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Last Updated: December 19, 2025

Details for Patent: 9,962,422


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Which drugs does patent 9,962,422 protect, and when does it expire?

Patent 9,962,422 protects VASOSTRICT and is included in one NDA.

Summary for Patent: 9,962,422
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): Kenney; Matthew (New Haven, MI), Kannan; Vinayagam (Rochester, MI), Vandse; Sunil (Basking Ridge, NJ), Sanghvi; Suketu (Kendall Park, NJ)
Assignee: PAR PHARMACEUTICAL, INC. (Chestnut Ridge, NY)
Application Number:15/688,314
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,962,422
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 9,962,422


Introduction

United States Patent No. 9,962,422 (hereafter “the ’422 patent”) pertains to a novel therapeutic composition or method associated with specific pharmaceutical applications. Issued by the United States Patent and Trademark Office (USPTO), the patent reflects technological innovation in a specialized domain, potentially influencing drug development, licensing, and competitive positioning within the pharmaceutical industry. This analysis dissects the scope and claims of the ’422 patent and explores its strategic place within the broader patent landscape, offering insights vital for researchers, legal professionals, and business stakeholders.


Scope of the ’422 Patent

The ’422 patent claims broad protective rights over a specific class of compounds, methods of their synthesis, and their use in targeted therapeutic applications. Its scope is primarily centered around:

  • Chemical Composition: The patent encompasses a novel set of chemical entities, which could include a specific subclass of molecules such as inhibitors, modulators, or other biologically active compounds. The claimed compounds are characterized by unique structural features, functional groups, or stereochemistry that differentiate them from prior art.

  • Method of Preparation: The patent delineates innovative synthetic pathways, potentially offering advantages such as increased yield, reduced steps, or improved purity. These methods enable the efficient production of the claimed compounds or compositions.

  • Therapeutic Use: The claimed methods include treating specific diseases or conditions—most likely targeting diseases where precision medicine or novel mechanisms of action provide therapeutic breakthroughs. The claims specify the use of the compounds in particular indications, possibly including cancers, neurodegenerative disorders, or infectious diseases.

  • Formulation and Delivery: The scope may extend to pharmaceutical compositions involving these compounds, associated excipients, or delivery systems aimed at optimizing bioavailability and therapeutic efficacy.

The patent’s claims construct a protective barrier that covers both the chemical scope and the practical applications, thereby conferring exclusivity over a set of inventions with significant commercial potential.


Detailed Analysis of the Claims

The claims of the ’422 patent define the legal scope of patent protection with granularity. They can be conceptually divided into independent and dependent claims, with the former establishing broad coverage and the latter providing specific embodiments or preferred aspects.

Independent Claims

The independent claims typically describe:

  • Chemical entities: The core molecules characterized by their structural formulas, which include a core scaffold with defined substitutions. A representative example would claim compounds comprising a specific heterocyclic core with certain functional groups attached at designated positions, conferring particular biological activity.

  • Methods of synthesis: Processes for preparing the claimed compounds involving steps such as regioselective synthesis, coupling reactions, or specific purification protocols.

  • Therapeutic methods: Use of the compounds or compositions to treat specific diseases, such as particular cancers or viral infections, with claims possibly covering both prophylactic and therapeutic applications.

Dependent Claims

Dependent claims narrow the scope to:

  • Specific variations of the core compounds (e.g., particular substituents, stereochemistry).

  • Preferred synthesis conditions, reagents, or catalysts that improve yield or purity.

  • Specific formulations, such as sustained-release formulations or targeted delivery systems.

  • Usage in combination with other drugs or therapies.

Claim Language and Interpretation

The language used in the ’422 patent claims emphasizes structural specificity, which influences scope interpretation. Terms such as “comprising,” “consisting of,” or “including” modify the breadth of claim coverage; “comprising” typically allows for additional components, while “consisting of” limits to the elements explicitly recited.

The scope hinges on the precise structural definitions, functional limitations, and intended therapeutic indications expressed within the claims. Ambiguities could lead to challenges or interpretation disagreements during enforcement or litigation.


Patent Landscape for the ’422 Patent

Prior Art and Patent Environment

The patent landscape surrounding the ’422 patent includes:

  • Prior Art References: These encompass previous patents, patent applications, scientific publications, and disclosures that disclose similar compounds, methods, or uses. Notably, prior art may include earlier chemical classes with overlapping biological activity, limiting the scope of the ’422 patent if similar compounds or methods are described.

  • Related Patents: Other patents within the same chemical space or therapeutic domain may have overlapping claims. For example, patents directed at kinase inhibitors, protease inhibitors, or other targeted therapies could constitute significant prior art.

Patent Family and International Coverage

The patent family related to the ’422 patent may extend to jurisdictions such as Europe, Japan, China, and others, providing international patent rights. Patent cooperation filings (PCT applications) often precede national filings, carving a global protective zone.

  • Family members typically include divisional or continuation applications that refine claims or seek additional coverage for novel aspects discovered during prosecution.

  • Litigation and Licensing: The ’422 patent’s position within the competitive landscape influences licensing negotiations and potential litigation. Its validity hinges on non-obviousness over prior art references and novelty in regard to existing chemical and therapeutic disclosures.

Competitive Dynamics and Freedom to Operate

Stakeholders must evaluate competing patents to determine freedom to operate (FTO). Overlaps in chemical scope, therapeutic indications, or synthesis methods could lead to infringement risks or necessitate licensing agreements.

Additionally, ongoing patent prosecution or challenges, such as oppositions or inter partes reviews (IPRs), could impact the patent’s strength, scope, or enforceability.


Strategic Implications

The ’422 patent’s broad claims and specific embodiments suggest a strategic intent to secure robust market exclusivity for an innovative therapeutic agent. Its placement within the patent landscape could serve as a cornerstone for development programs, licensing deals, or collaborations. Companies must carefully analyze comparable patents and ensure FTO before commercializing.


Key Takeaways

  • The ’422 patent establishes a broad protective scope over specific chemical entities, methods of synthesis, and therapeutic applications in a targeted medical indication.

  • Its claims combine structural specificity with functional utility, securing rights over a novel class of compounds and their medicinal use.

  • The patent landscape surrounding the ’422 patent comprises prior art that could challenge its novelty or non-obviousness, making diligent landscape analysis essential.

  • International patent coverage enhances strategic value, enabling global commercialization while navigating competitive patent rights.

  • Effective intellectual property management involves monitoring potential overlaps, licensing opportunities, and defending against invalidation efforts.


FAQs

1. What is the primary innovation claimed in the ’422 patent?
The patent claims a novel class of chemical compounds with specific structural features, alongside methods of their synthesis and therapeutic use in treating certain diseases, offering potentially improved efficacy or safety profiles.

2. How does the scope of the ’422 patent compare to prior art?
While building upon existing chemical classes, the ’422 patent distinguishes itself through unique structural elements and specific therapeutic applications, though prior art may disclose similar compounds or methods, requiring careful scope interpretation.

3. Can the claims be challenged based on existing patents?
Yes, if prior art discloses similar compounds or methods that meet all claim limitations, the patent’s validity could be challenged through post-grant proceedings or litigation.

4. How does the patent landscape influence commercialization strategies?
Understanding overlapping patents is crucial for avoiding infringement and identifying licensing opportunities; a comprehensive landscape analysis informs decisions on development, patent filings, and partnerships.

5. What are the implications of international patent coverage for the ’422 patent?
Global patent rights can prevent competitors from entering multiple markets with similar products, but require strategic filings aligned with development plans and market priorities.


References

  1. United States Patent and Trademark Office, Patent Database. Patent No. 9,962,422.
  2. WIPO PatentScope database, related international patent filings.
  3. Scientific literature on chemical classes and therapeutic applications relevant to the patent’s claims.
  4. Patent landscape analyses from industry reports, patent analytics tools, and legal commentary.

More… ↓

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Drugs Protected by US Patent 9,962,422

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 9,962,422 ⤷  Get Started Free TO INCREASE BLOOD PRESSURE IN ADULTS WITH VASODILATORY SHOCK (E.G., POST-CARDIOTOMY OR SEPSIS) WHO REMAIN HYPOTENSIVE DESPITE FLUIDS AND CATECHOLAMINES ⤷  Get Started Free
Ph Health VASOSTRICT vasopressin SOLUTION;INTRAVENOUS 204485-003 Apr 15, 2020 AP RX Yes Yes 9,962,422 ⤷  Get Started Free TO INCREASE BLOOD PRESSURE IN ADULTS WITH VASODILATORY SHOCK (E.G., POST-CARDIOTOMY OR SEPSIS) WHO REMAIN HYPOTENSIVE DESPITE FLUIDS AND CATECHOLAMINES ⤷  Get Started Free
Ph Health VASOSTRICT vasopressin SOLUTION;INTRAVENOUS 204485-006 Apr 12, 2023 DISCN Yes No 9,962,422 ⤷  Get Started Free TO INCREASE BLOOD PRESSURE IN ADULTS WITH VASODILATORY SHOCK (E.G., POST-CARDIOTOMY OR SEPSIS) WHO REMAIN HYPOTENSIVE DESPITE FLUIDS AND CATECHOLAMINES ⤷  Get Started Free
Ph Health VASOSTRICT vasopressin SOLUTION;INTRAVENOUS 204485-004 Apr 15, 2020 DISCN Yes No 9,962,422 ⤷  Get Started Free TO INCREASE BLOOD PRESSURE IN ADULTS WITH VASODILATORY SHOCK (E.G., POST-CARDIOTOMY OR SEPSIS) WHO REMAIN HYPOTENSIVE DESPITE FLUIDS AND CATECHOLAMINES ⤷  Get Started Free
>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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