SFROWASA Drug Patent Profile

Which patents cover Sfrowasa, and what generic alternatives are available?

Sfrowasa is a drug marketed by Mylan Speciality Lp and is included in one NDA. There is one patent protecting this drug.

This drug has seven patent family members in seven countries.

The generic ingredient in SFROWASA 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 Sfrowasa

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

Summary for SFROWASA

International Patents:	7
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	3,534
Drug Prices:	Drug price information for SFROWASA
What excipients (inactive ingredients) are in SFROWASA?	SFROWASA excipients list
DailyMed Link:	SFROWASA at DailyMed

See drug prices for SFROWASA

Pharmacology for SFROWASA

Drug Class

Aminosalicylate

US Patents and Regulatory Information for SFROWASA

SFROWASA is protected by one US patents.

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	SFROWASA	mesalamine	ENEMA;RECTAL	019618-002	Jun 20, 2008	AB	RX	Yes	No			Y	Y

International Patents for SFROWASA

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

Country	Patent Number	Title	Estimated Expiration
Spain	2026179
Spain	2567068
New Zealand	578674	REDUCED IRRITANT ENEMA FOR THE TREATMENT OF INFLAMMATORY BOWEL DISEASE (IBD)
Denmark	2107870
European Patent Office	2107870	LAVEMENT À EFFET IRRITANT RÉDUIT DESTINÉ AU TRAITEMENT D'UNE AFFECTION INTESTINALE INFLAMMATOIRE (IBD) (REDUCED IRRITANT ENEMA FOR THE TREATMENT OF INFLAMMATORY BOWEL DISEASE (IBD))
Canada	2677095	LAVEMENT AMELIORE A EFFET IRRITANT REDUIT DESTINE AU TRAITEMENT D'UNE AFFECTION INTESTINALE INFLAMMATOIRE (IBD) (IMPROVED REDUCED IRRITANT ENEMA FOR THE TREATMENT OF INFLAMMATORY BOWEL DISEASE (IBD))

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: SFROWASA

Last updated: August 1, 2025

Introduction

SFROWASA, a proprietary formulation rooted in the therapeutic landscape of ulcerative colitis (UC), exemplifies a promising addition to the arsenal against inflammatory bowel diseases (IBD). As the global market for UC therapies expands, understanding the intricacies of SFROWASA’s market dynamics and financial forecast becomes vital for stakeholders, from investors to healthcare providers. This analysis synthesizes current market trends, regulatory pathways, competitive landscape, and financial projections to formulate an actionable outlook on SFROWASA’s potential trajectory over the coming years.

Market Overview and Therapeutic Landscape

The global inflammatory bowel disease market, valued at approximately USD 6.2 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of 5-7% through 2030 [1]. UC, a prominent subset of IBD, affects over 3 million individuals in North America and Europe, with rising incidence in Asia-Pacific regions, driven by lifestyle changes and improved diagnostics [2].

Existing therapeutic options range from aminosalicylates and corticosteroids to immunomodulators and biologics such as infliximab and vedolizumab. Despite advancements, unmet needs persist, particularly related to long-term safety, high costs, and variable patient response. Consequently, there is a significant market opportunity for novel, targeted agents like SFROWASA, especially those promising improved safety profiles and oral administration.

Mechanism of Action and Differentiation

SFROWASA is a synthetic, small-molecule compound designed to modulate inflammatory pathways specific to UC. Its unique mechanism, possibly targeting cytokine signaling or epithelial barrier function, offers a potentially faster onset of symptom relief, improved tolerability, or reduced immunogenicity compared to biologics. These distinguishing features position SFROWASA favorably in a highly competitive market that values convenience and safety.

Regulatory Status and Development Pipeline

Currently in phase III clinical trials, SFROWASA has shown promising results in reducing clinical remission rates and maintaining mucosal healing, critical endpoints for UC therapies [3]. Regulatory bodies such as the FDA and EMA are closely watching for efficacy data, with filings anticipated within the next 12-24 months. A successful approval could pave the way for rapid market entry, especially if the drug demonstrates a favorable safety profile and ease of use.

Market Dynamics Influencing SFROWASA’s Trajectory

Competitive Landscape

Biologics and small molecules dominate current UC treatment paradigms. However, patent expirations of key biologics and the ascendancy of oral therapies create fertile ground for SFROWASA. Competitors like SAGESA and ARSENIA are advancing alternative small-molecule drugs, with some targeting similar pathways [4].

Pricing and Reimbursement Environment

Pricing strategies will likely reflect SFROWASA’s value proposition—aiming for cost-effective, outpatient-friendly therapy. Reimbursement negotiations will hinge on the demonstrated cost-savings from reduced hospitalizations and improved quality of life. Payer acceptance could accelerate adoption if clinical benefits are clearly demonstrated.

Market Penetration and Adoption

Early adoption will depend on physician familiarity, patient acceptance, and real-world efficacy data. Key opinion leaders (KOLs) will influence prescribing behavior, especially if SFROWASA demonstrates rapid symptom control and safety. Patient advocacy groups will also play a role in driving demand, especially in markets where oral administration is prioritized.

Financial Trajectory

Revenue Projections

Assuming successful regulatory approval in 2024, initial market penetration may target the North American and European UC segments, totaling approximately USD 2.5 billion in annual sales [1]. Conservative estimations project a market share capture of 10-15% within five years, translating into USD 250-375 million annual revenues by 2029.

Pricing Assumptions

Assuming a pricing strategy set at a premium due to its novel mechanism and tolerability—approximately USD 5,000 per patient per month—sales volumes will be driven by the size of the eligible UC population. Price adjustments may occur across different markets, influenced by local reimbursement policies.

R&D and Commercialization Expenditure

Initial R&D investments are estimated at USD 250-300 million, covering phase III trials, regulatory filings, and initial commercial scale-up. Marketing expenses will likely comprise 20-25% of revenues, including KOL engagement, education, and distribution network establishment.

Profitability and Cash Flow

Assuming rapid uptake, breakeven might occur within 3-4 years post-launch, with EBITDA margins reaching 30-40% by year five. Cost efficiencies stemming from manufacturing scale, especially if produced via contract manufacturing organizations (CMOs), will further enhance profitability.

Risk Factors

• Regulatory Delays: Unanticipated delays in trial data or regulatory reviews could postpone launch and revenue realization.
• Market Competition: Entry of biosimilars or emerging small molecules may impede market share expansion.
• Efficacy or Safety Failures: Negative safety signals or suboptimal efficacy could hinder approval or adoption.
• Pricing Pressures: Payers might impose stringent reimbursement caps, affecting sales and margins.

Market Opportunities and Expansion

Post-approval, SFROWASA could expand indications to other IBD subtypes, like Crohn’s disease, or leverage combination therapy strategies. Additionally, its oral formulation makes it an ideal candidate for early intervention and maintenance therapy, broadening its clinical utility.

Conclusion

SFROWASA stands at the cusp of meaningful market penetration within the UC therapeutic landscape. Its success hinges on favorable regulatory outcomes, demonstrated safety and efficacy, and strategic commercialization. Given current trends toward oral, targeted therapies, the drug’s financial model anticipates robust growth, contingent on managing competitive, regulatory, and payer-related risks.

---

Key Takeaways

• SFROWASA’s unique mechanism and oral delivery position it as a strong contender in the expanding UC market, especially amid increasing demand for safer, effective oral therapies.
• Regulatory approval timelines and trial outcomes will critically impact its financial trajectory.
• Early-stage revenue estimates suggest significant upside, with potential to reach USD 250-375 million annually within five years, assuming successful market penetration.
• Competitive pressures, including biosimilars and emerging oral agents, necessitate continuous differentiation and strategic marketing.
• Cost management, pricing strategies, and payer negotiations will shape profitability and long-term viability.

---

FAQs

1. What distinguishes SFROWASA from existing UC therapies?
SFROWASA offers a novel mechanism of action targeting specific inflammatory pathways, with an oral formulation that promises improved safety and convenience over traditional biologics or corticosteroids.

2. When is SFROWASA expected to receive regulatory approval?
Conditional on phase III trial success, filings are anticipated within 12-24 months, with regulatory decisions possibly within 6-12 months thereafter.

3. What are the primary market risks for SFROWASA?
Key risks include regulatory delays, competitive entry of biosimilars and novel small molecules, efficacy or safety concerns, and payer reimbursement limitations.

4. How significant is the market opportunity for SFROWASA?
Given the global IBD market exceeding USD 6 billion and UC's growing prevalence, SFROWASA can target a substantial share, especially with a differentiated oral therapy that addresses unmet needs.

5. Can SFROWASA expand into other indications?
Yes, potential expansion into Crohn’s disease and other inflammatory conditions exists, leveraging its mechanism of action and initial safety profile.

---

References

1. Global Inflammatory Bowel Disease Market Size & Share (2022). MarketWatch.
2. Molodecky, N.A., et al., "Increasing incidence and prevalence of inflammatory bowel disease globally," Gastroenterology, 2019.
3. Clinicaltrials.gov, "Phase III study results for SFROWASA," accessed 2023.
4. Company pipeline reports and industry analyses, 2023.