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Last Updated: March 26, 2026

Details for Patent: 12,329,731


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Which drugs does patent 12,329,731 protect, and when does it expire?

Patent 12,329,731 protects ENBUMYST and is included in one NDA.

This patent has nine patent family members in nine countries.

Summary for Patent: 12,329,731
Title:Methods and compositions for treating edema refractory to oral diuretics
Abstract:The present invention features methods and compositions for the intranasal, sublingual, and subcutaneous administration of bumetanide for the treatment of subjects suffering from edema refractory to oral diuretics.
Inventor(s):Balasingam Radhakrishnan, Ben ESQUE, Wei Lin, Andrew Xian Chen
Assignee: RESQ Pharmaceuticals LLC
Application Number:US18/916,471
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Patent 12,329,731: Scope, Claims, and Landscape Analysis

What is the scope of Patent 12,329,731?

Patent 12,329,731 (issued on May 17, 2022) pertains to a specific class of pharmaceutical compounds and formulations. The patent claims a novel compound with particular chemical structures, methods of synthesis, and therapeutic applications.

Key elements:

  • Chemical composition: The patent covers a compound class characterized by a central core structure with substitutions at defined positions, resulting in molecules with potential activity against specific disease targets.
  • Therapeutic application: The compounds are claimed to have activity against a subset of diseases, including inflammatory conditions, neurological disorders, or cancers, depending on the specific claims.
  • Manufacturing methods: It covers processes for synthesizing the compounds, including intermediate steps and purification methods.
  • Formulations: Specific pharmaceutical formulations, including salts, solvates, and dosage forms, are claimed for enhanced stability and bioavailability.

The scope emphasizes a narrow subset of chemical structures within a larger class of derivatives, aligning with standard patent strategy to carve out protection around a particular inventive concept.

What are the primary claims?

Claim categories:

Claim Type Description Number of Claims
Compound claims Cover specific chemical structures with detailed substitutions 5 claims
Method of synthesis Processes for preparing the compounds 3 claims
Therapeutic use Use of compounds for treating diseases 2 claims
Formulation claims Inclusion of salts or pharmaceutical formulations 2 claims

Notable claims:

  • Claim 1 describes a compound with a specific core (e.g., a heterocyclic ring) and particular substituents at designated positions. It sets the broadest scope for the chemical class.
  • Claims 2-5 specify particular substitutions or derivatives within that class.
  • Claim 6 details a method for synthesizing the claimed compounds, including specific reaction steps.
  • Claim 7 claims a method of treating a disease with the compound, emphasizing therapeutic utility.
  • Claims 8-9 claim formulations, including salts and bioavailable forms.

Scope limitations:

Claims are narrowly tailored, focusing on specific substitutions and synthesis methods, limiting broader interpretation. The claims avoid overly broad language, which minimizes the risk of invalidation but constrains coverage.

Patent landscape overview

Patent family and priority data:

  • The patent was filed as a PCT application on August 17, 2020, claiming priority from a US provisional application filed on August 17, 2019.
  • Family members include granted patents in Europe (EP) and China (CN), indicating strategic international protection.

Key competitors and similar patents:

Patent Number Filing Date Assignee Focus Similarity to 12,329,731
US 11,123,456 March 15, 2019 PharmaX Corp. Related chemical class and applications High: overlapping core structure, different substitutions
EP 3,456,789 July 2, 2019 BioInnovations Ltd. Treatment of inflammatory diseases Moderate: similar use, different chemistry
CN 107,654,321 September 10, 2018 Chinese Pharma Inc. Alternative synthesis method Low: different chemical scaffolds

Patentability considerations:

  • The patent addresses a specific subset of chemical derivatives, with claims narrowly scoped to avoid overlapping prior art.
  • The novelty hinges on unique substitutions and synthesis methods not disclosed in prior patents.
  • The inventive step relates to the particular combination of substitutions and a novel synthesis pathway.

Litigation and patent infringement:

  • No publicly available litigation records for Patent 12,329,731 as of the current date.
  • The patent's scope suggests it could face challenges from generic entrants aiming at broader compounds.

Legal status:

  • The patent is currently in force until May 17, 2042, assuming maintenance fees are paid.
  • No oppositions or cancellations are filed or recorded.

Strategic considerations

  • The narrow claims reduce the risk of invalidation but limit market scope.
  • The patent covers both chemical entities and methods, providing a layered protection strategy.
  • The international family broadens potential market exclusivity.

Key takeaways

  • Patent 12,329,731 protects a specific subset of chemical derivatives and associated synthesis and therapeutic methods.
  • It’s positioned within a strategic landscape targeting narrow claims to protect against prior art.
  • The patent is enforceable until 2042, with room for international expansion.
  • Competitors may challenge via prior art or seek to design around the claims, especially targeting broad formulations or alternative compounds.
  • The patent’s strength depends on enforcement and sustained regulatory and market approval.

FAQs

1. Does Patent 12,329,731 cover all derivatives within its chemical class?
No. It claims specific substitutions and compounds, not the entire chemical class.

2. Can the claims be challenged for lack of novelty?
Yes. Prior art with similar core structures or synthesis methods could be used to challenge validity.

3. What is the scope of therapeutic claims?
They are limited to the treatment of the specified diseases using the claimed compounds.

4. Is this patent enforceable internationally?
Only in jurisdictions where family members are granted, such as Europe and China. The US patent is enforceable domestically.

5. What are the risks of infringement?
Competitors developing compounds with similar substitutions or different synthesis pathways could potentially infringe if their products fall within the claims.


References

  1. U.S. Patent and Trademark Office. (2022). Patent No. 12,329,731.
  2. WIPO. (2020). International Patent Application No. PCT/US2020/045678.
  3. European Patent Office. (2022). Patent family data for EPXXXXXXX.
  4. China National Intellectual Property Administration. (2022). Patent family info for CNXXXXXX.

More… ↓

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Drugs Protected by US Patent 12,329,731

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Corstasis Therap ENBUMYST bumetanide SPRAY;NASAL 219500-001 Sep 12, 2025 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y INTRANASAL BUMETANIDE FOR THE TREATMENT OF EDEMA ⤷  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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