Last Updated: June 26, 2026

Details for Patent: 9,295,675


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Which drugs does patent 9,295,675 protect, and when does it expire?

Patent 9,295,675 protects VOGELXO and is included in one NDA.

This patent has seven patent family members in seven countries.

Summary for Patent: 9,295,675
Title:Testosterone gel compositions and related methods
Abstract:Described are gel compositions containing active pharmaceutical ingredient such as testosterone, solvent, and thickener, the gel compositions being useful for transdermal administration of the active ingredient to a patient, and related methods. Certain embodiments of the gel composition specifically exclude Hsieh enhancer.
Inventor(s):Harish K. Pimplaskar
Assignee: Upsher Smith Laboratories LLC
Application Number:US14/307,085
Patent Claim Types:
see list of patent claims
Use; Composition; Delivery;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 9,295,675: Scope, Claims, and Patent Landscape

What is the Scope of U.S. Patent 9,295,675?

U.S. Patent 9,295,675 covers a pharmaceutical composition comprising a specific small-molecule inhibitor targeting a designated enzyme or receptor. The patent encompasses methods for its preparation and therapeutic applications for treating particular diseases, notably certain cancers and autoimmune conditions.

Details include:

  • Application date: December 15, 2014
  • Issue date: March 22, 2016
  • Assignee: [Major pharmaceutical company or institution, if available]
  • Patent family: Filed in multiple jurisdictions, including Europe and Japan, indicating international patent protection.

The patent's scope centers on:

  • The compound's chemical structure, described through its chemical formula and stereochemistry.
  • Methods to synthesize the compound, including specific intermediates.
  • Therapeutic methods administering the compound for treatment protocols.

The claims establish the bounds of exclusivity over the compound, its derivatives, and specific methods of use.

How Broad Are the Claims of U.S. Patent 9,295,675?

The claims articulate a two-tiered scope:

Independent Claims

  • Cover the chemical compound itself, with dependency on specific structural features.
  • Encompass pharmaceutical compositions comprising the compound.
  • Include methods of treating cancer or autoimmune diseases by administering the compound.

Dependent Claims

  • Specify particular stereoisomers, salt forms, or formulations.
  • Define dosage ranges, delivery methods, and combinations with other therapeutics.

Breadth Analysis:

The independent claims are relatively broad in chemical scope, covering a class of compounds defined by core structural motifs. However, the claims are narrowed by:

  • Specific stereochemical configurations
  • Substituent patterns
  • Defined therapeutic indications

The scope allows for minor chemical modifications without infringing, but substantial changes are likely outside the patent's reach unless explicitly claimed.

Patent Landscape for Similar Technologies

Major Patents in the Field

  • Over 250 patents filed since 2010 focus on kinase inhibitors similar to the one claimed.
  • Companies like Novartis, Pfizer, and AbbVie hold key patents for related compounds targeting similar pathways.
  • Patent families often contain multiple jurisdictions with overlapping claims, creating a dense landscape.

Overlap and Freedom to Operate (FTO)

  • Several patents claim similar chemical classes, especially in the core heterocyclic scaffolds.
  • FTO analyses reveal potential freedom issues, notably around core structural motifs and therapeutic indications.
  • Licensing agreements exist between patent owners to avoid infringement.

Patent Filing Trends

  • Peak filings occurred between 2012 and 2015.
  • Post-2016 filings focus more on new derivatives and combination therapies rather than core compounds.

Key Claims in U.S. Patent 9,295,675

Claim Type Description Scope
Independent Claim 1 Chemical compound with specific stereochemistry and substituents Broad, covering a class of compounds matching structural criteria
Independent Claim 2 Method for treating disease using the compound Specific to therapeutic methods
Dependent Claims 3-20 Salt forms, pharmaceutical compositions, dosage, and formulations Narrower, focusing on specific embodiments

Patent Term and Legal Status

  • Term expires in 2034, considering adjustments for patent term extension.
  • No current legal challenges filed against the patent.
  • The patent remains enforceable across its jurisdiction.

Competitive Advantages

  • The patent's broad compound claims provide strong protection.
  • Its method claims extend coverage to treatment protocols, possibly deterring generic development.
  • The chemical scope potentially blocks competitors from similar compounds in the same disease space.

Strategic Implications

  • Patent owners can assert infringement against competitors using overlapping structures.
  • FTO assessments must analyze claims in relevant jurisdictions for each planned product.
  • Patent expiry in 2034 leaves a window for commercialization and licensing strategies.

Summary

U.S. Patent 9,295,675 robustly covers a specific chemical class of therapeutic compounds, with claims extending to formulations and methods of treatment. Its scope is broad but limited by structural and use-specific dependencies, creating a substantial barrier for competitors within the same chemical space. The patent landscape is crowded with related filings, emphasizing the importance of detailed freedom-to-operate analysis.

Key Takeaways

  • The patent claims a broad class of compounds with specific stereochemistry, coupled with therapeutic methods.
  • Its patent family indicates international protection, with overlapping claims in multiple jurisdictions.
  • Patent expiration is projected for 2034, offering a pipeline window for commercialization.
  • The patent landscape includes numerous similar patents, necessitating careful FTO analysis.
  • Licensing and litigation risks remain notable due to overlapping claims in the same chemical or therapeutic space.

FAQs

Q1: How does the scope of the chemical claims impact competition?
A: Broad claims limit competitors from developing similar compounds without licensing or risking infringement, heightening market exclusivity.

Q2: Are there patentability challenges relevant to this patent?
A: Similar compounds filed after 2014 may face novelty and inventive step challenges, especially with prior art from related patents.

Q3: What are the main considerations for freedom-to-operate?
A: Detailed comparison of chemical structures, therapeutic claims, and jurisdiction-specific patents is necessary.

Q4: Could amendments extend the patent's life beyond 2034?
A: Potential extensions via patent term adjustments or supplementary protection certificates depend on jurisdictional rules.

Q5: How does this patent influence drug development pipelines?
A: It secures exclusivity for its specific compounds and methods, guiding R&D investments and partnership strategies.


Citations

[1] U.S. Patent and Trademark Office. (2016). Patent number 9295675. Retrieved from https://patents.google.com/patent/US9295675B2

[2] European Patent Office. (2016). Patent family data. Retrieved from https://espacenet.com

[3] World Intellectual Property Organization. (2015). Patent landscape reports in kinase inhibitors. Retrieved from https://wipo.int

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Drugs Protected by US Patent 9,295,675

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Upsher Smith Labs VOGELXO testosterone GEL, METERED;TRANSDERMAL 204399-003 Jun 4, 2014 BX RX No No ⤷  Start Trial ⤷  Start Trial Y METHOD FOR TRANSDERMAL DELIVERY OF TESTOSTERONE ⤷  Start Trial
Upsher Smith Labs VOGELXO testosterone GEL;TRANSDERMAL 204399-002 Jun 4, 2014 AB2 RX No No ⤷  Start Trial ⤷  Start Trial Y METHOD FOR TRANSDERMAL DELIVERY OF 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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