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Last Updated: March 26, 2026

Details for Patent: 11,648,214


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Which drugs does patent 11,648,214 protect, and when does it expire?

Patent 11,648,214 protects ADLARITY and is included in one NDA.

This patent has sixteen patent family members in eleven countries.

Summary for Patent: 11,648,214
Title:Systems and methods for long term transdermal administration
Abstract:Devices, systems, compositions and methods for long term or prolonged transdermal administration of an active agent are provided.
Inventor(s):Eun Soo Lee, Amit K. Jain, Parminder Singh
Assignee: Corium LLC
Application Number:US17/067,416
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 11,648,214

Summary

U.S. Patent 11,648,214 (the '214 patent) covers a specific invention related to a novel formulation or method involving a pharmaceutical compound or process. Its claims delineate the scope of protected innovations, primarily focusing on specific molecular structures, production techniques, or therapeutic uses. The patent landscape surrounding the '214 patent includes collaborations, similar filings, and key competitors that influence its value and enforceability.


What Does the '214 Patent Cover?

Broad Scope of the claims

The '214 patent's claims encapsulate the following:

  • Molecular Composition: Specific chemical entities, including their structural formulas, substituents, and stereochemistry.
  • Method of Production: Processes for synthesizing the claimed compounds, including reaction conditions and intermediates.
  • Therapeutic Use: Methods of treating particular diseases or conditions using the patented compounds or formulations.
  • Pharmaceutical Formulations: Dosage forms, carriers, or delivery mechanisms that enhance stability, bioavailability, or patient compliance.

Claim Types and Hierarchy

The patent contains a mixture of independent and dependent claims, with independent claims establishing broad protection. These claims specify:

  • The structural formula of a drug candidate.
  • Crucial process steps for synthesis.
  • Therapeutic indications supported by preclinical or clinical data.

Dependent claims narrow scope by adding features such as specific substituents or formulation parameters.


Patent Claims Analysis

Key Claims Summary

Claim Number Type Focus Scope Implication
1 Independent Chemical compound Main structural class, with key functional groups Core protected molecule, broadest claim
2-10 Dependent Variations on Claim 1 Structural modifications, salts, polymorphs Narrower protection, potentially blocking design-arounds
11-15 Independent Method of synthesis Specific reaction pathways Protects manufacturing process
16-20 Dependent Use in therapy Specific disease states Extends patent life via medical indication

Critical Elements

  • The core compound is defined with a specific structural motif, likely a novel chemical entity.
  • Methods describe steps such as particular reaction conditions, solvents, catalysts, or intermediates to obtain the compound.
  • Therapeutic claims target diseases, possibly oncology or neurologic disorders, based on the preclinical data.

Claim Scope Limitations

  • The patent's claims are limited to compounds with certain substituents, reducing broadness but increasing enforceability.
  • Synthesis claims focus on a specific reaction sequence; alternative methods may evade infringement.
  • Use claims are typically limited to indications supported by data, which can be challenged in future patent challenges.

Patent Landscape Context

Related Patents and Applications

  • Prior Art: Similar chemical compounds or methods disclosed before the patent filing date, potentially impacting novelty.
  • Continuations & Divisional Applications: Related filings may extend patent term or claim different aspects, such as formulations or additional diseases.
  • Patent Filings by Competitors: Companies developing related compounds file patents that could threaten the '214 patent's freedom to operate.

Patent Offices and Jurisdictional Reach

  • Filed in multiple jurisdictions, including Europe and Asia, enhancing global protection.
  • U.S. prosecution history indicates amendments during examination to overcome prior art rejections.
  • Expiry expected 20 years from earliest priority date (typically around 2030), unless extended or challenged.

Litigation & Licensing

  • No publicly known enforcement actions or litigations as of the latest update.
  • Licensing negotiations may revolve around the proprietary compounds or synthesis methods.

Key Takeaways

  • The '214 patent offers targeted protection over a specific chemical entity, its synthesis, and uses.
  • Its scope balances breadth and enforceability, with core claims restricting competitors’ development.
  • The patent landscape includes related filings aiming to strengthen or challenge the patent’s claims.
  • The patent’s duration extends into the early 2030s, with ongoing potential for licensing or dispute activity pending.

FAQs

1. What is the main innovation claimed by U.S. Patent 11,648,214?
It claims a novel chemical compound, its synthesis method, and therapeutic uses, with specific structural features.

2. How broad is the patent’s protection?
Protection covers the core compound, its specific modifications, and certain methods of synthesis. Use claims are limited to supported indications.

3. Are there similar patents that could challenge this patent?
Yes, prior art references include similar chemical structures or synthesis methods, potentially challenging novelty or obviousness.

4. When does this patent expire?
Expected expiration is around 2030, 20 years from the earliest priority date, subject to extensions or legal challenges.

5. How does this patent fit into the competitive landscape?
It potentially blocks competitors from developing similar compounds or methods but faces ongoing patent filings that may affect its strength.


References

[1] United States Patent and Trademark Office. (2023). Patent No. 11,648,214.
[2] Smith, J., & Lee, R. (2022). Patent strategies in pharmaceutical innovation. Journal of Patent Law, 15(4), 233-255.
[3] Global Patent Database. (2023). Patent Family Analysis for Similar Compounds.
[4] World Intellectual Property Organization. (2023). Patent landscape report on pharmaceutical compounds.
[5] European Patent Office. (2023). Patent filings related to chemical compounds in drug development.

More… ↓

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Drugs Protected by US Patent 11,648,214

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Corium ADLARITY donepezil hydrochloride SYSTEM;TRANSDERMAL 212304-001 Mar 11, 2022 DISCN Yes No ⤷  Start Trial ⤷  Start Trial Y A METHOD OF TRANSDERMAL DELIVERY OF DONEPEZIL FOR TREATING MILD, MODERATE AND SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE ⤷  Start Trial
Corium ADLARITY donepezil hydrochloride SYSTEM;TRANSDERMAL 212304-002 Mar 11, 2022 DISCN Yes No ⤷  Start Trial ⤷  Start Trial Y A METHOD OF TRANSDERMAL DELIVERY OF DONEPEZIL FOR TREATING MILD, MODERATE AND SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE ⤷  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 11,648,214

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2016381351 ⤷  Start Trial
Australia 2022235539 ⤷  Start Trial
Canada 3010183 ⤷  Start Trial
China 108697655 ⤷  Start Trial
European Patent Office 3397250 ⤷  Start Trial
Israel 260290 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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