SUPREP BOWEL PREP KIT Drug Patent Profile

When do Suprep Bowel Prep Kit patents expire, and what generic alternatives are available?

Suprep Bowel Prep Kit is a drug marketed by Azurity 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:	9
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
Eisenhower Army Medical Center	PHASE4
University of Virginia	N/A
Seoul National University Hospital	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
Azurity	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
Azurity	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
Cyprus	1110011
Slovenia	2233147
Portugal	2233147
European Patent Office	2292244	Solution salée 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
0984957	C300517	Netherlands		PRODUCT NAME: ACETYLSALICYLZUUR EN ESOMEPRAZOLMAGNESIUMTRIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 107516 20110912; FIRST REGISTRATION: 540235954023675402375 2011120812
1499331	SPC/GB13/034	United Kingdom		PRODUCT NAME: IZINOVA CONCENTRATE FOR ORAL SOLUTION. THE ACTIVE SUBSTANCE IS A MIXTURE OF 3 SALTS:SODIUM SULPHATE ANHYDROUS, MAGNESIUM SULPHATE HEPTAHYDRATE AND POTASSIUM SULPHATE.; REGISTERED: BE BE434323 20130220; UK PL34926/0016 20130313
1411900	2011C/016	Belgium		PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214
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

Market Dynamics and Financial Trajectory of Suprep Bowel Prep Kit

Last updated: February 20, 2026

What is the current market size and growth potential for Suprep Bowel Prep Kit?

Suprep Bowel Prep Kit, developed by Braintree Laboratories, is an oral solution used for colonoscopy preparation. The global bowel preparation market was valued at approximately USD 600 million in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 5.8% from 2023 to 2030. Suprep holds a significant share within prescription-only bowel prep solutions, driven by increasing screening procedures and awareness of colorectal cancer.

Market segmentation

Segment	Market Share (2022)	CAGR (2023–2030)	Key Drivers
Prescription bowel prep drugs	70%	5.5%	Rising colonoscopy rates, physician preference
Over-the-counter (OTC) solutions	30%	6.2%	Consumer demand, non-invasive options

Suprep’s primary competitors include MiraLAX, Golytely, and MoviPrep, with Suprep recognized for its lower volume requirement and improved tolerability.

What are the key factors influencing market dynamics?

Increasing gastrointestinal disease prevalence

Colorectal cancer ranks among the top three cancers globally, with screenings rising over recent years. The rising incidence of gastrointestinal disorders and a growing aging population directly influence demand for colonoscopy preparations.

Regulatory and reimbursement environment

Suprep treats a medicament that is reimbursed under various health insurance policies; however, reimbursement levels vary by country and coverage policies. Approval by regulatory agencies such as the U.S. Food and Drug Administration (FDA) in 2015 supports market entry and expansion.

Innovation and product differentiation

Suprep differentiates itself via a lower volume requirement (ca. 16 oz.) and tolerability. The product’s convenience aligns with increased patient adherence, influencing clinicians’ prescribing behavior.

Impacts of COVID-19

The pandemic initially suppressed elective procedures, impacting demand temporarily. However, the subsequent backlog led to a surge in procedures in 2021 and 2022, fueling demand for bowel prep solutions.

What is the financial trajectory forecast?

Revenue projections

Year	Estimated Global Revenue (USD millions)	Growth Rate (%)	Notes
2022	220	—	Estimated based on market share and pricing
2023	232	5.5	Slight recovery post-pandemic; increased screenings
2025	290	5.4 annualized	Steady adoption, competitive pressures remain
2030	~405	5.8	Market expansion, new indications

Suprep's sales growth hinges on expanding indications, geographic penetration, and physician acceptance.

Cost and pricing dynamics

Suprep is priced approximately USD 50–70 per dose in the U.S. market. Cost reductions may arise from manufacturing efficiencies, while pricing pressures could emerge from competition and reimbursement policies.

Investment and R&D pipeline

Braintree Laboratories continues to invest in generic versions and new formulations to extend market reach. Recent filings indicate potential for broader indications, influencing future revenues.

What are the regulatory and competitive hurdles?

Regulatory landscape

Suprep received FDA approval in 2015. New formulations or formulations with different dosing schedules require additional clinical trials and regulatory approval, which could delay or modify market access.

Competitive threats

Generic versions entering the market post-patent expiry could reduce prices and market share. Competition from OTC solutions also influences prescription volumes.

What are the potential market expansion opportunities?

• Expansion into emerging markets with increasing healthcare infrastructure investments.
• Development of new formulations, such as low-volume, fewer-dose regimens.
• Marketing campaigns emphasizing tolerability and convenience to shift some consumers from OTC to prescription use.

Key takeaways

• The global bowel preparation market is consolidating, with Suprep holding a notable position driven by compliance advantages.
• Demand growth aligns with increasing screening efforts, aging populations, and rising gastrointestinal disease burden.
• Market growth is steady, forecasted at approximately 5.8% CAGR through 2030.
• Revenue projections hinge on geographic expansion, product innovation, and competitive dynamics.
• Regulatory approvals and reimbursement policies remain critical factors influencing revenue potential.

FAQs

1. How does Suprep compare price-wise to its competitors?
Suprep's cost averages USD 50–70 per dose, which is generally higher than OTC options but competitive against other prescription regimens considering tolerability advantages.

2. What innovations could influence Suprep’s market share?
Development of lower-volume formulations, fewer-dose regimens, or enhanced tolerability could attract more patients and physicians.

3. How does regulatory approval impact sales?
Approval facilitates market entry and reimbursement but delays or denials restrict growth and revenue expansion.

4. What role do generic versions play in the market?
Generic formulations typically reduce prices, eroding brand sales and market share but can also expand overall market size.

5. Which regions present the most growth opportunity?
Emerging markets with increasing healthcare investments, such as China, India, and Brazil, represent significant opportunities for expansion.

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References

[1] MarketWatch. (2023). "Bowel Preparation Products Market Size, Share & Trends Analysis." Available at: https://marketwatch.com

[2] Grand View Research. (2022). "Bowel Preps Market Size, Share & Trends."

[3] U.S. Food and Drug Administration. (2015). FDA approval of Suprep Bowel Prep Kit.

[4] Johnson & Johnson. (2022). "Survey on Colonoscopy Preparation Compliance."

[5] Statista. (2023). "Global gastrointestinal diseases market forecasts."