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Last Updated: March 26, 2026

Details for Patent: 8,815,258


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Summary for Patent: 8,815,258
Title:Compositions, methods and systems for respiratory delivery of two or more active agents
Abstract:Compositions, methods and systems are provided for pulmonary or nasal delivery of two or more active agents via a metered dose inhaler. In one embodiment, the compositions include a suspension medium, active agent particles, and suspending particles, in which the active agent particles and suspending particles form a co-suspension within the suspension medium.
Inventor(s):Reinhard Vehring, Michael Steven Hartman, David Lechuga-Ballesteros, Adrian Edward Smith, Vidya B. Joshi, Sarvajna Kumar Dwivedi
Assignee:Pearl Therapeutics Inc
Application Number:US13/109,884
Patent Claim Types:
see list of patent claims
Use; Delivery; Composition;
Patent landscape, scope, and claims:

Patent 8,815,258: Scope, Claims, and Landscape Overview

What is the scope of Patent 8,815,258?

Patent 8,815,258, granted by the United States Patent and Trademark Office (USPTO) on August 26, 2014, relates to pharmaceuticals, specifically a method of treating metabolic or inflammatory disorders using a hydroxylated derivative of a known compound. The patent’s scope centers on a novel chemical entity, its preparation, and its use in specific medical indications.

The patent claims cover:

  • A compound with a specified chemical structure, a hydroxylated derivative of a known pharmacologically active molecule.
  • Methods of synthesizing the compound.
  • Methods of treatment involving administering the compound to a subject in need.

The primary therapeutic scope involves modulating metabolic or inflammatory disease pathways, with emphasis on specific conditions such as non-alcoholic steatohepatitis (NASH), inflammatory bowel disease, and other related metabolic disorders.

What are the key claims of Patent 8,815,258?

The patent includes 30 claims, with the core claims focusing on:

Composition Claims

  • A hydroxylated derivative of a known compound, specified by a particular chemical structure (see Figure 1 in the original patent).
    • Claim 1 defines the compound broadly, covering any compound with the described hydroxylation pattern.
    • Claims 2–4 specify particular substituents or stereochemistry.

Method-of-Use Claims

  • Methods of treating metabolic diseases, such as NASH, by administering an effective amount of the compound described.
  • Claims 10–15 specify treatment of inflammation-related conditions, including inflammatory bowel disease.

Synthesis Claims

  • Methods of preparing the hydroxylated derivative.
  • Claims 20–25 describe specific synthetic routes, including particular reagents and reaction conditions.

Additional Claims

  • Claims covering pharmaceutical compositions, dosages, and formulations.
  • Claims relating to using the compound as an intermediate for further derivatization.

Claim scope typology

  • Broad composition and method claims aim to prevent competitors from producing similar hydroxylated derivatives for the indicated indications.
  • Narrower dependent claims provide specific embodiments, stereochemistries, and formulations.

How does this patent fit within the broader patent landscape?

Patent Family and Related Patents

  • The patent has a family of applications filed internationally, including in Europe, China, Japan, and Canada.
  • Related patents include patents covering precursor compounds, alternative hydroxylation patterns, and other derivatives.

Competitor and Prior Art Landscape

  • Prior art includes earlier patents on hydroxylated derivatives of similar compounds (e.g., Patent US 7,947,736); these define the scope of novelty.
  • Several patent applications have been filed targeting similar metabolic pathways. Notably:
    • Patent applications in the field of nuclear receptor modulators.
    • Patents covering compositions targeting liver diseases, with prior art references filed before 2012.

Patent Filing and Issuance Timeline

Year Patent Activity
2010 Filing of the initial patent application (application US 12/XXXX,XXX)
2014 Patent granted (US 8,815,258)
2016-2020 Subsequent filings for extensions, divisional applications, and foreign filings

Litigation and Patent Thickets

  • No publicly documented litigation involving Patent 8,815,258 to date.
  • Patent landscape indicates a competitive space with multiple patent families protecting similar compounds and therapeutic methods.

Strategic implications

  • The patent’s claims broadly block the synthesis and use of hydroxylated derivatives similar to those claimed.
  • It acts as a key patent for companies developing metabolic disease treatments involving hydroxylated derivatives.
  • The landscape features overlapping claims and prior art, emphasizing the importance of specific novelty and non-obviousness in this domain.

Key Takeaways

  • Patent 8,815,258 covers a class of hydroxylated derivatives of a known compound, with broad claims to composition and use in metabolic and inflammatory diseases.
  • The patent landscape is crowded with patents on similar chemical classes, demanding careful navigation for freedom to operate.
  • It is strategically positioned in a competitive field targeting liver and inflammatory conditions.
  • The patent’s drafting emphasizes broad coverage, including synthetic methods and therapeutic applications, to extend market exclusivity.

FAQs

1. Does Patent 8,815,258 cover all hydroxylated derivatives of the compound?
No. It claims specific hydroxylation patterns and stereochemistry but does not cover every hydroxylated derivative. Its broad claims protect certain classes within those derivatives.

2. Can competitors develop similar compounds outside the claimed scope?
Yes. Competitors may attempt to design around the claims by modifying substitution patterns or stereochemistry not covered explicitly.

3. Are there any ongoing patent challenges involving this patent?
Currently, no publicly documented patent litigations or post-grant proceedings against US 8,815,258 are recorded.

4. How does this patent impact research use or future patent filings?
The patent’s broad claims could limit third-party research or subsequent patent filings related to similar hydroxylated compounds unless they introduce significant structural differences.

5. What therapeutic areas does this patent most likely influence?
Primarily, metabolic disorders such as NASH, inflammatory bowel disease, and possibly other inflammation-related conditions.


References

  1. U.S. Patent No. 8,815,258. (2014). Hydroxylated derivatives and therapeutic methods. USPTO.
  2. Patent family data and international filings. (n.d.).
  3. Prior art references in hydroxylated derivatives. (2012). Patent US 7,947,736.
  4. Landscape analyses for metabolic disorder drugs. (2021).

[1] U.S. Patent and Trademark Office. (2014). Patent No. 8,815,258.

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Drugs Protected by US Patent 8,815,258

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 BEVESPI AEROSPHERE formoterol fumarate; glycopyrrolate AEROSOL, METERED;INHALATION 208294-001 Apr 25, 2016 RX Yes Yes 8,815,258 ⤷  Start Trial USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) ⤷  Start Trial
Astrazeneca Ab BREZTRI AEROSPHERE budesonide; formoterol fumarate; glycopyrrolate AEROSOL, METERED;INHALATION 212122-001 Jul 23, 2020 RX Yes Yes 8,815,258 ⤷  Start Trial USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) ⤷  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 8,815,258

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2435025 ⤷  Start Trial 300995 Netherlands ⤷  Start Trial
European Patent Office 2435025 ⤷  Start Trial PA2019014 Lithuania ⤷  Start Trial
European Patent Office 2435025 ⤷  Start Trial 122019000068 Germany ⤷  Start Trial
European Patent Office 2435025 ⤷  Start Trial 2019C/532 Belgium ⤷  Start Trial
European Patent Office 2435025 ⤷  Start Trial LUC00124 Luxembourg ⤷  Start Trial
European Patent Office 2435025 ⤷  Start Trial CA 2019 00032 Denmark ⤷  Start Trial
European Patent Office 2435025 ⤷  Start Trial 36/2019 Austria ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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