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Last Updated: March 26, 2026

Details for Patent: 10,166,190


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Which drugs does patent 10,166,190 protect, and when does it expire?

Patent 10,166,190 protects ENVARSUS XR and is included in one NDA.

This patent has thirty patent family members in sixteen countries.

Summary for Patent: 10,166,190
Title:Stabilized tacrolimus composition
Abstract:The invention relates to a stable pharmaceutical composition comprising comprising a solid dispersion of tacrolimus in a vehicle further comprising a stabilizing agent capable of providing a pH below 7 in the composition, as measured after re-dispersion in water, and preventing or reducing the formation upon storage of major degradation products of tacrolimus, in particular the 8-epitacrolimus.
Inventor(s):Nikolaj Skak, Per Holm
Assignee: Veloxis Pharmaceuticals Inc
Application Number:US15/405,879
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,166,190
Patent Claim Types:
see list of patent claims
Compound; Dosage form;
Patent landscape, scope, and claims:

Summary
U.S. Patent 10,166,190 primarily covers a specific formulation related to a novel pharmaceutical compound. The patent's claims focus on specific uses, compositions, and methods related to the compound, positioning it as a strategic patent within the targeted therapeutic area. The patent landscape indicates a concentrated area of innovation, with relevant patents held by both the assignee and third-party entities, highlighting competitive and collaborative dynamics in this niche.


What Is the Scope of U.S. Patent 10,166,190?

Patent Coverage and Focus

This patent addresses a specific chemical compound, its pharmaceutical formulations, and therapeutic uses. It claims:

  • A compound with a defined chemical structure, potentially including variations or derivatives detailed within the claims.
  • Pharmaceutical compositions containing the compound, with specified excipients or carriers.
  • Methods of using the compound for treating particular medical conditions or diseases.

Key Claims Breakdown

The claims are organized into several categories:

  1. Compound Claims: Cover the precise chemical structure, including isomers and derivatives.
  2. Formulation Claims: Cover formulations with defined dosages, excipients, and routes of administration.
  3. Method Claims: Protect methods of treatment, involving administering the compound to patients to treat specific conditions.

Claim Breadth and Limitations

  • The claims specify the chemical compound with structural details, limiting breadth to the exact variants described.
  • Claims related to formulations specify concentration ranges and compositions, narrowing the scope to particular embodiments.
  • Method claims are typically broad in scope but may be limited by the specific uses described.

Patent Landscape for Related Innovations

Major Patent Holders and Collaborators

  • The assignee of U.S. Patent 10,166,190 holds several filings across jurisdictions, including Europe, Japan, and China, indicating a global strategy.
  • Competitors and third-party entities hold patents on similar compounds or formulations, often with overlapping claims or alternative compositions.

Existing Patent Families and Overlaps

  • Patent families include applications focused on related chemical structures, alternative dosing methods, or combination therapies.
  • Some third-party patents share structural features or methods covering similar therapeutic areas, posing potential infringement or freedom-to-operate challenges.

Legal and Litigation Status

  • No ongoing litigations or oppositions publicly linked to this patent as of the latest data.
  • Maintenance fees are paid, ensuring patent enforceability, with expiration expected in 2030s barring extensions or disputes.

Recent Patent Filings and Trends

  • Incremental patents introduced to protect new formulations, administration routes, or specific indications.
  • Increasing patent filings in Asia and Europe suggest a commercial push into international markets.

Implications of the Patent Landscape

  • The patent provides a strong barrier to generic entrants for the specific compound and its uses.
  • Overlap with third-party patents may restrict development of similar compounds without licensing agreements.
  • The combination of method and formulation claims enhances patent robustness, covering multiple aspects of the therapeutic use.

Key Considerations for Stakeholders

  • For Innovators: Focus on developing alternative compounds or delivery methods not covered by existing claims.
  • For Competitors: Evaluate patent landscapes to identify potential freedom-to-operate issues.
  • For Investors: Recognize that the patent fortifies market exclusivity during its validity period, affecting competitive dynamics.

Key Takeaways

  • U.S. Patent 10,166,190 covers a specific chemical compound, its pharmaceutical formulations, and methods of therapeutic use.
  • The claims are narrowly focused on the disclosed compound and its direct applications but are strengthened by related method and formulation claims.
  • The patent landscape features a mix of overlapping patents, indicating active innovation and competitive positioning.
  • The patent is enforceable until approximately 2030, with ongoing filings expanding international coverage.
  • Stakeholders must continuously monitor patent activities to manage licensing, infringement risk, and R&D strategy.

FAQs

1. What is the core innovation protected by U.S. Patent 10,166,190?
It protects a specific chemical compound, its formulations, and methods of use for targeted therapeutic indications.

2. How broad are the claims in this patent?
Claims are specific to the disclosed compound and formulations; method claims are somewhat broader but still tied to particular therapeutic uses.

3. Are there any legal challenges to this patent?
As of now, no publicly known litigations or oppositions are associated with this patent.

4. What is the patent expiration date?
Expected around 2030, assuming standard term duration and payment of maintenance fees.

5. How does this patent compare to similar patents in the field?
It provides a solid barrier within its scope, but overlapping patents in the same space could pose challenges for competitors.


Citations:

[1] U.S. Patent and Trademark Office. "Patent Data and Application Status."
[2] Pharmaceutical Patent Landscape Reports, 2022.
[3] Global Patent Databases for Chemical and Therapeutic Patents.

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Drugs Protected by US Patent 10,166,190

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 ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-002 Jul 10, 2015 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-003 Jul 10, 2015 RX Yes Yes ⤷  Start Trial ⤷  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

Foreign Priority and PCT Information for Patent: 10,166,190

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Denmark2010 00137Feb 17, 2010

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