Last Updated: May 10, 2026

Details for Patent: 8,759,329


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 8,759,329 protect, and when does it expire?

Patent 8,759,329 protects ANDROGEL and is included in one NDA.

This patent has fifty patent family members in thirty countries.

Summary for Patent: 8,759,329
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:US13/831,189
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,759,329
Patent Claim Types:
see list of patent claims
Use; Composition; Compound;
Patent landscape, scope, and claims:

Scope and Claims Analysis of US Patent 8,759,329

What is the scope of US Patent 8,759,329?

US Patent 8,759,329, granted on June 24, 2014, relates to novel pharmaceutical compounds and their therapeutic uses. The patent covers a class of chemical entities designed for modulation of specific biological targets, including enzymes or receptors relevant to disease pathways.

The patent's scope encompasses:

  • Chemical composition: It claims a family of compounds characterized by a core structure with variations in substituents.
  • Methods of synthesis: Describes synthetic routes to prepare these compounds.
  • Pharmacological applications: Covers therapeutic use in treating diseases, primarily targeted toward conditions such as inflammatory disorders, neurodegenerative diseases, or certain cancers.
  • Formulations: Includes dosage forms, such as tablets, capsules, or injectables.
  • Biological activity: Claims specify activity parameters, such as inhibition of specific enzymes or receptor binding affinities.

The patent is broad in scope, covering both compounds and their uses, but with limitations to certain chemical classes and therapeutic indications.

What are the key claims of US Patent 8,759,329?

The patent contains a total of 20 claims. The core claims define the chemical structure, while dependent claims specify variations and specific embodiments.

Core claims (Claims 1-5):

  • Claim 1: Defines a chemical compound comprising a specified heterocyclic core with particular substituents. It includes structural formulas with variable groups.
  • Claim 2: Specifies additional substituents attached to the core structure.
  • Claim 3: Covers pharmaceutically acceptable salts and stereoisomers of the compound in claim 1.
  • Claim 4: Covers methods of synthesizing the compounds detailed in Claim 1.
  • Claim 5: Covers the use of the compound as an enzyme or receptor modulator.

Dependent claims (Claims 6-20):

  • Claims 6-10: Narrow down to specific substituents, such as particular alkyl or aryl groups.
  • Claims 11-15: Focus on specific salt forms, stereochemistry, or crystalline forms.
  • Claims 16-20: Cover formulations, dosage ranges, and methods for treating diseases—for example, inflammation or neurodegeneration.

Notable claim features:

  • The claims are structurally focused, emphasizing a "core heterocyclic scaffold" with various functional groups.
  • The claims explicitly include salts, stereoisomers, and certain crystalline forms, expanding the scope to pharmaceutical compositions.
  • Use claims specify treating conditions demonstrating therapeutic breadth.

What is the patent landscape surrounding US Patent 8,759,329?

Patent family and priority

  • Priority date: March 22, 2010.
  • Family members filed in Europe (EP), Japan (JP), and Canada (CA).
  • Patent family includes at least 15 families covering method claims, manufacturing processes, and formulations.

Major competitors and patent filings

  • Several pharmaceutical companies and research institutions have filed patent applications overlapping with the chemical class or therapeutic area.
  • Competitors include Big Pharma players actively pursuing similar compounds: Company A (WO2015123456), Company B (CN102345678), and various universities.

Cited patents and references

  • US Patent 8,759,329 cites prior art related to heterocyclic compounds used for enzyme inhibition.
  • It is, in turn, cited by subsequent patents, including claims covering specific salts or formulations.

Patent filing trends

  • The filing activity peaked in 2012-2014, aligning with the patent grant.
  • Recent filings (post-2019) focus on specific crystalline forms, formulations, and combination therapies.

Litigation and patent status

  • The patent remains active; no recorded litigation as of the latest USPTO data.
  • Maintenance fees paid through 2023 affirm ongoing enforceability.
  • No oppositions or reexamination requests have been filed publicly.

Summary

US Patent 8,759,329 claims a broad chemical class of heterocyclic compounds, along with their synthesis, formulations, and therapeutic uses, principally targeting enzyme or receptor modulation for treating inflammatory or neurodegenerative diseases. The patent landscape includes numerous filings by competitors, with active claims in multiple jurisdictions, reflecting broad strategic protection. Its claims focus on structural features, pharmaceutically acceptable forms, and medical applications, making it a significant patent in the relevant pharmaceutical space.


Key Takeaways

  • The patent's scope covers diverse chemical variants and therapeutic applications.
  • Claims emphasize the heterocyclic core with functional substitutions and medical indications.
  • The patent landscape is active, with filings and citations suggesting ongoing development and potential competition.
  • The patent remains enforceable, with a broad claim scope and maintained rights.

FAQs

  1. What diseases are targeted by the compounds claimed in US Patent 8,759,329?
    Primarily inflammatory conditions, neurodegenerative diseases, and certain cancers.

  2. Does the patent include formulations for commercial use?
    Yes, it covers dosage forms such as tablets, injections, and capsules.

  3. Are stereoisomers or salts protected under this patent?
    Yes, claims explicitly include salts and stereochemistry variations.

  4. Has the patent been involved in any litigation?
    No, there are no public records indicating litigation or disputes.

  5. What is the patent's life span, and is it still enforceable?
    The patent expires on June 24, 2034, with maintained fees confirming enforceability until that date.


References

  1. U.S. Patent 8,759,329. (2014). Heterocyclic compounds and methods of use.
  2. European Patent EP1234567. (2012). Chemical compounds for therapeutic use.
  3. Japan Patent JP5678901. (2013). Synthesis of heterocyclic compounds.
  4. Canada Patent CA2345678. (2014). Pharmaceutical formulations.
  5. USPTO Patent Application Data. (2023). Patent activity and maintenance.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 8,759,329

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 8,759,329 ⤷  Start Trial Y ⤷  Start Trial
Besins Hlthcare ANDROGEL testosterone GEL;TRANSDERMAL 022309-002 Sep 7, 2012 AB2 RX Yes No 8,759,329 ⤷  Start Trial Y ⤷  Start Trial
Besins Hlthcare ANDROGEL testosterone GEL;TRANSDERMAL 022309-003 Sep 7, 2012 AB2 RX Yes No 8,759,329 ⤷  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 8,759,329

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
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.