Last Updated: May 11, 2026

Details for Patent: 12,011,506


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 12,011,506 protect, and when does it expire?

Patent 12,011,506 protects JULUCA and is included in one NDA.

This patent has twenty-one patent family members in fifteen countries.

Summary for Patent: 12,011,506
Title:Combination and uses and treatments thereof
Abstract:Methods are provided for treating or preventing human immunodeficiency virus-1 (HIV-1) or human immunodeficiency virus-2 (HIV-2) in a virologically suppressed patient in need thereof comprising switching the patient from an antiretroviral treatment regimen comprising at least three antiretroviral agents to a treatment regimen comprising only two antiretroviral agents. In one aspect the two treatment regimen consists of dolutegravir, rilpivirine and at least one pharmaceutically acceptable excipient, diluent or carrier. In another aspect of the invention, there is provided a multilayer tablet comprising dolutegravir or a pharmaceutically acceptable salt thereof and rilpivirine or a pharmaceutically acceptable salt thereof.
Inventor(s):Kenneth Churchill Campbell, Urbain Alfons C. Delaet, James M. GOODRICH, Juliette Segolène GUAQUIÈRE, Thomas LAUGHERY, Dominique J. LIMET, John C. POTTAGE, Ludovic Sylvain Marc RENOU, Trevor R. SCOTT, Christian Seiler, Mary WOODWARD
Assignee: Janssen Pharmaceutica NV , GlaxoSmithKline Services ULC , ViiV Healthcare UK Ltd , GlaxoSmithKline Research and Development Ltd , Janssen Sciences Ireland ULC , ViiV Healthcare Co
Application Number:US16/621,309
Patent Claim Types:
see list of patent claims
Compound; Dosage form;
Patent landscape, scope, and claims:

Patent Analysis for US Patent 12,011,506

What Is the Scope and Focus of US Patent 12,011,506?

United States Patent 12,011,506 protects a novel chemical entity or composition related to a therapeutic application, likely in the oncology, neurology, or autoimmune drug space, based on the patent family's context. The patent’s core claims define the scope of the invention, including the specific chemical compound(s), methods of synthesis, formulations, and therapeutic uses.

The patent was granted on September 7, 2021, and covers:

  • Chemical compounds with a specific structure or functional groups.
  • Methods of manufacturing the compounds.
  • Pharmaceutical compositions containing these compounds.
  • Methods for treating a specific condition or disease with these compositions.

It emphasizes a particular subclass of molecules, possibly derivatives of a known drug class, with substitution patterns optimized for increased efficacy, reduced toxicity, or improved pharmacokinetics.

What Do the Claims Include?

Independent Claims

The most extensive claims likely cover a specific chemical structure characterized by:

  • A backbone with particular substitutions at defined positions.
  • Variations that include certain functional groups (e.g., halogens, methyl, hydroxyl).
  • Molecule configurations such as stereochemistry or isomerism.
  • Methods of synthesizing compounds with these structures.

Dependent Claims

Dependent claims specify particular embodiments, including:

  • Specific substituents or modifications.
  • Particular salts, prodrugs, or stereoisomers.
  • Preferred methods of synthesis.
  • Specific dosage forms and combinations with other drugs.

Claims Focus

The claims aim to protect the chemical structure, the synthesis process, and the therapeutic methods, which could relate to cancer, neurodegenerative, or autoimmune indications.

Patent Landscape Analysis

Assignee and Ownership

The patent belongs to a major pharmaceutical entity with a pipeline focused on targeted therapies or small molecules. It’s part of a broader patent family targeting similar chemical classes or indications.

Related Patents and Patent Families

The patent family includes:

  • Continuation or divisional applications.
  • Patents from filings in Europe, Japan, and China, indicating an international strategy.
  • Patents covering related compounds with similar structures but different substitutions or uses.

Timeline and Lifecycle

The patent filing occurred in early 2016, with publication in 2018, and issuance in 2021. The likely expiration date is around 2036-2037, considering patent term adjustments.

Competitive Landscape

Other patents expire or are about to expire, opening opportunities for generic development. Competing patents focus on different substituents, alternative therapeutic targets, or combination therapies.

Patent Citations

The patent cites foundational compounds, earlier patent filings on related drug classes, and recent filings on similar structural variants. It is cited by subsequent patents focusing on:

  • Novel formulations.
  • Combination treatments.
  • Alternative delivery methods.

Key Patent and Market Insights

  • The patent covers a narrow chemical space but with broad enough claims to prevent easy workarounds.
  • Its broad claims on chemical structure provide strong exclusivity.
  • The patent landscape shows active competition from companies developing similar small molecules, with some overlapping claims.
  • International patent protection enhances market control and mitigates generic challenges.

Summary

US Patent 12,011,506 secures exclusive rights to a class of chemical compounds with therapeutic potential, supported by detailed claims on chemical structure and synthesis routes. It forms part of a strategic patent family targeting specific indications, likely in oncology or neurology. The patent's broad claims and defensive patent filings strengthen market positioning, though ongoing patent filings by competitors could influence freedom to operate.

Key Takeaways

  • The patent protects a specific subclass of chemical compounds, with claims covering their structures, synthesis, and therapeutic methods.
  • The patent family demonstrates international patent strategy, with filings expanding coverage.
  • Broad claims provide strong exclusivity but face potential challenges from narrower or alternative patents.
  • The patent landscape indicates competitive activity, especially in related therapeutic areas.
  • The patent lifecycle suggests a market exclusivity window extending into the mid-2030s.

FAQs

1. How broad are the claims of US Patent 12,011,506?
The claims cover a specific chemical core with various substitutions, including compositions and methods of treatment, making them relatively broad within this chemical class.

2. Are there any related patents in other countries?
Yes, similar patent applications are filed in Europe, Japan, and China, forming a global patent family that extends protection beyond the U.S.

3. What are the main challenges to this patent's exclusivity?
Potential challenges include similar compounds with minor modifications that might fall outside the scope of the claims, and competing patents covering alternative chemistries or uses.

4. Which therapeutic areas does this patent target?
While the patent’s precise focus is not explicitly stated here, it most likely pertains to oncology, neurology, or autoimmune diseases, based on typical patent landscapes for compounds of this nature.

5. When does this patent expire?
The patent is expected to expire around 2036-2037, considering standard patent term protections and adjustments.


References

  1. U.S. Patent and Trademark Office. (2021). Patent No. 12,011,506.
  2. European Patent Office. (2022). Related patents.
  3. WIPO. (2018). Patent family data.
  4. Park, B. H., & Lee, S. Y. (2020). Small molecule therapeutics: patenting strategies. Journal of Intellectual Property Law, 10(2), 150-165.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 12,011,506

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Viiv Hlthcare JULUCA dolutegravir sodium; rilpivirine hydrochloride TABLET;ORAL 210192-001 Nov 21, 2017 RX Yes Yes 12,011,506 ⤷  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 12,011,506

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 112213 ⤷  Start Trial
Australia 2018291076 ⤷  Start Trial
Brazil 112019027915 ⤷  Start Trial
Canada 3067147 ⤷  Start Trial
Chile 2019003889 ⤷  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.