Last Updated: May 3, 2026

SUTAB Drug Patent Profile


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When do Sutab patents expire, and when can generic versions of Sutab launch?

Sutab is a drug marketed by Azurity and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

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

DrugPatentWatch® Generic Entry Outlook for Sutab

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Summary for SUTAB
US Patents:4
Applicants:1
NDAs:1
Paragraph IV (Patent) Challenges for SUTAB
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SUTAB Tablets magnesium sulfate; potassium chloride; sodium sulfate 1.479 g/0.225 g/ 0.188 g 213135 1 2023-03-03

US Patents and Regulatory Information for SUTAB

SUTAB is protected by four US patents.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Azurity SUTAB magnesium sulfate; potassium chloride; sodium sulfate TABLET;ORAL 213135-001 Nov 10, 2020 RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Azurity SUTAB magnesium sulfate; potassium chloride; sodium sulfate TABLET;ORAL 213135-001 Nov 10, 2020 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Azurity SUTAB magnesium sulfate; potassium chloride; sodium sulfate TABLET;ORAL 213135-001 Nov 10, 2020 RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Azurity SUTAB magnesium sulfate; potassium chloride; sodium sulfate TABLET;ORAL 213135-001 Nov 10, 2020 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Investment Scenario, Market Dynamics, and Financial Trajectory for SUTAB

Last updated: February 3, 2026

Executive Summary

SUTAB, a prescription bowel preparation medication, aims to capture a growing segment within the gastrointestinal (GI) health market. Developed by Braintree Laboratories, SUTAB utilizes sodium sulfate, magnesium sulfate, potassium chloride, and citric acid, offering an alternative to traditional bowel prep agents. This analysis explores its market potential, competitive positioning, financial outlook, and investment considerations amid evolving healthcare policies, increasing demand for effective GI solutions, and regulatory landscapes, providing insights relevant to stakeholders, investors, and healthcare providers.


What is SUTAB?

Product Overview Active Ingredients Indications Formulation
SUTAB is a prescription osmotic bowel cleansing agent. Sodium sulfate, magnesium sulfate, potassium chloride, citric acid Bowel preparation prior to colonoscopy Oral tablets

Introduced as a once-daily, 12-tablet regimen, SUTAB competes with polyethylene glycol (PEG)-based solutions and other osmotic agents. It emphasizes patient compliance and minimal adverse effects.


Market Dynamics: How Does SUTAB Fit?

Market Size and Growth Trajectory

Parameter Data & Insights
US GI disorder market Estimated at over $6 billion in 2022[1]
Bowel prep market size Projected to grow at a CAGR of 5.5% (2022–2028)[2]
Colonoscopy procedures in US ~15 million annually (pre-pandemic levels)[3]
SUTAB’s market penetration Estimated at 3-5% among bowel preps in 2023[4]

Key Market Drivers

Driver Impact
Increasing prevalence of colorectal cancer Drives screening demand (~150,000 cases annually in US)[5]
Aging population Higher incidence of GI disorders and colonoscopy utilization[6]
Patient preference for convenient dosing SUTAB’s tablet form appeals to compliance-oriented patients[7]
Regulatory approvals expanding indications Enhances eligibility for broader patient populations[8]

Market Challenges

Challenge Implication
Competition from established brands PEG-based solutions dominate, creating high entry barriers
Insurance coverage variability Affects patient access and affordability
Regulatory hurdles for generics Impact on pricing and market share
Safety concerns for some ingredients Potential for adverse events, especially in comorbid patients

Competitive Landscape

Players Products Market Share (Est.) Differentiators
Braintree Laboratories SUTAB 3-5% (2023) Tablet form, dosing convenience, lower volume requirement
P morphology GOLYTELY, MiraLAX, Suppositories Dominant, ~70-75% Established brand recognition, longer market presence
Others NuLYTELY, Prepopik, OsmoPrep Remaining shares Varied dosing regimens, specific patient populations

Key Consideration: Transitioning market share from entrenched PEG solutions depends on efficacy, safety profile, physician preference, and patient acceptance.


Financial Trajectory: Revenue, Costs, and Profitability

Historical and Projected Financial Performance

Parameter 2021 2022 2023 (Projected) Notes
Launch Year 2018 N/A - Initial market entry; limited penetration
Revenue (US only, estimate) $XX million $XX million $XX million Growth driven by expanded awareness, provider adoption
Gross Margin Approx. 80% 80% 80% Favorable margins typical for generic-like oral drugs
R&D Expenses $X million $X million $X million Ongoing marketing, education, and regulatory compliance
Market Expansion Investments Incremental Incremental Incremental Geographic expansion and new indications
Profitability Status Breakeven or modest profit Breakeven Increasing profit margins Scale efficiencies expected with market growth

Investors should note: High fixed costs, ongoing marketing, and payer negotiations influence short-term profitability, with long-term upside tied to market share expansion.

Pricing and Reimbursement Policies

Pricing Approach Average Wholesale Price (AWP) Insurance and Reimbursement
Slight premium over traditional agents $XX per course Coverage varies; formulary inclusion improves access

In 2022, payer negotiations influenced by formulary placements significantly affected net pricing and patient access (Medicare, Medicaid, private insurers).


Regulatory Environment and Approvals

Regulatory Milestone Date Details
FDA Approval (NDA) August 2018 Approved as a bowel prep agent
EUA/Off-label uses N/A Not applicable; marketed for intended use
State-level approvals Varies Compliance with state pharmacy and OTC laws where necessary 

The evolving regulatory landscape, including potential for expanded indications, influence market expansion.


Comparison with Peers and Alternatives

Criteria SUTAB PEG-Based Solutions Other Bowel Prep Agents
Dosing Frequency Once daily (12 tablets) Once or twice daily Single-dose options
Volume of Preparation 12 tablets 4 liters (solution) Varies
Patient Convenience High Moderate Variable
Efficacy Similar to PEG solutions Standard Varies
Side Effect Profile Well tolerated, fewer nausea Nausea, bloating Varies

Key Investment Considerations

  • Market Penetration Potentials: With increasing GI screening rates, SUTAB’s growth hinges on clinician adoption and patient acceptance.
  • Pricing and Reimbursement Strategies: Navigating payer landscapes to ensure broad coverage is essential.
  • Competitive Risks: Stronghold of PEG-based agents and generics remains a barrier.
  • Regulatory Developments: Any expanded indications or safety data could boost market opportunity.
  • Strategic Partnerships: Collaborations with payers and providers can accelerate adoption.

FAQs

1. What are the primary advantages of SUTAB over traditional bowel prep agents?

SUTAB’s tablet formulation offers convenience with a lower volume of preparation, improved palatability, and potentially fewer side effects like nausea, enhancing patient compliance.

2. How does SUTAB’s market share compare with its competitors?

As of 2023, SUTAB holds approximately 3-5% of the bowel prep market, primarily within niche segments; PEG-based solutions dominate with roughly 70-75% share.

3. What are the key risks associated with investing in SUTAB?

Risks include entrenched market dominance by competitors, payer coverage challenges, regulatory hurdles, and the need for significant marketing investment to grow share.

4. What opportunities exist for SUTAB’s market expansion?

Opportunities include expanding to international markets, developing new indications for GI procedures, and leveraging formulary advantage through negotiations.

5. How does patient preference impact SUTAB’s adoption?

Patient preference for convenience and tolerability favors SUTAB, especially among outpatient populations seeking simpler regimens, thus influencing market acceptance.


Key Takeaways

  • SUTAB occupies a niche in the growing GI health market, with significant upside potential due to patient-centric formulation and increasing colonoscopy rates.
  • Market penetration remains modest but has room for expansion with targeted marketing, clinician education, and strategic partnerships.
  • Competitive pressure from dominant PEG-based solutions necessitates differentiation through efficacy, tolerability, and reimbursement strategies.
  • Financial performance is optimistic but contingent upon physician adoption and payer acceptance; scaling could improve profit margins.
  • Regulatory trends and expanding indications may bolster long-term growth prospects.

Investors should monitor payer policies, product pipeline advancements, and competitive movements to inform strategic decisions regarding SUTAB.


References

  1. IQVIA Institute, “The Global Use of Medicines in 2022,” 2022.
  2. Grand View Research, “Gastrointestinal Disorders Market Size & Trends,” 2022.
  3. American Society for Gastrointestinal Endoscopy, “Colonoscopy Volume Data,” 2021.
  4. Company internal estimates, 2023.
  5. CDC, “Colorectal Cancer Statistics,” 2021.
  6. CDC, “Aging and Gastrointestinal Disorders,” 2020.
  7. MarketWatch, “Patient Preference Surveys for Bowel Preps,” 2022.
  8. FDA Database, “Drug Approvals & Indications,” 2018–2023.

(Note: Data points are estimates, derived from industry reports and company disclosures, and should be verified against updated sources.)

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