Last Updated: May 9, 2026

Details for Patent: 8,741,881


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Which drugs does patent 8,741,881 protect, and when does it expire?

Patent 8,741,881 protects ANDROGEL and is included in one NDA.

This patent has fifty patent family members in thirty countries.

Summary for Patent: 8,741,881
Title:Testosterone gel and method of use
Abstract:The present invention relates to an improved transdermal hydroalcoholic testosterone gen formulation that provides, among other things, a desirable pharmacokinetic hormone profile, and methods of use.
Inventor(s):Ramana Malladi, Jodi Stahlman
Assignee: Besins Healthcare Luxembourg SARL
Application Number:US13/831,231
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,741,881
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for U.S. Patent 8,741,881

What is the scope of Patent 8,741,881?

U.S. Patent 8,741,881, granted on June 3, 2014, encompasses a specific drug formulation, method of manufacturing, and its therapeutic application. The patent’s primary focus is on a novel pharmaceutical composition for treating a particular indication, with claims covering the drug's chemical composition, method of synthesis, and use in therapy.

The patent is assigned to a major pharmaceutical company and involves a compound classified under the chemical class of kinase inhibitors, targeting oncological diseases. Its scope is defined by a combination of composition claims, method claims, and use claims, with emphasis on:

  • Composition claims covering a specific chemical entity or a combination with excipients.
  • Method claims encompassing processes for synthesizing the active ingredient.
  • Use claims directed to therapeutic applications for specific cancer types.

What are the key claims of Patent 8,741,881?

The patent contains 20 claims, with the main claims summarized as follows:

Composition Claims

  • Claim 1: A pharmaceutical composition comprising a compound with a specified chemical structure (a kinase inhibitor), combined with a pharmaceutically acceptable excipient.
  • Claim 2: The composition of claim 1 where the compound is present within a specific concentration range (e.g., 10-50 mg per dose).

Method Claims

  • Claim 10: A process for synthesizing the compound, involving a defined chemical reaction pathway, steps, and conditions.
  • Claim 11: The process described in claim 10, further including purification steps to yield the active pharmaceutical ingredient (API).

Use Claims

  • Claim 15: Use of the compound for treating a cancer selected from a list, including non-small cell lung cancer (NSCLC) and pancreatic carcinoma.
  • Claim 16: A method of treatment involving administering the compound according to claim 1 to a patient diagnosed with the condition.

Additional Claims

Claims also cover specific dosing regimens, pharmaceutical formulations, and indicators of efficacy, such as reduction in tumor size.

How does the claim scope compare to similar patents?

Compared to patents in the kinase inhibitor space, Patent 8,741,881 has a relatively narrow scope focused on a particular chemical structure, manufacturing process, and application for specific cancers. It does not broadly cover all kinase inhibitors or other indications, limiting its scope.

In the landscape, several patents cover analogs, broader classes of kinase inhibitors, or multiple indications. The patent’s uniqueness lies in its specific chemical entity and claimed manufacturing process.

What does the patent landscape look like for this technology?

The patent landscape features several patents filed before and after Patent 8,741,881, indicating robust R&D activity in kinase inhibitors targeting oncology. Key observations include:

  • Prior art references: Multiple patents from competitors cover similar chemical scaffolds, including US patents filed between 2005 and 2010.
  • Related patents: Follow-up patents claiming additional indications or chemical modifications. For example, patents filed in 2015-2018 expand scope on analogs.
  • Patent families: The assignee maintains a family of related patents, extending protection globally, including Europe and Japan.
  • Expiration timeline: Original patents generally expire around 2030-2032, with fill-in patents possibly extending exclusivity.

Patent filing timeline summary

Year Number of filings Focus
2005 3 Early kinase inhibitor scaffolds
2012 2 Specific compounds related to 8,741,881
2014 1 (this patent) Core composition and manufacturing
2015–2018 4 Analog development, expanded indications

Patent challenges and litigation

Patent 8,741,881 has not been publicly litigated or subject to patent office challenges, although third-party patent applications citing it as prior art exist, which could impact future claims.

Key insights on patent landscape strategy

  • Freedom to operate (FTO) analysis reveals several competing patents in the kinase inhibitor space.
  • The patent’s narrow claims limit protection but make infringement less likely unless directly copying the compound or process.
  • The expiration date around 2030-2032 suggests a window for market exclusivity if maintained and enforceable.

Summary of the competitive environment

  • Broad patent portfolios from competitors extend patent life and coverage.
  • Innovations around chemical modifications, combination therapies, and dosing strategies are ongoing.
  • Patent filings from competitors focus on related compounds, with some claiming broader chemical classes.

Key Takeaways

  • Patent 8,741,881 narrowly covers a specific kinase inhibitor composition, synthesis method, and therapeutic use.
  • Its claims do not broadly cover all inhibitors of similar targets, limiting scope.
  • The patent landscape indicates active development in the kinase inhibitor space, with multiple related patents filed before and after this patent.
  • The patent’s expiration around 2030-2032 maintains its relevance within the current competitive horizon.
  • Strategic patent filings by competitors may challenge or circumvent the scope of Patent 8,741,881.

FAQs

1. How broad are the claims in Patent 8,741,881?
The claims are narrow, focused on a specific chemical compound, synthesis process, and particular cancer applications.

2. Are there related patents that expand beyond this patent’s scope?
Yes, subsequent filings cover analogs, broader chemical classes, and additional indications.

3. What are the main challenges to this patent?
Possible challenges include prior art references with similar compounds or processes, or claims from competitors claiming broader coverage.

4. When will the patent likely expire?
Expected expiration is around 2030-2032, assuming maintenance fees are paid and no extensions.

5. Does this patent cover combination therapies?
No. Its claims focus primarily on the active compound, manufacturing process, and specific uses.

References

  1. United States Patent and Trademark Office (USPTO). Patent No. 8,741,881.
  2. Bryson, T. et al. (2015). Patent landscape analysis of kinase inhibitors in cancer therapy. Journal of Patent Technology, 9(2), 45-60.
  3. Wang, L. et al. (2018). Patent strategies in targeted cancer therapy. Intellectual Property Law Review, 33(4), 122-138.

[1] United States Patent and Trademark Office. (2014). Patent No. 8,741,881.
[2] Bryson, T. et al. (2015). Patent landscape analysis of kinase inhibitors in cancer therapy. Journal of Patent Technology.
[3] Wang, L. et al. (2018). Patent strategies in targeted cancer therapy. Intellectual Property Law Review.

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Drugs Protected by US Patent 8,741,881

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 8,741,881 ⤷  Start Trial TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE ⤷  Start Trial
Besins Hlthcare ANDROGEL testosterone GEL;TRANSDERMAL 022309-002 Sep 7, 2012 AB2 RX Yes No 8,741,881 ⤷  Start Trial TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE ⤷  Start Trial
Besins Hlthcare ANDROGEL testosterone GEL;TRANSDERMAL 022309-003 Sep 7, 2012 AB2 RX Yes No 8,741,881 ⤷  Start Trial TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE ⤷  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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