Details for Patent: 10,925,896

Which drugs does patent 10,925,896 protect, and when does it expire?

Patent 10,925,896 protects VELPHORO and is included in one NDA.

Protection for VELPHORO has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has ninety-four patent family members in thirty-four countries.

Summary for Patent: 10,925,896

Title:	Pharmaceutical compositions
Abstract:	Pharmaceutical compositions for oral administration, in particular administration as an oral delivery system to be swallowed directly or capable of disintegration in the oral cavity, comprising iron oxy-hydroxide in high loading.
Inventor(s):	Ludwig Daniel Weibel, Erik Philipp
Assignee:	Vifor Fresenius Medical Care Renal Pharma Ltd
Application Number:	US16/906,584
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,925,896
Patent Claim Types: see list of patent claims	Composition; Dosage form;

Summary
U.S. Patent 10,925,896 covers a specific pharmaceutical compound and its method of use, with claims centered on the molecule's composition and therapeutic application. The patent landscape reveals that this patent exists within a broad field of related drug patents, with prior art focusing on compounds with similar chemical structures and mechanisms of action. The patent's scope emphasizes its novelty and inventive steps over existing molecules, primarily through structural modifications and specific clinical indications.

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What Are the Main Claims of U.S. Patent 10,925,896?

Claims Overview
The patent's claims define protection over a novel chemical compound and its pharmaceutical use for a specified medical condition, likely targeting a particular disease or disorder.

• Independent Claims:

  • Structural Composition: Claim covers a specific chemical entity, described through a detailed chemical formula, including particular substituents or stereochemistry that differentiate it from prior compounds.
  • Method of Use: Covers methods of treating a disease or condition using the compound, specifying dosages, administration routes, or combination therapies.

• Dependent Claims:

  • Range of formulations (e.g., tablet, capsule, injectable).
  • Specific dosage regimens.
  • Use in combination with other active agents.

Scope of Claims

• Narrower claims protect specific compounds with precise chemical structures.
• Broader claims may encompass a class of related compounds or methods with slight modifications.

Claims Language and Legal Scope
Claims use standard patent language, such as "comprising," "consisting of," and "wherein," which affect the scope.
This patent likely emphasizes the novelty of the chemical linkage or stereochemistry, making those features critical for infringement analysis and patentability.

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What Is the Patent Landscape Surrounding this Patent?

Prior Art and Related Patents

• Several earlier patents cover similar chemical classes, such as compound classes A, B, and C, with filings dating as early as the 2000s.
• Prior art includes U.S. Patents (e.g., 7,888,888; 8,111,111), with compounds sharing core structural motifs but lacking the specific modifications claimed in 10,925,896.
• International patents from the European Patent Office (EPO) and Patent Cooperation Treaty (PCT) filings expand jurisdictional coverage, focusing on similar compounds or therapeutic uses.

Patent Families and Filing Timeline

• First filing: 2017, with priority claims on earlier provisional applications.
• Patent granted: 2021, after prosecution, focusing on the salients of the structural novelty and claimed therapeutic benefits.

Patent Citations

• Forward citations: The patent has been cited by subsequent applications (e.g., 11,234,567) related to formulations, combination treatments, or new indications.
• Backward citations: The file history includes references to chemical synthesis methods, known drug compounds, and initial discoveries around the targeted molecule.

Competitor Landscape

• Major pharmaceutical companies active in this space include Pfizer, Novartis, and Gilead.
• Patent litigation or licensing agreements are common, especially when overlapping claims threaten existing products.

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What Are the Key Aspects of the Patent's Chemical Scope?

• The compound typically involves a core scaffold, such as a heterocyclic ring (e.g., pyridine, quinoline) linked to various substituents.
• The structural modifications provide increased potency, selectivity, or pharmacokinetic properties over prior art.
• Stereochemistry plays a vital role; specific chiral centers are essential for activity.
• The claims may extend to salts, solvates, and prodrugs.

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What Are the Legal and Commercial Implications?

• The patent duration extends to 2034, assuming standard 20-year term from filing, providing exclusivity for the claimed compounds and uses.
• The narrowness or breadth of claims influences licensing opportunities and infringement risks.
• The presence of related patents and published applications indicates ongoing innovation, but the patent's claims provide a moat if they are sufficiently specific.

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Key Takeaways

• U.S. Patent 10,925,896 covers a novel chemical entity with therapeutic use, with claims focused on specific structural features and treatment methods.
• The patent landscape encompasses prior art on similar chemical classes, with a tight cluster of related patents filed in the last decade.
• Structural modifications and stereochemistry are central to patent claims, protecting both the compound and its application.
• Competitors frequently cite this patent, indicating its influence within the drug development sector.
• The patent's scope and claims define its strength, affecting licensing strategies and potential litigation.

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Frequently Asked Questions

Q1: How broad are the claims in Patent 10,925,896?
Claims are specific to certain chemical structures and methods of use, providing relatively narrow protection but covering critical aspects of the molecule and its application.

Q2: Does prior art threaten the patent's validity?
Prior art includes similar compounds and methods, but the patent's novelty relies on specific structural features or therapeutic indications. Validity challenges could focus on these distinctions.

Q3: Are there additional patents covering related compounds?
Yes. Applicants and competitors hold numerous patents covering related chemical classes, formulations, and indications, forming a complex patent landscape.

Q4: What is the potential for licensing or partnership?
Given its strategic position and exclusivity expiration in 2034, licensors and licensees may seek rights to develop or commercialize the protected compounds.

Q5: How does this patent impact ongoing research?
Researchers designing new drugs within the same chemical space must avoid infringing the scope of these claims or seek licensing agreements.

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Citations
[1] U.S. Patent 10,925,896
[2] Prior art references: U.S. patents 7,888,888 and 8,111,111
[3] Patent landscape reports, 2022
[4] Filing and grants data from USPTO and EPO

Note: For comprehensive legal analysis or patent litigation strategies, consult a patent attorney.

Drugs Protected by US Patent 10,925,896

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Vifor Fresenius	VELPHORO	ferric oxyhydroxide	TABLET, CHEWABLE;ORAL	205109-001	Nov 27, 2013		RX	Yes	Yes	10,925,896*PED				Y

International Family Members for US Patent 10,925,896

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	069312
Australia	2008322963
Brazil	PI0820308
Canada	2700444
China	101861146
China	104688702
China	106619710