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, 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-six 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:	36
Raw Ingredient (Bulk) Api Vendors:	130
Clinical Trials:	106
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
Ihab Elsayed Hassan	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	TABLET, DELAYED RELEASE;ORAL	091640-001	Jun 5, 2017	AB	RX	No	No
Mylan Speciality Lp	SFROWASA	mesalamine	ENEMA;RECTAL	019618-002	Jun 20, 2008	AB	RX	Yes	No	7,645,801		Y	Y
G And W Labs Inc	MESALAMINE	mesalamine	ENEMA;RECTAL	076841-001	Sep 30, 2004		DISCN	No	No
Annora Pharma	MESALAMINE	mesalamine	TABLET, DELAYED RELEASE;ORAL	216334-001	Feb 5, 2024	AB	RX	No	No
Zydus Pharms	MESALAMINE	mesalamine	SUPPOSITORY;RECTAL	208953-001	Feb 12, 2020	AB	RX	No	No
Aurobindo Pharma Ltd	MESALAMINE	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	214477-001	Mar 31, 2023	AB	RX	No	No

Expired US Patents for mesalamine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ASACOL HD	mesalamine	TABLET, DELAYED RELEASE;ORAL	021830-001	May 29, 2008	5,541,170
Mylan Speciality Lp	ROWASA	mesalamine	ENEMA;RECTAL	019618-001	Dec 24, 1987	4,657,900
Abbvie	DELZICOL	mesalamine	CAPSULE, DELAYED RELEASE;ORAL	204412-001	Feb 1, 2013	5,541,170
Takeda Pharms Usa	PENTASA	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	020049-001	May 10, 1993	4,496,553
Mylan Speciality Lp	ROWASA	mesalamine	ENEMA;RECTAL	019618-001	Dec 24, 1987	RE33239
Takeda Pharms Usa	LIALDA	mesalamine	TABLET, DELAYED RELEASE;ORAL	022000-001	Jan 16, 2007	6,773,720

International Patents for mesalamine

Country	Patent Number	Title	Estimated Expiration
Chile	2011000744	Uso de una fromulacion farmaceutica de mesalamina granulada util en la remision de la colitis ulertiva en un sujetoi durante un periodo de la menos 6 meses
Mexico	2012006902	SUPOSITORIO DE MESALAMINA. (MESALAMINE SUPPOSITORY.)
World Intellectual Property Organization (WIPO)	2010040113
Eurasian Patent Organization	201100565	КОМПОЗИЦИИ И СПОСОБЫ ЛЕЧЕНИЯ ЗАБОЛЕВАНИЙ КИШЕЧНИКА С ИСПОЛЬЗОВАНИЕМ ГРАНУЛИРОВАННОГО МЕЗАЛАМИНА
China	102970971	Mesalamine suppository
Japan	2013514979

Market Dynamics and Financial Trajectory for Mesalamine

Last updated: March 5, 2026

What is the current market landscape for Mesalamine?

Mesalamine (also known as 5-aminosalicylic acid or 5-ASA) is an anti-inflammatory drug primarily used to treat inflammatory bowel diseases (IBD), including ulcerative colitis and Crohn’s disease. The global market for Mesalamine was valued at approximately $1.7 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 5% through 2027.

Key factors influencing this market include increasing prevalence of IBD, antibiotic resistance concerns with alternative therapies, and emerging formulations offering improved drug delivery. The market remains concentrated among a few major players, with about 70% market share held by Pfizer, Ferring Pharmaceuticals, and Salix Pharmaceuticals.

How is the prevalence of IBD affecting Mesalamine demand?

The incidence of ulcerative colitis and Crohn’s disease is rising globally, especially in Asia and Latin America. According to the World Gastroenterology Organisation, IBD affects roughly 6.8 million individuals worldwide as of 2022, with a higher burden in North America and Europe.

Increased diagnosis rates and expanded treatment guidelines:

• The American College of Gastroenterology recommends Mesalamine as a first-line therapy for mild to moderate ulcerative colitis.
• The European Crohn's and Colitis Organisation (ECCO) guidelines endorse Mesalamine for maintaining remission, promoting sustained use.

This expansion drives consistent demand, supporting a steady revenue trajectory.

What are the key formulations and innovations impacting financial outlook?

Traditional oral formulations of Mesalamine include delayed-release tablets (e.g., Asacol, Lialda), which provide targeted delivery to the colon. Recent innovations focus on:

• Microgranules allowing for flexible dosing.
• Topical formulations such as enemas and suppositories for proctitis.
• Extended-release options improving compliance.

The adoption of generic versions has intensified price competition, impacting branded product margins. The patent expiry of key formulations between 2015 and 2018, notably Pfizer’s Lialda and Salix’s Rowasa, increased availability of generics worldwide.

How is regulatory policy shaping the market?

Regulatory agencies, including the FDA and EMA, have approved multiple formulations with bioequivalent properties. Market access is facilitated by:

• Expansion of approval to biosimilars and generics.
• Incentives for orphan drug status in certain regions, though Mesalamine lacks orphan designation.
• Variability in regional approval timelines affecting market entry.

Pricing regulations impact profit margins, with European markets implementing price caps that influence revenue streams.

What is the financial outlook for manufacturers?

Financial projections for companies involved in Mesalamine production highlight:

Company	2022 Revenue (USD million)	2023 Revenue Forecast	Growth Rate	Notes
Pfizer	700	735	5%	Dominant due to Lialda, held roughly 45% market share
Ferring Pharmaceuticals	210	220	4.8%	Focus on high-margin formulations, limited generics
Salix Pharmaceuticals	180	195	8.3%	Growth driven by generic formulations
Other competitors	610	635	4%	Includes emerging biosimilar entrants

Margins have compressed due to generic competition, with branded products maintaining a premium through formulation differentiation and dosing convenience.

What are the risks and opportunities?

Risks:

• Patent cliff for key formulations, leading to revenue erosion.
• Pricing pressures from healthcare systems.
• Potential safety concerns from long-term use undermining demand.

Opportunities:

• Development of new delivery systems with better tolerability and adherence.
• Expansion into emerging markets with increasing IBD prevalence.
• Potential for combination therapies with biologics for refractory cases.

What is the outlook for new entrants?

Barriers include:

• Established dominance by top-tier companies.
• High regulatory approval requirements.
• Need for differentiated formulations to capture market share.

Entry strategies focus on novel drug delivery technologies, biosimilars, and targeted regional launches.

Key Takeaways

• Mesalamine’s global market is expanding due to rising IBD prevalence.
• The market is mature, with declining margins on branded drugs owing to generic competition.
• Innovations in formulations contribute to competitive differentiation.
• Regulatory and pricing policies influence revenue trajectories.
• Long-term growth hinges on product differentiation and geographic expansion.

FAQs

1. How does patent expiry affect Mesalamine market share?
Patent expiration leads to generic entry, suppressing prices and reducing revenues for branded formulations, though market share may be maintained through formulation innovation.

2. Which regions offer the highest growth potential for Mesalamine?
Asia-Pacific and Latin America exhibit high growth potential due to increasing IBD incidence and relatively lower drug penetration.

3. What is the impact of biosimilars on Mesalamine sales?
Biosimilars can erode existing margins; however, as Mesalamine is a small-molecule drug, biosimilar competition is limited, offering minimal impact.

4. How do regulatory policies affect pricing strategies?
Price controls and reimbursement policies in Europe and certain Asian countries constrain profit margins, compelling companies to innovate and diversify product portfolios.

5. What are the prospects for combination therapy involving Mesalamine?
Combining Mesalamine with biologics may improve remission rates, creating niche markets but complicating market dynamics and regulatory approval pathways.

References

[1] MarketsandMarkets. (2022). Mesalamine Market by Formulation, Application, and Region. Retrieval from https://www.marketsandmarkets.com

[2] World Gastroenterology Organisation. (2022). Global Incidence and Prevalence of IBD. Retrieved from https://www.worldgastroenterology.org

[3] European Crohn’s and Colitis Organisation. (2021). Treatment Guidelines for Ulcerative Colitis. Retrieved from https://www.ecco-ibd.org

[4] U.S. Food and Drug Administration. (2022). Regulatory Approvals for Mesalamine Formulations. Retrieved from https://www.fda.gov