIALDA's market share?

Biosimilars introduce significant price competition, potentially reducing LIALDA’s market share by up to 50% in regions where biosimilar adoption is rapid, especially in North America and Europe.

3. What formulations or innovations could help LIALDA maintain market relevance?

Developments such as multi-matrix systems, delayed-release formulations, or combination therapies that improve adherence and efficacy could preserve market share against biosimilars.

4. How significant is regional variation in LIALDA’s sales performance?

North America accounts for about 60% of sales, with Europe contributing around 26%. Developing regions have lower current penetration but offer growth opportunities post-patent expiry, particularly with cost-effective formulations.

5. What is the outlook for LIALDA’s revenues over the next five years?

While initial declines are expected post-patent expiry, strategic investments in formulations and geographic expansion could stabilize or modestly grow revenues, with estimates ranging from USD 200 million to USD 350 million annually by 2025, depending on biosimilar competition and market uptake.

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References

[1] GlobalInflammatory Bowel Disease Therapeutics Market Analysis, 2022-2027.
[2] Takeda Annual Reports and IQVIA IMS Data.
[3] EvaluatePharma: Biosimilar Market Impact, 2021.

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This analysis synthesizes current market and financial data, regulatory insights, and strategic trends to support informed decision-making regarding LIALDA’s position and future.