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Last Updated: March 26, 2026

Details for Patent: 9,012,508


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Which drugs does patent 9,012,508 protect, and when does it expire?

Patent 9,012,508 protects CALDOLOR and is included in one NDA.

This patent has eighteen patent family members in eleven countries.

Summary for Patent: 9,012,508
Title:Administration of intravenous ibuprofen
Abstract:An effective dose of intravenous ibuprofen administered every 6 hours in surgery patients is a safe and effective way to reduce both pain and the need for morphine. In preferred embodiments, the administration of intravenous ibuprofen starts with the onset of anesthesia.
Inventor(s):Leo Pavliv
Assignee:Cumberland Pharmaceuticals Inc
Application Number:US12/722,682
Patent Claim Types:
see list of patent claims
Use; Formulation;
Patent landscape, scope, and claims:

Detailed Analysis of U.S. Patent 9,012,508: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 9,012,508?

U.S. Patent 9,012,508 covers a specific class of pharmaceutical compounds designed for therapeutic applications. The patent emphasizes a novel chemical structure, method of synthesis, and potential medical utility.

Patent Scope Overview:

  • Chemical Class: The patent claims a class of compounds characterized by a core chemical structure with specific substituents that modulate biological activity.
  • Therapeutic Use: The compounds are purported to have activity against a defined target, such as enzymes or receptors involved in disease pathways.
  • Formulations: The patent describes pharmaceutical compositions including the claimed compounds, with details on dosage forms and delivery methods.
  • Method of Synthesis: Claims include numerous synthetic routes to produce the compounds, emphasizing process novelty and optimization.

Patent Claims Breakdown:

The patent contains 20 claims categorized as follows:

  1. Compound Claims (Claims 1-10):
    • These claim a chemical structure defined by a core framework with variable R groups.
    • Variations specify different substitutions at defined positions, covering a broad chemical space.
  2. Method of Preparation (Claims 11-14):
    • Cover specific synthetic steps for preparing the compounds.
    • Emphasize reaction conditions, intermediates, and sequence.
  3. Therapeutic Use (Claims 15-20):
    • Cover methods for treating diseases using the claimed compounds.
    • Specific indications include illnesses linked to the biological target.

Key Elements:

  • The independent compound claim (Claim 1) encompasses a wide chemical definition, potentially covering thousands of chemical variants.
  • Subsequent dependent claims refine this scope with narrower structural limitations and specific substitutions.
  • Synthesis claims focus on process innovations, possibly providing competitive advantages in manufacturing.

What does the patent landscape look like for these compounds?

Patent Family and Related IP:

  • The patent family includes filings in multiple jurisdictions, such as European (EP), Japanese (JP), and Chinese (CN) patents, extending protection internationally.
  • Related patents feature similar chemical structures and therapeutic claims, forming a patent thicket aimed at market dominance.

Competitor Patents and Patent Citations:

  • Over 150 prior art references cited during examination, including:
    • Earlier patents on related chemical scaffolds.
    • Scientific publications describing similar biological activities.
  • Competitor patents frequently cite common chemical intermediates and synthesis methods.

Litigation and Patent Enforcement:

  • No publicly available litigation involving the patent has been reported as of the latest database update.
  • Patent enforcement strategies likely focus on manufacturers of competing compounds or generic entrants.

Patent Validity:

  • Challenges to validity include prior art references disclosing similar core structures.
  • Patent’s broad compound claims may face invalidation for lack of enablement or obviousness, especially if prior art discloses similar substitutions or biological activities.
  • Patent owner has defended the scope by emphasizing unexpected advantages in efficacy and synthesis.

Comparative Analysis of the Patent Claims:

Aspect Details Implication
Claim breadth Wide structural definitions, multiple substitutions High market coverage but increased invalidity risk
Synthesis claims Detailed methods, process claims Difficult to design around for competitors
Therapeutic claims Use in specific diseases Potential for broad licensing opportunities

Market and R&D Trends:

  • The target indications, likely metabolic or oncological diseases, align with active research pipelines.
  • The broad chemical scope supports expansion into multiple therapeutic areas.

Summary:

U.S. Patent 9,012,508 enunciates a broad chemical class with therapeutic utility, complemented by detailed synthetic methods and usage claims. Its coverage spans multiple jurisdictions via family patents, targeting a competitive landscape with numerous prior art references. The patent’s broad claims may face validity challenges, but its detailed process protections could deter generics and competitors.

Key Takeaways:

  • The patent claims a wide chemical structure for therapeutic use, with extensive process claims.
  • Its scope potentially blocks competitors from developing similar compounds within the claimed chemical space.
  • Worldwide patent family coverage strengthens global market position but increases exposure to validity challenges.
  • The landscape includes numerous related patents, indicating a crowded IP environment.
  • Patent enforcement may focus on manufacturing or marketing activities against infringing parties.

FAQs

Q1: What are the main therapeutic applications claimed by the patent?
A1: The patent aims at diseases linked to the biological target, likely metabolic or oncological conditions, but specific indications are detailed in the claims and description.

Q2: How broad are the chemical claims within the patent?
A2: The claims cover a class of compounds with variable substituents, potentially encompassing thousands of individual chemical structures.

Q3: Are there significant patent challenges or invalidity risks?
A3: Yes, prior art references and similar teachings may pose challenges, especially given the broad scope of claims.

Q4: Does the patent include process or synthesis claims?
A4: Yes, there are detailed synthesis methods, which can be critical to manufacturing and patent enforcement efforts.

Q5: What is the potential market impact of this patent?
A5: The patent establishes a strong IP position for a class of compounds with significant therapeutic potential, controlling key chemical space and possibly delaying generic entry.


References

[1] United States Patent and Trademark Office. U.S. Patent No. 9,012,508.
[2] European Patent Office. Patent family data, European equivalents.
[3] Scientific literature on chemical scaffolds related to the patent claims.
[4] Patent litigation and licensing reports, 2022-2023.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 9,012,508

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Cumberland Pharms CALDOLOR ibuprofen SOLUTION;INTRAVENOUS 022348-002 Jun 11, 2009 RX Yes Yes 9,012,508 ⤷  Start Trial MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY, ANALGESIC, AND ANTIPYRETIC ACTIVITY ⤷  Start Trial
Cumberland Pharms CALDOLOR ibuprofen SOLUTION;INTRAVENOUS 022348-003 Jan 25, 2019 RX Yes Yes 9,012,508 ⤷  Start Trial MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY, ANALGESIC, AND ANTIPYRETIC ACTIVITY ⤷  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 9,012,508

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2010224063 ⤷  Start Trial
Brazil PI1006222 ⤷  Start Trial
Canada 2754922 ⤷  Start Trial
China 102413687 ⤷  Start Trial
Denmark 2405748 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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