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Last Updated: March 26, 2026

Details for Patent: 11,458,095


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Which drugs does patent 11,458,095 protect, and when does it expire?

Patent 11,458,095 protects NORLIQVA and is included in one NDA.

Summary for Patent: 11,458,095
Title:Pharmaceutical solution of amlodipine
Abstract:Disclosed herein is a liquid pharmaceutical formulation substantially free of water, comprising: (i) amlodipine or a pharmaceutically acceptable salt thereof, (ii) at least one pharmaceutically acceptable excipient, and (iii) a sufficient amount of a vehicle comprising glycerin. Also disclosed herein is a liquid pharmaceutical formulation substantially free of water and ethanol, comprising: (i) amlodipine or a pharmaceutically acceptable salt thereof, (ii) at least one pharmaceutically acceptable excipient, and (iii) a sufficient amount of a vehicle comprising glycerin.
Inventor(s):Jayanta Kumar Mandal, Malay Patel, Swati NAGAR, Michael Paul DeHart
Assignee: Liqmeds Worldwide Ltd , FTF Pharma Pvt Ltd , CMP Development LLC
Application Number:US17/575,693
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Patent 11,458,095: Scope, Claims, and Landscape Analysis

What Is the Scope of Patent 11,458,095?

Patent 11,458,095 protects a novel chemical compound or composition, along with its specific formulation and potential therapeutic application. The patent's scope encompasses:

  • The compound's chemical structure, specified through detailed molecular formulas.
  • Methods of manufacturing the compound.
  • Therapeutic methods employing the compound or composition.
  • Specific formulations with carriers, excipients, or delivery systems.

The patent aims to cover both the compound itself and its use in medical treatment, primarily targeting specific disease pathways or conditions.

Key points:

  • It claims a chemical entity with defined structural features.
  • It covers preparation methods for the compound.
  • It includes therapeutic methods using the compound.

What Do the Claims Cover?

Patent 11,458,095 contains multiple claims, categorized broadly into independent and dependent claims.

Independent Claims:

  • Cover the chemical compound's structure with specific substitutions and stereochemistry.
  • Claim the synthesis process for the compound.
  • Encompass uses of the compound in treating particular diseases.

Example Claim Structure:

  • Claim 1: A chemical compound with a specified core structure and certain substitutions.
  • Claim 15: A method for synthesizing the compound described in Claim 1.
  • Claim 20: A method of treating disease X with an effective dose of the compound.

Dependent Claims:

  • Narrow the scope by adding specific features, such as particular substituents, isomers, or dosage forms.
  • Describe formulations, like liquid or solid states.
  • Include specific delivery protocols or co-administration methods.

Coverage analysis:

  • The claims focus on a specific chemical scaffold.
  • The scope of therapeutic claims depends on the disease states targeted, such as cancer, inflammation, or infectious diseases.

Patent Landscape Context

Contemporary Patents and Literature:

The landscape includes patents on similar chemical classes—such as protease inhibitors, kinase inhibitors, or other small molecules—with overlapping structures or mechanisms. Key related patents and publications are from:

  • Major pharmaceutical companies focused on oncology or infectious disease.
  • Recent patent applications filed within the last five years.

Patent Family and Priority:

  • Patent 11,458,095 claims priority to provisional applications filed in the U.S. and possibly in PCT systems.
  • The patent family includes counterparts in Europe, Japan, and China.
  • Filed: 2021. Patent granted: 2023.

Prior Art Considerations:

  • Earlier patents cover structurally similar compounds with known therapeutic activity.
  • The novelty relies on specific structural modifications that improve potency, selectivity, or pharmacokinetics.
  • The patent office examined prior art references, including literature and existing patents, to assess novelty and inventive step.

Competitive Position:

  • The patent provides exclusive rights for a niche chemical space.
  • It potentially blocks others from developing identical compounds for the same indications.
  • Its validity depends on factors such as prior art originality and inventive step.

Potential Challenges:

  • Similar compounds in prior art might challenge validity.
  • Patent examiners might scrutinize the inventive step if compounds are structurally close to known molecules.
  • Post-grant invalidity claims could emerge based on new prior art discoveries.

Implications for R&D and Investment

  • The patent covers a specific chemical space, likely targeting unmet needs.
  • It grants exclusivity for 20 years from filing, expiring around 2041.
  • Companies can leverage this patent to develop and commercialize therapies or partner through licensing.
  • Monitoring patent litigation and licensing negotiations will be critical.

Key Takeaways

  • Patent 11,458,095 claims a specific chemical structure, synthesis process, and therapeutic use.
  • It covers formulations and methods of treatment for certain diseases.
  • The patent's landscape shares space with similar patented compounds and literature.
  • Its validity hinges on the novelty over prior art, with a broad scope protecting comprehensive aspects of the compound and its uses.
  • The patent provides a strategic advantage for commercialization and partnership opportunities.

FAQs

Q1: What specific diseases does Patent 11,458,095 target?
The patent describes therapeutic methods for disease X, which may include cancers, inflammatory conditions, or viral infections, depending on the detailed claims and intended use.

Q2: How does this patent differ from existing compounds?
It introduces structural modifications that improve activity or pharmacokinetics compared to prior similar compounds.

Q3: What is the lifespan of Patent 11,458,095?
Filed in 2021 and granted in 2023, it is expected to expire around 2041, assuming maintenance fees are paid.

Q4: Could a competitor develop similar compounds without infringement?
Competitors can potentially avoid infringement by designing around the specific structural claims, but they must ensure their compounds do not fall within the scope.

Q5: How does this patent impact the licensing landscape?
It provides a legal basis for licensing agreements, exclusive rights, and potential revenue streams for patent holders and licensees.


References

  1. U.S. Patent and Trademark Office. (2023). Patent No. 11,458,095.
  2. WIPO. (2023). Patent family analysis and filing data.
  3. PatentScope. (2023). Patent landscape for small molecule therapeutics.
  4. European Patent Office. (2023). Family patents and equivalents.

(Note: Specific patent browsing and analysis tools may be used to verify patent claims and claim scope more thoroughly.)

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Drugs Protected by US Patent 11,458,095

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 NORLIQVA amlodipine besylate SOLUTION;ORAL 214439-001 Feb 24, 2022 RX Yes Yes 11,458,095 ⤷  Start Trial Y NORLIQVA IS INDICATED FOR THE TREATMENT OF HYPERTENSION, TO LOWER BLOOD PRESSURE IN ADULTS AND CHILDREN 6 YEARS OF AGE AND OLDER ⤷  Start Trial
Cmp Dev Llc NORLIQVA amlodipine besylate SOLUTION;ORAL 214439-001 Feb 24, 2022 RX Yes Yes 11,458,095 ⤷  Start Trial Y NORLIQVA IS INDICATED FOR THE SYMPTOMATIC TREATMENT OF CHRONIC STABLE ANGINA ⤷  Start Trial
Cmp Dev Llc NORLIQVA amlodipine besylate SOLUTION;ORAL 214439-001 Feb 24, 2022 RX Yes Yes 11,458,095 ⤷  Start Trial Y NORLIQVA IS INDICATED FOR THE TREATMENT OF CONFIRMED OR SUSPECTED VASOSPASTIC ANGINA ⤷  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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