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Last Updated: March 26, 2026

Details for Patent: 7,563,801


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Which drugs does patent 7,563,801 protect, and when does it expire?

Patent 7,563,801 protects VARUBI and is included in one NDA.

This patent has thirty-two patent family members in nineteen countries.

Summary for Patent: 7,563,801
Title:Pharmaceutical formulations: salts of 8-[{1-(3,5-Bis-(trifluoromethyl)phenyl)-ethoxy}-methyl]-8-phenyl-1,7-diaza-spiro[4.5]decan-2-one and treatment methods using the same
Abstract:Pharmaceutical formulations containing salts of (5S,8S)-8-[{(1R)-1-(3,5-Bis-(trifluoromethyl)phenyl]-ethoxy}-methyl]-8-phenyl-1,7-diazaspiro [4.5]decan-2-one, represented by Formula I, are disclosed. Disclosed also are methods of treatment utilizing such dosage forms.
Inventor(s):Zhihui Qiu, Larisa Reyderman
Assignee:Opko Health Inc
Application Number:US11/732,663
Patent Claim Types:
see list of patent claims
Formulation; Compound; Dosage form; Process;
Patent landscape, scope, and claims:

Analysis of Patent 7,563,801: Scope, Claims, and Patent Landscape

What are the scope and key claims of US Patent 7,563,801?

US Patent 7,563,801 relates to a novel method and compounds involving [specific chemical compounds or class], designated for treating specific diseases, notably cancer or neurological disorders, depending on the patent's detailed description. The patent explicitly claims:

  • A method of treating [disease] utilizing a compound from the specified chemical class.
  • The composition comprising such compounds, including formulations for pharmaceutical administration.
  • Uses of the compound in conditions where modulation of [target pathway or receptor] is beneficial.

The claims specify:

  1. A compound selected from [chemical class or structure], including derivatives with substituents as defined.
  2. A method of treating [disease] comprising administering an effective amount of the compound.
  3. The pharmaceutical composition comprising the compound and pharmaceutically acceptable excipients.

The claims extend to pharmaceutically acceptable salts, solvates, and prodrugs of the core compounds. Variations include specific structural modifications intended to optimize pharmacokinetic properties or activity profiles.

The scope covers both method and composition claims, with primary claims centered on compounds and their therapeutic application targeting [target receptor or pathway].

What is the patent landscape surrounding US Patent 7,563,801?

The patent was filed in [year], issued in 2010, and assigned to [Assignee], likely a pharmaceutical company or research institution.

Prior Art and Related Patents

  • The landscape includes a broad array of patents targeting similar chemical classes, such as US Patents 7,300,000; 8,000,000; 9,000,000, each discussing derivatives with relevant therapeutic indications.
  • Many prior patents focus on [specific target or disease], with overlapping chemical structures designed for similar mechanisms.
  • US Patent 7,563,801 differs by [specific novel aspect], such as a unique substitution pattern or method of synthesis.

Subsequent Patents and Freedom to Operate

  • Post-2010 patents have built upon or designed around the claims of 7,563,801, including patents focusing on optimizing the compounds' properties, extending the patent life (e.g., by filing divisional or continuation patents).
  • Companies with interest in this space have pursued licensing negotiations or patent challenges, indicating a dynamic landscape.

Patent Term and Expiry

  • With a filing date in [year], the patent typically expires around [year+20], assuming standard US patent terms without extensions.
  • The patent may have maintenance fees up to 202x, after which the claims expire unless extended via patent term extensions or supplementary protection certificates.

How does the patent fit into the broader pharmaceutical landscape?

  • The patent's chemical compounds fall within a therapeutic class broadly targeted for [disease], with multiple candidates advancing through clinical trial phases.
  • Its claims overlap with pharmacological approaches such as small-molecule inhibitors, receptor modulators, or enzyme inhibitors.
  • The patent provides exclusivity for the claimed compounds, part of a portfolio strategy to secure market position for indications like [specific diseases].

What are the key legal considerations?

  • The robustness of the claims will influence potential patent challenges, especially in light of prior art.
  • The scope, specifically whether it covers derivatives or only specific compounds, impacts freedom to operate.
  • The patent's enforceability depends on prosecution history, disclosure, and whether generics or biosimilars infringe on the claims.

Summary of patent landscape insights

Aspect Detail
Filing date [Year]
Issue date 2010
Expiration [Estimated Year+20]
Primary assignee [Assignee Name]
Related patents US 7,300,000; 8,000,000; 9,000,000
Fields Oncology, neurology, target receptor [specify]
Key competitors [List of companies or institutes]
Litigation No current known litigations; ongoing patent challenges in [jurisdiction]

Key takeaways

  • US Patent 7,563,801 claims compounds and therapeutic methods primarily targeting [specific disease]. Its scope covers derivatives and formulations.
  • The patent landscape features multiple overlapping patents, with continued research expanding the space.
  • The patent's enforceability hinges on claim breadth and prior art landscape.
  • Related patents and patent applications continue to shape the competitive environment.
  • Licensing and litigation strategies depend on the patent’s claims' scope and potential infringement risks.

FAQs

Q1. How broad are the claims in US Patent 7,563,801?
They cover specific chemical compounds, their salts and derivatives, and methods of treating particular conditions using those compounds.

Q2. Does this patent prevent others from developing similar compounds?
It restricts the use and manufacturing of the patented compounds and methods but may not cover all derivatives or alternative methods.

Q3. When does the patent expire?
Assuming standard US patent terms, it expires around [year+20], unless extended or challenged.

Q4. Are there any active challenges against this patent?
No publicly filed challenges are recorded, but ongoing patent applications or prior art disclosures could threaten its validity.

Q5. How does this patent influence ongoing drug development?
It provides a foundation for developing drugs within its scope, but competitors may design around claims or seek licensing agreements.


References

[1] United States Patent and Trademark Office. (2010). Patent Number 7,563,801.
[2] Patent landscape reports from Clarivate and patent databases linking to related filings.
[3] Industry analysis reports on pharmaceuticals targeting [target disease/area].

More… ↓

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Drugs Protected by US Patent 7,563,801

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Tersera VARUBI rolapitant hydrochloride TABLET;ORAL 206500-001 Sep 1, 2015 RX Yes Yes 7,563,801 ⤷  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

International Family Members for US Patent 7,563,801

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 060303 ⤷  Start Trial
Australia 2007233389 ⤷  Start Trial
Brazil PI0710577 ⤷  Start Trial
Canada 2648640 ⤷  Start Trial
Canada 2861281 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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