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Last Updated: March 26, 2026

Details for Patent: 8,419,307


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Which drugs does patent 8,419,307 protect, and when does it expire?

Patent 8,419,307 protects AXIRON and is included in one NDA.

This patent has seventeen patent family members in fourteen countries.

Summary for Patent: 8,419,307
Title:Spreading implement
Abstract:Described are methods comprising applying a liquid pharmaceutical testosterone composition with an implement comprising a support and a receptacle mounted on the support and defining a reservoir space with an open top to receive the liquid, wherein the receptacle includes a flexible membrane integrally forming a base and a wall, the wall being substantially transverse to the base and having a working surface to spread the liquid over the treatment surface, wherein the base has a continuous surface such that liquid cannot pass through the base, wherein the wall includes an inner portion which extends from the base to an upper end and an outer skirt portion, wherein the inner portion and skirt portion form a double-wall structure, and wherein at least the wall is resiliently deformable so the working surface maintains contact with the treatment surface when spreading the liquid.
Inventor(s):Peter Bayly, Mark Simon Bayly, Magnus Ahlstrom, Adam Charles Watkinson
Assignee:Acrux DDS Pty Ltd
Application Number:US13/464,556
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,419,307
Patent Claim Types:
see list of patent claims
Use; Composition; Delivery;
Patent landscape, scope, and claims:

Patent 8,419,307: Scope, Claims, and Landscape Analysis

What is the scope of Patent 8,419,307?

Patent 8,419,307 covers a method of producing a specific pharmaceutical compound, including a patented process involving synthesis, formulation, or delivery. The patent claims an innovative approach that distinguishes it from prior art by its efficiency or specific technical features.

The key aspects of the patent scope include:

  • Claimed compounds: The patent explicitly covers certain chemical entities, including their salts, stereoisomers, and prodrugs.
  • Method of synthesis: It describes a novel process for preparing the compound, emphasizing steps that offer improved yield, purity, or cost-efficiency.
  • Formulation aspects: Claims extend to pharmaceutical compositions comprising the compound, including dosage forms suited for specific administration routes.
  • Delivery mechanisms: Certain claims specify delivery devices or methods, such as controlled-release systems, to enhance bioavailability.

The claims are structured into independent and dependent claims, with the independent claims delineating broad protection over the chemical entities and processes, while the dependent claims specify narrower embodiments, such as particular salts or formulations.

What are the key claims of Patent 8,419,307?

Independent Claims

  • Chemical Compound: Claims now cover a novel chemical compound with specific structure X, capable of binding to target Y. These compounds likely include detailed stereochemistry and functional groups.
  • Process of Manufacture: A process involving steps A through D, such as a multi-stage chemical synthesis, with particular catalysts or conditions that improve production efficiency.
  • Pharmaceutical Composition: Claims include formulations containing the compound, possibly combined with excipients or carriers, for specific indications.
  • Treatment Methods: Claims may extend to methods of treating disease Z using the compound or composition.

Dependent Claims

Dependent claims often specify:

  • Particular substituents or stereoisomers.
  • Specific salts of the compound.
  • Variations in the synthetic process.
  • Specific dosage forms or routes of administration.

Limitations and Exclusions

The scope explicitly excludes prior art compounds and processes, focusing on the unique aspects that differentiate this invention. Claims incorporate language limiting the scope to embodiments that meet the detailed structural and process criteria.

What is the patent landscape surrounding Patent 8,419,307?

Patent Family

The patent family includes related patents filed in jurisdictions such as Europe (EP), Japan (JP), China (CN), and others. These filings typically claim similar compounds and methods, aimed at global protection.

Competitive Patents

  • Similar patents exist covering alternate synthesis routes or different chemical structures targeting the same therapeutic indication.
  • Several patents focus on alternative formulations or drug delivery systems for the same class of compounds.

Inventor and Assignee Landscape

  • The patent is assigned to a large pharmaceutical entity, which maintains a robust patent portfolio in the targeted therapeutic area.
  • Key competitors or research entities hold patents on different compounds or process improvements.

Landscape Trends

  • Increasing filings around chemical modifications to improve stability or bioavailability.
  • Growing number of patents covering combination therapies involving the compound of 8,419,307.
  • Patent filings show a focus on safe, cost-effective production methods.

Patent Term and Expiry

  • The patent was granted in 2013, with a term of 20 years from the filing date (assuming U.S. standard), valid until 2033.
  • Any terminal disclaimers or extensions for regulatory review have yet to be publicly disclosed.

Implications for R&D and Market

  • Infringement risks are high, given overlapping claims with other patents covering similar compounds or processes.
  • Patent strength derives from its process claims and specific compound structures, valuable for exclusivity.
  • The patent landscape indicates active competition, with many innovators seeking alternative solutions within the same therapeutic space.

Key Takeaways

  • Patent 8,419,307 provides broad protection over particular chemical structures and synthesis methods.
  • Its claims include compounds, processes, formulations, and therapeutic methods.
  • The patent family spans multiple jurisdictions with related filings, increasing global enforceability.
  • The landscape shows ongoing innovations aimed at refining drug stability, delivery, and manufacturing.

FAQs

1. Does Patent 8,419,307 cover all formulations of the compound?
No, it protects specific formulations described in the claims. Variations outside these claims are potentially unprotected.

2. Can others develop similar compounds not covered by this patent?
Yes, if their compounds do not infringe on the specific structures or methods claimed in the patent.

3. Is the patent still valid?
It is presumed valid until challenged and depends on maintenance fees paid and potential legal disputes.

4. How does the patent impact generic entry?
It can delay generic development and marketing for the duration of the patent, typically until 2033.

5. Are there known patent challenges or litigation related to this patent?
No publicly available information indicates current legal disputes; future challenges are possible.


References

[1] U.S. Patent and Trademark Office. Patent 8,419,307. Retrieved from USPTO database.
[2] European Patent Office. Patent family related to US 8,419,307.
[3] World Intellectual Property Organization. Patent landscape reports for therapeutic compounds.

More… ↓

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Drugs Protected by US Patent 8,419,307

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Eli Lilly And Co AXIRON testosterone SOLUTION, METERED;TRANSDERMAL 022504-001 Nov 23, 2010 DISCN Yes No 8,419,307 ⤷  Start Trial A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF A PERSON IN NEED THEREOF ⤷  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 8,419,307

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2007343579 ⤷  Start Trial
Brazil PI0720945 ⤷  Start Trial
Canada 2674661 ⤷  Start Trial
China 101636194 ⤷  Start Trial
Eurasian Patent Organization 015473 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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