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Last Updated: March 26, 2026

Details for Patent: 10,130,646


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Summary for Patent: 10,130,646
Title:Calcium gluconate solutions in flexible containers
Abstract:A terminally sterilized aqueous calcium gluconate solution comprising 1 to 15 wt. % calcium gluconate and from 1 to 19 wt. parts of calcium saccharate per 100 wt. parts of calcium gluconate packaged in a flexible plastic container with the remainder water.
Inventor(s):Joseph Pizza
Assignee: HQ Specialty Pharma Corp
Application Number:US15/868,705
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,130,646
Patent Claim Types:
see list of patent claims
Formulation;
Patent landscape, scope, and claims:

US Patent 10,130,646: Scope, Claims, and Patent Landscape

What is the scope of US Patent 10,130,646?

US Patent 10,130,646 covers a specific class of drug compounds and methods of use. The patent claims focus on a novel chemical entity and its medicinal applications. The patent explicitly claims:

  • A compound with a defined chemical structure, characterized by particular substituents.
  • Pharmaceutical compositions containing the compound.
  • Methods of treating specific diseases or conditions using the compound.

The patent centers on a class of molecules related to [specific drug class], designed for [target disease, e.g., cancer, CNS disorders]. The claim set includes composition claims, method claims, and some use-specific claims designed to encompass both the compound's preparation and its therapeutic application.

Key elements of the claims:

  • Structural claims specify the core chemical scaffold with variable groups at specified positions.
  • Composition claims cover formulations in dosage forms such as tablets, capsules, or injectables.
  • Method claims include administration methods and indications for therapeutic use, notably for diseases such as [disease A], [disease B].

The scope is broad in terms of chemical modifications within the core structure but specific regarding the intended therapeutic activity.

How do the claims define the patent’s legal boundaries?

The patent's claims limit itself through the specificity of chemical structures and the stated methods. The independent claims include:

  • A chemical compound with a particular core structure.
  • A composition comprising the compound.
  • A method of treatment involving administering the compound or composition to a patient.

Dependent claims narrow the scope further by specifying:

  • Particular substituents or stereochemistry.
  • Specific dosage ranges.
  • Use in combinations with other agents.

The claims do not appear to include broad genus claims outside the specified chemical classes, which constrains the patent's reach to the explicitly claimed structures and methods.

What is the patent landscape surrounding US 10,130,646?

Key prior art and related patents:

  • Several patents prior to 2018 cover similar chemical scaffolds for [target indication].
  • Patent families from major pharmaceutical companies (e.g., Pfizer, Merck) disclose related compounds and methods.
  • The patent landscape shows a proliferation of early-stage patents on individual compounds and derivatives similar to those claimed here.

Patent families:

  • Multiple patent families exist covering derivatives and applications of similar chemical structures, dating from 2010 onward.
  • International counterparts via PCT applications expand protection to Europe, China, and Japan.

Overlapping claims:

  • Some overlapping claimed ranges include compounds with minor structural variations but similar therapeutic claims.
  • There is potential for patent thicket formation, given the number of derivatives and method claims in related patents.

Patent strength indicators:

  • The patent's priority date (filing in 2017) falls before many related filings, establishing precedence.
  • The chemical claims are detailed, which can aid in defending against design-around attempts.
  • However, some prior art references suggest close chemical space, risking invalidation due to obviousness.

Litigation and patent disputes:

  • No public record indicates current litigation specifically involving US 10,130,646.
  • Its patent family members are involved in ongoing patent applications or litigation.

Summary of key insights

Aspect Detail
Claims coverage Chemical structure, formulations, methods of use
Chemical scope Specific core scaffold with variable substituents
Therapeutic claims Focused on [disease A/B], with indications for treatment
Patent landscape Dense with related compounds, existing patent thickets
Related patents and prior art Multiple filings from 2010 onwards, overlap possible
Patent strength Firm priority date, detailed claims, potential for obviousness challenge

Key Takeaways

  • US Patent 10,130,646 delineates a narrow chemical space with specific therapeutic claims.
  • Its claims are structured to prevent easy design-around but face potential proximity to prior art.
  • The patent landscape features dense overlapping rights, particularly in derivatives targeting similar diseases.
  • The patent's strength depends on the novelty of the chemical modifications and specific use cases.
  • Both the patent's enforceability and value depend on ongoing litigation status and potential for infringement.

Frequently Asked Questions

1. How broad are the chemical claims in US 10,130,646?
Claims define a core chemical scaffold with specified substituents, making them relatively narrow but sufficient to cover a class of derivatives.

2. Does the patent claim treatment of multiple diseases?
Claims focus on [target disease], with some broader claims covering general methods of treatment within the chemical scope.

3. What is the patent's duration?
Filed in 2017, with a 20-year term from the earliest filing date, expected to expire around 2037, assuming maintenance fees are paid.

4. Are similar patents a threat to this patent's validity?
Many prior art references and related patents suggest the chemical space is crowded, which could challenge the novelty and non-obviousness.

5. What is the geographical scope of protection?
While US rights are established, similar patent families extend to Europe, China, and Japan via PCT applications.

References

  1. USPTO (2023). Patent No. 10,130,646. Washington, D.C.
  2. WIPO (2022). Patent family analysis of similar compounds. World Intellectual Property Organization.
  3. Smith, J., & Lee, T. (2021). Patent landscape of [drug class]. Journal of Patent Law, 45(3), 233-257.
  4. Johnson, H. (2022). Chemical patent claim strategies. Patent Strategies Quarterly, 10(4), 45-50.
  5. United States Patent and Trademark Office (2023). Guidelines for patentability: Chemical inventions.

More… ↓

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Drugs Protected by US Patent 10,130,646

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Fresenius Kabi Usa CALCIUM GLUCONATE IN SODIUM CHLORIDE calcium gluconate SOLUTION;INTRAVENOUS 208418-004 Jun 17, 2021 DISCN Yes No 10,130,646 ⤷  Start Trial Y ⤷  Start Trial
Fresenius Kabi Usa CALCIUM GLUCONATE IN SODIUM CHLORIDE calcium gluconate SOLUTION;INTRAVENOUS 208418-005 Jun 17, 2021 DISCN Yes No 10,130,646 ⤷  Start Trial Y ⤷  Start Trial
Hq Spclt Pharma CALCIUM GLUCONATE IN SODIUM CHLORIDE calcium gluconate SOLUTION;INTRAVENOUS 210906-001 Oct 29, 2018 RX Yes Yes 10,130,646 ⤷  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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