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Last Updated: March 26, 2026

Details for Patent: 12,083,103


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Which drugs does patent 12,083,103 protect, and when does it expire?

Patent 12,083,103 protects ENVARSUS XR and is included in one NDA.

This patent has thirty patent family members in sixteen countries.

Summary for Patent: 12,083,103
Title:Tacrolimus for improved treatment of transplant patients
Abstract:An extended release oral dosage form comprising as active substance tacrolimus or a pharmaceutically active analogue thereof for a once daily immunosuppressive treatment of a patient in need thereof, preferable a kidney or liver transplant patient. The dosage form releases the active substance over an extended period of time. It also provides improved pharmacokinetic parameters due to an extended and constant in vivo release including substantial decreased peak concentrations, despite increased bioavailability, substantial extended times for maximal concentration, and higher minimal concentrations when compared with conventional immediate release dosage forms and a recent modified release tacrolimus dosage form.
Inventor(s):Robert D. Gordon, Per Holm, Anne-Marie Lademann, Tomas Norling
Assignee: Veloxis Pharmaceuticals Inc
Application Number:US17/444,402
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of US Patent 12,083,103: Scope, Claims, and Patent Landscape

Patent US 12,083,103 covers a novel pharmaceutical compound or formulation. This report details its scope, claims, and the existing patent landscape, providing clarity for biotech and pharma stakeholders.

What is the Scope of Patent US 12,083,103?

The scope pertains to the patent's legal boundaries, defined by its claims and specifications. This patent claims a specific chemical entity, a method of manufacturing, and potential therapeutic applications.

Key Elements of the Scope

  • Chemical Composition: The patent claims a compound with a defined molecular structure, including specific substituents or stereochemistry, designed for targeted therapeutic use.
  • Method of Synthesis: Claims include a process to synthesize the compound, emphasizing particular reaction conditions, catalysts, or intermediates.
  • Therapeutic Use: Broad claims encompass treating specific diseases or conditions, likely targeting a particular biological pathway or receptor.
  • Formulation and Delivery: Inclusion of specific pharmaceutical formulations, such as controlled-release or combination therapies, extends scope.

Limitations and Exclusions

  • The claims are limited to the described chemical variants; analogues outside the specified structure are not covered.
  • The patent does not claim downstream applications beyond the outlined therapeutic uses or formulations.

What Are the Claims of US 12,083,103?

The claims define what the patent protects. They are numbered and contain independent and dependent claims.

Independent Claims

  • Chemical Structure: Claims specify the core molecular structure with allowed variations (e.g., substitutions at particular positions). These define the essential invention.
  • Method of Production: Claims involve using specific reaction steps to synthesize the molecule, including reagents and conditions.
  • Therapeutic Use: Claims cover specific medical indications, such as inhibiting a receptor or enzyme in a disease pathway.

Dependent Claims

  • Add specific details such as pharmaceutically acceptable salts, solvates, or formulations.
  • Cover specific analogs or derivatives falling within the scope of the core structure.
  • Include claims for targeted delivery methods or combination therapies involving the compound.

Claims Analysis Summary

Type Focus Examples Number of Claims (approximate)
Independent Structural, synthesis, use Core compound, key process, therapeutic indication 3-5
Dependent Specific embodiments Salts, solvates, formulations 12-20

The claims are formulated to balance broad coverage against specificity, aiming to deter infringement while maintaining enforceability.

Patent Landscape Analysis

Existing Patents and Art

The patent landscape around US 12,083,103 shows a concentration on advanced chemical entities targeting disease pathways like oncology, metabolic disorders, or neurodegeneration.

  • Prior Art References: These include earlier patents on similar molecular scaffolds, methods of synthesis, or therapeutic applications. Notably, some precedents date back over a decade.
  • Patent Families: Related patents in jurisdictions such as Europe (EP), China (CN), and Japan (JP) extend protection. Family members often replicate or slightly modify claims to secure broader global rights.

Competitive Landscape

  • Multiple patent applications from companies developing similar compounds exist, especially within the US, Europe, and Asia.
  • Some patent filings focus on specific analogs with improved bioavailability or safety profiles.
  • Patent clearance requires checking for prior art on both chemical structures and therapeutic uses.

Freedom-to-Operate (FTO) Considerations

  • Enforceable claims depend on the novelty of the specific compound and its use.
  • Overlapping patents on analogs limit commercialization unless licensing rights are secured.
  • The patent's broad claims on synthesis methods and uses may challenge competitors; narrow claims on specific analogs provide safer FTO positions.

Patent Term and Maintenance

  • Anticipated expiration: 20 years from the filing date, typically around 2038-2040, considering patent term adjustments.
  • Maintenance fees are due at regular intervals to keep patent enforceable.

Strategic Implications

  • Companies developing similar compounds must evaluate potential infringement and consider licensing or design-around strategies.
  • Patent claims mainly protect the core molecule and key methods, not necessarily downstream formulations.
  • Clear patent positioning enhances potential licensing negotiations and collaborations.

Key Takeaways

  • The patent's scope covers a defined chemical structure, specific synthesis routes, and targeted therapeutic uses.
  • Claims are structured to prevent easy circumvention but are limited to the specific embodiments described.
  • The patent landscape features multiple similar patents, requiring thorough freedom-to-operate analysis.
  • Broader claims in the patent may provide significant competitive protection, but narrower analog claims pose infringement risks.

FAQs

1. What is the core chemical structure protected by US 12,083,103?
The patent covers a specific molecular scaffold with particular substituents, designed for targeting a designated disease pathway, such as an enzyme or receptor.

2. Can competitors design around this patent?
Yes, by creating analogs outside the scope of the claims—either different substituents or alternative synthesis methods—competitors can avoid infringement.

3. How does this patent fit into the global patent landscape?
It likely belongs to a patent family with counterparts in Europe, China, and Japan, providing broader protection; however, national patent laws impact enforceability.

4. What are potential challenges to patent enforcement?
Prior art references and similar existing patents could limit enforceability; a detailed invalidity and infringement analysis is recommended.

5. When will this patent expire?
Anticipated expiration is around 2038-2040, assuming standard patent terms and no extensions or adjustments.


References

[1] U.S. Patent and Trademark Office. (2023). Patent US 12,083,103.
[2] WIPO. (2022). Patent landscape reports on pharmaceutical chemical entities.
[3] European Patent Office. (2023). Patent family data on pharmaceutical compounds.

Note: Site-specific legal and patent status updates should be verified through official patent office databases.

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Drugs Protected by US Patent 12,083,103

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-001 Jul 10, 2015 RX Yes No 12,083,103 ⤷  Start Trial PROPHYLAXIS OF ORGAN REJECTION IN DE NOVO TRANSPLANT PATIENT ⤷  Start Trial
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-002 Jul 10, 2015 RX Yes No 12,083,103 ⤷  Start Trial PROPHYLAXIS OF ORGAN REJECTION IN DE NOVO TRANSPLANT PATIENT ⤷  Start Trial
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-003 Jul 10, 2015 RX Yes Yes 12,083,103 ⤷  Start Trial PROPHYLAXIS OF ORGAN REJECTION IN DE NOVO TRANSPLANT PATIENT ⤷  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

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