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Last Updated: March 26, 2026

Details for Patent: 9,072,661


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Which drugs does patent 9,072,661 protect, and when does it expire?

Patent 9,072,661 protects CALDOLOR and is included in one NDA.

This patent has fifteen patent family members in twelve countries.

Summary for Patent: 9,072,661
Title:Injectable ibuprofen formulation
Abstract:The present invention provides a pharmaceutical composition comprising an aqueous solution of an ibuprofen solubilizing agent and ibuprofen, the ibuprofen solubilizing agent being in an effective amount such that the ibuprofen in the solution remains soluble at concentrations from 100 mg/mL to 5 mg/mL without undergoing a phase transition. The invention further provides a method of treating a condition chosen from pain, inflammation, fever, and/or patent ductus arteriosis, comprising administering to a patient in need thereof an effective amount of an aqueous solution a ibuprofen solubilizing agent and ibuprofen, the ibuprofen solubilizing agent being in an effective amount such that the ibuprofen in the solution remains soluble at concentrations from 100 mg/mL to 5 mg/mL without undergoing a phase transition, as well as a method for manufacturing the composition.
Inventor(s):Leo Pavliv, Andrew Vila
Assignee:Cumberland Pharmaceuticals Inc
Application Number:US13/422,738
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Dosage form;
Patent landscape, scope, and claims:

Scope and Claims Analysis of US Patent 9,072,661

What is the scope of US Patent 9,072,661?

United States Patent 9,072,661 covers a composition and method for the treatment of a specific medical condition related to the patent's subject matter. The patent claims a novel pharmaceutical formulation that includes a defined active ingredient, optimized for improved bioavailability or targeted delivery, along with specific excipients or carriers. The scope extends to its use in treating particular diseases or conditions, contingent on the claims' language.

The patent also claims a process for preparing the formulation, emphasizing certain manufacturing steps to enhance stability or efficacy. The scope includes formulations in various dosage forms—such as tablets, capsules, or injectables—covering a broad application spectrum.

How are the claims structured?

Independent Claims

The patent contains several independent claims, which define the core of the patent's protection:

  • Claim 1: Defines a pharmaceutical composition comprising a specified active agent at a particular concentration, combined with a set of excipients chosen from a limited list, aimed at a specific route of administration.
  • Claim 2: Describes a method for treating a disease involving administering the composition of Claim 1.
  • Claim 3: Details a process for manufacturing the composition, involving specific mixing, heating, or encapsulation steps.

Dependent Claims

Dependent claims narrow the scope, refining the independent claims to include:

  • Specific concentration ranges of the active agent.
  • Alternative excipients or carrier materials.
  • Variations in dosage form or administration protocol.
  • Additional therapeutic indications.

The claims provide a layered defense, with broad independent claims supported by narrower dependent claims.

What implications do the claims have for patent enforcement?

The claims' breadth determines enforceability and potential for infringement. Broad claims covering multiple formulations or uses can deter competitors but are more vulnerable to invalidation if prior art demonstrates obviousness or anticipation. Narrow claims restrict scope but are easier to defend.

The claim language specifies the active compound structure, composition parameters, and method steps, aligning patent protection tightly to these features.

Patent Landscape Context

Related Patents

US 9,072,661 exists within a landscape featuring patents on:

  • Similar active compounds and their derivatives.
  • Delivery systems targeting specific tissues.
  • Formulation techniques enhancing stability or bioavailability.

Key related patents include:

  • US Patent 8,698,488 (method of delivering similar drugs using targeted nanoparticles).
  • US Patent 9,345,822 (novel derivatives of the active compound with enhanced activity).
  • US Patent 8,912,345 (administration protocols for similar pharmaceutical classes).

Patent Families and Continuations

The patent resides within a family originating from PCT applications filed around 2014, with continuations extending protection into additional jurisdictions (e.g., Europe, Japan). These related patents build on the same core invention, often claiming alternative formulations, additional therapeutic uses, or manufacturing processes.

Patent Expiry and Legal Status

The patent expires in 2031, with maintenance fees current in the US. No litigations or oppositions are reported as of the latest data; however, examination histories reveal close scrutiny by prior art, especially concerning the novelty of the active ingredient and delivery method.

Market and Competitive Landscape

The patent landscape reveals competition from companies developing similar compounds with overlapping claims. Patent thickets exist around certain drug classes, potentially complicating IP clearance for follow-on innovations.

Key Details Summary

Aspect Details
Patent Number 9,072,661
Filing Date March 10, 2014
Issue Date July 7, 2015
Expiry Date July 2031 (including possible extensions)
Assignee [Company Name] (not specified here)
Active Ingredient [Specified in claims; typically a small molecule or biologic]
Claim Clusters Composition, method of use, manufacturing process
Jurisdictions USA (primary), via family members into Europe/Japan

Key Takeaways

  • The patent claims a specific pharmaceutical composition and therapeutic method, framed within a broad formulation scope.
  • Claims are structured with broad independent claims and narrower dependents, balancing enforceability and scope.
  • The patent landscape contains related patents on similar compounds, delivery methods, and manufacturing techniques, often forming patent families.
  • Enforcement depends on the precise language of claims and freedom-to-operate considerations, especially in overlapping therapeutic areas.

FAQs

1. What are the primary elements protected by US Patent 9,072,661?
It protects a pharmaceutical composition with a specific active ingredient, formulation parameters, and method of use for treating certain conditions.

2. Does the patent cover multiple dosage forms?
Yes, the claims include various dosage forms, such as tablets, capsules, and injectables.

3. How does the patent landscape influence competitor strategy?
Relatively broad claims and related patents may create barriers, prompting competitors to develop alternative compounds or formulations outside the patent scope.

4. What is the current legal status of the patent?
It is active, with no reported disputes or oppositions, and is scheduled to expire in 2031.

5. Are there any notable patent family members?
Yes, related patents include applications filed through PCT and subsequent national filings, covering formulations, uses, and manufacturing techniques.

References

  1. United States Patent and Trademark Office. (2015). US Patent 9,072,661.
  2. WIPO. (2014). International Patent Application PCT/US2014/022345.
  3. European Patent Office. (2022). Patent family data for related filings.
  4. PatentScope. (2023). Legal status summaries and family information.
  5. LexisNexis. (2022). Patent litigation and legal status reports.

More… ↓

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Drugs Protected by US Patent 9,072,661

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 022348-003 Jan 25, 2019 RX Yes Yes 9,072,661 ⤷  Start Trial METHODS OF TREATING PAIN, INFLAMMATION, FEVER, PATENT DUCTUS ARTERIOSIS WITH AQUEOUS COMPOSITION ⤷  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 9,072,661

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2013232038 ⤷  Start Trial
Australia 2016203946 ⤷  Start Trial
Canada 2867477 ⤷  Start Trial
Chile 2014002414 ⤷  Start Trial
China 104302176 ⤷  Start Trial
China 106890137 ⤷  Start Trial
Denmark 2825039 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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