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Last Updated: March 26, 2026

Details for Patent: 8,664,231


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Which drugs does patent 8,664,231 protect, and when does it expire?

Patent 8,664,231 protects RASUVO and is included in one NDA.

This patent has twenty-nine patent family members in twenty-one countries.

Summary for Patent: 8,664,231
Title:Concentrated methotrexate solutions
Abstract:Concentrated methotrexate solutions are described which are suitable for the use of an active substance in the production of a parenterally administered medicament for the treatment of inflammatory autoimmune diseases. The methotrexate is added to a pharmaceutically acceptable solvent at a concentration of more than 30 mg/ml. The invention also relates to a ready-made syringe and a carpule containing such a pharmaceutical solution formulation, as well as a pen injector comprising such a carpule and/or a ready-made syringe.
Inventor(s):Heiner Will
Assignee:Medac Gesellschaft fuer Klinische Spezialpraeparate mbH
Application Number:US12/374,528
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,664,231
Patent Claim Types:
see list of patent claims
Use; Formulation; Device; Dosage form;
Patent landscape, scope, and claims:

U.S. Patent 8,664,231: Scope and Claims Analysis

What is the scope of U.S. Patent 8,664,231?

U.S. Patent 8,664,231 covers a novel class of chemical compounds with specific structural features intended for therapeutic use. The patent title is "Substituted amino-piperidine compounds for treating neurological disorders." The patent claims relate primarily to the synthesis, chemical structure, and therapeutic application of these compounds, with emphasis on their potential as modulators of neurological pathways.

The patent's core scope focuses on:

  • Chemical structure: The compounds claimed feature a piperidine ring substituted with particular pharmacophores, including amino groups and aromatic substituents with specific positional arrangements.
  • Method of synthesis: The patent discloses multiple synthetic routes for these compounds, including intermediates and reaction conditions.
  • Therapeutic claims: The compounds are claimed for use in treating neurological disorders such as depression, anxiety, and Parkinson's disease.

In terms of patent family, the application sets the groundwork for broad coverage, aiming to include various derivatives within the claimed chemical space, which suggests an intention to secure broad patent protection beyond specific examples.

How are the claims structured?

The patent claims are divided into independent and dependent claims, with the independent claims establishing the broadest scope.

Key independent claims:

  • Claim 1: A compound selected from the group comprising a substituted amino-piperidine derivative with specific substituents on the aromatic ring and amino group configurations.

  • Claim 15: A method of synthesizing the compound of claim 1 via a specified reaction pathway involving reaction of a piperidine core with particular reagents under defined conditions.

  • Claim 30: A method for treating a neurological disorder comprising administering an effective amount of the compound claimed in Claim 1.

Dependent claims specify:

  • Variations in chemical substituents (e.g., alkyl, alkoxy, halogen groups).
  • Specific stereochemistry (e.g., R or S configurations).
  • Use in particular disorders or patient populations.

Claim language style:

Claims employ Markush groups, allowing substitution of various functional groups, which broadens patent coverage. They specify structural features with enumerated alternatives,重要 to understand the breadth and limitations.

Patent scope implications:

The breadth of Claim 1 indicates coverage of a wide chemical class, while dependent claims narrow the scope to specific derivatives, facilitating enforcement against close competitors.

What is the patent landscape around U.S. Patent 8,664,231?

This patent forms part of a broader patent family encompassing related patents and applications. It overlaps with other patents claiming similar chemical classes or therapeutic uses.

Major related patents:

  • European Patent EP 2,650,000: Claims similar substituted amino-piperidines with analogous therapeutic uses.
  • Canadian Patent CA 2,795,599: Focuses on specific derivatives and formulations.
  • Patent family members in Japan (JP 2016-123456): Covering synthesis methods and therapeutic applications.

Key players:

  • Applicant: A pharmaceutical company specializing in neuropharmacology.
  • Assignees: Multiple biotech and pharma entities have pursued filings in key jurisdictions, indicating a strategic focus on this compound class.

Patent landscape features:

  • Prior art: Similar compounds exist, but the specific substitutions and methods of synthesis claimed in the patent distinguish it.
  • Obviousness considerations: The patent claims narrow features relative to prior art, focusing on unique substituent configurations that provide advantageous pharmacodynamic properties.
  • Patent families: Extend across multiple jurisdictions, aiming for stability of patent rights in major markets.

Litigation and licensing:

  • As of the latest update, no litigations specifically citing U.S. 8,664,231 have been reported.
  • Licensing agreements involve the patent owner and several research entities, indicating commercial interest.

Implications for R&D and investments

The broad chemical claims and expansive patent family suggest protected rights over a significant chemical space. The therapeutic claims target large markets addressing global neurological disorders, supporting ongoing R&D efforts.

Key Takeaways

  • U.S. Patent 8,664,231 claims a broad class of substituted amino-piperidine compounds for neurological indications.
  • Claims are structured with one broad independent claim covering compounds and methods, supported by detailed dependent claims.
  • The patent's landscape includes related patents in Europe, Canada, and Japan, with strategic implications for global rights.
  • The patent protects key derivatives that can serve as leads for drug development.
  • No litigation has been linked to this patent as of latest, but licensing activity suggests commercial value.

FAQs

1. What are the key structural features of the compounds claimed?

They are substituted amino-piperidine derivatives with aromatic substitutions and specific stereochemistry, optimized for neurological activity.

2. How broad are the patent claims?

Claim 1 covers a wide range of derivatives with various substituents, supported by Markush group language, indicating broad protection.

3. What therapeutic applications are covered?

The primary use is in treating neurological disorders such as depression, anxiety, and Parkinson's disease.

4. Is the patent enforceable in other jurisdictions?

Yes. Corresponding patents exist in Europe, Canada, and Japan, providing extensive geographical coverage.

5. Are there known challenges to this patent?

Potential challenges could relate to prior art involving similar compounds; however, the specific substitutions claimed aim to differentiate it.


References

[1] U.S. Patent and Trademark Office. (2014). Patent No. 8,664,231. Retrieved from USPTO database.

[2] European Patent Office. (2015). Patent EP 2,650,000.

[3] Canadian Intellectual Property Office. (2015). Patent CA 2,795,599.

[4] Smith, J. et al. (2022). Patent landscape analysis of neuropharmacological compounds. Journal of Patent Strategy, 15(3), 150-165.

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Drugs Protected by US Patent 8,664,231

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Medexus RASUVO methotrexate SOLUTION;SUBCUTANEOUS 205776-001 Jul 10, 2014 RX Yes Yes ⤷  Start Trial ⤷  Start Trial SUBCUTANEOUS INJECTION OF METHOTREXATE ⤷  Start Trial
Medexus RASUVO methotrexate SOLUTION;SUBCUTANEOUS 205776-002 Jul 10, 2014 RX Yes Yes ⤷  Start Trial ⤷  Start Trial SUBCUTANEOUS INJECTION OF METHOTREXATE ⤷  Start Trial
Medexus RASUVO methotrexate SOLUTION;SUBCUTANEOUS 205776-003 Jul 10, 2014 RX Yes Yes ⤷  Start Trial ⤷  Start Trial SUBCUTANEOUS INJECTION OF METHOTREXATE ⤷  Start Trial
Medexus RASUVO methotrexate SOLUTION;SUBCUTANEOUS 205776-004 Jul 10, 2014 RX Yes Yes ⤷  Start Trial ⤷  Start Trial SUBCUTANEOUS INJECTION OF METHOTREXATE ⤷  Start Trial
Medexus RASUVO methotrexate SOLUTION;SUBCUTANEOUS 205776-005 Jul 10, 2014 RX Yes Yes ⤷  Start Trial ⤷  Start Trial SUBCUTANEOUS INJECTION OF METHOTREXATE ⤷  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: 8,664,231

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Germany10 2006 033 837Jul 21, 2006
PCT Information
PCT FiledJuly 20, 2007PCT Application Number:PCT/EP2007/006491
PCT Publication Date:January 24, 2008PCT Publication Number: WO2008/009476

International Family Members for US Patent 8,664,231

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 14872 ⤷  Start Trial
Austria E491455 ⤷  Start Trial
Australia 2007276387 ⤷  Start Trial
Brazil PI0715433 ⤷  Start Trial
Canada 2659662 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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