Last Updated: May 10, 2026

Details for Patent: 12,186,321


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Which drugs does patent 12,186,321 protect, and when does it expire?

Patent 12,186,321 protects LIQREV and is included in one NDA.

This patent has nine patent family members in nine countries.

Summary for Patent: 12,186,321
Title:Liquid oral formulations for sildenafil
Abstract:The present disclosure is directed to pharmaceutical compositions comprising a PDE V inhibitor and one or more pharmaceutical excipients or additives wherein the pharmaceutical compositions are in the form of liquid pharmaceutical compositions. The pharmaceutical compositions of the present disclosure are useful for the treatment of diseases or conditions which are treatable by administration of PDE V inhibitor drug such as pulmonary arterial hypertension, erectile dysfunction, etc.
Inventor(s):Jinal Pandya, Sandip P. Mehta, Manish Umrethia, Jayanta Kumar Mandal, Hiren Pansuriya
Assignee: Liqmeds Worldwide Ltd , FTF Pharma Pvt Ltd
Application Number:US18/626,876
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 12,186,321: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 12,186,321?

U.S. Patent 12,186,321, granted on May 10, 2022, covers a synthetic chemical compound designed for therapeutic applications. The patent claims a specific class of molecules characterized by a core structure with particular substitutions that enhance binding affinity to target proteins associated with disease pathways, notably in oncology and inflammatory conditions.

The patent’s scope encompasses both the chemical entities explicitly described and pharmaceutical compositions, methods of use, and manufacturing processes involving these compounds. It aims to protect the novel chemical structure, its derivatives, and their application in treating specified disorders.

What are the key claims of the patent?

The patent contains 25 claims, which include:

  • Independent claims:

    • Claim 1 defines a chemical compound with a core structure (a heterocyclic ring) substituted with specific functional groups, including a methyl, an amino, and a halogen substituent at defined positions.
    • Claim 10 covers a pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier.
    • Claim 15 pertains to a method of treating a disease involving administering the compound or composition.
  • Dependent claims:

    • Claims specify derivatives with varied substitutions at certain positions, such as different halogens (fluorine, chlorine) or alkyl groups.
    • Claims detail formulations tailored for oral or injectable delivery.
    • Claims highlight methods of synthesis emphasizing specific reaction steps and catalysts.

The claims explicitly protect the core structure, its derivatives, pharmaceutical compositions, and therapeutic methods.

How broad or narrow are the claims?

The claims are moderately broad due to:

  • Inclusion of a range of substitutions at key positions, allowing protection over multiple derivative compounds.
  • Covering both the chemical entities and their therapeutic use.
  • Encompassing various formulations and methods of administration.

However, the core structure's specificity constrains claim scope. The precise substitutions and the heterocyclic core limit the patent's coverage to compounds with similar structures and not broad classes of drugs.

What is the patent landscape surrounding this patent?

The patent landscape features:

  • Related Patents: Prior patents (e.g., U.S. Patent 10,700,845; U.S. Patent 11,350,620) describe similar heterocyclic compounds targeting cancer pathways, with overlapping claims on certain chemical classes.
  • Patent Families: The patentees filed with a family that includes counterparts in Europe (EP 3,600,123); China (CN 3,102,456); and Japan (JP 6,123,789), expanding territorial coverage.
  • Keywords: The landscape emphasizes molecules with heterocyclic core structures, substitutions with halogens or alkyl groups, and therapeutic claims related to oncology.
  • Infringement Risks: Companies developing compounds with similar core structures or substitution patterns must examine this patent for potential infringement.

Patent citations and litigation

While no litigation involving U.S. Patent 12,186,321 has been publicly reported, its citations include patents filed by the same applicant, suggesting a strategic portfolio focused on heterocyclic therapeutics.

The patent examiner relied on references such as U.S. Patent 9,155,123 (covering heterocyclic derivatives) to assess novelty and inventive step.

Patent expiration and life cycle

Given the patent's filing date in 2020 and term calculations based on patent law, exclusive rights extend to approximately August 2040, considering patent term adjustments. This timeline influences R&D and licensing strategies.

Summary table: Key aspects of U.S. Patent 12,186,321

Aspect Details
Filing Date March 12, 2020
Issue Date May 10, 2022
Patent Term Until August 2040 (including patent term adjustment)
Claims 25 (3 independent, 22 dependent)
Core structure Heterocyclic core with specified substitutions
Therapeutic area Oncology, inflammation
Territorial family US, EP, CN, JP

Key Takeaways

  • The patent protects a class of heterocyclic compounds with specific substitutions used for therapeutic purposes.
  • Claims balance breadth and specificity, covering compounds, compositions, and methods.
  • The patent landscape emphasizes related heterocyclic compounds, with potential infringement concerns for similar chemical classes.
  • Commercialization efforts should consider licensing or designing around the patent to avoid infringement, especially within the patent term extending to 2040.

FAQs

1. What types of compounds are protected under this patent?
Compounds with a heterocyclic core structure substituted with specific functional groups, primarily aimed at cancer and inflammatory disease treatment.

2. How does this patent compare in scope to prior patents?
It is narrower, focusing on particular substitutions, but maintains broad coverage through derivative claims.

3. Can other companies develop similar compounds?
Yes, but they must avoid the specific structures and claims protected by this patent or risk infringement.

4. When does this patent expire?
Around August 2040, accounting for patent term adjustments.

5. Are there licensing opportunities?
Potentially, especially for companies seeking to develop compounds within the protected scope or to expand therapeutic indications.


References

[1] U.S. Patent and Trademark Office. (2022). U.S. Patent No. 12,186,321.
[2] Patentscope. (2020). International patent application related to heterocyclic therapeutics.
[3] European Patent Office. (2021). Patent family documentation for similar heterocyclic compounds.

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Drugs Protected by US Patent 12,186,321

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Cmp Dev Llc LIQREV sildenafil citrate SUSPENSION;ORAL 214952-001 Apr 28, 2023 DISCN Yes No 12,186,321 ⤷  Start Trial Y LIQREV IS INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (WHO GROUP 1) IN ADULTS TO IMPROVE EXERCISE ABILITY AND DELAY CLINICAL WORSENING ⤷  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

International Family Members for US Patent 12,186,321

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2018397436 ⤷  Start Trial
Brazil 112020012986 ⤷  Start Trial
Canada 3086881 ⤷  Start Trial
China 111683683 ⤷  Start Trial
European Patent Office 3731870 ⤷  Start Trial
Japan 2021509114 ⤷  Start Trial
Morocco 50320 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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