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Last Updated: December 22, 2024

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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 Braintree Labs 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. One supplier is 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
Finished Product Suppliers / Packagers: 1
Drug Prices: Drug price information for SUTAB
What excipients (inactive ingredients) are in SUTAB?SUTAB excipients list
DailyMed Link:SUTAB at DailyMed
Drug patent expirations by year for SUTAB
Drug Prices for SUTAB

See drug prices for SUTAB

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
Braintree Labs SUTAB magnesium sulfate; potassium chloride; sodium sulfate TABLET;ORAL 213135-001 Nov 10, 2020 RX Yes Yes 11,382,864 ⤷  Subscribe ⤷  Subscribe
Braintree Labs SUTAB magnesium sulfate; potassium chloride; sodium sulfate TABLET;ORAL 213135-001 Nov 10, 2020 RX Yes Yes 10,143,656 ⤷  Subscribe Y ⤷  Subscribe
Braintree Labs SUTAB magnesium sulfate; potassium chloride; sodium sulfate TABLET;ORAL 213135-001 Nov 10, 2020 RX Yes Yes 11,033,498 ⤷  Subscribe ⤷  Subscribe
Braintree Labs SUTAB magnesium sulfate; potassium chloride; sodium sulfate TABLET;ORAL 213135-001 Nov 10, 2020 RX Yes Yes 11,638,697 ⤷  Subscribe Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

SUTAB Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SUTAB

Introduction

SUTAB, a sulfate-based tablet colonoscopy preparation, has marked a significant milestone in the U.S. Colonoscopy Bowel Preparation Drugs market since its approval by the U.S. Food and Drug Administration (FDA) in November 2020. Here, we delve into the market dynamics and financial trajectory of SUTAB, highlighting its impact, growth prospects, and challenges.

Market Need and Demand

The demand for effective and patient-friendly colonoscopy preparations has been on the rise, driven by the increasing need for colorectal cancer screening. Traditional liquid colonoscopy preparations often deter patients due to their poor taste and the large volume required, creating a gap in the market that SUTAB aims to fill[4].

Approval and Launch

SUTAB, developed by Sebela Pharmaceuticals, is the first tablet colonoscopy preparation to receive FDA approval in over a decade. The FDA approval was based on positive Phase 3 clinical trials that demonstrated the safety and efficacy of SUTAB compared to traditional polyethylene glycol and ascorbate preparations (PEG-EA)[4].

Clinical Efficacy

Clinical trials have shown that SUTAB achieves a high rate of cleaning success, with 92.4% efficacy, which is non-inferior to PEG-EA (89.3%). This high efficacy rate, combined with its tablet form, makes SUTAB an attractive alternative for patients[4].

Market Impact

The introduction of SUTAB has the potential to significantly impact the U.S. Colonoscopy Bowel Preparation Drugs market. Here are a few key points:

Increased Patient Compliance

SUTAB's tablet form is more palatable and easier to administer than traditional liquid preparations, which can increase patient compliance and willingness to undergo colonoscopy screenings. This can lead to higher screening rates and better health outcomes for colorectal cancer[4].

Market Growth

The U.S. Colonoscopy Bowel Preparation Drugs market, which was valued at USD 483.02 million in 2021, is expected to grow at a CAGR of 3.0% from 2022 to 2030. The launch of SUTAB and other innovative products is a key driver of this growth, as it expands the market by offering more convenient and effective options[1].

Competitive Landscape

The market is characterized by strategic collaborations and acquisitions among key players. For instance, Sebela Pharmaceuticals' acquisition of Braintree Laboratories Inc. in 2018 expanded its gastroenterology product portfolio, positioning it more competitively in the market[1].

Financial Trajectory

While specific financial data for SUTAB alone is not publicly available, the overall financial performance of Sebela Pharmaceuticals and the broader market trends provide insights into its potential financial trajectory.

Revenue Potential

Given the market size and growth rate, SUTAB is expected to contribute significantly to the revenue of Sebela Pharmaceuticals. The company's strategy to introduce innovative products like SUTAB is aimed at capturing a larger share of the growing market[1].

Sales Performance

The launch of SUTAB has been well-received, with the product offering a safe and effective alternative to traditional preparations. As more patients and healthcare providers adopt SUTAB, it is likely to see steady sales growth, contributing to the overall revenue of Sebela Pharmaceuticals[4].

Challenges and Limitations

Despite its potential, SUTAB faces several challenges:

Side Effects

Like other colonoscopy preparations, SUTAB can cause side effects such as abdominal pain, abdominal swelling, nausea, and vomiting. These side effects can be a barrier to widespread adoption and may impact patient compliance[1].

Competition

The market is competitive, with other companies like Ferring Pharmaceuticals launching their own colonoscopy preparations, such as Clenpiq. This competition can affect the market share and pricing strategy for SUTAB[1].

Industry Expert Insights

Industry experts highlight the significance of SUTAB in improving patient compliance and outcomes. For example, Alan Cooke, President and CEO of Sebela Pharmaceuticals, noted that "alternative colonoscopy preparations, like SUTAB, can play an important role in encouraging more patients to get screened for colorectal cancer"[4].

Key Statistics

  • Market Size: The U.S. Colonoscopy Bowel Preparation Drugs market was valued at USD 483.02 million in 2021[1].
  • Growth Rate: Expected to grow at a CAGR of 3.0% from 2022 to 2030[1].
  • Efficacy Rate: SUTAB demonstrated a 92.4% cleaning success rate in clinical trials[4].
  • Patient Compliance: Improved patient compliance is expected due to the more palatable tablet form of SUTAB[4].

Conclusion

SUTAB represents a significant advancement in the U.S. Colonoscopy Bowel Preparation Drugs market, offering a safe, effective, and patient-friendly alternative to traditional liquid preparations. While it faces challenges such as side effects and competition, its potential to increase patient compliance and drive market growth is substantial.

Key Takeaways

  • SUTAB is the first tablet colonoscopy preparation approved by the FDA in over a decade.
  • It offers a high efficacy rate and is more palatable than traditional liquid preparations.
  • The product is expected to drive growth in the U.S. Colonoscopy Bowel Preparation Drugs market.
  • Side effects and competition are key challenges.
  • Industry experts see SUTAB as a crucial tool in increasing patient compliance for colorectal cancer screenings.

FAQs

What is SUTAB and how is it different from traditional colonoscopy preparations?

SUTAB is a sulfate-based tablet colonoscopy preparation approved by the FDA. It is different from traditional preparations because it comes in a tablet form, which is more palatable and easier to administer than the large volumes of liquid required by traditional preparations.

What are the key benefits of using SUTAB for colonoscopy preparation?

The key benefits include a high efficacy rate (92.4%), improved patient compliance due to its tablet form, and a safer alternative to traditional liquid preparations.

How does SUTAB impact the U.S. Colonoscopy Bowel Preparation Drugs market?

SUTAB is expected to contribute to the growth of the market, which is projected to reach USD 621.75 million by 2030, growing at a CAGR of 3.0% from 2022 to 2030.

What are the potential challenges for SUTAB in the market?

Challenges include side effects such as abdominal pain, nausea, and vomiting, as well as competition from other colonoscopy preparations like Clenpiq.

How does SUTAB align with public health goals for colorectal cancer screening?

SUTAB aligns with public health goals by increasing patient compliance for colonoscopy screenings, which is crucial for early detection and treatment of colorectal cancer.

What is the current market size and growth projection for the U.S. Colonoscopy Bowel Preparation Drugs market?

The market was valued at USD 483.02 million in 2021 and is expected to grow at a CAGR of 3.0% from 2022 to 2030, reaching USD 621.75 million by 2030.

Sources

  1. Reports and Data: U.S. Colonoscopy Bowel Preparation Drugs Market
  2. Biospace: Sutro Biopharma Reports Full Year 2023 Financial Results
  3. Stop TB Partnership: Global Drug Facility Announces Historic Price Reductions
  4. PR Newswire: Sebela Pharmaceuticals Announces U.S. Launch of SUTAB Tablets
  5. Sutro Biopharma: Third Quarter 2024 Financial Results and Business Highlights

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