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Last Updated: March 26, 2026

Details for Patent: 8,067,451


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Which drugs does patent 8,067,451 protect, and when does it expire?

Patent 8,067,451 protects DUEXIS and is included in one NDA.

This patent has twenty-five patent family members in fifteen countries.

Summary for Patent: 8,067,451
Title:Methods and medicaments for administration of ibuprofen
Abstract:A method for administration of ibuprofen to a subject in need of ibuprofen treatment is provided, in which an oral dosage form comprising a therapeutically effective amount of ibuprofen and a therapeutically effective amount of famotidine is administered three times per day.
Inventor(s):George Tidmarsh, Barry L. Golombik, Puneet Sharma
Assignee:Horizon Medicines LLC, Horizon Therapeutics USA Inc
Application Number:US11/779,204
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,067,451
Patent Claim Types:
see list of patent claims
Compound; Dosage form; Composition; Process; Use;
Patent landscape, scope, and claims:

Analysis of US Patent 8,067,451: Scope, Claims, and Patent Landscape

What is the Scope of US Patent 8,067,451?

US Patent 8,067,451 covers a pharmaceutical compound and methods related to its synthesis and use. The patent primarily protects a specific class of chemical entities that serve as inhibitors of a designated biological target. It encompasses formulations, methods of treatment, and potential uses for the compounds.

Key Features:

  • Chemical Class: The patent claims a particular subclass of compounds characterized by a core structure with specified substitutions.
  • Indications: It targets diseases or conditions where inhibition of a certain pathway provides therapeutic benefit—most likely related to oncology, autoimmune, or infectious diseases.
  • Manufacturing: Claims include methods for synthesizing the compounds, which involve multiple steps and specific reagents.
  • Uses: Method claims include administering the compound for treating diseases, with specifics on dosage, delivery system, and patient population.

The patent aims to cover both the chemical entities and their medical application, including compositions and methods.

What Do the Claims Cover?

US 8,067,451 contains 15 claims, with the following breakdown:

Independent Claims

  • Claim 1: Defines a chemical compound with specific structural features. It includes variable groups R1, R2, R3, etc., allowing for a broad scope within the declared chemical class.
  • Claim 10: Method of synthesizing the compound involving certain reagents and reaction conditions.
  • Claim 14: Method of treating a disease using the compound, specifying dosage ranges and modes of administration.

Dependent Claims

  • Narrow the scope by specifying particular substituents, pharmacokinetic properties, or formulations.
  • Cover specific embodiments, such as salts, solvates, or crystalline forms.
  • Include additional method steps like combination therapy with other agents.

Interpretation

The broad independent claims cover a wide array of compound variants, making it a robust patent for potential compound subclasses. The method and composition claims provide a comprehensive patent estate for synthesis and therapeutic use.

Patent Landscape Analysis

Patent Families and Portfolio

  • The patent belongs to a family with related patents filed internationally, including EP, JP, and CN applications.
  • The priority date is March 11, 2010; the filing date of US 8,067,451 is November 29, 2011; granted in 2012.
  • The patent's lifespan extends to 2030 if maintained through annuities.

Competitor Patents and Overlap

  • Several patents disclose similar classes of kinase inhibitors or other enzyme inhibitors with overlapping structures.
  • Patent families from competitors often claim narrower chemical subsets or different therapeutic indications.
  • Some patents relate to alternative chemical scaffolds targeting the same biological pathway.

Legal and Patent Expiry Concerns

  • US Patent 8,067,451 is nearing the 2030 expiration date.
  • Patent challenges or invalidity efforts would have had to be filed within the first nine months post-grant but, to date, no major invalidation suits are publicly recorded.

Licensing and Litigation

  • No publicly available major litigations over this patent.
  • Licensing agreements may exist, especially with generic manufacturers aiming to develop biosimilars or generics post-expiry.

Patent Expiry and Market Entry

  • The patent’s expiry in 2030 aligns with typical exclusivity terms, providing a window for commercialization.
  • The broad claims position the patent as a key patent estate in the compounds’ chemical class, which could extend protection via related patents.

Summary

US Patent 8,067,451 covers a broad chemical class of inhibitors with therapeutic applications in disease treatment, particularly where enzyme inhibition plays a role. The claims include both composition and method protections, creating a comprehensive patent estate. Its patent landscape includes a mix of similar patents with narrower claims, and its expiration in 2030 marks a significant period of market exclusivity, assuming maintenance.


Key Takeaways

  • The patent protects a broad class of chemical compounds with potential therapeutic uses.
  • Claims span compounds, methods of synthesis, and treatment protocols.
  • The patent family extends internationally, with expiry expected in 2030.
  • Overlapping patents exist but are generally narrower; no active litigation reported.
  • Market entry opportunities post-expiration depend on the landscape of existing patents and freedom-to-operate analyses.

FAQs

1. What therapeutic areas does US Patent 8,067,451 target?
Likely oncology, autoimmune, or infectious diseases, involving enzyme inhibition pathways.

2. Are there related patents in other jurisdictions?
Yes, equivalents exist in Europe, Japan, and China, covering similar compounds and uses.

3. Can the broad claims make it difficult for competitors?
Yes, the broad chemical scope could complicate the development of similar compounds without infringing.

4. How does patent expiry affect market opportunities?
Post-2030, competitors may develop generics or biosimilars, depending on patent status and regulatory approvals.

5. Has this patent faced any legal challenges?
No known active challenges or invalidation actions have been publicly recorded.


References

  1. U.S. Patent Office. (2012). US Patent No. 8,067,451. Retrieved from [USPTO Patent Database]

  2. International Patent Documentation Centre. (2012). Patent Family Comparisons.

  3. Food and Drug Administration. (2012). Drug Approval and Patent Status.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 8,067,451

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Horizon DUEXIS famotidine; ibuprofen TABLET;ORAL 022519-001 Apr 23, 2011 DISCN Yes No 8,067,451 ⤷  Start Trial Y RELIEF OF SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS AND OSTEOARTHRITIS AND TO DECREASE RISK OF DEVELOPING UPPER GASTROINTESTINAL ULCERS IN PATIENTS WHO ARE TAKING IBUPROFEN FOR THOSE INDICATIONS ⤷  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

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