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Last Updated: March 26, 2026

Details for Patent: 8,486,925


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Which drugs does patent 8,486,925 protect, and when does it expire?

Patent 8,486,925 protects ANDROGEL and is included in one NDA.

This patent has fifty patent family members in thirty countries.

Summary for Patent: 8,486,925
Title:Testosterone gel and method of use
Abstract:The present invention relates to an improved transdermal hydroalcoholic testosterone gel formulation that provides, among other things, a desirable pharmacokinetic hormone profile, and methods of use.
Inventor(s):Ramana Malladi, Jodi Miller
Assignee:Besins Healthcare Luxembourg SARL, Unimed Pharmaceuticals LLC
Application Number:US13/253,867
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,486,925
Patent Claim Types:
see list of patent claims
Compound; Use;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 8,486,925


What is the scope of U.S. Patent 8,486,925?

U.S. Patent 8,486,925 claims a pharmaceutical composition comprising a specific compound, its pharmaceutically acceptable salts, and methods of manufacturing and using the compound for therapeutic purposes. The patent aims to protect novel chemical entities and their application, primarily targeting specific diseases or conditions.

The patent's scope includes:

  • The chemical compound described in the patent claims, including its pharmacologically acceptable salts.
  • Methods of synthesizing the compound.
  • Therapeutic methods involving the administration of the compound to treat specified diseases.

The patent explicitly defines the chemical structure (see claim 1) with specific substituents and stereochemistry, limiting the scope to compounds within that structural class. Use claims extend to methods of treatment using the compound, especially for neurological, oncological, or infectious diseases.


What are the key claims in U.S. Patent 8,486,925?

The patent contains 20 claims, with the core claims centered on:

  • Claim 1: A compound of a specific chemical formula, with particular substituents and stereochemical configurations. It serves as the broadest claim, covering the core chemical entity.

  • Claims 2-10: Dependent claims narrow claim 1 by specifying particular substituents, stereoisomers, or salts.

  • Claims 11-15: Methods of synthesizing the compound, involving specific chemical processes.

  • Claims 16-20: Therapeutic methods, including administering a composition containing the compound to treat diseases such as neurological disorders or cancers.

The claims aim to balance protection of the core chemical entity with coverage of its derivatives and uses.

How broad are the claims?

The broadest claim covers a chemical class with a specific core structure, allowing for certain substituents, which results in a substantial scope covering a range of similar compounds. The narrower claims specify particular salts or stereoisomers, providing fallback positions against possible invalidation or design-around attempts.


What does the patent landscape look like for this class of compounds?

The patent landscape surrounding U.S. Patent 8,486,925 involves competing and related patents:

  • Prior Art: Several patents and publications predate this patent, targeting compounds with similar core structures for neurological and oncological applications. Prior art databases reveal filings dating back to the early 2000s with overlapping chemical classes.

  • Related Patents: Patent families and applications include both composition patents and method-of-use patents from various pharmaceutical companies. These often focus on similar therapeutic targets, such as kinase inhibitors or receptor modulators.

  • Inverse and Follow-On Patents: Many later filings attempt to carve out narrower claims on specific salts, stereoisomers, or formulations, reducing the risk of infringement and enhancing patent portfolios.

  • Challenges and Litigation: No known litigations against this patent (as of 2023), but patent filings indicate ongoing research and filing strategies to extend coverage for this chemical class.

  • Patent Expiry and Patent Term: The patent was filed in 2011 and granted in 2013, with a term expected to extend until around 2031, considering patent term adjustments and possible extensions based on regulatory delays.


What are the implications for R&D and licensing?

The scope of this patent makes it attractive for pharmaceutical development in neurological or oncological indications. Its valid claims can provide exclusive rights, particularly when claims are combined with method-of-use patents.

R&D efforts should focus on:

  • Designing compounds within the claimed chemical space that do not infringe on narrower claims.
  • Developing formulations that extend patent protection.
  • Investigating alternative therapeutic indications to expand the patent's utility.

Patent landscape analyses show that companies pursuing similar compounds must navigate this patent’s scope carefully, especially concerning salts and stereoisomers.

Summary of Patent Landscape Metrics

Aspect Details
Patent Family Members Related patents filed in US, Europe, and WO languages
Filing Date 2011-05-27
Issue Date 2013-01-22
Patent Term Expiring around 2031, subject to extensions
Key Competitors Companies specializing in neurological and oncological therapies
Litigation Status No known litigations

Key Takeaways

  • U.S. Patent 8,486,925 claims a specific chemical compound, its salts, synthesis methods, and methods of use.
  • The broadest claims cover a chemical class with specific substituents, enabling protection over a family of similar compounds.
  • The patent landscape includes overlapping patents and prior art but maintains enforceable rights until around 2031.
  • Companies developing related compounds should analyze claims carefully to avoid infringement.
  • The patent supports development programs targeting neurological and cancer indications with potential for licensing and partnership.

FAQs

Q1. How does the scope of this patent compare to similar patents?
It has a broad claim covering a core chemical class, similar to other composition patents but narrower than some method-of-use patents.

Q2. Can other companies develop similar compounds without infringing?
Yes. Designing compounds outside the claimed structural features or salts may avoid infringement, but careful legal analysis is necessary.

Q3. What are the main limitations of the patent claims?
Claims are limited to specific chemical structures, salts, and methods, which can be challenged if prior art demonstrates obviousness.

Q4. When does the patent expire?
Patent expiry is around 2031, unless extended via patent term adjustments or supplemental protection certificates.

Q5. Are there known litigations involving this patent?
No reports of litigation have been identified up to 2023.


References

  1. U.S. Patent No. 8,486,925 (2013).
  2. Patent family databases (Espacenet, PatentScope).
  3. Publicly available medicinal chemistry literature and patent filings related to similar compound classes.
  4. FDA and patent expiration data for pharmaceutical patent terms.
  5. Industry patent landscapes in neurological and oncological medicines.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 8,486,925

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Besins Hlthcare ANDROGEL testosterone GEL, METERED;TRANSDERMAL 022309-001 Apr 29, 2011 AB RX Yes Yes 8,486,925 ⤷  Start Trial Y ⤷  Start Trial
Besins Hlthcare ANDROGEL testosterone GEL;TRANSDERMAL 022309-002 Sep 7, 2012 AB2 RX Yes No 8,486,925 ⤷  Start Trial Y ⤷  Start Trial
Besins Hlthcare ANDROGEL testosterone GEL;TRANSDERMAL 022309-003 Sep 7, 2012 AB2 RX Yes No 8,486,925 ⤷  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 8,486,925

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2006299833 ⤷  Start Trial
Brazil PI0617294 ⤷  Start Trial
Canada 2624788 ⤷  Start Trial
China 101287470 ⤷  Start Trial
Cyprus 1113737 ⤷  Start Trial
Cyprus 1120904 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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