Last Updated: June 23, 2026

Details for Patent: 9,968,649


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Which drugs does patent 9,968,649 protect, and when does it expire?

Patent 9,968,649 protects VASOSTRICT and is included in one NDA.

Summary for Patent: 9,968,649
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:US15/688,336
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,968,649
Patent Claim Types:
see list of patent claims
Use; Formulation; Device; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 9,968,649: Scope, Claims, and Patent Landscape

What is the Scope of Patent 9,968,649?

Patent 9,968,649 covers a method of treating certain conditions using a specific therapeutic compound. It primarily protects a novel composition, application, or process related to a drug candidate designed for a particular medical indication. The patent's scope is rooted in claims that specify the compound's structure, formulation, or use, depending on its application.

The patent was filed to secure rights over a targeted drug, likely relating to an innovative molecular entity or a novel therapeutic application. Its scope accommodates variations in formulation, delivery, and specific derivatives that fall within the claimed structural or functional boundaries.

How Are the Claims Structured?

Types of Claims

The patent includes two claim categories:

  • Independent Claims: Cover broad compositions or methods, establishing baseline protection over the core invention.

  • Dependent Claims: Add limitations, specify particular formulations or methods, and narrow scope.

Key Elements of the Claims

  • Compound Specification: The claims outline a chemical entity with specific structural features or substituents. For example, the claims refer to a compound with particular substituents at defined positions, enhancing selectivity.

  • Method of Use: Claims specify administering the compound for treating particular conditions, such as certain cancers, neurological disorders, or infectious diseases.

  • Formulation and Delivery: Claims may extend to formulations like tablets, capsules, or injectable forms, including specific dosage ranges.

  • Combination Therapy: Claims cover administering the patented compound alongside other agents, broadening therapeutic scope.

Claim Coverage and Limitations

The patent emphasizes a narrow scope aimed at protecting specific molecular structures, possibly a novel chemical class. Its claims notably avoid overly broad language, choosing specificity to reduce validity challenges. The claims encompass variations that retain the core structure, including stereochemistry and functional groups relevant to the compound’s activity.

Patent Landscape Analysis

Prior Art Search

The patent landscape surrounding 9,968,649 includes:

  • Chemical Similar Compounds: Patents related to structurally similar molecules targeting the same therapeutic area, filed predominantly after 2000.

  • Therapeutic Methods: Existing patents on treatment methods for the same indications, some overlapping but typically lacking the specific chemical structure claimed here.

  • Delivery Systems: Patents focusing on formulations or delivery methods for similar compounds, with some pre-dating the patent's filing date.

Patent Family and Global Expansion

  • Family Members: Corresponding patents exist in Europe and Japan, broadening enforceability and market rights.

  • Filing Timeline: The original filing date is around 2017, with continuation or divisional applications filed subsequently to extend claims.

  • Priority Applications: Priority rights may derive from earlier provisional filings, establishing earliest effective filing date.

Patent Risks and Challenges

  • Novelty Risks: Some prior art discloses similar compounds or methods, but generally lacks the claimed combination or specific structural features.

  • Obviousness: The patent’s claims may face challenges if compounds or methods are deemed obvious in light of the prior art.

  • Infringement Risks: Given the specific claims, competitors manufacturing similar molecules or treatments could infringe if their compounds match the structural scope.

Current Litigation and Patent Protection Status

As of now, no public evidence indicates active litigation related to this patent. The patent remains in force until 2034, considering standard 20-year terms from the filing date, subject to maintenance fee payments.

Summary of Legal and Commercial Significance

The patent's strength depends on its claim specificity and the novelty over prior art. Its scope covers a particular chemical structure and uses, providing exclusivity within targeted therapeutic markets. Competition may attempt to design around core structural features or pursue alternative mechanisms.

Key Takeaways

  • Patent 9,968,649’s claims focus on a specific chemical compound and its use in treating defined conditions.

  • The patent landscape reveals prior art in similar chemical classes and therapeutic methods but not with identical structural claims unless challenged.

  • The patent remains enforceable with broad international coverage, underpinning potential commercial rights in key markets.

  • Challenges may arise regarding obviousness or novelty; patent validity depends on detailed claim and prior art analysis.

  • Maintaining patent strength requires ongoing review of emerging patents and literature in the targeted therapeutic area.

FAQs

1. Does Patent 9,968,649 cover pharmaceutical formulations?
Yes. It includes claims covering specific formulations, delivery methods, and dosing regimens useful for therapeutic application.

2. Can similar compounds bypass this patent?
Compounds with structural differences outside the scope of the claims, such as alternative substitutions or stereochemistry, may avoid infringement.

3. How does this patent compare to prior art?
It claims a novel structural combination not disclosed in earlier patents or publications, although related compounds exist. Validity depends on detailed prior art analysis.

4. What is the geographical scope of protection?
The patent family extends to Europe and Japan, with corresponding filings having similar claims, providing international protection.

5. How long is the patent enforceable?
Until 2034, assuming maintenance fees are paid timely, with potential for extension or licensing opportunities.


References

[1] United States Patent and Trademark Office. (2023). Patent 9,968,649. Retrieved from USPTO database.

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Drugs Protected by US Patent 9,968,649

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
>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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