SUPREP BOWEL PREP KIT Drug Patent Profile

Which patents cover Suprep Bowel Prep Kit, and what generic alternatives are available?

Suprep Bowel Prep Kit is a drug marketed by Braintree Labs and is included in one NDA.

The generic ingredient in SUPREP BOWEL PREP KIT is magnesium sulfate; potassium sulfate; sodium sulfate. There are one hundred and forty-six drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the magnesium sulfate; potassium sulfate; sodium sulfate profile page.

Summary for SUPREP BOWEL PREP KIT

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	8
Patent Applications:	35
Drug Prices:	Drug price information for SUPREP BOWEL PREP KIT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SUPREP BOWEL PREP KIT
DailyMed Link:	SUPREP BOWEL PREP KIT at DailyMed

See drug prices for SUPREP BOWEL PREP KIT

Recent Clinical Trials for SUPREP BOWEL PREP KIT

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

Sponsor	Phase
University of Virginia	N/A
Seoul National University Hospital	Phase 4
Bo-In Lee	Phase 4

See all SUPREP BOWEL PREP KIT clinical trials

Pharmacology for SUPREP BOWEL PREP KIT

Drug Class	Calculi Dissolution Agent Osmotic Laxative Potassium Salt
Mechanism of Action	Magnesium Ion Exchange Activity Osmotic Activity
Physiological Effect	Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption Inhibition Small Intestine Fluid/Electrolyte Absorption Stimulation Large Intestine Fluid/Electrolyte Secretion

Paragraph IV (Patent) Challenges for SUPREP BOWEL PREP KIT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SUPREP BOWEL PREP KIT	Oral Solution	magnesium sulfate; potassium sulfate; sodium sulfate	17.5 g/3.13 g/1.6 g	022372	1	2010-11-08

US Patents and Regulatory Information for SUPREP BOWEL PREP KIT

SUPREP BOWEL PREP KIT is protected by zero US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Braintree Labs	SUPREP BOWEL PREP KIT	magnesium sulfate; potassium sulfate; sodium sulfate	SOLUTION;ORAL	022372-001	Aug 5, 2010	AA	RX	Yes	Yes

Expired US Patents for SUPREP BOWEL PREP KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Braintree Labs	SUPREP BOWEL PREP KIT	magnesium sulfate; potassium sulfate; sodium sulfate	SOLUTION;ORAL	022372-001	Aug 5, 2010

International Patents for SUPREP BOWEL PREP KIT

See the table below for patents covering SUPREP BOWEL PREP KIT around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	03092589
Austria	528011
European Patent Office	2292244	Solution salée pour le nettoyage du colon (Salt Solution for Colon Cleansing)
European Patent Office	1499331	SOLUTION SALINE POUR LE NETTOYAGE DU COLON (SALT SOLUTION FOR COLON CLEANSING)
Australia	2003231160	SALT SOLUTION FOR COLON CLEANSING
Denmark	1499331

Supplementary Protection Certificates for SUPREP BOWEL PREP KIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0984957	C300483	Netherlands		PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMTRIHYFRAAT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 0001 20110524
1411900	2011C/016	Belgium		PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214
0124495	SPC/GB01/006	United Kingdom		PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727
1499331	C 2013 026	Romania		PRODUCT NAME: EZICLENCONCENTRAT PENTRU SOLUTIE ORALA AMESTEC DE 3 SARURI NA2SO4 MGSO4 K2SO4 AMESTEC DE SULFAT DE SODIU, SULFAT DEMAGNEZIU SI SULFAT DE POTASIU; NATIONAL AUTHORISATION NUMBER: RO 5417/2013/01; DATE OF NATIONAL AUTHORISATION: 20130228; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): BEBE434323; DATE OF FIRST AUTHORISATION IN EEA: 20130220
1020461	300482	Netherlands		PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMZOUT; NATIONAL REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: GB PL 17091/0263 - 0001 20101105
1499331	C300615	Netherlands		PRODUCT NAME: NATRIUMSULFAAT, MAGNESIUMSULFAAT EN KALIUMSULFAAT; NAT. REGISTRATION NO/DATE: RVG 110863 20130417; FIRST REGISTRATION: BE 434323 20130220

Market Dynamics and Financial Trajectory for the Suprep Bowel Prep Kit

Last updated: July 27, 2025

Introduction

The Suprep Bowel Prep Kit, developed by Brand Arzneimittel and marketed predominantly in the United States, is a prescription-only solution used for bowel cleansing prior to colonoscopy procedures. Its popularity stems from efficacy, patient tolerability, and ease of administration relative to traditional bowel prep agents. As the global demand for colonoscopy procedures increases—driven by colorectal cancer screening guidelines, aging populations, and technological advancements—the market dynamics and financial prospects for Suprep and comparable products are evolving rapidly. This report assesses the key factors influencing the market, projections for growth, and potential challenges within the competitive landscape.

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Market Overview and Size

The global colonoscopy bowel prep market, valued approximately at USD 600 million in 2022, is growing at a compounded annual growth rate (CAGR) of around 5% to 7% (source: industry reports). The increase is primarily attributable to the rising incidence of colorectal cancer, especially in developed countries, and the widespread adoption of preventive health measures. In the U.S., the prevalence of colorectal screening is offsetting declines in other emerging markets. Within this rapidly expanding segment, Suprep has secured a significant market share due to its combination of efficacy and patient-centered benefits.

Market Drivers

1. Rising Incidence of Colorectal Cancer

Colorectal cancer remains the third leading cause of cancer-related deaths globally. The American Cancer Society estimates over 150,000 new cases annually in the U.S. alone (2021), prompting a steady increase in colonoscopy screening rates, which directly impacts demand for bowel prep products like Suprep [1].

2. Guideline Recommendations for Screening

Updated guidelines from organizations such as the US Preventive Services Task Force (USPSTF) and the American Society of Gastrointestinal Endoscopy endorse colonoscopy as a primary screening modality, further propelling demand. As guidelines favor minimally invasive, tolerable prep agents, Suprep’s improved tolerability becomes a competitive advantage.

3. Technological Innovations and Patient Preferences

The shift toward patient-friendly preparations—characterized by reduced volume, lower taste burden, and fewer adverse effects—favors Suprep, which offers a lower-volume formula compared to traditional polyethylene glycol (PEG) solutions.

4. Aging Populations

Demographic shifts toward older age brackets, particularly in North America and Europe, increase the baseline necessity for colonoscopies, expanding the potential market size for bowel cleansing agents.

5. Healthcare Access and Screening Programs

Enhanced screening initiatives and increased healthcare insurance coverage directly correlate with higher procedure volumes, expanding revenue opportunities for market players like Suprep.

Competitive Landscape

Suprep’s main competitors include polyethylene glycol-based solutions (e.g., GoLYTELY, Moviprep), sodium sulfate-based products (e.g., OsmoPrep), and other low-volume agents (e.g., Nulytely). Market positioning hinges on factors such as efficacy, tolerability, safety profile, and costs.

Strengths of Suprep

• Low Volume: Typically administered as two 6-ounce doses, enhancing patient compliance.
• Palatability: Flavored formulations improve taste profile.
• Efficacy and Safety: Proven effectiveness with a favorable safety profile in clinical trials.

Challenges

• Cost Considerations: Suprep’s pricing, often higher than generic solutions, may limit access in some markets.
• Regulatory Dynamics: Patent protections and regulatory approvals influence market exclusivity; patent expiry risks could introduce generic competition.
• Patient Compliance: The requirement of multiple dosing and dietary restrictions may deter some users.

Regulatory and Patent Landscape

Suprep’s patent protections, granted in various jurisdictions, underpin its market exclusivity. Patent expiries, projected within the next 4-6 years, pose a risk of intensified generic competition, which could compress profit margins and inhibit revenue growth. The company’s strategic patent filings and formulation innovations are crucial for maintaining competitive differentiation.

Financial Trajectory and Revenue Projections

Historical Performance

Over the past five years, the market for bowel prep kits has demonstrated steady growth, with Suprep’s sales reflecting an approximate CAGR of 4%-6%. Key revenue streams derive from direct sales to hospitals, outpatient clinics, and specialty pharmacies.

Forecasted Growth

By 2025, the global market for bowel preps projected to reach USD 850-900 million, with Suprep’s share anticipated to maintain or slightly increase due to its favorable profile [2]. The increasing procedure volumes, coupled with expanding geographic reach into emerging markets, bolster revenue growth prospects.

Factors Influencing Revenue

• Procedure Volume Growth: As colonoscopy numbers grow annually, especially in aging demographics, sales of Suprep are expected to rise proportionally.
• Pricing Strategies: Margins will be influenced by pricing adjustments, competitive pressures, and negotiations with payers.
• Market Penetration: Broader adoption in outpatient clinics and international markets will enhance revenue streams.
• Regulatory Approvals: Approval of new formulations or indications could open additional revenue channels.

Potential Headwinds

• Generic Entry: Entry of low-cost generics post-patent expiry could erode market share.
• Reimbursement Dynamics: Evolving payer policies might influence pricing and access.
• Market Saturation: Growing prevalence of alternative preparation methods, such as one-day regimens or novel agents, could temper growth.

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Strategic Outlook

The future growth of Suprep hinges on ongoing innovation, strategic marketing, and expanding clinical evidence supporting its advantages. Investments in patient education, adherence optimization, and international approval pathways are vital. Additionally, diversification into related gastrointestinal products may offset risks related to patent expiry.

Conclusion

The market for colonoscopy bowel prep kits, with Suprep as a significant player, is positioned for sustained growth driven by demographic trends, clinical guidelines, and technological advances. While competitive pressures and patent cliffs present challenges, strategic innovation and expanding access could bolster Suprep’s financial trajectory in the coming years.

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Key Takeaways

• Growing Market: The global bowel prep market is expanding at a CAGR of approximately 5-7%, driven by increasing colorectal cancer screenings.
• Competitive Edge: Suprep’s low-volume, palatable formulation offers advantages over traditional solutions, fostering patient adherence.
• Patent and Competition Risks: Patent expirations pose future threats; early innovation and patent filing are critical.
• Market Expansion: International growth and penetration into outpatient settings present lucrative opportunities.
• Financial Outlook: Revenues are expected to grow in tandem with procedure volumes, though pressures from generics and payers require strategic management.

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FAQs

1. How does Suprep compare to traditional bowel preparation solutions?
Suprep offers a lower-volume, flavored solution that enhances patient compliance and tolerability, with a comparable or superior efficacy profile to traditional PEG-based preparations.

2. What are the main factors impacting Suprep's market share?
Market share is influenced by competition from generics, pricing strategies, reimbursement policies, and clinical preferences for alternative agents.

3. How might patent expiries affect Suprep’s financial outlook?
Patent expiries could allow generic entrants to enter the market, increasing competition and potentially reducing revenue margins.

4. What international opportunities exist for Suprep?
Expanding into emerging markets with increasing screening initiatives presents significant growth potential subject to regulatory approvals and local market dynamics.

5. What innovations could sustain Suprep’s growth?
Development of improved formulations, combination therapies, and evidence-based clinical studies demonstrating superior outcomes will support sustained growth.

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References

[1] American Cancer Society. Colorectal Cancer Facts & Figures 2021-2023.
[2] MarketResearch.com. Global Bowel Preps Market Report, 2022.