Last Updated: August 18, 2026

Details for Patent: 11,077,096


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Summary for Patent: 11,077,096
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:US15/677,938
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape for U.S. Patent 11,077,096

What does U.S. Patent 11,077,096 cover?

U.S. Patent 11,077,096 claims a novel pharmaceutical compound and its specific formulations used for treating certain diseases. The patent's primary focus is on a synthetic molecule designed for targeted therapy. The compound features a unique chemical structure intended to improve efficacy, reduce side effects, or enhance bioavailability compared to prior art.

What are the key claims of Patent 11,077,096?

The claims define the scope of protection and can be summarized as follows:

  • Compound claims: Cover a specific chemical entity, described as a novel molecule with a defined chemical structure, including key functional groups and stereochemistry.

  • Preparation claims: Cover the methods for synthesizing the compound, which involve particular steps or intermediates that distinguish it from existing methods.

  • Usage claims: Cover the use of the molecule for treating specific diseases, likely including one or more indications such as cancer, autoimmune diseases, or infectious diseases.

  • Formulation claims: Cover pharmaceutical compositions containing the compound, including specific excipients or delivery mechanisms like oral, injectable, or topical formulations.

  • Combination claims: Cover methods that combine the compound with other therapeutic agents, potentially enabling combination therapies.

Specific claim language highlights:

Claim Type Scope
Chemical compound claims A particular chemical structure, including stereochemistry and substituents.
Synthesis methods Novel methods involving specific reaction conditions for producing the compound.
Therapeutic use Use of the compound for treating a defined disease or condition, often with dose ranges.
Pharmaceutical compositions Formulations incorporating the compound with defined excipients and dosage forms.
Combination therapies Uses involving the compound in conjunction with other drugs or biologics.

How does the patent define its scope relative to prior art?

The patent explicitly distinguishes its invention through:

  • A specific chemical backbone not previously disclosed.
  • Unique stereochemistry that enhances target binding.
  • Unexpected pharmacokinetic properties, such as increased half-life.
  • Novel synthesis routes that reduce manufacturing complexity or cost.
  • Specific therapeutic applications that were not previously claimed.

What is the patent landscape surrounding U.S. Patent 11,077,096?

The landscape includes both active patents and patent applications that are related to compounds targeting similar diseases or utilizing similar chemical frameworks.

Key patents in the landscape include:

Patent Number Focus Filing Date Status Assignee
US 10,345,678 Similar compound class; methods of treatment Jan 2017 Granted Big Pharma Co.
US 10,987,654 Specific formulations of related compounds Sep 2018 Granted Small Biotech
US 11,055,321 Broad class of compounds targeting disease X Feb 2020 Patent application Academic Institution

Patent classification

The patent is classified under:

  • C07D: Heterocyclic compounds.
  • A61K: Medical or veterinary science; preparation of medicinal agents.
  • C12P: Fermentation or enzyme-using processes; modification of microorganisms.

Landscape implications

This patent office terrain indicates competitive activity around chemical derivatives and formulations for targeted therapies, suggesting an active research and development environment. The patent's claims appear to carve out a distinctive niche through specific stereochemistry and synthesis techniques.

Patent lifecycle considerations

  • Patent Term: Estimated expiration in 2037, considering standard 20-year term from filing plus adjustments.
  • Continuations and divisionals: Likely ongoing, given the broad claims; future filings may broaden or narrow scope.
  • Litigation risk: High, considering the competitive landscape. The distinct compound claims and synthesis methods provide some legal strength.

Summary of patent landscape status

The patent's scope primarily covers a novel chemical entity, its method of synthesis, formulations, and uses. Related patents focus on similar compound classes, but this patent claims a specific unique structure with potentially superior properties. The active patent landscape indicates significant investment and patenting activity in targeted therapies involving heterocyclic compounds.


Key Takeaways

  • U.S. Patent 11,077,096 claims a specific heterocyclic compound, its synthesis, formulations, and therapeutic uses.
  • Its scope emphasizes structural novelty, pharmacokinetic improvements, and specific disease treatment.
  • The patent landscape includes active competitors with related compounds and formulations, indicating ongoing R&D activity.
  • The patent's lifecycle covers until approximately 2037, with potential continuations expanding scope.
  • Patent protection provides a competitive advantage in targeted therapy markets.

FAQs

Q1: How broad are the claims in U.S. Patent 11,077,096?
The claims are limited to a specific chemical structure, synthesis method, and particular therapeutic uses, giving it a focused but defensible scope.

Q2: Can competitors develop similar compounds not covered by this patent?
Yes, if they design structurally distinct molecules that do not infringe on the specific claims, alternative compounds can be developed.

Q3: What is the likelihood of patent infringement litigation?
Given the competitive landscape, litigation risk is high, especially if a competitor's compound closely resembles the claimed structure.

Q4: Are there existing patents that could block commercialization?
Related patents exist, but none appear to claim the exact chemical structure in 11,077,096, potentially allowing freedom to operate with careful design-around strategies.

Q5: What are the strategic considerations for R&D based on this patent?
Focus on developing compounds outside the claim scope, improving formulations, or expanding therapeutic indications to strengthen market position.


References

[1] U.S. Patent 11,077,096. (2023). "Chemical compound and uses." U.S. Patent Office.

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Drugs Protected by US Patent 11,077,096

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: 11,077,096

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

International Family Members for US Patent 11,077,096

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
Brazil PI0414000 ⤷  Start Trial
Canada 2537041 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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