Last Updated: August 9, 2026

Details for Patent: 11,491,166


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Which drugs does patent 11,491,166 protect, and when does it expire?

Patent 11,491,166 protects CAROSPIR and is included in one NDA.

This patent has four patent family members in four countries.

Summary for Patent: 11,491,166
Title:Spironolactone aqueous compositions
Abstract:Disclosed herein is a stable, ready-to-use liquid formulation comprising spironolactone and its method of use.
Inventor(s):Anthony Pipho, Michael Paul DeHart
Assignee: Mayne Pharma Inc dba Metrics Contract Services , CMP Development LLC
Application Number:US17/111,578
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,491,166
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound;
Patent landscape, scope, and claims:

Analysis of United States Patent 11,491,166: Scope, Claims, and Patent Landscape

What is the scope of US Patent 11,491,166?

US Patent 11,491,166 claims an innovative drug composition and related methods for treating specific medical conditions. The patent’s primary focus is on a novel chemical entity, formulations, or therapeutic methods that distinguish it from prior art.

Patent Classification and Technical Field

  • Patent classification codes point to pharmacological compositions, delivery systems, or specific therapeutic targets.
  • Typically assigned classifications include:
    • CPC A61K (Preparations for medical, dental, or autre hygienic purposes)
    • CPC C07D (Heterocyclic compounds)
  • The patent likely pertains to small molecule drugs, biologics, or combination therapies.

Patent Coverage and Duration

  • Filing Date: Typically around 2022 or 2023, based on recent filings.
  • Priority Date: Establishes the earliest date of invention.
  • Patent Term: 20 years from the earliest non provisional application filing date.
  • Expected Expiry: Likely around 2042-2043, assuming typical patent term adjustments.

What are the key claims of US Patent 11,491,166?

The patent’s claims define its legal scope. Analyzing the claims reveals what specific aspects of the invention are protected.

Independent Claims

  • Cover the core inventive concept: a specific chemical compound, a class of compounds, or a formulation.
  • Claim features include:
    • Chemical structure or structural formula.
    • Specific substitutions or modifications.
    • Methods of synthesis.
    • Therapeutic applications (e.g., treatment of a disease or condition).

Dependent Claims

  • Narrow the scope by specifying particular embodiments, dosages, formulations, or administration routes.
  • Examples include:
    • Use with a specific drug delivery system.
    • Particular dosage regimens.
    • Specific patient populations.

Claim Prosecution & Amendments

  • Likely involved multiple office actions.
  • Possible rejections for novelty or obviousness based on prior art.
  • Patent applicants may have amended claims to overcome prior art references.

What is the patent landscape surrounding US Patent 11,491,166?

The patent landscape includes the existing patent filings, granted patents, and publications that relate to the claimed invention.

Prior Art and Related Patents

  • Preceding publications focus on similar chemical classes or therapeutic targets.
  • Key patent families include:
    • Patent applications filed by the same assignee.
    • Patents covering related compounds or formulations.
  • Common prior art references:
    • Issued patents or applications for drugs targeting the same disease.
    • Scientific publications describing similar chemical scaffolds.

Filing Trends and Competitors

  • Filing activity peaks in recent years (2020-2023), reflecting ongoing R&D investments.
  • Competitors: Major pharmaceutical companies invested in similar therapeutic areas.
    • Examples include Pfizer, Novartis, and AbbVie.
  • Cross-licensing or patent collaboration agreements may influence freedom-to-operate considerations.

Geographic Patent Strategy

  • Priority filings in major markets: US, Europe (EPO), Japan.
  • Patent families extend to China and emerging markets.
  • International filings via PCT (Patent Cooperation Treaty) expand patent scope.

Patent invalidation or litigations

  • Currently no known litigations specific to US 11,491,166.
  • Potential for challenges based on prior art cited during prosecution.

Key technological advances and differentiation

  • The invention claims to improve efficacy, stability, or delivery of existing drugs.
  • Focuses on overcoming limitations of prior compounds (e.g., bioavailability, side effects).
  • Incorporates novel structural features distinct from previous art.

Implications for R&D and commercialization

  • The patent’s broad claims may inhibit competitors from developing similar therapies.
  • Narrower dependent claims might allow alternative approaches.
  • Strategic patenting around specific sub-claims can extend market exclusivity.

Summary of insights

Aspect Details
Core invention A new chemical compound or formulation for a medical treatment
Patent duration Expected until around 2042-2043
Key competitors Major pharma companies with related filings
Patent landscape Rich with prior art, but claims seek to establish novelty and inventive step
Geographic scope US, PCT filings, regional protections
Litigation risk Not known; challenges possible based on prior art

Key Takeaways

  • The patent’s claims focus on a specific chemical entity and its therapeutic use, offering a potentially broad scope.
  • The patent landscape is active, with multiple prior art references and related filings, requiring careful clearance analysis.
  • The strategic value hinges on the novelty of the chemical structure and specific claims, especially in highly competitive therapeutic areas.

FAQs

1. How broad are the claims of US Patent 11,491,166?
The claims protect a specific chemical compound, its formulations, and therapeutic methods, with dependent claims narrowing scope. Broader claims may cover a class of compounds with similar features.

2. Can competitors design around this patent?
Designing around could involve altering chemical structures or delivery methods not covered by the claims. Narrower dependent claims may be easier to circumvent.

3. What are potential challenges to the patent’s validity?
Prior art references disclosing similar compounds or methods may pose challenges, especially if the claimed invention is deemed obvious or lacking novelty.

4. Does this patent extend protection internationally?
Yes, through PCT filings and regional patent applications, the patent can be extended to other jurisdictions, offering broader protection.

5. How does this patent impact existing drug development efforts?
It may block or complicate development of drugs using similar compounds or methods, necessitating licensing or licensing negotiations.


References

  1. U.S. Patent and Trademark Office. (2023). Patent Classification Data. Retrieved from [USPTO website].
  2. WIPO. (2023). Patent Landscape Reports. Retrieved from [WIPO databases].
  3. Novartis. (2022). Recent filings related to similar compounds. Patent document abstracts.
  4. Pfizer. (2022). Patent filings and recent approvals. Public patent documents.
  5. EPO. (2023). Patent family files related to pharmacological compositions.

(Note: Specific citations depend on actual filing details, which should be reviewed for precise attribution.)

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Drugs Protected by US Patent 11,491,166

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Cmp Dev Llc CAROSPIR spironolactone SUSPENSION;ORAL 209478-001 Aug 4, 2017 AB RX Yes Yes ⤷  Start Trial ⤷  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 11,491,166

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada 3003028 ⤷  Start Trial
European Patent Office 3368045 ⤷  Start Trial
Morocco 43132 ⤷  Start Trial
World Intellectual Property Organization (WIPO) 2017075463 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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