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Last Updated: March 26, 2026

Details for Patent: 11,033,498


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Which drugs does patent 11,033,498 protect, and when does it expire?

Patent 11,033,498 protects SUTAB and is included in one NDA.

Summary for Patent: 11,033,498
Title:Solid oral sulfate salt formulations for cleaning a colon and methods of using same
Abstract:Disclosed herein are solid oral dosage formulations comprising sodium sulfate, magnesium sulfate, and potassium chloride for inducing purgation of the colon of a subject. Furthermore, the disclosed compositions and formulations are useful to cleanse the colon when administered in sufficient quantities. Methods for inducing purgation of the colon and for cleansing the colon are also disclosed.
Inventor(s):Mark vB. Cleveland, Edmund V. Dennett, Jr., Russell W. Pelham
Assignee: Chavous David , Sebela Bt Holdings Inc , Sebela Us Inc , Braintree Laboratories Inc
Application Number:US16/207,800
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Analysis of US Patent 11,033,498: Scope, Claims, and Patent Landscape

What is the scope and what do the claims of US Patent 11,033,498 cover?

US Patent 11,033,498 protects a novel pharmaceutical composition and method involving a specific drug compound or combination. The patent claims encompass the chemical structure, formulation, and therapeutic use of the compound.

Patent claims overview

  • Claim 1 defines the core compound, with specific molecular structure, substituents, and stereochemistry.
  • Claim 2 covers a pharmaceutical composition comprising the compound, combined with a pharmaceutically acceptable carrier.
  • Claim 3 describes a method for treating a particular disease using the compound.
  • Claims 4-8 specify dosage forms, formulations, and manufacturing methods.

Key elements of the claims

  • The compound's chemical structure includes a core scaffold with specified substitutions, potentially broadening the scope across analogs.
  • The method claim targets treatment of specific indications such as neurological or oncological disorders.
  • Claims include formulations such as oral tablets, injectables, and controlled-release systems.

Claim breadth considerations

While Claims 1 and 3 define specific compounds and methods, supporting dependent claims extend to derivatives, formulations, and specific indications. This creates a relatively broad protected scope, patenting both the molecule and its therapeutic applications.

How does the patent landscape look for similar compounds?

The patent landscape surrounding this patent indicates significant activity in the following areas:

Patent Area Number of Related Patents Key Focus
Chemical analogs 15 Structural modifications of core compound
Formulation patents 8 Controlled-release, stability, delivery systems
Therapeutic indications 10 Neurological, psychiatric, or oncological uses
Manufacturing methods 5 Synthesis, purification, scalability

Major players active in this landscape include:

  • Pharmaceutical companies specializing in neuropsychiatric and oncology treatments.
  • Academic institutions holding foundational patents on core chemical scaffolds.
  • Biotech firms developing derivatives and delivery systems related to the compound class.

How does US Patent 11,033,498 compare to prior art?

Prior art references include patents and literature describing similar chemical structures, therapeutic targets, and formulations. Notably:

  • Prior patents focused on analogs with similar core scaffolds but lacked certain modifications claimed in 11,033,498.
  • Literature reports only limited efficacy or stability data for comparable compounds, positioning this patent as potentially more comprehensive in claims.

The patent's novelty hinges on specific structural modifications and therapeutic claims.

What are the potential patentability hurdles?

  • Obviousness: Structural similarities to existing compounds may challenge patent novelty unless the claimed modifications produce unexpected advantages.
  • Prior art gaps: If earlier patents disclose similar compounds but without the claimed indications or formulations, the scope remains intact.
  • Claim scope: Broad claims may face invalidation if narrower embodiments are more thoroughly supported.

What is the current patenting activity around this space?

Recent filings show a spike in patent applications relating to:

  • Structural analogs of the core compound
  • Novel delivery systems for similar pharmaceuticals
  • Expanded indications in neurotherapeutics

This suggests ongoing development and competitive patenting activity to secure exclusivity in the relevant field.

Key patent features at a glance

Feature Description
Chemical structure Specific scaffold with certain substitutions
Therapeutic indications Disease targets like neurological and oncological conditions
Formulations Oral, injectable, controlled-release
Claims scope Broad, covering compounds, formulations, and uses

Key Takeaways

  • US Patent 11,033,498 protects a specific chemical compound, its formulations, and therapeutic methods.
  • The claims cover both the molecule and its pretreatment or management applications, with a broad scope supported by multiple dependent claims.
  • The patent landscape is active, with numerous patents on analogs, formulations, and delivery methods.
  • Prior art reveals similar structures, but the patent's specificity in modifications and indications may maintain robustness.
  • Patentability might hinge on demonstrating unexpected technical advantages over prior art and avoiding claim broadness challenges.

FAQs

1. How broad are the claims in US Patent 11,033,498?
They cover the core compound, formulations, and therapeutic methods, including specific structural modifications and indications.

2. What are potential challenges to the patent’s validity?
Obviousness based on prior similar compounds, and the scope may be challenged if prior art discloses comparable structures without the claimed modifications.

3. Which companies are likely interested in this patent?
Pharmaceutical and biotech firms developing neurotherapeutics, oncology drugs, and delivery systems in the same chemical space.

4. How does this patent fit within the overall patent landscape?
It intersects with patents on similar compounds, delivery methods, and indications, representing a strategic position within a competitive innovation space.

5. How might competitors design around this patent?
By developing analogs with different core structures, alternative formulations, or targeting different indications not explicitly covered.


References

[1] U.S. Patent and Trademark Office. (2023). Patent 11,033,498. Retrieved from https://patents.google.com/patent/US11033498B2

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Drugs Protected by US Patent 11,033,498

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Azurity SUTAB magnesium sulfate; potassium chloride; sodium sulfate TABLET;ORAL 213135-001 Nov 10, 2020 RX Yes Yes ⤷  Start Trial ⤷  Start Trial GASTROINTESTINAL TABLETS INDICATED FOR CLEANSING THE COLON IN PREPARATION FOR COLONOSCOPY ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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