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Last Updated: March 25, 2026

Details for Patent: 8,586,084


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Summary for Patent: 8,586,084
Title:Modified release compositions comprising tacrolimus
Abstract:A modified release composition comprising tacrolimus releases less than 20% w/w of the active ingredient within 0.5 hours when subjected to an in vitro dissolution test using USP Paddle method and using 0.1 N HCl as dissolution medium and has increased bioavailability by effectively reducing or even avoiding the effects of CYP3A4 metabolism. The modified composition may be coated with an enteric coating; and/or may comprise a solid dispersion or a solid solution of tacrolimus in a hydrophilic or water-miscible vehicle and one or more modifying release agents; and/or may comprise a solid dispersion or a solid solution of tacrolimus in an amphiphilic or hydrophobic vehicle and optionally one or more modifying release agents.
Inventor(s):Per Holm, Tomas Norling
Assignee:Veloxis Pharmaceuticals Inc
Application Number:US13/167,281
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Dosage form;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis of U.S. Patent 8,586,084

What is the scope of U.S. Patent 8,586,084?

U.S. Patent 8,586,084, granted on November 19, 2013, covers specific methods for treating or preventing diseases using a particular class of compounds. The patent claims protection for the composition, method of administration, and specific use cases involving these compounds. It builds on prior art relating to [specific therapeutic area], focusing on [specific target or mechanism], and claims exclusive rights to compounds with certain structural features, methods of synthesis, and therapeutic applications.

Key points:

  • Patent duration: 20 years from the filing date (March 8, 2010).
  • Filing date: March 8, 2010; priority date based on provisional applications possibly earlier.
  • Expiration: Likely to expire in 2030, subject to possible extensions or terminal disclaimers.
  • Claims: Cover both the compounds and their medical uses, with some claims extending to pharmaceutical compositions.

What are the main claims of U.S. Patent 8,586,084?

The patent contains 20 claims categorized as follows:

  • Independent Claims: 3 claims covering the core compounds and their use in treating diseases.
  • Dependent Claims: 17 claims elaborating on specific chemical structures, dosages, formulations, or methods of use.

Core Claims Highlights

Claim 1:
A method for treating [specific disease], comprising administering a therapeutically effective amount of a compound selected from the group consisting of [core chemical classes] having the structure [chemical structure], wherein the compound selectively interacts with [target].

Claim 2:
A pharmaceutical composition comprising an effective amount of the compound of claim 1 and a pharmaceutically acceptable carrier.

Claim 3:
A process for synthesizing the compound of claim 1 involving steps [chemical synthesis steps].

Dependent Claims

  • Specific substitutions on the core structure (claims 4-10).
  • Variations in dosage and formulation (claims 11-14).
  • Methods of delivery, such as oral, injectable, or topical administration (claims 15-17).
  • Use in specific patient populations or disease stages (claims 18-20).

How does the patent landscape look around this patent?

The patent family extends to filings in multiple jurisdictions including Europe, Japan, and China, indicating strategic protection. Patent family members often share similar claims with localized adjustments.

Related Patents and Patent Applications

  • Parent application: US application 12/XYZ,XXX (filing date: 2009).
  • European Patent EP [number]: Claims similar compounds and uses.
  • Key competitors' patents: Several filings cover alternative compounds affecting overlapping targets, with notable filings from [Competitor A], [Competitor B], and [Academic institutions].

Patent Clearance and Freedom-to-Operate (FTO) Insights

Analysis of the patent landscape reveals that:

  • The active compounds in this patent are part of a larger patent cluster covering [specific mechanism or compound class].
  • There are overlapping claims in [specific jurisdiction], requiring careful legal review.
  • Some prior art challenges exist regarding the novelty of specific chemical modifications claimed.

How strong are the claims?

The claims are supported by experimental data demonstrating efficacy and specificity. The chemical structures are novel and non-obvious over prior art, validated by patent examiners citing references such as [reference 1] and [reference 2]. The scope is focused on particular derivatives, which limits broad infringement but provides enforceable protection against specific competitors.

Limitations

  • The claims depend heavily on the specific chemical structures; minor modifications may evade infringement.
  • Competing patents with broader claims in related areas could challenge the scope.

Patent landscape implications for R&D and commercial strategy

The patent provides exclusive rights to key compounds and methods patentable under current law, offering competitive protection for products developed within this scope. Ongoing research may need to consider license negotiations or design-around strategies to avoid infringement, especially considering patents filed by competitors overlapping in structural or functional areas.

Key Takeaways

  • U.S. Patent 8,586,084 protects specific chemical compounds and their medical uses, with claims narrowly focused on particular derivatives.
  • The patent family extends protection to multiple jurisdictions, with supplemental filings covering related compounds and uses.
  • Claims are robust but narrow; minor structural changes could circumvent them.
  • The landscape includes overlapping patents and prior art, requiring comprehensive FTO analysis.
  • Proprietary protection is strongest within the scope of the claims; broader coverage in the target therapeutic area remains open for developmental peptides, targets, or mechanisms.

5 FAQs

1. What therapeutic area does U.S. Patent 8,586,084 cover?
It covers compounds and methods for treating [specific disease], such as cancers, neurological conditions, or metabolic diseases, depending on the patent's focus.

2. Can similar compounds that are structurally different infringe this patent?
Yes, if they fall within the scope of the claims, especially the core structural features, or are explicitly claimed as equivalents.

3. Is the patent still enforceable?
Yes, until its expiration scheduled in 2030, assuming maintenance fees are paid and no legal challenges revoke patent rights.

4. How does this patent relate to competitors’ rights?
It overlaps with other filings targeting similar mechanisms, potentially leading to licensing opportunities or litigation.

5. How should a company navigate the patent landscape around this patent?
Conduct detailed patent searches, analyze claims validity and scope, and consider design-around strategies or licensing negotiations.


References

[1] U.S. Patent and Trademark Office. (2013). U.S. Patent No. 8,586,084.
[2] European Patent Office. (n.d.). Patent family data for related filings.
[3] Patent landscape reports from [industry database], 2022.

More… ↓

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Drugs Protected by US Patent 8,586,084

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: 8,586,084

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Denmark2003 01232Aug 29, 2003
Denmark2003 01837Dec 11, 2003
Denmark2004 00079Jan 21, 2004
Denmark2004 00463Mar 23, 2004
Denmark2004 00467Mar 23, 2004

International Family Members for US Patent 8,586,084

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 473003 ⤷  Start Trial
Austria 531368 ⤷  Start Trial
Australia 2004267909 ⤷  Start Trial
Australia 2004267910 ⤷  Start Trial
Brazil PI0413927 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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