Mesalamine - Generic Drug Details

What are the generic drug sources for mesalamine and what is the scope of freedom to operate?

Mesalamine is the generic ingredient in ten branded drugs marketed by Abbvie, Teva Pharms Usa, Salix, Alembic, Alkem Labs Ltd, Amta, Aurobindo Pharma Ltd, Mylan, Novast Labs, Sun Pharm, Zydus Pharms, Takeda Pharms Usa, Encube, G And W Labs Inc, Padagis Israel, Mylan Speciality Lp, Actavis Mid Atlantic, Amneal, Amring Pharms, Annora Pharma, Rising, Sandoz, Meda Pharms, Apil, Actavis Labs Fl, Sinotherapeutics Inc, and Teva Pharms Inc, and is included in thirty-eight NDAs. There are four patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Mesalamine has thirty-six patent family members in eighteen countries.

There are twenty-eight drug master file entries for mesalamine. Forty suppliers are listed for this compound.

Summary for mesalamine

International Patents:	36
US Patents:	4
Tradenames:	10
Applicants:	27
NDAs:	38
Drug Master File Entries:	28
Finished Product Suppliers / Packagers:	40
Raw Ingredient (Bulk) Api Vendors:	181
Clinical Trials:	94
Patent Applications:	6,416
Drug Prices:	Drug price trends for mesalamine
Drug Sales Revenues:	Drug sales revenues for mesalamine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for mesalamine
What excipients (inactive ingredients) are in mesalamine?	mesalamine excipients list
DailyMed Link:	mesalamine at DailyMed

See drug prices for mesalamine

See drug sales revenues for mesalamine

Recent Clinical Trials for mesalamine

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

Sponsor	Phase
Tanta University	N/A
AHS Cancer Control Alberta	Phase 2
Manal Ali Mahrous Hamouda Faculty of Pharmacy, Menufia University	Phase 2

See all mesalamine clinical trials

Pharmacology for mesalamine

Drug Class

Aminosalicylate

Medical Subject Heading (MeSH) Categories for mesalamine

Anti-Inflammatory Agents, Non-Steroidal

Paragraph IV (Patent) Challenges for MESALAMINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DELZICOL	Delayed-release Capsules	mesalamine	400 mg	204412	1	2014-06-17
CANASA	Suppository	mesalamine	1000 mg	021252	1	2013-05-24
APRISO	Extended-release Capsules	mesalamine	0.375 g	022301	1	2012-04-03
ASACOL HD	Delayed-release Tablets	mesalamine	800 mg	021830	1	2011-07-13
LIALDA	Delayed-release Tablets	mesalamine	1.2 g	022000	1	2009-12-16
ASACOL	Delayed-release Tablets	mesalamine	400 mg	019651	1	2007-06-22

US Patents and Regulatory Information for mesalamine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Encube	MESALAMINE	mesalamine	ENEMA;RECTAL	216941-001	May 30, 2023	AB	RX	No	No
Takeda Pharms Usa	PENTASA	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	020049-002	Jul 8, 2004	AB	RX	Yes	Yes
Alembic	MESALAMINE	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	216967-001	Oct 28, 2022	AB	RX	No	No

Expired US Patents for mesalamine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	PENTASA	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	020049-001	May 10, 1993
Abbvie	ASACOL HD	mesalamine	TABLET, DELAYED RELEASE;ORAL	021830-001	May 29, 2008
Apil	ASACOL	mesalamine	TABLET, DELAYED RELEASE;ORAL	019651-001	Jan 31, 1992

International Patents for mesalamine

Country	Patent Number	Title	Estimated Expiration
Canada	2784772	SUPPOSITOIRE DE MESALAMINE (MESALAMINE SUPPOSITORY)
Canada	2690450	SUPPOSITOIRE A BASE DE MESALAMINE (MESALAMINE SUPPOSITORY)
Mexico	2012006902	SUPOSITORIO DE MESALAMINA. (MESALAMINE SUPPOSITORY.)

Mesalamine Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Mesalamine

Introduction to Mesalamine

Mesalamine, an aminosalicylate, is a crucial medication in the treatment of inflammatory bowel diseases (IBD), particularly ulcerative colitis and, to a lesser extent, Crohn's disease. It is available in various forms, including delayed-release oral tablets, extended-release oral capsules, rectal enemas, and rectal suppositories[2].

Market Drivers

The mesalamine market is driven by several key factors:

Increasing Prevalence of IBD

The rising incidence of IBD worldwide is a significant driver. In the United States alone, IBD affects an estimated 3 million adults, according to the Crohn's & Colitis Foundation. This increasing prevalence, especially in developed countries, has led to a growing demand for effective treatment options like mesalamine[1].

Advancements in Drug Delivery Systems

The development of novel drug delivery systems, such as extended-release and multi-matrix formulations (e.g., MMX mesalamine), has improved patient compliance and treatment outcomes. These formulations allow for once-daily dosing, which enhances adherence and reduces the pill burden, leading to better disease control and quality of life[5].

Growing Awareness and Healthcare Expenditure

Increasing awareness about IBD and available treatments, coupled with rising healthcare expenditure in regions like Asia-Pacific, is driving the market. Countries such as China, India, and Japan are experiencing rapid growth due to these factors[1].

Market Size and Growth

Current Market Size

The global mesalamine market was robust in 2021 and is expected to continue growing. By 2030, the market size is forecast to reach approximately $212.6 million, with a compound annual growth rate (CAGR) of around 3.8% to 5-6% during the forecast period[1][3].

Regional Variations

• North America: Currently the largest market for mesalamine, driven by the high prevalence of IBD, well-established healthcare infrastructure, and favorable reimbursement policies[1][4].
• Asia-Pacific: Expected to witness the highest growth rate due to increasing IBD incidence, rising healthcare expenditure, and growing awareness about the disease and treatments in countries like China, India, and Japan[1].

Competitive Landscape

The mesalamine market is highly competitive, with several global and regional players. Key strategies include:

Research and Development

Leading pharmaceutical companies are focusing on R&D to develop novel mesalamine formulations with improved efficacy, safety, and patient convenience. Clinical trials are also being conducted to expand the indications and patient populations for mesalamine use[1].

Product Differentiation

The market is characterized by intense competition and product differentiation strategies. Companies are investing in advanced technologies such as nanoparticle-based drug delivery and mucoadhesive polymers to enhance localized delivery of mesalamine to inflamed gut tissues[1].

Forms and Strengths of Mesalamine

Mesalamine is available in various forms, each with different strengths:

• Delayed-Release Oral Tablets: 800 mg, 1200 mg
• Delayed-Release Oral Capsules: 400 mg
• Extended-Release Oral Capsules: 250 mg, 375 mg, 500 mg
• Rectal Enema: 4 g per 60 mL
• Rectal Suppository: 1000 mg[2].

Cost and Financial Considerations

Cost Variability

The cost of mesalamine varies based on the form and strength prescribed, treatment plan, insurance coverage, and the pharmacy used. Generic versions of mesalamine are generally less expensive than brand-name versions but are considered equally safe and effective[2].

Insurance and Financial Assistance

Insurance coverage significantly impacts the cost of mesalamine. Patients can benefit from talking to their doctors, pharmacists, or insurance providers to understand the costs and available financial assistance programs[2].

Future Outlook

Continued Growth

The future outlook for the mesalamine market is promising, driven by the increasing prevalence of IBD, growing awareness about available treatments, and the development of advanced drug delivery systems. Oral mesalamine formulations, particularly extended-release and targeted delivery systems, are expected to maintain their dominance[1].

Technological Advancements

The use of advanced technologies such as nanoparticle-based drug delivery and mucoadhesive polymers will continue to enhance the localized delivery of mesalamine, improving treatment outcomes and patient compliance[1].

Clinical Efficacy

Studies have shown that mesalamine, especially in once-daily formulations like MMX mesalamine, is effective in inducing and maintaining clinical remission in patients with mild-to-moderate ulcerative colitis. This efficacy, combined with a favorable safety profile, will continue to drive market growth[5].

Key Takeaways

• The mesalamine market is driven by the increasing prevalence of IBD and advancements in drug delivery systems.
• North America is the largest market, but the Asia-Pacific region is expected to witness the highest growth rate.
• The market is highly competitive, with a focus on R&D and product differentiation.
• Mesalamine is available in various forms and strengths, with costs varying based on form, strength, and insurance coverage.
• The future outlook is promising, with continued growth expected due to technological advancements and clinical efficacy.

FAQs

Q: What is the primary use of mesalamine?

A: Mesalamine is primarily used to treat ulcerative colitis, a type of inflammatory bowel disease (IBD).

Q: What are the different forms of mesalamine available?

A: Mesalamine is available in delayed-release oral tablets, extended-release oral capsules, rectal enemas, and rectal suppositories.

Q: Why is the Asia-Pacific region expected to see high growth in the mesalamine market?

A: The Asia-Pacific region is expected to witness high growth due to the increasing incidence of IBD, rising healthcare expenditure, and growing awareness about the disease and available treatments in countries like China, India, and Japan.

Q: How does the cost of mesalamine vary?

A: The cost of mesalamine varies based on the form and strength prescribed, treatment plan, insurance coverage, and the pharmacy used.

Q: What are the benefits of once-daily mesalamine formulations like MMX mesalamine?

A: Once-daily formulations like MMX mesalamine improve patient adherence by reducing the pill burden and frequency of dosing, leading to better disease control and quality of life.

Sources

1. DataHorizon Research: Mesalamine Market Size, Share & Forecast 2033.
2. Medical News Today: Mesalamine cost 2024: Coupons and more.
3. Taiwan News: Mesalamine Market Trends 2025 Industry Size, Segments, Share.
4. Reports and Data: Mesalamine Market Size, Growth, and Industry Development by 2030.
5. Science.gov: Once-daily MMX mesalamine: Topics by Science.gov.