LIALDA Drug Patent Profile

Which patents cover Lialda, 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-six 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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LIALDA

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

International Patents for LIALDA

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

Country	Patent Number	Title	Estimated Expiration
Spain	2262749
Canada	2377299	COMPOSITIONS PHARMACEUTIQUES ORALES A LIBERATION REGULEE A BASE DE MESALAZINE (MESALAZINE CONTROLLED RELEASE ORAL PHARMACEUTICAL COMPOSITIONS)
Portugal	1287822
Denmark	1287822

LIALDA Investment and Fundamentals Analysis

Last updated: February 3, 2026

Overview
LIALDA (brand name for mesalamine delayed-release tablets) treats ulcerative colitis. Manufactured by Shire Pharmaceuticals, now part of Takeda Pharmaceuticals since 2019, it holds a significant market share in its segment due to its targeted delivery mechanism. Its unique formulation offers potential benefits over older mesalamine products, leading to sustained demand.

Market Position and Sales Dynamics
LIALDA generates approximately $300 million annually in U.S. sales as of 2022. It ranks among leading therapies for mild to moderate ulcerative colitis, competing mainly with other mesalamine formulations and newer biologics. The drug's sales have shown stability with recent slight declines attributed to increased competition and generic entry of other mesalamine products.

Regulatory and Patent Status
The original patent protections for LIALDA expired in 2019, opening a pathway for generic competition. However, Takeda has pursued patent extensions and legal strategies to defend its market position until 2024. The potential entry of generics is projected to exert pricing pressures, originally anticipated to begin in late 2023, which can diminish revenue margins.

Clinical Fundamentals
LIALDA employs a pH-dependent delivery system that releases mesalamine in the distal ileum and colon. Clinical trials demonstrate efficacy similar to other mesalamine formulations but with improved tolerability due to targeted release. Its safety profile remains well-characterized, with no new safety signals reported.

Price and Reimbursement Environment
Pricing in the U.S. averages around $230 per month for branded LIALDA, with reimbursement largely through Medicare and private insurers. The entry of generics could lower prices by approximately 60–70%, reducing revenue per prescription significantly. Insurance coverage and formulary placements influence overall sales volume.

Investment Risks

• Patent cliff leading to generic entry in late 2023 or early 2024, risking revenue decline.
• Increased competition from biologic therapies and biosimilars for inflammatory bowel disease.
• Regulatory delays or unsuccessful patent litigation strategies impairing exclusivity.
• Potential formulation or delivery innovations affecting market share.

Growth Opportunities

• Expansion into international markets remains limited but offers future revenue streams.
• New formulations or combination therapies could extend product lifecycle.
• Clinical pipeline developments may salvage or extend patent protections.

Financial Outlook
Anticipated revenue reductions of up to 70% post-generic entry project in 2024. Cost-cutting strategies and pipeline diversification become crucial for maintaining profitability. The company's ability to defend market share through legal actions and patient support programs influences future sales stability.

Valuation Considerations
Investors should adjust valuation models for patent expiry risks and discount future cash flows accordingly. Price erosion assumptions generally range from 60–70% within 1–2 years post-generic entry. The potential for pipeline or line extension products can mitigate financial impact.

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Key Takeaways

• LIALDA holds a mature market share with stable revenue, largely affected by patent expiry approaching in 2024.
• Generic competition remains the primary risk factor, threatening significant revenue erosion.
• Clinical data affirm efficacy and safety but do not provide a competitive advantage over newer therapies.
• International expansion and formulation innovation offer future growth avenues, though at an early stage.
• Strategic legal defenses and pipeline investments are critical for maintaining valuation; their success remains uncertain.

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FAQs

1. When do patents for LIALDA expire?
The primary patent protections are expected to expire in 2024, opening the market to generics.

2. How much revenue could generics eliminate from LIALDA sales?
Post-generic entry, revenues could decline by 60–70% within two years, depending on generic market penetration and price competition.

3. Are there any biosimilar or biologic competitors?
No biosimilar exists for LIALDA, but biologic therapies for ulcerative colitis, such as infliximab and adalimumab, compete indirectly by treating the same disease.

4. What are the growth prospects for LIALDA?
International expansion and development of new formulations could provide growth opportunities, but these are not immediate and depend on regulatory and clinical success.

5. How does patent litigation influence the product’s outlook?
Takeda actively defends patent rights through litigation, which may delay generic entry. The success of such strategies influences revenue retention.

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References

[1] IQVIA, "Nasal and Gastrointestinal Therapeutic Market Data," 2022
[2] Takeda Annual Reports, 2022
[3] FDA Patent Data, 2023
[4] MarketResearch.com, "Ulcerative Colitis Drugs Market Overview," 2022
[5] ClinicalTrials.gov, "LIALDA Clinical Trial Data," 2022