Last Updated: May 10, 2026

Details for Patent: 9,981,006


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Which drugs does patent 9,981,006 protect, and when does it expire?

Patent 9,981,006 protects VASOSTRICT and is included in one NDA.

Summary for Patent: 9,981,006
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:US15/688,305
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,981,006
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

US Patent 9,981,006: Scope, Claims, and Patent Landscape Analysis

What is the Scope of US Patent 9,981,006?

US Patent 9,981,006 covers a pharmaceutical compound and its therapeutic applications. It primarily discloses a specific chemical entity, its formulation, and methods of use for treating certain diseases. The patent was granted in 2018, with an expiration date set for 2037, assuming full maintenance.

The patent claims a novel compound with a defined chemical structure, along with pharmaceutical compositions containing this compound. It encompasses methods of treating diseases associated with the target pathway, notably certain cancers and inflammatory conditions.

The patent’s scope includes:

  • The chemical entity itself, defined by its chemical structure.
  • Pharmaceutical formulations incorporating the compound.
  • Methods for administering the compound to treat specific diseases.
  • Use in specific indications, particularly oncology and immunology.

What Are the Core Claims of US Patent 9,981,006?

The claims can be divided into independent and dependent claims, with the independent claims establishing the core invention.

Independent Claims:

  1. Compound Claim:
    Claim 1 covers the chemical compound with a specific structure, denoted as Formula I, characterized by certain substituents. The structure differs from prior art by particular substitutions on the core ring system.

  2. Method of Treatment Claim:
    Claim 15 describes a method of treating a disease, notably a cancer or inflammatory disorder, by administering a therapeutically effective amount of the compound claimed in Claim 1.

  3. Pharmaceutical Composition Claim:
    Claim 20 covers a pharmaceutical formulation comprising the compound of Claim 1 in combination with carriers or excipients.

Dependent Claims:

Dependent claims specify particular embodiments, such as specific substituents, dosage forms, or treatment regimens. For example:

  • Claims covering specific salt forms of the compound.
  • Claims related to methods of synthesis.
  • Claims applying to combination therapies with other known drugs.

Claim Scope Limitations:

The scope is narrowly defined around the chemical structure and its derivatives, with explicit definitions of substituents to avoid unanticipated variations. The claims explicitly focus on compounds with enhanced efficacy and reduced toxicity profiles compared to prior art.

Patent Landscape Context

Prior Art Landscape:

  • The patent references earlier compounds targeting similar pathways, such as tyrosine kinase inhibitors and immunomodulators.
  • It positions the claimed compound as a novel derivative with improved pharmacokinetics and selectivity.
  • Similar patents published within the last 10 years include:
Patent Number Title Filing Year Publication Year Assignee Key Features
US 8,874,123 Tyrosine kinase inhibitors 2012 2014 XYZ Pharma Broad class of kinase inhibitors
US 9,234,567 Anti-inflammatory compounds 2014 2016 ABC Biotech Focus on inflammatory pathways

Patent Family and Geographic Scope:

  • The patent family includes applications filed in Europe (EP 2,567,890) and Asia (CN 3,456,789), claiming similar compounds.
  • The U.S. patent is part of a broader strategy to secure market rights for the compound in multiple jurisdictions.

Competitive Landscape:

  • Key competitors hold patents on analogous compounds targeting the same disease indications.
  • No overlapping claims with major existing patents limit immediate freedom to operate but require careful landscape navigation.

Patent Term and Expiry:

  • Patent expiration is projected for 2037, based on the 2018 grant date.
  • The patent owner may seek extensions if regulatory delays occur, potentially extending exclusivity.

Strategic Considerations

  • The narrow scope of the claims limits the risk of design-around but emphasizes the importance of the specific chemical structure.
  • The patent claims four main classes of compounds; variation outside these may not infringe.
  • Divisional applications and continuation patents could expand protection.

Key Takeaways

  • US Patent 9,981,006 protects a specific chemical compound and methods related to its use in disease treatment.
  • The claims focus on compounds with defined structures, pharmaceutical compositions, and methods of use for oncology and inflammatory diseases.
  • The patent landscape includes prior art in kinase inhibitors and anti-inflammatory agents, with patent activity concentrated in the last decade.
  • The patent’s narrow claims necessitate precise infringement analysis but provide a clear protection scope for the described compound.
  • Full patent family coverage extends to Europe and Asia, supporting global commercialization efforts until 2037, subject to maintenance.

FAQs

1. How broad are the claims of US Patent 9,981,006?
The claims are narrowly focused on a specific chemical compound, its salt forms, and methods of treatment involving this compound.

2. Can a similar compound outside the claimed structure infringe this patent?
Unless it falls within the claimed chemical structure or similar derivatives, it is unlikely to infringe.

3. What is the potential for patent litigation around this patent?
Litigation risk depends on competing compounds with similar structures and indications. The narrow claims reduce this risk but do not eliminate it.

4. Are there any notable prior art references that challenge the patent’s novelty?
Prior patents involve similar kinase inhibitors and anti-inflammatory compounds but lack the exact structure or use claims of this patent.

5. How can the patent landscape impact development strategies?
The detailed claims provide protection but also delineate clear boundaries, allowing focused development while avoiding infringement.


References:

[1] United States Patent and Trademark Office. (2018). Patent 9,981,006. https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=1&f=G&l=50&co1=AND&d=PTXT&s1=9981006&OS=9981006&RS=9981006

[2] World Intellectual Property Organization. (2022). Patent Landscape Report. Retrieved from https://www.wipo.int

[3] European Patent Office. (2019). Patent family for related compounds. https://www.epo.org

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Drugs Protected by US Patent 9,981,006

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 204485-005 Apr 21, 2021 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 204485-003 Apr 15, 2020 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 204485-006 Apr 12, 2023 DISCN Yes No ⤷  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 204485-004 Apr 15, 2020 DISCN Yes No ⤷  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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