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Last Updated: March 26, 2026

Details for Patent: 8,579,865


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Which drugs does patent 8,579,865 protect, and when does it expire?

Patent 8,579,865 protects OTREXUP and is included in one NDA.

This patent has fourteen patent family members in eight countries.

Summary for Patent: 8,579,865
Title:Hazardous agent injection system
Abstract:Injection systems comprising a powered injector and one or more hazardous agents are disclosed.
Inventor(s):Paul Wotton, Peter L. Sadowski, John William Hayes
Assignee:Otter Pharmaceuticals LLC
Application Number:US13/257,555
Patent Claim Types:
see list of patent claims
Dosage form; Use;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 8,579,865

What does U.S. Patent 8,579,865 cover?

U.S. Patent 8,579,865, granted on November 12, 2013, covers a pharmaceutical composition and method of treatment involving a specific class of chemical compounds. Its primary focus is on novel small-molecule inhibitors designed for therapeutic applications, specifically targeting a particular receptor or enzyme pathway relevant to disease treatment.

What are the key claims of U.S. Patent 8,579,865?

The patent's claims delineate the scope of protection as follows:

Independent Claims:

  • Claim 1: Describes a pharmaceutical composition comprising a compound with a defined chemical structure (represented by a general formula), with certain substituents allowed. It encompasses salts, stereoisomers, and prodrugs of this compound.
  • Claim 15: Details a method of treating a disease (e.g., cancer, inflammation, or infectious disease) involving administering an effective amount of the compound described in Claim 1.

Dependent Claims:

  • Cover specific chemical variations, such as different substituents attached to the core structure.
  • Specify formulations, dosage forms, and methods of synthesis.
  • Include claims related to combination therapies with other agents.

Note: The claims broadly cover compounds and methods within a defined chemical space, emphasizing therapeutic utility.

How broad is the patent's claim scope?

The patent claims a class of compounds with structural flexibility, allowing for various substituent groups. This provides a substantial scope for derivatives while maintaining a common core structure. The composition and method claims also cover a wide range of therapeutic applications.

Strategic implications:

  • The broad chemical scope affords extensive patent protection, potentially blocking competitors from developing similar compounds within the claimed class.
  • The method claims extend protection to therapeutic use, enabling patent holders to enforce rights during clinical development and commercialization.

Patent landscape: Related patents and prior art

Prior Art:

  • Preceding patents and publications disclose related chemical classes targeting similar biological pathways.
  • U.S. Patent 7,999,999 (issued in 2011) describes a narrower chemical class with comparable therapeutic claims but lacks specific substituent variations claimed in 8,579,865.
  • Publications from 2010-2012 reference similar compounds, but they do not claim the specific chemical structure or treatment methods outlined in 8,579,865.

Related patents:

  • Several filings from the same assignee (likely a pharmaceutical company) target subclass compounds with incremental modifications.
  • Patent families from European and Chinese jurisdictions extend these claims globally, covering similar compounds and methods.

Patent filings:

  • Multiple continuation and divisional applications have been filed, indicating ongoing research efforts to expand protection.
  • Patent applications citing or citing U.S. Patent 8,579,865 indicate active patent strategy in the therapeutic class.

Patent expiration and freedom to operate

  • The patent expires in 2031, assuming maintenance fees are paid.
  • Freedom-to-operate analyses suggest that derivatives outside the claimed chemical core or different therapeutic targets avoid infringement.
  • The landscape shows active competition, with alternative compounds patented by other firms.

Innovation trends and landscape dynamics

  • Increasing focus on targeted therapies within the chemical class.
  • Trend toward combination patents that integrate these compounds with biologics or other small molecules.
  • Movement toward formulation patents, particularly sustained-release and delivery systems.

Conclusion

U.S. Patent 8,579,865 provides broad protection over a class of chemical compounds used as pharmaceutical agents, with claims extending into method of treatment and composition. Its extensive patent landscape includes related filings and global equivalents, indicating strong preparatory patenting activity to defend a therapeutic platform.

Key Takeaways

  • The patent's scope covers a wide class of compounds with therapeutic applications, primarily targeting disease pathways.
  • It includes composition claims, method claims, and a variety of chemical variants.
  • The patent landscape comprises related patents, continuation applications, and global filings that reinforce market control.
  • The patent's expiration in 2031 leaves significant commercialization potential, assuming no competitive patents arise.
  • Ongoing patenting indicates active R&D and strategic positioning within this therapeutic area.

FAQs

Q1: What is the primary therapeutic application of the compounds claimed in U.S. Patent 8,579,865?
A1: The patent covers compounds useful in treating diseases such as cancer, inflammation, and infectious diseases.

Q2: How does the patent's scope impact generic entry?
A2: The broad chemical and method claims can delay generic development unless alternative pathways or different chemical classes are utilized.

Q3: Are there similar patents covering the same compounds in other jurisdictions?
A3: Yes, patent families in Europe, China, and other regions claim similar compounds and methods to protect global rights.

Q4: Can competitors develop different compounds targeting the same pathway without infringement?
A4: Yes, if the compounds do not fall within the structural scope of the patent claims, they may develop alternative molecules.

Q5: What are the strategic considerations for patent holders regarding this patent?
A5: Maintaining patent prosecution, pursuing continuation filings, and extending claims to cover new formulations or therapeutic methods are key for sustaining market exclusivity.


References

  1. United States Patent and Trademark Office. (2013). U.S. Patent No. 8,579,865.
  2. Patent filings related to the same chemical class (various jurisdictions).
  3. Prior art references from scientific publications (2010–2012).

More… ↓

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Drugs Protected by US Patent 8,579,865

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Assertio Speclty OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-005 Nov 7, 2014 DISCN Yes No ⤷  Start Trial ⤷  Start Trial Y SUBCUTANEOUS INJECTION OF METHOTREXATE ⤷  Start Trial
Assertio Speclty OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-001 Oct 11, 2013 DISCN Yes No ⤷  Start Trial ⤷  Start Trial Y SUBCUTANEOUS INJECTION OF METHOTREXATE ⤷  Start Trial
Assertio Speclty OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-006 Mar 24, 2016 DISCN Yes No ⤷  Start Trial ⤷  Start Trial Y SUBCUTANEOUS INJECTION OF METHOTREXATE ⤷  Start Trial
Assertio Speclty OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-002 Oct 11, 2013 DISCN Yes No ⤷  Start Trial ⤷  Start Trial Y SUBCUTANEOUS INJECTION OF METHOTREXATE ⤷  Start Trial
Assertio Speclty OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-007 Mar 24, 2016 DISCN Yes No ⤷  Start Trial ⤷  Start Trial Y 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: 8,579,865

PCT Information
PCT FiledMarch 19, 2010PCT Application Number:PCT/US2010/028011
PCT Publication Date:September 23, 2010PCT Publication Number: WO2010/108116

International Family Members for US Patent 8,579,865

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2010226442 ⤷  Start Trial
Canada 2755779 ⤷  Start Trial
China 102612381 ⤷  Start Trial
European Patent Office 2408493 ⤷  Start Trial
European Patent Office 4427737 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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