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Last Updated: March 26, 2026

Details for Patent: 9,427,421


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Which drugs does patent 9,427,421 protect, and when does it expire?

Patent 9,427,421 protects CETYLEV and is included in one NDA.

This patent has one patent family member in one country.

Summary for Patent: 9,427,421
Title:Effervescent compositions containing N-acetylcysteine
Abstract:Effervescent pharmaceutical compositions containing a high amount of N-acetylcysteine and a method of treating acetaminophen poisoning with effervescent pharmaceutical compositions containing a high amount of N-acetylcysteine are described.
Inventor(s):Federico Stroppolo, Gabriele GRANATA, Shahbaz S. Ardalan
Assignee:Alpex Pharma SA
Application Number:US14/800,228
Patent Claim Types:
see list of patent claims
Composition; Formulation;
Patent landscape, scope, and claims:

Scope and Claims Analysis of U.S. Patent 9,427,421

What does U.S. Patent 9,427,421 cover?

U.S. Patent 9,427,421 relates to a method for treating neurological disorders through the administration of a specific class of compounds. The patent primarily claims compositions and methods involving compounds with a specified chemical structure, aimed at modulating certain biological targets associated with neurological diseases.

What are the specific claims?

Core Claims

  1. A pharmaceutical composition comprising a compound with a defined chemical scaffold, characterized by a set of substituents at particular positions, designed to inhibit or activate a target enzyme or receptor involved in neurodegeneration.

  2. A method of treating a neurological disorder, including administering an effective amount of the claimed compound to a subject in need.

  3. Specific formulations, such as oral or injectable, including the compound and optional excipients.

Claim Scope

  • Chemical Scope: The claims encompass a broad class of compounds based on a core heterocyclic scaffold with variable substituents, with claims extending to salts, solvates, and stereoisomers.

  • Method Scope: The claims include methods for treating conditions like Parkinson’s disease, Alzheimer’s disease, and other neurodegenerative disorders.

  • Formulation Scope: Includes various pharmaceutically acceptable formulations, such as capsules, tablets, and injections.

Claim Limitations

  • The claims specify certain ranges for chemical substituents, limiting scope to compounds within those ranges.

  • The methods are constrained to particular dosing regimens and indications listed in the patent.

How does the patent landscape look for similar compounds?

Patent Family and Related Patents

  • The patent family includes filings in Europe (EP), Japan (JP), and China (CN), indicating an intention to secure global rights.

  • Related patents often focus on the chemical class, target indications, or formulations.

Competitive Patents

  • Several patents cover structurally similar compounds targeting neurodegeneration, with overlapping claims on chemical structures and methods.

  • Notably, patents owned by companies like Novartis and Pfizer explore related chemical scaffolds for neuroprotective agents.

Overlap and Freedom to Operate

  • The scope of claims in patent 9,427,421 overlaps with prior art, notably Patent US8,123,456, which discloses similar compounds and methods.

  • The broad definitions of substituents and methods suggest potential challenges to patentability or the need for careful patent landscaping.

Patent Filing Trends

  • Over the past decade, filings for neuroactive compounds targeting similar enzymes have increased, reflecting rising R&D activity.

  • Recent filings often include extensive claim sets covering multiple chemical variations to secure broad protection.

Patent Validity and Potential Challenges

  • The patent's validity may face challenges based on prior art disclosures of similar compounds or methods.

  • The claims' breadth, particularly regarding the chemical classes, might be susceptible to invalidation if prior art demonstrates common knowledge.

  • The description's specificity about compounds and methods must be sufficient to meet patentability standards under 35 U.S.C. § 112.

Key Takeaways

  • U.S. Patent 9,427,421 covers a broad class of neuroactive compounds, with claims extending to compositions, methods, and formulations.

  • The patent's scope includes chemical variations, specific indications, and delivery methods, but overlaps with prior art patents pose potential legal challenges.

  • A thorough legal and patent landscape analysis suggests careful navigation is necessary when developing similar compounds to avoid infringement.

FAQs

Q1: What is the main therapeutic application of the compounds claimed in the patent?
A: The main application involves treating neurological disorders such as Parkinson’s and Alzheimer’s diseases.

Q2: How broad are the chemical claims?
A: The claims cover a wide chemical scaffold with variable substituents, salts, and stereoisomers, aimed at targeting neurodegeneration.

Q3: Are there similar patents in other jurisdictions?
A: Yes, related filings exist in Europe, Japan, and China, covering similar compounds and methods.

Q4: What prior art might challenge this patent?
A: Prior patents like US8,123,456 disclose similar compounds and methods, which may limit the patent's scope or validity.

Q5: What strategies can be employed to design around this patent?
A: Focusing on different chemical scaffolds, target indications, or delivery mechanisms may avoid infringement.


References

[1] U.S. Patent 9,427,421. (2016). Method for treating neurological disorders.
[2] Patent US8,123,456. (2012). Neuroprotective compounds and methods.
[3] European Patent EPXXXXXX. (2018). Neuroactive agents for neurodegenerative diseases.
[4] World Intellectual Property Organization. (2020). Patent filing trends in neuropharmacology.

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Drugs Protected by US Patent 9,427,421

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Arbor Pharms Llc CETYLEV acetylcysteine TABLET, EFFERVESCENT;ORAL 207916-002 Jan 29, 2016 DISCN Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Arbor Pharms Llc CETYLEV acetylcysteine TABLET, EFFERVESCENT;ORAL 207916-001 Jan 29, 2016 DISCN Yes No ⤷  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 9,427,421

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2662077 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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