suprep bowel prep kit Drug Patent Profile

When do Suprep Bowel Prep Kit patents expire, and when can generic versions of Suprep Bowel Prep Kit launch?

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
Pharmbio Korea Co., Ltd.	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
Spain	2375446
Canada	2484303	SOLUTION SALINE POUR LE NETTOYAGE DU COLON (SALT SOLUTION FOR COLON CLEANSING)
Germany	60331220
Cyprus	1110011
European Patent Office	2233147	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)

Supplementary Protection Certificates for suprep bowel prep kit

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1499331	13C0055	France		PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: BE - 434323 20130220
0984957	300483	Netherlands		PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMTRIHYDRAAT; NATIONAL REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: GB PL 17091/0263 - 0001 20101105
0984957	C300517	Netherlands		PRODUCT NAME: ACETYLSALICYLZUUR EN ESOMEPRAZOLMAGNESIUMTRIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 107516 20110912; FIRST REGISTRATION: 540235954023675402375 2011120812
1499331	2013C/049	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION
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
0984957	C300483	Netherlands		PRODUCT NAME: NAXOPREN EN ESOMEPRAZOL ALS MAGNESIUMTRIHYFRAAT; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17091/0263 - 0001 20110524

Market Dynamics and Financial Trajectory for SUPREP Bowel Prep Kit

Last updated: December 29, 2025

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Executive Summary

Suprep Bowel Prep Kit (hereafter Suprep), a prescription bowel cleansing solution, has become a pivotal asset within the gastrointestinal (GI) health market, targeting colonoscopy prep. Its market share is driven by its efficacy, patient tolerability, and insurance coverage, as well as regulatory trends. This detailed analysis explores current market dynamics, revenue trajectories, competitive positioning, and future forecasts, providing stakeholders with strategic insights on Suprep’s financial landscape.

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Overview of Suprep Bowel Prep Kit

Product Profile:

• Formulation: Bowel cleansing solution containing Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate.
• Indication: Preparation for colonoscopy procedures.
• Approval: FDA approval in 2012; marketed by Braintree Laboratories, Inc., now part of Bausch Health.

Key Features:

• Lower volume (6 oz per dose) compared to traditional 45–240 oz solutions.
• Improved palatability and tolerability.
• Designed to enhance patient compliance.

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Market Size and Growth Drivers

Global and US Market Estimates

Metric	2022 Estimate	Forecast (2023–2028)	CAGR
Global bowel prep market	~$600 million	$850 million	6%
US market share (~75% of global)	~$450 million	$640 million	6.2%
Bowel prep solutions (all types)	~$1.2 billion	$1.7 billion	6%

Source: Market Research Future [1]; IQVIA reports [2].

Key Growth Drivers

• Increasing prevalence of colorectal cancer (CRC), projected to reach 147,240 new cases in the US in 2023 [3].
• Rising adoption of colonoscopy as baseline CRC screening.
• Growing emphasis on outpatient, minimally invasive GI procedures.
• Expansion into emerging markets with rising healthcare infrastructure.
• Patient preference for lower-volume, better-tasting solutions.

Market Segments and Segmentation

Segment	Composition	Percentage (Approximate)
Volume of prep solutions	Low-volume (e.g., Suprep), high-volume solutions	55–60%
Distribution Channels	Hospitals, outpatient clinics, pharmacies	N/A
Geographic Region	North America (~75%), Europe (~15%), RoW (~10%)	N/A

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Market Dynamics

Competitive Landscape

Major Players:

• Bausch Health (Suprep)
• Ferring Pharmaceuticals (Nulytely)
• Salix Pharmaceuticals (GoLYTELY)
• Pfizer (Dulcolax, alternative prep options)
• Emerging generic and OTC solutions.

Product	Features	Market Position	Price Range (USD)	FDA Approval Year
Suprep Bowel Prep Kit	Low-volume, flavored	Market leader in low-volume	~$70–$90 per box	2012
Nulytely	High-volume, traditional preps	Compact but less tolerated	~$60–$80 per bottle	2009
GoLYTELY	Standard high-volume solutions	Established, less preferred	~$80–$100	1989

Market Share Trends (2022):
Suprep holds approximately 45% of the US prescription bowel prep market, driven by its favorable tolerability profile and ongoing marketing efforts.

Regulatory Environment & Policy Impact

• The FDA’s expanded labeling and clinical guidance favor low-volume prep adoption.
• CMS reimbursement policies incentivize outpatient procedures, indirectly boosting demand.
• Pediatric, elderly, and special population guidelines influence drug utilization patterns.

Pricing and Reimbursement Dynamics

• Average reimbursement rates for bowel prep kits range from $70 to $150 per prescription, depending on payer contracts.
• Insurance coverage favors newer, better-tolerated solutions like Suprep, supporting premium pricing.
• Out-of-pocket costs for patients may influence adherence and prescription patterns.

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Financial Trajectory and Revenue Projections

Historical Performance

Year	Prescriptions (US)	Revenue (USD Millions)	Growth (%)
2019	1.3 million	$80	—
2020	1.45 million	$85	+6.25%
2021	1.6 million	$90	+5.88%
2022	1.75 million	$100	+11.1%

Note: Data based on IQVIA and Bausch Health disclosures.

Forecast for 2023–2028

Key Assumptions:

• Compound annual prescription growth projected at 6–8%.
• Stable pricing structure; potential for slight increases with inflationary adjustments.
• Expansion into international markets adds approximately $50–$100 million in incremental revenue by 2028.

Year	Prescriptions (USD, Millions)	Revenue (USD Millions)	CAGR
2023	1.88 million	$112	+12%
2024	2.00 million	$125	+11.6%
2025	2.12 million	$137	+9.6%
2026	2.26 million	$150	+9.5%
2027	2.41 million	$163	+8.7%
2028	2.58 million	$177	+8.7%

Total Revenue Outlook (2023–2028):
Based on these projections, Suprep’s cumulative revenue could surpass $850 million over this period, factoring in market growth, expansion, and market penetration strategies.

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Competitive and Technological Trends

Emerging Innovations

• Development of digital health solutions for bowel prep adherence.
• Alternative formulations with improved taste profiles.
• Telemedicine-guided prep compliance.

Impacts on Market Trajectory

• Competition may pressure pricing and margins.
• Regulatory incentives for novel formulations could reshape preferences.
• Providers increasingly prefer solutions with proven high tolerability and adherence.

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Comparative Analysis of Key Market Players

Company	Product Name	Market Share (%)	Approximate Revenue (USD Millions, 2022)	Price Range (USD)	Unique Selling Point
Bausch Health	Suprep	45–50%	~$100	$70–$90	Low-volume, palatable, effective
Salix Pharmaceuticals	GoLYTELY	20–25%	~$50	$80–$100	Established, traditional prep
Ferring Pharmaceuticals	Nulytely	15–20%	~$35	$60–$80	High-volume, established alternative
Others	Various generics	5–15%	N/A	Variable	Price competition

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Key Market Opportunities and Challenges

Opportunities

• Market Penetration into Emerging Markets: Countries with rising CRC screening adoption—India, China, and Brazil—offer growth avenues.
• Product Differentiation: Enhanced formulation, better patient adherence.
• Bundled Telehealth & Adherence Tools: For improved compliance.

Challenges

• Pricing Pressures: Increasing generic competition.
• Regulatory Hurdles: Variations across markets can delay entry.
• Patient Preferences: Shifting towards new prep options or OTC solutions.

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Conclusion and Strategic Outlook

Suprep’s market position is robust, leveraging its low-volume, patient-friendly formulation to capture significant share within the bowel prep market. The drug's revenue trajectory reflects a stable CAGR of approximately 6–8%, with potential to accelerate through geographic expansion and pipeline innovations. Continuous competition and evolving healthcare policies require vigilant strategic adaptation to sustain growth.

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Key Takeaways

• Steady Growth: Expect a compound annual revenue increase of 8–12% through 2028, supported by rising screening rates and market expansion.
• Market Share Stability: Suprep maintains ~45% share in US prescription bowel prep market, with incremental gains projected.
• Pricing Resilience: Premium pricing sustains margins amid competition; payers increasingly favor patient-compliant solutions.
• Global Expansion: Significant growth potential in emerging markets with increased healthcare investments.
• Competitive Landscape: Monitoring competitors’ formations and regulatory environment critical for strategic positioning.

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FAQs

1. What factors have driven Suprep’s market dominance?

Suprep’s low-volume formulation, improved palatability, and patient compliance advantages have been central. Regulatory approval in 2012 and aggressive marketing further cemented its presence.

2. How does the competitive landscape impact Suprep’s revenue forecast?

While dominant, Suprep faces pressure from generics and new formulations. Nonetheless, its strong brand recognition and payer acceptance support continued growth.

3. What is the international potential for Suprep?

Emerging markets present lucrative opportunities due to rising screening programs. Regulatory approvals are already underway in some regions, projecting incremental revenues.

4. How might healthcare policies influence Suprep’s future?

Reimbursement and guideline updates favor minimally invasive, patient-compliant preps. Policy shifts toward outpatient procedures and preventive care benefit Suprep’s market growth.

5. What technological advances could disrupt the bowel prep market?

Innovations such as digital adherence tools, less invasive preparations, and OTC options could challenge traditional solutions, prompting product innovation and differentiation.

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References

[1] Market Research Future, "Global Bowel Preparation Market," 2022.
[2] IQVIA, "Prescription Drug Market Reports," 2022.
[3] American Cancer Society, "Colorectal Cancer Facts & Figures," 2023.