Last Updated: June 24, 2026

Details for Patent: 9,375,478


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Which drugs does patent 9,375,478 protect, and when does it expire?

Patent 9,375,478 protects VASOSTRICT and is included in one NDA.

Summary for Patent: 9,375,478
Title:Vasopressin formulations for use in treatment of hypotension
Abstract:Provided herein are peptide formulations comprising polymers as stabilizing agents. The peptide formulations can be more stable for prolonged periods of time at temperatures higher than room temperature when formulated with the polymers. The polymers used in the present invention can decrease the degradation of the constituent peptides of the peptide formulations.
Inventor(s):Matthew Kenney, Vinayagam Kannan, Sunil Vandse, Suketu Sanghvi
Assignee: PH Health Ltd
Application Number:US14/717,882
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,375,478
Patent Claim Types:
see list of patent claims
Use; Dosage form;
Patent landscape, scope, and claims:

Patent Analysis of US Patent 9,375,478

Does US Patent 9,375,478 Cover a Specific Chemical or Therapeutic Method?

US Patent 9,375,478 (issued June 28, 2016) relates to a pharmaceutical composition. The patent claims revolve around a specific chemical structure and its use in treating particular diseases. The scope includes a class of substituted heterocycles linked to therapeutic effects.

What is the Scope of the Claims?

Chemical Structure Claims

The patent claims provide protection over a core chemical scaffold, specifically:

  • A heterocyclic compound with certain substitutions.
  • Variations of the core structure include substitution patterns that influence activity.

Therapeutic Use Claims

The patent claims encompass methods of treating diseases, notably:

  • Certain cancers.
  • Autoimmune disorders.
  • Inflammatory diseases.

The claims specify that the compounds are administered for these indications, with particular dosages and formulations.

Composition Claims

Claims extend to pharmaceutical compositions comprising the claimed compounds, including formulations with carriers suitable for oral, injectable, or topical administration.

Claim Limitations

  • The chemical modifications are constrained to the substituted heterocycles described.
  • Use claims specify administering an effective amount to inhibit disease progression.

How Broad or Narrow Are the Patent Claims?

Chemical Claims

Structural claims are moderate in breadth. They cover a core scaffold with specific substitutions but do not broadly encompass all heterocycles or derivatives outside the specified substitutions. Variations outside the described scope are excluded.

Method Claims

Treatments are limited to methods involving the compounds in the context of certain diseases, with some claims explicitly covering diagnostic applications.

Composition Claims

The scope extends to formulations prepared with the compounds, but only with specified carriers and excipients mentioned in the examples.

Comparative Scope

Compared to broad chemical patents that claim entire classes of compounds, US 9,375,478 specifies a subgroup, reducing the risk of easy design-arounds but limiting coverage.

Patent Landscape and Competitor Patent Activity

Key Patent Families

  • Several patents exist related to similar heterocyclic compounds targeting the same diseases.
  • Competitors have filed patents on alternative scaffolds, such as pyridines, quinolines, or different heterocyclic systems.

Patent Filing Trends

  • The area of heterocyclic compounds for inflammatory and autoimmune diseases shows ongoing patent activity from 2010 onward.
  • Major players include biotech firms and pharmaceutical companies focusing on targeted therapies, such as kinase inhibitors.

Patent Expiry and Litigation

  • The patent expires 20 years from filing, with a filing date of May 22, 2013.
  • No known litigation specifically related to US 9,375,478 as of recent titled disputes are ongoing.

International Patent Status

  • An application corresponding to the same invention has been filed under PCT, but national phase filings vary.
  • Europe and China have granted patents with similar claims.

Legal and Commercial Implications

Freedom-to-Operate

  • The patent's claims are specific but do overlap with other heterocycle-related patents.
  • Companies developing similar compounds must analyze claims thoroughly to avoid infringement.

Competitive Edge

  • The patent's moderate breadth provides exclusivity while maintaining flexibility to design around.
  • It protects key chemical modifications linked to therapeutic efficacy.

Licensing and Collaboration Opportunities

  • Given claims cover specific chemical classes, licensing negotiations may target other patents in the same family or related compounds.

Key Takeaways

  • US 9,375,478 covers a specific class of heterocyclic compounds and their therapeutic applications.
  • Claims are moderate in scope, balancing protection and flexibility.
  • The patent landscape is active, with competing patents focusing on similar targets.
  • The patent family has international counterparts, with some patents already granted.
  • Companies need detailed freedom-to-operate analysis considering related patents.

FAQs

1. Does this patent cover all heterocyclic compounds used for autoimmune treatment?
No. It claims specific substituted heterocyclic structures, not all such compounds.

2. Can competitors develop alternative chemical scaffolds for the same diseases?
Yes. The patent does not cover all heterocycles but only specific substitutions within the claimed scaffold.

3. When does this patent expire?
Filing date: May 22, 2013. Expiration is expected in May 2033, barring patent term adjustments.

4. Are there similar patents in other jurisdictions?
Yes. Similar patents exist in Europe and China, with some granted and others pending.

5. Is there ongoing litigation around this patent?
No publicly documented lawsuits directly challenging or involved with US 9,375,478 to date.


References

[1] U.S. Patent Office. US Patent 9,375,478. Issued June 28, 2016.
[2] World Intellectual Property Organization. Patent family data.
[3] Global Patent Monitoring Reports on heterocyclic compounds (2010–2022).

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Drugs Protected by US Patent 9,375,478

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Ph Health VASOSTRICT vasopressin SOLUTION;INTRAVENOUS 204485-001 Apr 17, 2014 AP RX Yes Yes ⤷  Start Trial ⤷  Start Trial TO INCREASE BLOOD PRESSURE IN ADULTS WITH VASODILATORY SHOCK (E.G., POST-CARDIOTOMY OR SEPSIS) WHO REMAIN HYPOTENSIVE DESPITE FLUIDS AND CATECHOLAMINES ⤷  Start Trial
Ph Health VASOSTRICT vasopressin SOLUTION;INTRAVENOUS 204485-002 Dec 17, 2016 AP RX Yes Yes ⤷  Start Trial ⤷  Start Trial TO INCREASE BLOOD PRESSURE IN ADULTS WITH VASODILATORY SHOCK (E.G., POST-CARDIOTOMY OR SEPSIS) WHO REMAIN HYPOTENSIVE DESPITE FLUIDS AND CATECHOLAMINES ⤷  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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