SFROWASA Drug Patent Profile

Which patents cover Sfrowasa, and when can generic versions of Sfrowasa launch?

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. Forty 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:	181
Patent Applications:	4,157
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	7,645,801		Y	Y

International Patents for SFROWASA

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

Country	Patent Number	Title	Estimated Expiration
Spain	2567068
Spain	2026179
Israel	81799	PACKAGED PHARMACEUTICAL COMPOSITION CONTAINING BISULFITE STABILIZED SOLUTION OF 5-AMINOSALICYCLIC ACID AND METHODS FOR THE PREPARATION THEREOF
Germany	3773657
Australia	2008211124	Improved reduced irritant enema for the treatment of Inflammatory Bowel Disease (IBD)

SFROWASA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SFROWASA (Mesalamine Rectal Suspension)

Introduction to SFROWASA

SFROWASA is a sulfite-free formulation of mesalamine, a medication used primarily for the treatment of ulcerative colitis, a type of inflammatory bowel disease (IBD). It is administered as a rectal suspension, providing localized treatment directly to the affected area.

Market Need and Demand

The market for IBD treatments is significant and growing due to the increasing prevalence of ulcerative colitis and other inflammatory bowel diseases. Patients often require long-term management, which drives the demand for effective and well-tolerated treatments like SFROWASA[4].

Efficacy and Clinical Outcomes

SFROWASA has demonstrated efficacy in reducing the overall disease activity index (DAI) in patients with ulcerative colitis. Clinical trials have shown that SFROWASA significantly reduces the severity of disease parameters such as stool frequency, rectal bleeding, mucosal inflammation, and physician’s assessment of disease severity compared to placebo. These improvements are typically observed within 3 to 21 days, with a usual treatment course of 3 to 6 weeks[1].

Competitive Landscape

The market for 5-aminosalicylic acid (5-ASA) products, which include mesalamine formulations like SFROWASA, is competitive. Other 5-ASA products such as balsalazide, PENTASA, olsalazine, and LIALDA are also available. However, SFROWASA's sulfite-free formulation can be an advantage for patients sensitive to sulfites, differentiating it from some other mesalamine products[4].

Pricing and Reimbursement

The pricing of SFROWASA can vary based on geographical location, insurance coverage, and healthcare policies. In general, 5-ASA products are considered essential medications and are often covered by health insurance plans, including Medicaid, which helps in maintaining a stable market demand[4].

Financial Performance

While specific financial data for SFROWASA alone is not readily available, the overall market for IBD treatments is substantial. Pharmaceutical companies that produce 5-ASA products typically see steady revenue streams due to the chronic nature of the conditions these medications treat.

Revenue Streams

• Prescription Sales: The primary revenue source for SFROWASA is through prescription sales. Given its efficacy and the necessity of long-term treatment for ulcerative colitis, SFROWASA can generate consistent revenue.
• Market Share: The market share of SFROWASA within the 5-ASA segment would depend on its competitive advantages, such as its sulfite-free formulation, and marketing efforts.

Cost Structure

• Research and Development: Ongoing R&D costs are crucial for maintaining and improving the formulation, as well as for conducting clinical trials to expand indications or improve efficacy.
• Manufacturing and Distribution: Costs associated with the production and distribution of SFROWASA would include raw materials, manufacturing processes, and logistics.
• Marketing and Sales: Significant investments are typically made in marketing and sales to maintain market presence and compete with other 5-ASA products.

Market Trends and Projections

The IBD treatment market is expected to grow due to increasing prevalence rates and the need for effective treatments. Here are some trends and projections:

Growing Prevalence

• The rising incidence of ulcerative colitis and other IBDs is expected to drive the demand for treatments like SFROWASA.

Regulatory Environment

• Regulatory approvals and compliance are critical for the continued sale and development of SFROWASA. Any changes in regulatory requirements could impact the market dynamics.

Competitive Innovations

• Innovations in drug delivery systems and new formulations could pose competition to SFROWASA. However, its sulfite-free status remains a unique selling point.

Financial Trajectory

While specific financial data for SFROWASA is not provided, here are some general insights into the financial trajectory of similar pharmaceutical products:

Revenue Growth

• Companies producing 5-ASA products often experience stable revenue growth due to the chronic nature of the treated conditions. For example, Zydus Lifesciences, which has a portfolio including various formulations, saw its India branded formulation business grow at a 9.6% CAGR over FY18-22[2].

Profit Margins

• Profit margins can be influenced by factors such as manufacturing costs, R&D expenses, and market competition. Companies in the pharmaceutical sector often see fluctuations in profit margins due to these factors. For instance, Zydus Lifesciences experienced a compression in EBITDA margin over FY18-22[2].

Research and Development

• Continuous investment in R&D is essential for maintaining market position and expanding product indications. This is evident from the increased R&D costs as a percentage of sales seen in companies like Zydus Lifesciences[2].

Key Takeaways

• Efficacy: SFROWASA has shown significant efficacy in reducing disease activity in ulcerative colitis patients.
• Market Demand: The growing prevalence of IBDs drives the demand for treatments like SFROWASA.
• Competitive Advantage: The sulfite-free formulation of SFROWASA differentiates it from other mesalamine products.
• Financial Stability: The chronic nature of treated conditions ensures stable revenue streams for 5-ASA products.
• Regulatory Compliance: Maintaining regulatory approvals is crucial for the continued market presence of SFROWASA.

FAQs

What is SFROWASA used for?

SFROWASA is used for the treatment of ulcerative colitis, a type of inflammatory bowel disease.

How does SFROWASA differ from other mesalamine products?

SFROWASA is a sulfite-free formulation of mesalamine, which can be beneficial for patients sensitive to sulfites.

What are the common side effects of SFROWASA?

Common side effects can include rectal pain, diarrhea, and headache, though the incidence of adverse events is generally similar to other 5-ASA formulations[4].

How long does it take to see the effects of SFROWASA?

The effects of SFROWASA can be seen within 3 to 21 days, with a typical treatment course of 3 to 6 weeks[1].

Is SFROWASA covered by health insurance?

Yes, SFROWASA is typically covered by health insurance plans, including Medicaid, due to its essential nature in treating ulcerative colitis[4].

Sources

1. Medthority: SFROWASA Sulfite-Free Formulation MESALAMINE 4 g/60mL Meda Pharmaceuticals Inc.
2. Systematix: Systematix Research - Zydus Lifesciences India formulations.
3. Pfizer: Pfizer-Near-Term-Launches-High-Value-Pipeline-Day-Presentation.
4. Medicaid: Therapeutic Class Overview - Inflammatory Bowel Disease Agents.