MESALAMINE - Generic Drug Details

What are the generic sources for mesalamine and what is the scope of patent protection?

Mesalamine is the generic ingredient in ten branded drugs marketed by Abbvie, Teva Pharms Usa, Salix, Alembic, Alkem Labs Ltd, Amta, Annora Pharma, Aurobindo Pharma Ltd, Mylan, Novast Labs, Sun Pharm, Zydus Pharms, Takeda Pharms Usa, Encube, G And W Labs Inc, Novitium Pharma, Padagis Israel, Mylan Speciality Lp, Actavis Mid Atlantic, Amneal, Amring Pharms, Quagen, Rising, Sandoz, Meda Pharms, Apil, Actavis Labs Fl, Sinotherapeutics Inc, and Teva Pharms Inc, and is included in forty-two 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. Thirty-eight suppliers are listed for this compound.

Summary for MESALAMINE

International Patents:	36
US Patents:	4
Tradenames:	10
Applicants:	29
NDAs:	42
Drug Master File Entries:	28
Finished Product Suppliers / Packagers:	38
Raw Ingredient (Bulk) Api Vendors:	130
Clinical Trials:	104
Patent Applications:	7,353
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
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa	PHASE4
Prof. Dr. Ahmed Ibrahim Mohammed El Mallah, faculty of pharmacy, Alexandria University.	PHASE2
Assoc. Prof. Dr. Noha Alaa Eldin Hassan Hamdy, Faculty of pharmacy, Alexandria University.	PHASE2

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
Zydus Pharms	MESALAMINE	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	208954-001	Aug 12, 2021	AB	RX	No	No
Takeda Pharms Usa	PENTASA	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	020049-002	Jul 8, 2004	AB	RX	Yes	Yes
Abbvie	CANASA	mesalamine	SUPPOSITORY;RECTAL	021252-001	Jan 5, 2001		DISCN	No	No
Sun Pharm	MESALAMINE	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	214585-001	May 11, 2022	AB	RX	No	No
Amneal	MESALAMINE	mesalamine	SUPPOSITORY;RECTAL	210509-001	Jan 2, 2020		DISCN	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	4,496,553
Abbvie	ASACOL HD	mesalamine	TABLET, DELAYED RELEASE;ORAL	021830-001	May 29, 2008	5,541,171
Apil	ASACOL	mesalamine	TABLET, DELAYED RELEASE;ORAL	019651-001	Jan 31, 1992	5,541,170
Salix	APRISO	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	022301-001	Oct 31, 2008	8,337,886
Salix	APRISO	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	022301-001	Oct 31, 2008	8,956,647

International Patents for MESALAMINE

Country	Patent Number	Title	Estimated Expiration
South Africa	201102442	COMPOSITIONS AND METHODS FOR THE TREATMENT OF BOWEL DISEASES WITH GRANULATED MESALAMINE
Australia	2010339837
Ukraine	108838	КОМПОЗИЦІЇ ТА СПОСОБИ ЛІКУВАННЯ ЗАХВОРЮВАНЬ КИШЕЧНИКУ З ВИКОРИСТАННЯМ ГРАНУЛЬОВАНОГО МЕЗАЛАМІНУ
Canada	2784772
World Intellectual Property Organization (WIPO)	2011084638

Market Dynamics and Financial Trajectory for MESALAMINE

Last updated: November 19, 2025

Introduction

Mesalamine, also known as 5-aminosalicylic acid, is a cornerstone in the treatment of inflammatory bowel diseases (IBD), notably ulcerative colitis and Crohn’s disease. As a locally acting anti-inflammatory agent, mesalamine has sustained its relevance in gastroenterology, supported by evolving market dynamics, technological advancements, and regulatory considerations. This analysis delineates the current market landscape, competitive forces, innovation trajectory, and the financial outlook for mesalamine, providing insight for stakeholders in the pharmaceutical ecosystem.

Market Overview and Therapeutic Significance

Mesalamine’s therapeutic value stems from its ability to reduce inflammation directly within the intestinal mucosa without significant systemic absorption, minimizing adverse effects. According to EvaluatePharma, the global IBD drugs market was valued at approximately USD 19.8 billion in 2021, with mesalamine accounting for a substantial share, given its position as a first-line therapy[1].

The prevalence of ulcerative colitis and Crohn’s disease shows increasing trends globally, driven by urbanization, lifestyle changes, and enhanced diagnostic capabilities. North America and Europe remain dominant markets, but rapid growth in Asia-Pacific offers significant expansion opportunities. The rising patient base ensures consistent demand for mesalamine formulations, including fixed-dose combinations and controlled-release systems.

Market Drivers

1. Rising Incidence and Prevalence of IBD
   A 2021 study projected the global prevalence of IBD to reach 6.8 million cases by 2030, driven by increased diagnosis and awareness[2]. The chronic nature of IBD necessitates long-term treatment regimens, predominantly utilizing mesalamine, for disease management and remission maintenance.

2. Advancements in Formulations and Delivery Systems
   Innovations in drug delivery, such as multi-matrix systems, once-daily dosing, and targeted release mechanisms, have enhanced patient compliance and therapeutic efficacy. Pharmaceutical companies investing in advanced formulations boost market penetration and volume.

3. Patent Expirations and Generic Entry
   Several branded mesalamine formulations face imminent patent expiries, encouraging generic entries that trigger price competition, expand accessibility, and foster market growth through affordability.

4. Regulatory Approvals and Expanded Indications
   Regulatory agencies, such as the FDA and EMA, have approved new formulations and expanded indications for mesalamine-based drugs, further consolidating their role in IBD management.

Market Restraints and Challenges

1. Generic Competition and Pricing Pressures
   The expiry of patents leads to proliferation of generics, which significantly reduces market revenues for branded formulations. Price erosion, especially in high-volume markets, constrains profit margins.

2. Therapeutic Alternatives and Biosimilars
   The advent of biologic agents like infliximab and adalimumab offers alternative treatment options for IBD, especially in moderate to severe cases. While biologics are reserved for refractory cases, their presence affects overall mesalamine demand.

3. Safety and Adherence Concerns
   Despite its safety profile, long-term adherence remains challenging, influenced by adverse effects and patient preferences. The emerging data on minimal systemic absorption underscores the need for continued formulation innovation.

4. Regulatory Challenges and Market Access
   Stringent regulatory policies and reimbursement hurdles across different jurisdictions impact the market expansion of innovative mesalamine formulations.

Competitive Landscape

Major pharmaceutical players include Ferring Pharmaceuticals, Salix Pharmaceuticals (a division of Bausch Health), and Sun Pharmaceutical Industries, among others. Ferring’s Asacol, Salix’s Rowasa, and several generics constitute the primary product pool. Patent cliffs have prompted diversification into combination therapies and alternative delivery systems.

Emerging biotechs are investing in targeted delivery and personalized medicine approaches to differentiate their offerings, potentially reshaping the market landscape in the next decade.

Financial Trajectory and Market Forecast

The mesalamine market is projected to grow at a compound annual growth rate (CAGR) of approximately 4-6% over the next five years (2023-2028), driven chiefly by rising disease prevalence and technological innovations in drug delivery.

Revenue Streams

• Brand-Name Drugs: Continued revenues from established brands like Asacol, Pentasa, and Lialda, though facing pressure from generics.
• Generics: Rapid market penetration post-patent expiry results in increased volume, albeit with reduced profit margins.
• New Formulations: Innovative delivery systems promise premium pricing and extend patent protection, offering significant revenue potential.

Key Growth Opportunities

• Expansion into emerging markets, leveraging lower regulation barriers and growing healthcare infrastructure.
• Development of combination therapies to address refractory IBD cases.
• Incorporation of digital health tools to improve adherence and monitoring, adding value to existing formulations.

Financial Risks

• Accelerated generic proliferation could compress margins.
• Competition from biologics and emerging oral therapies for IBD.
• Regulatory delays or restrictions impacting new product launches.

Innovation and Future Outlook

Continued research focuses on enhancing mesalamine’s efficacy and reducing administration burden. Controlled-release formulations, dual-action compounds, and gut-specific delivery systems are under development. Such innovations aim to maintain therapeutic relevance amidst a dynamic IBD treatment landscape.

Additionally, pharmacogenomics may enable personalized mesalamine therapies, optimizing efficacy and minimizing adverse effects. The integration of digital health platforms to monitor adherence and disease activity presents another avenue for growth.

Key Takeaways

• The mesalamine market is witnessing steady growth, sustained by rising IBD prevalence and innovative formulations.
• Patent expiries pose challenges but also unlock opportunities via generics, which expand access and volume.
• Competition from biologics and alternative therapies influences market share, demanding differentiation through innovation.
• Geographic expansion, particularly in Asia-Pacific, remains a strategic priority owing to demographic trends.
• Investment in targeted delivery systems and digital health integration is crucial for capturing future growth.

Conclusion

Mesalamine’s market dynamics are defined by a confluence of increasing demand, technological advancement, and competitive pressures. While patent cliffs and emerging therapies present challenges, continued innovation and strategic geographic expansion can sustain its financial trajectory. Stakeholders must navigate regulatory landscapes cautiously, capitalize on technological progress, and focus on enhancing patient adherence to ensure long-term profitability.

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FAQs

1. What are the primary drivers of mesalamine demand?
   Rising incidence of ulcerative colitis and Crohn’s disease, ongoing need for maintenance therapy, and advancements in drug delivery systems are primary drivers.

2. How will patent expiries affect mesalamine’s market share?
   Patent expiries will lead to increased generic competition, reducing branded revenues but expanding overall market volume and improving affordability.

3. Are there new formulations of mesalamine in development?
   Yes, ongoing research focuses on controlled-release, targeted delivery, and combination therapies to enhance efficacy and patient adherence.

4. How does competition from biologic agents impact mesalamine’s market?
   Biologics are used for moderate to severe IBD; however, mesalamine remains first-line for mild cases. Biologics may reduce overall global demand but do not replace mesalamine’s role in maintenance therapy.

5. What are key strategic opportunities for stakeholders in this market?
   Expanding into emerging markets, investing in innovative formulations, integrating digital health solutions, and focusing on personalized medicine are essential strategies.

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Sources:

[1] EvaluatePharma, 2022. Global Inflammatory Bowel Disease Market Report.
[2] Global Burden of Disease Study, 2021. Estimated projections of IBD prevalence.