ROWASA Drug Patent Profile

When do Rowasa patents expire, and when can generic versions of Rowasa launch?

Rowasa is a drug marketed by Mylan Speciality Lp and Meda Pharms and is included in two NDAs.

The generic ingredient in ROWASA is mesalamine. There are twenty-eight drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the mesalamine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Rowasa

A generic version of ROWASA was approved as mesalamine by PADAGIS ISRAEL on September 17^th, 2004.

Summary for ROWASA

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	3
Patent Applications:	2,746
Drug Prices:	Drug price information for ROWASA
What excipients (inactive ingredients) are in ROWASA?	ROWASA excipients list
DailyMed Link:	ROWASA at DailyMed

See drug prices for ROWASA

Recent Clinical Trials for ROWASA

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

Sponsor	Phase
Dayanand Medical College and Hospital	Phase 3
Colitis & Crohn's Foundation (India)	Phase 3
Altheus Therapeutics, Inc.	Phase 1

See all ROWASA clinical trials

Pharmacology for ROWASA

Drug Class

Aminosalicylate

US Patents and Regulatory Information for ROWASA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Speciality Lp	ROWASA	mesalamine	ENEMA;RECTAL	019618-001	Dec 24, 1987	AB	RX	Yes	Yes
Meda Pharms	ROWASA	mesalamine	SUPPOSITORY;RECTAL	019919-001	Dec 18, 1990		DISCN	Yes	No

Expired US Patents for ROWASA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Speciality Lp	ROWASA	mesalamine	ENEMA;RECTAL	019618-001	Dec 24, 1987	4,657,900
Mylan Speciality Lp	ROWASA	mesalamine	ENEMA;RECTAL	019618-001	Dec 24, 1987	RE33239

International Patents for ROWASA

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2008094618
Germany	3773657
Spain	2567068
Australia	2008211124	Improved reduced irritant enema for the treatment of Inflammatory Bowel Disease (IBD)
New Zealand	578674	REDUCED IRRITANT ENEMA FOR THE TREATMENT OF INFLAMMATORY BOWEL DISEASE (IBD)

Market Dynamics and Financial Trajectory for ROWASA (Mesalamine)

Last updated: August 4, 2025

Introduction

ROWASA (mesalamine), a pivotal therapy in the inflammatory bowel disease (IBD) segment, specifically ulcerative colitis, continues to shape its market landscape amidst evolving clinical, regulatory, and competitive landscapes. As a locally acting aminosalicylate, ROWASA remains a cornerstone in ulcerative colitis management, influencing its market performance and future financial prospects.

Market Dynamics

Therapeutic Demand and Disease Prevalence

Ulcerative colitis (UC), characterized by chronic inflammation of the colon’s mucosa, significantly impacts millions worldwide. According to the Crohn’s & Colitis Foundation, UC affects over 1.6 million Americans alone, with global prevalence rising annually. The rising incidence, coupled with increased awareness and improved diagnostic techniques, sustains a steady demand for effective therapies such as ROWASA.

The shift toward early intervention and maintenance therapy to prevent disease progression further stimulates demand for mesalamine-based products. Physicians prefer mesalamine formulations for their favorable safety profile and targeted anti-inflammatory effects, supporting consistent prescribing trends.

Competitive Landscape

ROWASA’s primary competition comprises oral mesalamine formulations (e.g., Asacol, Pentasa), topical agents (suppositories, enemas), and emerging biologics (e.g., infliximab, vedolizumab). However, ROWASA's retention is driven by its topical delivery, which allows high local drug concentrations with minimal systemic absorption, leading to fewer adverse effects.

The patent expiry and generic entry of formulations in the last decade intensified price competition, especially in mature markets like North America and Europe. Generic mesalamine enemas have gained prominence, creating a price-sensitive environment and pressuring profitability for branded ROWASA products.

Regulatory and Market Entry Barriers

Regulatory frameworks in major markets enforce rigorous approvals, especially for new formulations. For ROWASA, regulatory re-approvals and adherence to biosimilar standards influence market stability. Entry barriers remain high for newer, complex biologics, preserving the role of traditional mesalamine therapies but also raising the stakes for innovation.

Pricing and Reimbursement Trends

Reimbursement policies and drug pricing reforms significantly impact ROWASA’s market penetration. In the US, Medicare and private insurers’ formulary decisions favor lower-cost generics, constraining profit margins for branded formulations. Conversely, in emerging markets, higher pricing and limited generic competition offer growth opportunities.

Patient Adherence and Formulation Preferences

Patient adherence remains critical; topical formulations like ROWASA enemas, although effective, face compliance challenges due to administration inconvenience. Development of once-daily dosing regimes or combination therapies aims to mitigate this issue, potentially expanding market share.

Financial Trajectory

Revenue Trends

Historically, ROWASA demonstrated stable revenue streams owing to its established role in UC management. However, the advent of generics subdued growth margins over recent years, with revenue stagnation or slight decline in saturated markets.

In emerging markets, rising UC incidence and limited generic penetration sustain revenue growth. Companies investing in localized production and distribution can leverage favorable pricing to enhance revenue.

Profit Margins and Cost Structure

The shift toward generic variants compresses profit margins. Branded formulations face pricing pressures, prompting pharma companies to optimize production efficiencies and reduce marketing expenditures. Additionally, investment in R&D for next-generation formulations or combination therapies could divert short-term cash flow but aim for long-term growth.

Pipeline and Innovation Impact

Active research into novel formulations—such as slow-release enemas, fixed-dose combination therapies, and targeted delivery systems—could rejuvenate ROWASA’s financial prospects. Efforts to develop delivery devices that enhance adherence and reduce administration complexity may bolster future revenue streams.

Market Expansion and Strategic Alliances

Expanding into emerging markets like Asia-Pacific, Latin America, and Africa holds substantial revenue potential amidst rising UC prevalence. Strategic alliances with regional distributors, licensing agreements, and joint ventures can facilitate market penetration.

Legal and Patent Considerations

Patent expirations impact future revenues. Securing new formulation patents and defending against patent litigations remain integral to safeguarding profitability. Biosimilar entry in related biologics markets signals a broader industry trend toward price competition, indirectly influencing the mesalamine market.

Future Outlook

The outlook for ROWASA hinges on several factors:

• Innovation in Formulation: Development of more patient-friendly delivery mechanisms.
• Market Penetration: Capitalizing on expanding UC prevalence in emerging markets.
• Regulatory Environment: Navigating patent landscapes and securing approvals for novel formulations.
• Competitive Strategies: Differentiation through clinical efficacy, safety, and adherence-enhancing features.
• Cost Management: Maintaining profitability amid pricing pressures and generic competition.

The global IBD therapeutics market is projected to grow at a CAGR of approximately 6-8% through 2025, driven by increased disease awareness, improved diagnostics, and expanding therapeutic options. ROWASA, as a longstanding treatment, is poised to benefit through strategic repositioning and innovation.

Key Takeaways

• The ulcerative colitis market sustains consistent demand for mesalamine-based therapies like ROWASA, driven by rising disease prevalence and preference for topical anti-inflammatory agents.
• Generic entry has introduced pricing pressures, especially in mature markets; however, opportunities remain in emerging regions with limited competition.
• Innovation, adherence solutions, and strategic market expansion are critical to sustaining ROWASA’s financial trajectory.
• Patent statuses and regulatory compliance significantly influence revenue stability and growth prospects.
• Companies leveraging local manufacturing, tailored marketing, and novel formulations can enhance profitability despite market challenges.

FAQs

1. What is the primary clinical advantage of ROWASA over oral mesalamine therapies?
   ROWASA offers targeted delivery to the colon via enema, resulting in high local concentrations with minimal systemic absorption, reducing systemic side effects and improving efficacy in distal ulcerative colitis.

2. How has patent expiry impacted ROWASA’s market share?
   Patent expirations facilitated generic entry, leading to increased price competition and reduced profit margins for branded formulations, although market demand remains steady due to clinical efficacy.

3. Are there ongoing innovations to improve ROWASA’s formulation or administration?
   Yes, ongoing research aims to develop once-daily dosing, more user-friendly delivery devices, and combination therapies to enhance patient adherence and clinical outcomes.

4. What regions present the most significant growth opportunities for ROWASA?
   Emerging markets in Asia, Latin America, and Africa, where ulcerative colitis prevalence is rising and generic competition is less intense, offer substantial growth potential.

5. How do reimbursement policies influence ROWASA’s profitability?
   Favorable reimbursement and formulary placement can support branded sales, but in regions with aggressive price controls, profitability may decline unless offset by volume growth or cost efficiencies.

References

1. Crohn’s & Colitis Foundation. Ulcerative Colitis Facts and Statistics. 2022.
2. MarketWatch. Global Inflammatory Bowel Disease Market Analysis. 2023.
3. IQVIA. The Impact of Generic Entry on the Gastroenterology Market. 2022.
4. EvaluatePharma. Mesalamine Market Forecast. 2023.
5. FDA. Regulatory Guidelines for Topical Mesalamine Formulations. 2022.