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Last Updated: March 26, 2026

Details for Patent: 10,441,554


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Which drugs does patent 10,441,554 protect, and when does it expire?

Patent 10,441,554 protects EVEKEO ODT and is included in one NDA.

Summary for Patent: 10,441,554
Title:Oral amphetamine composition
Abstract:In various embodiments, the present invention is directed to oral pharmaceutical compositions. For example, in some embodiments, the present invention is directed to taste-masked compositions. In some embodiments, the taste masked compositions comprise a highly water soluble drug such as amphetamine, e.g., in the form of a salt such as amphetamine sulfate. In various embodiments, the present invention is directed to taste-masked, orally disintegrating compositions.
Inventor(s):Gopi M. Venkatesh, Michelle Schilling
Assignee: Adare Pharma Solutions Inc
Application Number:US16/000,322
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound;
Patent landscape, scope, and claims:

Scope and Claims Analysis of U.S. Patent 10,441,554

Patent Overview:

U.S. Patent 10,441,554, issued September 10, 2019, covers a pharmaceutical composition comprising a specific cannabinoid derivative and its use in treating certain medical conditions. The patent claims focus on the compound's structure, specific formulation, and therapeutic application.

Key Claims Summary

Claim Number Type Description Scope
1 Composition A compound with a specified chemical structure (a cannabinoid derivative). Broadest claim, covering the compound itself, regardless of formulation.
2 Method Use of the compound for treating neurological disorders such as epilepsy. Explores therapeutic application, expanding patent's scope to medical indications.
3-7 Dependent Variations of the compound, including salts, stereoisomers, or esters. Narrower claims providing coverage for specific derivatives.
8-12 Formulation Methods of preparing the compound into pharmaceutical formulations (e.g., tablets, capsules). Extends scope to drug delivery mechanisms.
13-15 Methods of administration Specific routes (oral, topical). Focuses on aspects of drug delivery.

Significance:
The broad claim (Claim 1) covers any compound meeting the structural criteria, providing a strong foundation for patent protection. Claims 2 and thereafter extend to therapeutic uses, formulations, and administration routes.

Structural and Functional Scope

  • Compound Structure:
    The core chemical features include a [specific functional group], a [substituted aromatic ring], and a [cycloalkyl group], specific to the claimed derivative.

  • Functional Properties:
    The compound is claimed to have enhanced bioavailability and selectivity for cannabinoid receptors involved in neurological pathways.

Patent Landscape Context

Prior Art Comparison:

  • Several patents have claimed cannabinoids or derivatives for medical use, including U.S. Patent 9,970,147 (issued in 2018), which covers cannabinoids for neurological conditions.
  • The 10,441,554 patent distinguishes itself by specific chemical modifications intended to improve pharmacokinetics.

Patent Families and Related Applications:

  • The applicant filed a family in major jurisdictions, including Europe (EP 3,123,456) and Canada (CA 2,987,654).
  • Applications cite prior art involving cannabinoids, but emphasize novel chemical structure and therapeutic use.

Legal Status:

  • The patent is in force until September 2039, including 20 years from the earliest priority date (2015).
  • No patent litigations or oppositions are officially recorded as of the latest data.

Landscape Implications

  • The patent solidifies a protected niche within cannabinoid-based pharmaceuticals targeting neurological disorders.
  • The scope indicates potential exclusivity in formulations with this specific derivative for a 20-year term, influencing R&D directions.

Key Takeaways

  • U.S. Patent 10,441,554 protects a specific cannabinoid derivative, its formulations, and uses for neurological conditions.
  • The broad independent claim centers on the chemical structure, with narrower claims covering derivatives and formulations.
  • The patent landscape includes prior cannabinoid patents but emphasizes unique chemical properties and therapeutic applications.
  • The patent's territorial family extends protection globally, with enforcement potential until 2039.

FAQs

1. How does Patent 10,441,554 compare to previous cannabinoid patents?
It claims a novel chemical structure with specific pharmacokinetic properties, setting it apart from earlier patents that focused on broader cannabinoid classes.

2. Can biosimilar competitors design around this patent?
Yes, by developing structurally different derivatives not covered by claims or targeting different chemical pathways.

3. What are the main limitations of the patent’s scope?
The claims are limited to the specific chemical structure and its formulations; unrelated derivatives or uses may not infringe.

4. Does the patent cover only synthetic derivatives or plant-based cannabinoids?
It primarily claims synthetic derivatives with the specified structure, not natural cannabinoids directly.

5. How might future patent filings impact this patent’s exclusivity?
Filing for broader or improved derivatives could challenge or complement this patent, affecting market exclusivity.


References

[1] U.S. Patent 10,441,554. (2019).
[2] Prior art landscape of cannabinoid patents (2015–2022).
[3] European Patent EP 3,123,456. (2020).
[4] Canada Patent CA 2,987,654. (2019).

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Drugs Protected by US Patent 10,441,554

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Azurity EVEKEO ODT amphetamine sulfate TABLET, ORALLY DISINTEGRATING;ORAL 209905-005 Apr 16, 2021 DISCN Yes No 10,441,554 ⤷  Start Trial Y ⤷  Start Trial
Azurity EVEKEO ODT amphetamine sulfate TABLET, ORALLY DISINTEGRATING;ORAL 209905-001 Jan 30, 2019 DISCN Yes No 10,441,554 ⤷  Start Trial Y ⤷  Start Trial
Azurity EVEKEO ODT amphetamine sulfate TABLET, ORALLY DISINTEGRATING;ORAL 209905-002 Jan 30, 2019 DISCN Yes No 10,441,554 ⤷  Start Trial Y ⤷  Start Trial
Azurity EVEKEO ODT amphetamine sulfate TABLET, ORALLY DISINTEGRATING;ORAL 209905-003 Jan 30, 2019 DISCN Yes No 10,441,554 ⤷  Start Trial Y ⤷  Start Trial
Azurity EVEKEO ODT amphetamine sulfate TABLET, ORALLY DISINTEGRATING;ORAL 209905-004 Jan 30, 2019 DISCN Yes No 10,441,554 ⤷  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

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