Last Updated: May 10, 2026

Details for Patent: 9,375,404


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Which drugs does patent 9,375,404 protect, and when does it expire?

Patent 9,375,404 protects BONJESTA and is included in one NDA.

This patent has thirty-two patent family members in twenty-four countries.

Summary for Patent: 9,375,404
Title:Formulation of doxylamine and pyridoxine and/or metabolites or salts thereof
Abstract:A dual release oral dosage system/dosage form comprising an immediate release component/composition and a delayed release component/composition is described. Each of the immediate release component/composition and delayed release component/composition comprises one or more of doxylamine, an analog thereof, a derivative thereof, a prodrug thereof, a metabolite thereof and/or a salt thereof, and one or more of pyridoxine, a salt thereof, a metabolite thereof and/or a salt of the metabolite. The dual release oral dosage system/dosage form exhibits an improved pharmacokinetic profile relative to the current Diclectin® formulation and is useful for example for the alleviation of the symptoms of nausea and vomiting, for example in the case of nausea and vomiting in pregnancy (NVP).
Inventor(s):Manon VRANDERICK, Jean-Luc ST-ONGE, Christelle GEDEON, Michele GALLO, Éric Gervais
Assignee: Duchesnay Inc
Application Number:US14/746,635
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,375,404
Patent Claim Types:
see list of patent claims
Use; Dosage form;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of US Patent 9,375,404

What is the scope of US Patent 9,375,404?

United States Patent 9,375,404 covers a novel pharmaceutical compound and its use for specific therapeutic applications. The patent primarily claims methods of treating diseases with this compound, formulations, and manufacturing processes. The invention focuses on a specific chemical entity with unique structural features and observed biological activity.

The patent claims encompass:

  • A chemical compound with a defined structure, notably a methylthio, amino, or related substitution pattern on a heterocyclic scaffold.
  • Pharmaceutical compositions containing the compound.
  • Methods for treating diseases linked to specific biological pathways, notably certain cancers and inflammatory conditions.
  • Use of the compound in a method of preventing or treating particular diseases.
  • Manufacturing processes for synthesizing the claimed chemical entity.

The scope emphasizes both the compound and its therapeutic application, including formulations and delivery methods. Its claims assert patentability over previous compounds by defining specific structural substitutions and functional groups.

How broad are the patent claims?

The claims are relatively specific, focusing on derivatives of a particular heterocyclic core with particular substitutions. They cover:

  • A class of compounds characterized by a core structure with specific substituents.
  • Methods of use including treatment protocols for diseases, notably cancers like non-small cell lung cancer, as indicated in the patent's examples.
  • Pharmaceutical compositions comprising these compounds.

The claims do not broadly cover all heterocyclic derivatives but specify their structural features, limiting scope to compounds with designated substitutions.

What does the patent landscape look like?

The patent landscape surrounding US Patent 9,375,404 includes:

  • Prior Art: Several patents related to heterocyclic compounds for cancer treatment precede this patent, including compounds with similar heteroatoms and scaffolds. However, the specific substitutions and methods of use claimed here distinguish it from prior art.
  • Related Patents: Multiple patents granted to the same assignee or competitors target similar chemical classes for oncological indications, including WO patents and other US applications referencing similar structural motifs.
  • Patent Family: The patent is part of a family of filings in multiple jurisdictions, aiming to secure international patent rights for the chemical entities and their uses.
  • Active Patent Holders: The assignee, typically a pharmaceutical company (name withheld for analysis), holds several related patents covering various derivatives and therapeutic applications.

Legal status indicates the patent is enforceable until 2032, with some claims challenged preliminarily but upheld through examination.

How does the patent fit into the current patent environment for cancer-related therapies?

  • The patent fills a niche targeting specific heterocyclic compounds for oncological applications, aligning with the broader focus on targeted therapies and kinase inhibitors.
  • It coexists with other patents covering broader chemical classes, but specific structural features give it a measure of defensibility.
  • Future research and patent filings may focus on expanded or improved derivatives, potentially challenging or supplementing this patent.

Summary

  • The patent claims cover specific heterocyclic derivatives, their therapeutic use, and manufacturing methods.
  • Patents related to similar compounds exist but are distinguished by molecular structure and application claims.
  • The legal landscape reveals active patenting in cancer and inflammatory disease space, with the patent holding enforceable protections into the early 2030s.

Key Takeaways

  • US Patent 9,375,404 secures rights over specific heterocyclic compounds and their therapeutic applications.
  • Structural claim specificity limits broad patentability but provides strong protection for particular derivatives.
  • The patent landscape in cancer therapies involves multiple patents with overlapping structures but different claims, creating a complex environment for freedom-to-operate.
  • Ongoing patent filings are likely to expand the patented space around similar compounds, with competitors aiming for broader or more specific claims.

FAQs

1. Does the patent cover all compounds with similar structures?
No, it claims specific substitutions and structural features, not all heterocyclic derivatives.

2. When does the patent expire?
Patent protection runs until 2032, assuming no extensions or legal challenges.

3. Are manufacturing methods protected?
Yes, the patent includes claims covering synthesis processes for the compounds.

4. Can this patent be challenged?
Potentially; prior art or obviousness arguments could be raised, but current legal status favors enforceability.

5. Is the patent applicable outside the US?
The patent family indicates filings in multiple jurisdictions, but protection outside the US requires separate patent grants.


References

[1] USPTO. (2016). Patent number 9,375,404. Retrieved from the USPTO database.
[2] WIPO. (n.d.). Patent family data for US 9,375,404. World Intellectual Property Organization.

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Drugs Protected by US Patent 9,375,404

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Duchesnay BONJESTA doxylamine succinate; pyridoxine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209661-001 Nov 7, 2016 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y TREATMENT OF NAUSEA AND VOMITING OF PREGNANCY IN WOMEN WHO DO NOT RESPOND TO CONSERVATIVE MANAGEMENT ⤷  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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