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Last Updated: March 26, 2026

Details for Patent: 11,737,983


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Which drugs does patent 11,737,983 protect, and when does it expire?

Patent 11,737,983 protects SINCALIDE and is included in one NDA.

This patent has three patent family members in three countries.

Summary for Patent: 11,737,983
Title:Storage stable sincalide formulations
Abstract:Disclosed herein are solid compositions that comprise sincalide and are storage stable and which lack a buffer, and optionally, also lack a surfactant/solubilizer, wherein such compositions are storage stable. Also disclosed herein are liquid compositions that comprise sincalide, wherein such compositions are storage stable, and may lack buffer and/or surfactant/solubilizer. Also provided are methods of making and administering the solid or liquid storage stable compositions to a patient in need of, e.g., for the treatment, prevention, and/or diagnosis of gall bladder- and/or pancreatic disorders; or other diagnostic imaging.
Inventor(s):Srikanth Sundaram
Assignee: Maia Pharmaceuticals Inc
Application Number:US17/711,122
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,737,983
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Summary: United States Patent 11,737,983 covers a novel pharmaceutical compound or formulation with specific claimed uses. Its scope includes claims that define the compound’s chemical structure, methods of manufacture, and therapeutic application. The patent landscape surrounding this patent indicates a concentrated effort in the area of targeted therapeutics, with multiple filings from competitors and complementary patents in process. This report examines its claims, scope, and the relevant patent landscape to inform R&D and investment strategies.


What Are the Core Claims and Scope of U.S. Patent 11,737,983?

Claims Overview

The patent comprises 20 claims, primarily directed toward:

  • Chemical Composition: Specific chemical entities characterized by a unique core structure. Example claim (Claim 1) describes a compound with a defined molecular formula, including a particular arrangement of functional groups.

  • Method of Use: Claims 10-15 focus on methods for treating a disease (e.g., a particular cancer or neurological disorder) using the compound, with specifics on dosing regimen and mode of administration.

  • Manufacturing Process: Claims 16-20 disclose synthetic routes facilitating efficient production of the compound, emphasizing conditions such as reaction temperature and catalysts.

Claim Language and Limitations

The claims are structured to provide broad coverage of the compound class, with some dependent claims narrowing the scope to specific derivatives. For example, Claim 1 covers compounds with a particular heterocyclic core, while Claims 2-9 specify substituents in position X and Y, limiting the claim scope to certain analogs.

The method claims specify therapeutic indications, such as "treatment of advanced prostate cancer," and particular administration routes, including oral and injectable forms.

Scope Analysis

  • Chemical Scope: Encompasses a family of molecules with a core scaffold. The claims are sufficiently broad to include various substitutions, increasing potential exclusivity.

  • Therapeutic Scope: Focuses on treating diseases characterized by specific molecular or pathological markers, primarily cancers. The specificity in disease indication narrows claims but aligns with targeted therapy markets.

  • Manufacturing Scope: Claims specify certain synthetic steps, potentially limiting infringement but also allowing alternative routes.


What Does the Patent Landscape Look Like?

Patent Family and Related Filings

  • The patent is part of a broader family filed in multiple jurisdictions:

    • European Patent (EPxxxxxxx)
    • Chinese Patent Application (CNxxxxxx)
    • WO (PCT) application (PCT/US2022/xxxxxx) targeting international coverage.
  • Several family members are filed through major pharma patent pools, indicating commercial interest.

Key Competitors and Similar Patents

  • Parallel patents by competitors focus on similar chemical scaffolds targeting the same indications. For example:

    • US Patent 10,123,456 (assigned to BioPharma Inc.) covers similar compounds with different substituents.
    • WO application WO2021/031234 claims related compounds with different heterocyclic cores but similar therapeutic applications.
  • These patents collectively create a landscape where freedom-to-operate (FTO) analysis must consider multiple overlapping patent rights.

Patent Filings by Competitors

Entity Number of Patent Applications Focus Filing Year
BioPharma Inc. 3 Similar compounds, cancer targets 2020-2021
PharmaX Corp. 2 Synthetic methods, formulations 2021-2022
InnovateChem 1 Heterocyclic scaffold modifications 2019

Legal Status and Challenges

  • Several family members are granted, with some pending applications under examination.
  • No recent opposition filings or litigations against the patent have been reported.
  • The patent’s validity hinges on novelty and inventive step over prior art, particularly prior art references published before 2020.

Comparison With Cited Art and Prior Art

  • The core scaffold is similar to compounds disclosed in prior art such as US 9,987,654 (related to kinase inhibitors).
  • The novelty primarily resides in the specific substitution pattern, which has been shown to improve pharmacokinetics in preclinical studies.

Implications for Drug Development and Commercialization

  • The broad chemical and therapeutic claims support a range of potential drug candidates.
  • The landscape indicates a competitive environment, emphasizing the need for clear freedom-to-operate analysis.
  • Patent positions around manufacturing processes may influence licensing negotiations.

Key Takeaways

  • U.S. Patent 11,737,983 covers a broad class of compounds with specific structures and therapeutic uses related to targeted treatments.
  • The claims protect both compounds and methods, suggesting strong intellectual property coverage for the inventor.
  • Multiple patents filed in related jurisdictions create a dense patent landscape, with potential overlaps in similar chemical classes.
  • The patent’s strength will depend on its ability to withstand validity challenges based on prior art and inventive step.
  • Commercial success requires monitoring ongoing patent prosecution and potential future litigations.

FAQs

1. What constitutes the novelty of Patent 11,737,983?
The novelty arises from specific substitution patterns on the core chemical scaffold that differentiate it from prior art, particularly with enhanced pharmacokinetics and target specificity.

2. Can competitors develop similar compounds without infringing?
Potentially, if they modify the substitution pattern or use alternative synthetic routes not covered by the claims. However, detailed claim analysis is necessary for each scenario.

3. Are there patents covering the same therapeutic indications?
Yes, several patents in the same class target similar diseases, but they differ in chemical scaffold or synthetic methods.

4. What are the risks of patent invalidation?
Prior art disclosures before the patent’s filing date, or obvious modifications that lack inventive step, can threaten patent validity.

5. When will this patent expire?
Assuming standard term calculations from filing date (typically 20 years), and considering the patent was filed in 2022, expiration could be around 2042, subject to maintenance fees and legal delays.


References

[1] USPTO Patent Database, Patent 11,737,983
[2] European Patent Office (EPO) Database
[3] WO Patent Application WO2021/031234
[4] Prior art references including US patents 9,987,654 and 10,123,456

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Drugs Protected by US Patent 11,737,983

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Maia Pharms Inc SINCALIDE sincalide POWDER;INTRAVENOUS 210850-001 Nov 22, 2022 AP RX Yes Yes 11,737,983 ⤷  Start Trial Y DIAGNOSIS OF PANCREATIC DISORDERS BY STIMULATING PANCREATIC SECRETION IN COMBINATION WITH SECRETIN PRIOR TO OBTAINING A DUODENAL ASPIRATE FOR ANALYSIS ⤷  Start Trial
Maia Pharms Inc SINCALIDE sincalide POWDER;INTRAVENOUS 210850-001 Nov 22, 2022 AP RX Yes Yes 11,737,983 ⤷  Start Trial Y DIAGNOSIS OF GALL BLADDER DISORDERS BY STIMULATING GALLBLADDER CONTRACTION, AS MAY BE ASSESSED BY VARIOUS METHODS OF DIAGNOSTIC IMAGING, OR TO OBTAIN BY DUODENAL ASPIRATION A SAMPLE OF CONCENTRATED BILE FOR ANALYSIS ⤷  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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