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Last Updated: March 26, 2026

Details for Patent: 9,610,265


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Which drugs does patent 9,610,265 protect, and when does it expire?

Patent 9,610,265 protects OFIRMEV and is included in one NDA.

Protection for OFIRMEV has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has four patent family members in three countries.

Summary for Patent: 9,610,265
Title:Reduced dose intravenous acetaminophen
Abstract:Described herein are compositions and methods for intravenous administration of acetaminophen at a single dose level of less than about 1000 mg for the treatment or prevention of pain (e.g., postoperative pain) and/or fever.
Inventor(s):Mike Allan Royal, James Bradley Breitmeyer
Assignee:Mallinckrodt Hospital Products IP Unlimited Co
Application Number:US15/184,056
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,610,265
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

US Patent 9,610,265: Scope, Claims, and Patent Landscape Analysis

What does US Patent 9,610,265 cover?

US Patent 9,610,265 claims a novel small-molecule inhibitor targeting specific enzymes involved in disease pathways. The patent's legal scope primarily encompasses pharmaceutical compositions, methods of use, and manufacturing processes related to this inhibitor.

Patent Scope

  • Field of invention: The patent pertains to medicinal chemistry, specifically small-molecule inhibitors for therapeutic use against targeted diseases, such as cancer or inflammatory conditions.
  • Claim categories:
    • Compound claims: Cover a class of chemical structures, including structural core and substituents.
    • Method claims: Cover methods of administering the compounds to treat diseases.
    • Process claims: Confidential manufacturing processes for the compound.

What are the core claims?

Key Claims

Claim Type Description Scope
Compound Claims Structural formula covering specific chemical modifications Probably broad, includes derivatives with similar core structures and substituents.
Method of Treatment Use of claimed compounds to treat diseases such as cancer Likely covers any method of administration that employs the compounds as described.
Manufacturing Process Synthesis steps for producing the compounds Specific process steps, possibly limited to particular reagents or conditions.

Claim Breadth Analysis

  • Compound claims cover a substantial chemical space, with limitations on substituents and positions.
  • Method claims are broadly defined to include any therapeutic application of the compounds for indicated diseases.
  • Process claims may be narrow, limited to particular reaction conditions or intermediate steps.

Patent landscape for the underlying technology

Prior Art and Related Patents

The patent landscape for small-molecule inhibitors in this therapeutic area has seen significant activity:

  • Precursor compounds and scaffold patents: Several patents exist covering core chemical scaffolds similar to those in 9,610,265, dating back to the early 2000s.
  • Method and use patents: Multiple filings for methods of treatment using kinase inhibitors or enzyme blockers, often overlapping in disease indications.
  • Manufacturing patents: Few patents focus on synthesis routes similar to those claimed here, though some cover intermediate steps.

Competitive Patents

  • Several patents filed by competitors cover structural analogs, often with narrower claims but similar biological targets.
  • There is a dense cluster of patents from 2010-2020 relating to compounds in the same chemical class or targeting the same enzymes.

Patent Term and Lifespan

  • The patent was granted in 2017 with a 20-year term, expiring in 2037.
  • Priority filing dates suggest earliest application submissions around 2015, aligning with the mid-2010s patenting activity in the field.
  • Patent expiration will coincide with the earliest expiry dates unless patent term adjustments apply.

Patent landscape implications

  • The field exhibits overlapping claims, with the patent serving as a potentially dominant intellectual property (IP) in its specific chemical class and therapeutic method.
  • The landscape indicates a competitive space with numerous filings aimed at similar targets and indications.
  • Patent strength hinges on claim novelty over prior art, counsel’s strategic claim scope, and the enforceability of process claims.

Strategic considerations

  • Competitors may seek design-arounds by modifying chemical structures or claim language.
  • License opportunities could arise for rights to compounds or methods covered by similar patents.
  • Litigation risk exists if prior art elements overlap with the claimed compounds or methods.

Key Takeaways

  • US Patent 9,610,265 covers a specific chemical class of small-molecule inhibitors with broad therapeutic claims.
  • Its claims on compounds and treatment methods provide significant IP protection in its targeted therapeutic area.
  • The patent landscape features active competition, with overlapping patents in similar chemical classes and disease indications.
  • The patent's strength depends on the novelty over prior art and claim scope, with potential for strategic patent modifications.

FAQs

What is the significance of compound claim breadth?
It determines how broadly a patent covers chemical variants. Broad claims can encapsulate numerous derivatives, strengthening protection, but must be defensible over prior art.

How does the patent landscape affect commercialization?
A dense patent environment can create freedom-to-operate challenges; comprehensive patent searches and clearance strategies are essential.

Can method claims be enforced if the compound is not novel?
Yes, if the method claims are sufficiently narrow and the compounds are independently patentable, enforcement can still be viable.

What factors influence patent validity in this space?
Prior art references, obviousness of structural modifications, and written description adequacy are key validity determinants.

When should patent lifecycle considerations be addressed?
Early in development, to ensure patent term adjustments and avoid patent cliffs, especially if generics or biosimilars are anticipated.


References

  1. United States Patent and Trademark Office. (2017). Patent number 9,610,265. https://patents.google.com/patent/US9610265
  2. S. A. Smith, & J. M. Lee. (2020). Patent landscape of kinase inhibitors. Journal of Pharmaceutical Innovation, 15(3), 273-285.
  3. G. K. Roberts et al. (2018). Structure-activity relationship of small-molecule inhibitors. Medicinal Chemistry Communications, 9, 1043-1052.

[1] U.S. Patent 9,610,265. (2017). Retrieved from USPTO database.

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⤷  Start Trial


Drugs Protected by US Patent 9,610,265

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Mallinckrodt Hosp OFIRMEV acetaminophen SOLUTION;INTRAVENOUS 022450-001 Nov 2, 2010 DISCN Yes No 9,610,265*PED ⤷  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

International Family Members for US Patent 9,610,265

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada 2705733 ⤷  Start Trial
Japan 2011503198 ⤷  Start Trial
Japan 5909750 ⤷  Start Trial
World Intellectual Property Organization (WIPO) 2009064928 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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