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. Forty 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:	112
Clinical Trials:	13
Patent Applications:	4,185
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
Denmark	1198226
Canada	2377299	COMPOSITIONS PHARMACEUTIQUES ORALES A LIBERATION REGULEE A BASE DE MESALAZINE (MESALAZINE CONTROLLED RELEASE ORAL PHARMACEUTICAL COMPOSITIONS)
Spain	2194732
European Patent Office	1287822	Compositions pharmaceutiques orales à liberation régulée à base de mésalazine (Mesalazine controlled release oral pharmaceutical compositions)

LIALDA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for LIALDA (Mesalamine)

Introduction

LIALDA, a brand name for the drug mesalamine, is a locally acting 5-aminosalicylic acid (5-ASA) used primarily for the induction and maintenance of remission in adults with mild to moderate ulcerative colitis. Here, we delve into the market dynamics and financial trajectory of LIALDA, highlighting key factors influencing its market performance.

Market Size and Growth

The global mesalamine (LIALDA) market has been experiencing steady growth. As of 2021, the market size was valued at USD 156.5 million, and it is projected to reach USD 220.21 million by 2032, growing at a Compound Annual Growth Rate (CAGR) of 5.3% during this period[1].

Driving Factors

Several factors are driving the growth of the LIALDA market:

Increasing Incidence of Inflammatory Bowel Diseases (IBD)

The rising prevalence of ulcerative colitis and Crohn's disease is a significant driver. As healthcare awareness and diagnostic capabilities improve, more individuals are being identified with these conditions, leading to an increased demand for treatments like LIALDA[3].

Improved Diagnostic Methods

Advancements in diagnostic techniques have enhanced the ability to identify and treat IBD, contributing to the growing demand for 5-aminosalicylates like LIALDA[3].

Patient Awareness and Treatment Adherence

Increased patient awareness about medical treatments and better adherence to treatment regimens are also boosting the market[1].

Competitive Landscape

The LIALDA market is characterized by a mix of branded and generic competitors:

Branded Market

Shire, now part of Takeda, has been a major player in the market with LIALDA. However, the expiration of patents has opened the door for generic competition[2].

Generic Competition

The FDA approval of a generic version of LIALDA by Zydus Cadila marked a significant shift. Zydus enjoys a six-month exclusivity period, which may limit immediate competition from other generic manufacturers. The complexity of replicating LIALDA's formulation and the need for clinical trials may also deter other companies from entering the market quickly[2].

Financial Impact of Generic Competition

The introduction of generic competition is expected to impact Shire's revenues and earnings. Analysts predict a 2% to 3% hit on revenues and a 4% to 6% hit on earnings per share through fiscal 2020 due to this competition. However, the exclusive period for Zydus and the challenges in replicating LIALDA may mitigate the immediate financial impact[2].

Regional Market Performance

North America

North America dominates the market for 5-aminosalicylates, including LIALDA, due to advanced healthcare practices, high treatment rates, and the presence of numerous market players. The region's growth is fueled by innovative treatments and supportive government policies[3].

Other Regions

Other regions, such as Europe and Asia-Pacific, also contribute significantly to the market. The expanding patient base and increasing healthcare expenditure in these regions are key drivers of growth[3].

Challenges and Opportunities

High Unmet Clinical Need

Despite the growth, the 5-aminosalicylates market, including LIALDA, faces challenges such as high unmet clinical needs in ulcerative colitis. This presents an opportunity for pharmaceutical companies to innovate and diversify their product portfolios[3].

Impact of COVID-19

The COVID-19 pandemic disrupted global supply chains, affecting the production and distribution of pharmaceuticals. However, this also highlighted the resilience of the healthcare sector and the need for reliable treatments for chronic conditions like IBD[3].

Key Players

The LIALDA market includes several key players:

• Shire (Takeda): The original developer and marketer of LIALDA.
• Zydus Cadila: The first company to receive FDA approval for a generic version of LIALDA.
• Dr. Falk Pharma: A significant player in the 5-aminosalicylates market.
• Ferring: Another major company operating in this space.
• Ethypharm Pharmaceutical: Known for its contributions to the gastrointestinal drug market[1][3].

Future Trends

Advancements in Drug Formulations

The market is expected to be shaped by advancements in drug formulations, including delayed-release tablets and other innovative delivery systems[3].

Personalized Medicine and Combination Therapies

There is an increasing focus on personalized medicine and combination therapies, which could further enhance the market for LIALDA and similar drugs[3].

Adverse Reactions and Safety Profile

LIALDA has a well-documented safety profile, with common adverse reactions including headache, flatulence, and gastrointestinal disorders. Serious adverse reactions are less common but can include renal impairment and pancreatitis[4].

Conclusion

The LIALDA market is poised for continued growth driven by increasing incidence of IBD, improved diagnostic methods, and patient awareness. While generic competition presents a challenge, the complexity of the drug's formulation and the exclusive period for Zydus may limit immediate competition. The market's future will be shaped by innovations in drug formulations, personalized medicine, and combination therapies.

Key Takeaways

• The global mesalamine (LIALDA) market is projected to reach USD 220.21 million by 2032.
• The market is driven by the increasing incidence of IBD, improved diagnostic methods, and patient awareness.
• Generic competition, particularly from Zydus Cadila, is expected to impact Shire's revenues.
• North America dominates the market due to advanced healthcare practices and high treatment rates.
• The market faces challenges such as high unmet clinical needs and disruptions from the COVID-19 pandemic.

FAQs

What is the expected market size of LIALDA by 2032?

The global mesalamine (LIALDA) market is expected to touch USD 220.21 million by 2032[1].

What is the CAGR of the LIALDA market?

The LIALDA market is expected to exhibit a CAGR of 5.3% during the forecast period[1].

What are the primary drivers of the LIALDA market?

The primary drivers include the increasing incidence of IBD, improved diagnostic methods, and increased patient awareness regarding medical treatments[1].

Who are the key players in the LIALDA market?

Key players include Shire (Takeda), Zydus Cadila, Dr. Falk Pharma, Ferring, and Ethypharm Pharmaceutical[1][3].

What are the common adverse reactions associated with LIALDA?

Common adverse reactions include headache, flatulence, and gastrointestinal disorders. Serious reactions can include renal impairment and pancreatitis[4].

How has the COVID-19 pandemic impacted the LIALDA market?

The pandemic disrupted global supply chains and affected the production and distribution of pharmaceuticals, but it also highlighted the need for reliable treatments for chronic conditions like IBD[3].

Sources

1. Business Research Insights: Mesalamine (Lialda) Market Size, Share |Global Report 2032
2. FiercePharma: Shire's $800M Lialda confronted by generic but Zydus copy will fly solo for now
3. IndustryArc: 5-Aminosalicylates Drugs Market Share, Size and Industry Growth
4. FDA: LIALDA (Mesalamine) - accessdata.fda.gov
5. Market Research Intellect: Global Mesalamine Lialda Market Size And Forecast