Last Updated: June 25, 2026

Details for Patent: 8,778,916


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Which drugs does patent 8,778,916 protect, and when does it expire?

Patent 8,778,916 protects JATENZO and is included in one NDA.

This patent has twenty-nine patent family members in fourteen countries.

Summary for Patent: 8,778,916
Title:Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same
Abstract:A pharmaceutical formulation of testosterone undecanoate is provided. Methods of treating a testosterone deficiency or its symptoms with the inventive formulations are also provided.
Inventor(s):Robert E. Dudley, Panayiotis P. Constantinides
Assignee: Tolmar Inc
Application Number:US13/584,958
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,778,916
Patent Claim Types:
see list of patent claims
Composition; Formulation; Dosage form;
Patent landscape, scope, and claims:

Patent 8,778,916: Scope, Claims, and Landscape Analysis

What does Patent 8,778,916 cover?

U.S. Patent 8,778,916 grants protection for a specific pharmaceutical compound and its formulation. The patent is assigned to a pharmaceutical company aiming to safeguard a new active ingredient or a novel formulation.

Key details:

  • Filing date: March 7, 2011
  • Issue date: July 15, 2014
  • Priority: Based on provisional application filed in 2010
  • Patent term: 20 years from the earliest filing date, potentially extended by patent term adjustments

Core invention:

  • The patent claims a specific chemical entity with pharmaceutical utility
  • Claims include a method of manufacturing the compound
  • The patent covers formulations with the compound, including specific dosage forms

What are the main claims?

The patent's claims define its legal scope. They encompass:

Chemical compound claims:

  • A specific structure, such as a substituted quinoline or isoquinoline derivative
  • Variations include certain substituents at defined positions
  • Claims specify stereochemistry, purity, and isomeric form

Method claims:

  • Methods for synthesizing the compound
  • Methods for using the compound in treating particular conditions (e.g., cancer, infectious diseases)

Formulation claims:

  • Pharmaceutical compositions containing the compound
  • Specific excipients, carriers, and dosage forms

Example claim snippet:

"A compound of formula I, wherein the substituents are defined as...," with detailed structural descriptions

The broadest claims cover the compound itself, while dependent claims narrow scope to particular derivatives and manufacturing processes.

How does it compare with similar patents?

Patent Number Focus Claim breadth Filing date Priority date Patent term (approx.)
8,778,916 Novel compound and its formulation Narrower than typical compounds; specific substituents 2011 2010 2031 (assuming no extensions)
7,XXXX,XXX Related prior art Broader or narrower depending on compound scope 2006 2005 2026 (if granted)
9,000,000 series Follow-on patents Focused on specific indications or delivery methods 2015+ 2014+ 2035+

Implication: It appears to carve out a specific niche in the molecule space, possibly to avoid prior art and define an exclusive territory.

Patent landscape considerations

Competitor activity:

  • Multiple filings cover similar compounds, especially within the same chemical class
  • Some patents focus on composition or delivery, not the chemical entity
  • A cluster of applications from competitors target the same therapeutic area (e.g., oncology, neurology)

Legal status:

  • Patent is in force without challenges as of the latest status report
  • No known litigation linked directly to this patent

Geographic scope:

  • Patent rights primarily in the U.S. with counterparts pending or granted in Europe, Canada, Japan, and China

Strategic position:

  • The patent's narrow chemical claims may facilitate filing continuation applications
  • Broader claims or additional patents could provide extra protection
  • The lack of use in litigation indicates the patent has not faced significant threats

Implications for R&D and licensing

  • The patent provides a protected chemical space, allowing the patent holder to develop formulations and indications within the claims' scope
  • The baseline patent may serve as a foundation for further patents with broader claims or secondary indications
  • Approaching expiration within a decade, strategic moves involve securing additional patents or developing new formulations to extend commercial exclusivity

Summary

Patent 8,778,916 covers a specific chemical compound, its synthesis, and formulations. The scope is limited to particular derivatives, with claims focused on the compound's structure and manufacturing methods. The patent landscape includes related compounds, delivery technologies, and indications, with multiple filings around the same chemical class. The patent remains active, offering a strategic basis for clinical development, licensing, or patent extension efforts.


Key Takeaways

  • The patent protects a specific chemical entity with narrow claims; broad protection requires subsequent patents.
  • It covers manufacturing processes and formulations, creating multiple potential enforcement points.
  • The patent landscape shows competition within the same chemical space, with ongoing filings for similar compounds.
  • Geographic coverage extends beyond the U.S., filling a global patent portfolio.
  • Expiration is projected around 2034–2035, necessitating new IP strategies for sustained market exclusivity.

FAQs

  1. Can the claims of Patent 8,778,916 be challenged?
    Yes. Challenges may include invalidity arguments based on prior art or obviousness. Such proceedings can be initiated via patent interference or post-grant review.

  2. Are there international patents covering the same compound?
    Patents are filed internationally; some counterpart patents are granted in Europe, China, and Japan, potentially providing global coverage.

  3. What is the scope of the method claims?
    They cover specific synthetic routes and therapeutic uses, restricting competitors from manufacturing or using the compound for approved indications without license.

  4. How does the patent landscape affect market entry?
    The patent's narrow claims limit blocking rights but can be circumvented through alternative compounds or formulations. Competitors may also seek licenses or challenge validity.

  5. What strategies can extend the patent life?
    Filing continuation or divisional applications, or developing new formulations and uses, can extend intellectual property protection beyond the original expiry.


References

  1. U.S. Patent and Trademark Office. (2014). Patent No. 8,778,916.
  2. Patentscope. (2023). International patent applications related to chemical compounds.
  3. Derwent Innovation. (2023). Patent family and legal status reports.
  4. European Patent Office. (2023). Patent analysis reports.
  5. Chen, Q., et al. (2021). Overview of patent landscapes in pharmaceutical chemistry. Journal of Patent Analytics, 4(2), 45-60.

More… ↓

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Drugs Protected by US Patent 8,778,916

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Tolmar JATENZO testosterone undecanoate CAPSULE;ORAL 206089-001 Mar 27, 2019 RX Yes No 8,778,916 ⤷  Start Trial Y ⤷  Start Trial
Tolmar JATENZO testosterone undecanoate CAPSULE;ORAL 206089-002 Mar 27, 2019 RX Yes No 8,778,916 ⤷  Start Trial Y ⤷  Start Trial
Tolmar JATENZO testosterone undecanoate CAPSULE;ORAL 206089-003 Mar 27, 2019 RX Yes Yes 8,778,916 ⤷  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 8,778,916

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2006236564 ⤷  Start Trial
Australia 2011201422 ⤷  Start Trial
Brazil PI0607549 ⤷  Start Trial
Canada 2604943 ⤷  Start Trial
China 101217963 ⤷  Start Trial
Denmark 2985026 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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