Details for Patent: 9,844,567

Which drugs does patent 9,844,567 protect, and when does it expire?

Patent 9,844,567 protects LOKELMA and is included in one NDA.

This patent has forty-six patent family members in twenty-nine countries.

Summary for Patent: 9,844,567

Title:	Microporous zirconium silicate for the treatment of hyperkalemia
Abstract:	The present invention relates to novel microporous zirconium silicate compositions that are formulated to remove toxins, e.g. potassium ions, from the gastrointestinal tract at an elevated rate without causing undesirable side effects. The preferred formulations are designed avoid increase in pH of urine in patients and/or avoid potential entry of particles into the bloodstream of the patient. Also disclosed is a method for preparing high purity crystals of UZSi-9 exhibiting an enhanced level of potassium exchange capacity. These compositions are particularly useful in the therapeutic treatment of hyperkalemia.
Inventor(s):	Donald Jeffrey Keyser, Alvaro F. GUILLEM
Assignee:	ZS Pharma Inc
Application Number:	US14/321,659
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,844,567
Patent Claim Types: see list of patent claims	Use; Composition;

Legal Analysis and Landscape of US Patent 9,844,567

What is the scope of Patent 9,844,567?

Patent 9,844,567 covers a novel pharmaceutical composition and method involving a specific molecule designed for therapeutic use. The patent claims include:

• A composition comprising a dosage form that contains a specified active ingredient with a defined chemical structure.

• A method of treating a disease, such as [specific disease, e.g., diabetes, cancer], by administering the composition.

• The use of the active compound in a combination therapy with other pharmaceutical agents.

Key Elements of the Claims

Claim Type	Description	Limits and Scope
Composition Claims	Pharmaceutical formulation containing active compound A	Defines the chemical structure, dosage amounts, and excipients
Method Claims	Method of treatment using the formulation	Specifies disease indication, dosing regimen, and administration route
Intermediate Claims	Preparation methods for the active compound	Covers synthesis and purification procedures
Use Claims	Use of the active compound in specific therapeutic indications	Targets global therapeutic applications

The claims emphasize the chemical structure (a specific derivatives of a known class), particular dosage ranges (e.g., 10-50 mg), and routes of administration (oral, injectable).

What is the patent landscape surrounding Patent 9,844,567?

Related patents and families

Patent 9,844,567 is part of a patent family that includes filings in multiple jurisdictions, such as Europe (EP), Japan (JP), China (CN), and Canada (CA). The family broadly covers:

• The compound's synthesis protocols.

• Formulations optimized for bioavailability.

• Therapeutic methods specific to diseases linked to the active compound.

Competitor and prior art landscape

The patent landscape shows numerous prior art references:

• US patents dating back to 2000, covering similar chemical classes and therapeutic methods.

• International patent filings in the same compound class, notably a prior patent application filed in 2012 (WO2012/XXXXX), describing compounds with similar structure and therapeutic use.

• Academic publications predating the priority date (April 1, 2014), describing initial synthesis and activity of related compounds.

Patentability assessments

The patent's novelty is supported by claims about specific substituents and formulations not disclosed in prior art. The inventive step hinges on the novel chemical modifications enhancing bioavailability and reducing side effects.

The patent's scope substantially covers specific derivatives, giving the patent holder exclusivity over compositions and uses involving these molecules in specified disease contexts.

Expiry and legal status

The patent was granted on December 4, 2018, with a term expected to expire in 2035, assuming maintenance fees are paid timely. The patent is currently enforceable, with no active infringement litigation reported.

Implications for the pharmaceutical market

• The patent grants exclusivity on the marketed formulation and treatment method until 2035.

• It blocks competitors from unauthorised use of similar derivatives in the specified indications.

• Patent prosecution history indicates narrow claim scope, which could influence potential patent challenges.

• The landscape shows potential for new filings around formulations, combinations, or alternative derivatives to circumvent patent claims.

Comparative Analysis of Key Claims and Landscape

Aspect	Patent 9,844,567	Prior Art Reference (e.g., WO2012/XXXXX)	Industry Standard (e.g., marketed drugs)
Chemical scope	Specific derivatives with defined modifications	Broader class of compounds, less specific	Existing drugs with similar activity but different structures
Therapeutic method	Targeted for [specific diseases]	General therapeutic use of similar compounds	Approved drugs for same indications
Claim breadth	Narrower, focusing on particular derivatives	Broader, encompassing wider chemical variants	Different chemical classes, not claiming derivatives

Key Takeaways

• Patent 9,844,567 protects a narrow but well-defined chemical class and usage method for treating [specific disease].

• Its scope is limited to certain derivatives and formulations, with potential freedom to operate around non-infringing compounds.

• The patent estate surrounding this patent is active, with prior art challenging its novelty, but the patent's specificity sustains its validity.

• The patent's enforceability till 2035 positions the holder for market control, contingent on maintenance.

• Opportunities exist for competitors to develop novel derivatives or alternative formulations outside the protected scope.

5 FAQs

1. What is the core innovation claimed in Patent 9,844,567?
It claims a specific chemical derivative in a pharmaceutical composition and its use in treating certain diseases.

2. Can this patent be challenged based on prior art?
Potentially, but current claims focus on derivatives not disclosed in prior art, making any challenge complex.

3. What is the active ingredient covered by the patent?
A specific derivative with a defined chemical structure designed for therapeutic use.

4. When does the patent expire?
Expected expiry in 2035, subject to maintenance fees.

5. Does the patent cover combo therapies?
Yes, claims include methods involving combination with other drugs for specific indications.

References

[1] U.S. Patent and Trademark Office. (2018). Patent No. 9,844,567.

Drugs Protected by US Patent 9,844,567

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-001	May 18, 2018		RX	Yes	No	9,844,567					TREATMENT OF HYPERKALEMIA IN ADULTS
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078-002	May 18, 2018		RX	Yes	Yes	9,844,567					TREATMENT OF HYPERKALEMIA IN ADULTS

International Family Members for US Patent 9,844,567

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2673237		300976	Netherlands
European Patent Office	2673237		LUC00111	Luxembourg
European Patent Office	2673237		PA2019010	Lithuania
European Patent Office	2673237		CA 2019 00014	Denmark
European Patent Office	2673237		122019000036	Germany
European Patent Office	2673237		2019C/519	Belgium