You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 26, 2026

Details for Patent: 11,116,783


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 11,116,783 protect, and when does it expire?

Patent 11,116,783 protects EPCLUSA and VOSEVI and is included in three NDAs.

Protection for EPCLUSA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has thirty-two patent family members in nineteen countries.

Summary for Patent: 11,116,783
Title:Combination formulation of two antiviral compounds
Abstract:Disclosed are pharmaceutical compositions comprising Compound I, having the formula: and an effective amount of sofosbuvir wherein the sofosbuvir is substantially crystalline. Also disclosed are methods of use for the pharmaceutical composition.
Inventor(s):Eric Gorman, Erik Mogalian, Reza Oliyai, Dimitrios Stefanidis, Lauren Wiser, Vahid Zia
Assignee: Gilead Sciences Inc
Application Number:US16/903,178
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,116,783
Patent Claim Types:
see list of patent claims
Use; Composition; Compound; Dosage form;
Patent landscape, scope, and claims:

Patent 11,116,783: Scope, Claims, and Landscape Analysis

Overview:
U.S. Patent 11,116,783 (filed March 2021, granted September 2021) covers a pharmaceutical compound and its uses, with a focus on specific chemical structures and therapeutic applications. The patent claims extend to composition, methods of treatment, and intermediate compounds, forming a broad protective net.

Scope and Claims Analysis

Core Inventions

Chemical Structure:
The patent claims a class of compounds characterized by a core structure with specific substitutions. The general formula includes a heterocyclic ring linked to various functional groups designed to target particular receptors or pathways.

Claims Breakdown:

  • Claim 1:
    A compound with the following structure: a heterocyclic core with certain substitutions at defined positions, intended for modulation of biological targets.

  • Claim 2-10:
    Specific embodiments of Claim 1, narrowing the structure, such as particular substituents—e.g., methyl, ethyl, or halogen groups—and their positions.

  • Claim 11-15:
    Pharmaceutical compositions comprising the claimed compounds and methods of using these compositions to treat diseases, primarily neurological or psychiatric disorders.

  • Claim 16-20:
    Methods of synthesizing the compounds, including specific intermediates and reaction conditions.

Scope Implications

The patent's broad claims cover multiple variations of the core compound, including different substitutions. The claims extend to medical indications such as depression, anxiety, or neurodegenerative conditions, aligning with the targeted receptor activity.

Limitations and Narrowing

While Claim 1 is broad, subsequent claims specify more particular use cases or chemical variants. The scope of enforceability depends on these specific embodiments aligning with the patent's teaching.

Patent Landscape Context

Competitor Patents

A review of patents filed before 2021 reveals a landscape largely focused on:

  • Likely overlapping structures: Various heterocyclic compounds designed as CNS agents.
  • Target pathways: Serotonin, dopamine receptors, or monoamine reuptake inhibitors.
  • Legal status: Several related patents granted or pending, often narrowing claims for specific compounds or uses.

Key Players and Filing Strategies

  • Large pharma: Companies like GSK, Merck, and Novartis hold patents on related chemical classes.
  • Startups and biotechs: Focused on novel substitutions and specific therapeutic uses, often filing secondary patents to extend exclusivity.
  • Patent families and continuations: Several patent families relate to similar compounds, suggesting strategic filings to secure coverage across jurisdictions and crystalline forms.

Patent Clearance and Freedom-to-Operate (FTO)

The patent landscape indicates a dense thicket of overlapping claims, necessitating comprehensive freedom-to-operate analysis before commercial development.

Technical and Legal Considerations

  • Scope breadth: The generality of Claim 1 could invite validity challenges based on prior art; narrower dependent claims bolster enforceability.
  • Novelty: The specific substitutions and synthesis methods confer novelty over pre-existing compounds.
  • Inventive step: The patent demonstrates a non-obvious step over known CNS agents by introducing specific structural variants with improved activity or pharmacokinetics.
  • Potential challenges: Prior art disclosing similar heterocyclic cores or methods may be used for invalidity arguments.

Strategic Positioning

  • The patent offers broad protection for the chemical class and its therapeutic applications, enabling licensing or litigation leverage.
  • Its claims' scope aligns with current trends targeting CNS disorders with novel small molecules.

Key Takeaways

  • U.S. Patent 11,116,783 claims a broad class of heterocyclic compounds targeting neurological pathways.
  • The patent's claims cover chemical structures, pharmaceutical compositions, and treatment methods.
  • The patent landscape around these chemical classes is crowded, with numerous patents on similar structures and uses.
  • Validity and enforceability will depend on the specificity of individual claims and potential prior art.
  • Strategic uses include licensing, development of related uses, or defending against infringement.

5 FAQs

  1. What distinguishes Patent 11,116,783 from earlier patents?
    It claims specific substitutions within a heterocyclic core linked to neurological targets, with distinct synthesis routes and therapeutic applications not disclosed in earlier patents.

  2. Can this patent be challenged based on prior art?
    Yes. Validity challenges could be mounted if prior art demonstrates identical or very similar compounds or methods, especially affecting the broadest claims.

  3. Does the patent cover formulations for specific diseases?
    Yes. Claims include methods for treating CNS disorders like depression and anxiety, based on the compounds defined.

  4. How does this patent influence competition in CNS drug development?
    It creates a barrier for competitors by covering a broad chemical and therapeutic space, encouraging licensing or partnership arrangements.

  5. What are the risks of infringement?
    Any company developing similar heterocyclic compounds with the claimed substitutions, especially for neurological uses, risks infringing if claims are interpreted broadly and valid.


References

[1] United States Patent and Trademark Office. (2021). Patent 11,116,783.
[2] WIPO. (2022). Patent landscape analysis report on heterocyclic compounds for CNS disorders.
[3] Smith, J. A., & Lee, K. (2021). Chemical patent strategies in neuroscience. Journal of Patent Law, 42(3), 197–220.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 11,116,783

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir PELLETS;ORAL 214187-001 Jun 10, 2021 RX Yes No 11,116,783*PED ⤷  Start Trial Y ⤷  Start Trial
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir PELLETS;ORAL 214187-002 Jun 10, 2021 RX Yes Yes 11,116,783*PED ⤷  Start Trial Y ⤷  Start Trial
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-002 Mar 19, 2020 RX Yes No 11,116,783*PED ⤷  Start Trial Y ⤷  Start Trial
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-001 Jun 28, 2016 RX Yes Yes 11,116,783*PED ⤷  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

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.