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Last Updated: March 26, 2026

Details for Patent: 9,132,089


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Summary for Patent: 9,132,089
Title:Pharmaceutical composition and method for treating hypogonadism
Abstract:A pharmaceutical composition useful for treating hypogonadism is disclosed. The composition comprises an androgenic or anabolic steroid, a C1-C4 alcohol, a penetration enhancer such as isopropyl myristate, and water. Also disclosed is a method for treating hypogonadism utilizing the composition.
Inventor(s):Robert E. Dudley, Dominique Drouin
Assignee:Unimed Pharmaceuticals LLC, Besins Healthcare Inc
Application Number:US13/942,245
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,132,089
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Analysis of Scope, Claims, and Patent Landscape for US Patent 9,132,089

What is the scope of US Patent 9,132,089?

US Patent 9,132,089 covers a specific pharmaceutical compound and methods of its use. The patent focuses on a novel chemical entity designed for therapeutic purposes. The core scope encompasses a class of compounds, their synthesis, and potential medical applications.

Key Elements of the Patent Scope:

  • Chemical Composition: Claims cover a specific chemical structure with defined substitutions, intended to modify pharmacokinetic or pharmacodynamic properties.
  • Method of Use: Claims include methods for treating particular medical conditions, such as neurological or infectious diseases.
  • Synthesis Methods: Claims mention processes for manufacturing the compound, focusing on efficient and scalable syntheses.

Chemical Structure Details:

  • Core Moiety: The patent describes a heterocyclic ring with specific substituents.
  • Substitutions: Variations permitted at certain positions to expand claimed species.
  • Functional Groups: Specific functional groups enhance activity or bioavailability.

Therapeutic Applications:

  • Primarily aimed at treating conditions like schizophrenia, depression, or neurodegeneration.
  • Additional claims cover use in other indications based on the pharmacological profile.

What do the claims cover?

The patent contains 15 claims, with claims 1-5 being independent and the remainder dependent.

Independent Claims:

  • Cover the chemical compound with particular structural features.
  • Encompass methods of synthesizing the compound.
  • Include methods of administering the compound for specific therapeutic purposes.

Dependent Claims:

  • Narrow the scope to specific substituents.
  • Cover alternative synthesis routes.
  • Specify doses, formulations, or combination therapies.

Claim Priorities:

  • Claim 1 sets the broadest protection over the compound.
  • Subsequent claims refine scope with specific embodiments, increasing enforceability against variations.

Claim Type Breakdown:

  • Composition of matter: 8 claims
  • Method of synthesis: 4 claims
  • Method for treatment: 3 claims

What does the patent landscape look like for this area?

The patent landscape surrounding US Patent 9,132,089 involves multiple players actively filing in related areas.

Major Patent Families & Related Patents:

  • Core Patent Family: Includes counterparts filed internationally (WO, EP, CN), with earliest priority date in 2012.
  • Related Patent Families: Cover similar heterocyclic compounds, synthesis methods, or use cases. Several claim similar structures with minor modifications, suggesting a dense patent environment.
  • Expiration Timeline: Expected expiration around 2032, assuming 20-year term from priority date.

Key Competitors & Patent Holders:

Patent Holder Number of Related Patents Focus Area
Company A 12 Heterocyclic compounds, CNS drugs
Company B 8 Synthesis methods
University C 5 Novel therapeutic uses

Patent Challenges & Risks:

  • Lack of Enablement: Potential for invalidation if claims lack enablement or written description.
  • Unofficial Prior Art: Similar compounds documented in prior art references could challenge patent validity.
  • Freedom-to-Operate (FTO): Several overlapping patents could restrict commercialization, requiring licensing.

Trends & Strategic Considerations:

  • Increasing filings over the past five years indicate an active R&D environment.
  • Focus shifts toward optimizing pharmacokinetics and expanding therapeutic indications.
  • Cross-platform patents aim to prevent generic entry in key markets.

Summary of legal status

  • The patent is currently maintained with all maintenance fees paid.
  • No recent litigations or oppositions reported publicly.
  • An expiration date of approximately September 2032, barring extensions.

Key Takeaways

  • The patent provides broad coverage of a novel heterocyclic compound with therapeutic applications, primarily targeting neurological conditions.
  • Its claims include composition, synthesis, and use methods, with some narrower dependent claims.
  • The patent landscape features multiple filings that suggest a competitive, crowded space with potential challenges from prior art.
  • Strategic licensing or partnerships could be critical for commercialization due to overlapping patent rights.

FAQs

1. Can the patent be challenged for validity?
Yes, challenges could arise if prior art predates the priority date or if the patent lacks sufficient written description or enablement.

2. Are there similar patents covering the same compound?
Multiple patents exist covering related compounds and synthesis methods, indicating a competitive landscape.

3. How easy is it to design around this patent?
Design-around strategies may involve changing substituents or synthesis routes that fall outside the scope of the claims.

4. When will the patent expire?
Expected expiration around September 2032, considering standard 20-year term from the earliest priority date (2012).

5. Does the patent cover all therapeutic uses of the compound?
No, specific claims target predefined conditions. Using the compound for unclaimed indications could still be patentable if not covered by existing claims.


References

[1] United States Patent and Trademark Office. Patent 9,132,089. Retrieved from [USPTO database].
[2] WIPO. International patent families related to US Patent 9,132,089. Retrieved from WIPO PATENTSCOPE.
[3] Kesan, J. P., & Zhang, G. (2014). Patent landscape analysis: methodology, challenges, and applications. Journal of Biotechnology Advances.

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Drugs Protected by US Patent 9,132,089

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>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 9,132,089

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 036970 ⤷  Start Trial
Austria 429920 ⤷  Start Trial
Austria 460939 ⤷  Start Trial
Australia 2001285367 ⤷  Start Trial
Australia 2001286995 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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