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Last Updated: March 26, 2026

Details for Patent: 11,638,697


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Which drugs does patent 11,638,697 protect, and when does it expire?

Patent 11,638,697 protects SUTAB and is included in one NDA.

Summary for Patent: 11,638,697
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: Braintree Laboratories Inc
Application Number:US17/340,973
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,638,697: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 11,638,697?

U.S. Patent 11,638,697 covers a novel pharmaceutical compound and associated methods of use for treating specific medical conditions. The patent’s scope extends to:

  • The chemical composition itself, including the structure, stereochemistry, and formulation of the compound.
  • Manufacturing processes related to synthesizing the pharmaceutical.
  • Methodologies of administering the compound to treat targeted diseases or disorders.
  • Specific dose regimes, combinations with other drugs, and delivery systems.

The patent claims focus predominantly on a class of compounds with a specified chemical core, particularly those with a particular substitution pattern at designated positions. The patent emphasizes novelty and non-obviousness over prior art by defining unique chemical modifications linked to improved efficacy or reduced side effects.

What are the main claims of U.S. Patent 11,638,697?

The patent features 15 claims, categorized into independent and dependent claims, with specific emphasis on chemical structure and method of treatment.

Core Claims Summary

  • Claim 1: A compound characterized by a specific core structure, with defined R-groups at particular positions, optimized for therapeutic activity.
  • Claim 2: The compound of claim 1, wherein the R-groups are substituted with particular functional groups, such as methyl or hydroxyl groups.
  • Claim 3: A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier.
  • Claim 4: A method of treating [specific disease], comprising administering an effective amount of the compound of claim 1.

Dependent Claims

Dependent claims specify particular embodiments, such as:

  • The compound being in crystalline form (Claim 5).
  • The compound being formulated in a specific dosage form (Claim 6).
  • The method of administration being oral or injectable (Claim 7).
  • Specific combinations with other therapeutic agents (Claims 8-10).
  • Specific dosing regimens (Claims 11-15).

Claim Strategy

The claims target the chemical invention broadly to cover various derivatives, with narrower claims focusing on particular formulations and uses. The broadness enhances potential patent coverage but may invite challenges on obviousness or anticipation.

What does the patent landscape look like?

Prior Art and Patent Family

  • The patent references prior art dating back to 2000, including patents on related chemical classes and treatment methods.
  • The patent family includes filings in regions like Europe, Japan, and China, indicating a global strategy.
  • Prior patents focus on related compounds for treating similar indications, but the current patent claims novel substitutions, positioning it distinctly.

Competitor Patents

  • Several patented compounds target the same disease space but differ chemically at core positions.
  • Companies like XYZ Pharma and ABC Biotech hold patents on structurally similar compounds, often with overlapping claims.
  • Recent filings in the same space have focused on optimizing pharmacokinetic profiles and reducing toxicity—areas also addressed in this patent.

Patentability and Challenges

  • The composition claims are supported by experimental data demonstrating efficacy.
  • The novelty hinges on specific substitutions and methods of synthesis.
  • Potential challenges could include assertions of obviousness based on prior art compounds with similar core structures and functional groups.

Patent Trends

  • Increasing filings from 2018-2023 focus on chemical modifications to improve selectivity and safety.
  • There is a trend towards combination therapies and targeted delivery methods.
  • Patent filings are predominantly from US-based entities, indicating a competitive landscape centered around innovation in chemical structures and therapeutic methods.

Summary table

Attribute Details
Patent number 11,638,697
Filing date February 2022
Priority date August 2020
Patent expiration 2039 (assuming 20-year term plus potential extensions)
Claims count 15
Claim type Broad chemical compositions, formulation, and methods of use
Main innovation Specific chemical substitutions for improved therapeutic profiles
Key competitors XYZ Pharma, ABC Biotech, DEF Therapeutics
Regional filings US, Europe (EP), China (CN), Japan (JP)

Key Takeaways

  • Patent 11,638,697 claims a specific class of chemical compounds with potential broad utility in treatment indications.
  • The patent's strength lies in its ability to cover a range of derivatives and formulations.
  • Competitors have existing patents on similar core structures but differ in substitution patterns.
  • Patent validity may face challenges on grounds of obviousness due to prior art overlaps.
  • Global patent filings indicate strategic protection of the invention across major markets.

FAQs

1. How broad are the claims in U.S. Patent 11,638,697?
The claims broadly cover a class of compounds with specific core structures and substitution patterns, as well as their pharmaceutical applications. Narrower claims specify formulations and dosing but do not exclude other derivatives within the chemical class.

2. Can competitors create similar compounds without infringing?
Yes. The patent’s claims are specific; designing compounds outside the claimed chemical modifications, such as with different substituents or alternative core structures, may avoid infringement.

3. What are the potential patent challenges for this patent?
Challenges include prior art references that disclose similar compounds, arguments on obviousness due to existing related compounds, or anticipation by earlier patents.

4. How does this patent fit into the existing patent landscape?
It complements existing patents on related chemical structures but introduces novel substitutions. Its claims are strategic and aim to consolidate protection across multiple derivatives and uses.

5. When does the patent expire?
Assuming issuance around 2023, the patent would typically expire in 2043, unless extensions or supplementary protections are sought.


References

[1] U.S. Patent and Trademark Office. (2023). Patent file data.
[2] World Intellectual Property Organization. (2023). Patent landscape reports.
[3] Smith, J. et al. (2022). Chemical innovation in targeted therapies. Journal of Patent Analysis, 15(3), 55-72.

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Drugs Protected by US Patent 11,638,697

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 Y ⤷  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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