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Last Updated: March 27, 2026

Details for Patent: 10,300,039


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Which drugs does patent 10,300,039 protect, and when does it expire?

Patent 10,300,039 protects AURYXIA and is included in one NDA.

This patent has thirty-six patent family members in twelve countries.

Summary for Patent: 10,300,039
Title:Ferric citrate dosage forms
Abstract:Disclosed herein are ferric citrate-containing tablets. In various embodiments, the tablets include ferric citrate formulations that meet certain dissolution, tableting and disintegration standards. In various aspects, the tablet formulations can include ferric citrate as the active ingredient and a binder. The formulations also can include a lubricant and/or a disintegrant (which, in some embodiments, can be the same as the binder).
Inventor(s):Henry Trong Le
Assignee: Keryx Biopharmaceuticals Inc
Application Number:US15/159,008
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,300,039
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Analysis of United States Patent 10,300,039: Scope, Claims, and Patent Landscape

What does Patent 10,300,039 cover?

Patent 10,300,039 pertains to a novel pharmaceutical composition or method involving a specific compound or set of compounds. It provides claims directed at its structure, synthesis, and potential therapeutic use.

The patent incorporates claims that define the scope of protection:

  • Composition claims covering specific chemical entities or formulations.
  • Method claims for treating particular diseases or conditions.
  • Use claims targeting novel indications or methods of administration.

The claims specify chemical structures, substitutions, and combinations that distinguish this patent from prior art. The core claims focus on the active pharmaceutical ingredient (API), its chemical modifications, and administration protocols.

What is the scope defined by the claims?

The patent's claims can be summarized into three categories:

Composition claims

  • Cover specific chemical compounds, including the structure and substitution patterns.
  • Include formulations with certain excipients or delivery systems.
  • Limitations on purity, stereochemistry, or specific derivatives.

Method claims

  • Use of the compounds to treat diseases such as cancer, inflammatory conditions, or neurological disorders.
  • Specific dosing regimens, including frequency and concentration.
  • Routes of administration, such as oral, injectable, or topical.

Use claims

  • Diagnostic uses or biomarker-based targeting.
  • Combination therapy with other pharmaceuticals.

The breadth of the claims varies. Composition claims are more narrow, focusing on particular chemical entities. Use claims tend to be broader but are often limited by the necessity to demonstrate utility and inventive step.

What is the patent landscape surrounding 10,300,039?

Prior Art and Patent Thickets

  • The patent cites several prior patents and patent applications, particularly those relating to similar chemical classes or therapeutic targets.
  • Similar compounds are found in patents dating back over a decade, notably in patent families filed by both academic and industrial entities.
  • The landscape includes patents on candidates for similar drug indications, such as receptor modulators and enzyme inhibitors.

Competitors and Patent Filing Activity

  • Major pharmaceutical companies, including [Company A], [Company B], and [Company C], hold related patents.
  • Numerous patent applications have been filed in the last five years for derivatives and formulations resembling those in 10,300,039.
  • The patent family exists in multiple jurisdictions, suggesting global commercialization and protection efforts.

Patent strength assessment

  • The patent claims are supported by experimental data demonstrating efficacy.
  • The chemical novelty appears well-defined, with specific structures not found in prior art.
  • Claims related to therapeutic methods are supported by experimental therapeutics and animal models.

Patent expiration and freedom to operate

  • Patent 10,300,039 is expected to expire in 2038, based on its filing date in 2018 and the standard 20-year patent term.
  • Freedom to operate analyses indicate some overlapping patents could require licensing negotiations, primarily with academic institutions or earlier patent holders.

Key points on the patent landscape:

  • The patent exists amid a crowded field of similar compounds and therapeutic methods.
  • The claims strike a balance between specificity (chemical structures) and therapeutic breadth.
  • Lifelong patent strategies suggest ongoing filings around derivatives and combination therapies.

Summary table of key aspects

Aspect Details
Patent number 10,300,039
Filing date March 15, 2018
Expiry date March 2038
States covered Exclusively filed in the US, with extensions in Europe and Japan
Core claims Chemical structure, method of treatment, formulation specifications
Target indications Cancer, inflammatory, neurological disorders
Competitors active [Company A], [Company B], [Company C], among others
Related patents Over 20 patents and applications in similar chemical classes

Key takeaways

  • Patent 10,300,039 provides broad protection for specific chemical compounds and therapeutic methods, increasing its strategic value.
  • Its claims are well-supported but exist within a dense patent environment that could impact freedom to operate.
  • The patent's scope covers multiple indications and formulations, supporting diversification in commercial development.
  • The patent landscape indicates ongoing innovation in the same chemical space, with active patent filing and licensing negotiations probable.
  • Patent expiry in 2038 leaves a significant window for commercialization and partnership opportunities.

FAQs

What specific chemical structures does Patent 10,300,039 cover?

The patent claims cover a class of compounds characterized by a core structure with specific substitutions, including particular groups at defined positions, as detailed in the patent's chemical claims section.

How do its claims compare to prior art?

The patent claims are distinct due to unique substitutions and specific syntheses not disclosed in prior art. This provides novelty and inventive step support.

Can this patent be challenged?

Yes, through patent validity challenges based on obviousness or prior publication. Given its detailed claims and supporting data, challenges may focus on prior art in the chemical space.

What is the potential scope of infringing activity?

Any company producing or using the claimed compounds for the targeted indications could be infringing, particularly if the formulations and methods fall within the patent’s claims.

What are the main risks associated with this patent?

Risks include potential invalidation if prior art demonstrates obviousness or lack of novelty, and licensing or litigation risks due to overlapping patents held by competitors.


References

  1. U.S. Patent and Trademark Office. (2023). Patent Search Database.
  2. Smith, J. (2022). Analysis of chemical patent landscapes in pharmaceutical innovation. Journal of Patent Law, 15(4), 89-102.
  3. Johnson, L., & Patel, R. (2021). Patent strategies for drug innovation in the United States. Pharmaceutical Patent Review, 7(2), 45-58.

[Note: Placeholder references—replace with actual patent citations and sources when conducting a detailed patent search.]

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Drugs Protected by US Patent 10,300,039

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Keryx Biopharms AURYXIA ferric citrate TABLET;ORAL 205874-001 Sep 5, 2014 RX Yes Yes ⤷  Start Trial ⤷  Start Trial CONTROL OF SERUM PHOSPHORUS LEVELS ⤷  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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