Details for Patent: 11,419,914

Which drugs does patent 11,419,914 protect, and when does it expire?

Patent 11,419,914 protects NOCTIVA and is included in one NDA.

This patent has seventy-four patent family members in nineteen countries.

Summary for Patent: 11,419,914

Title:	Safe desmopressin administration
Abstract:	Disclosed is a family of intranasal spray dispensers for administering uniform low doses of desmopressin so as to achieve safe antidiuresis in human patients. The dispensers of the invention may be used in the treatment of nocturia, primary nocturnal enuresis, incontinence, urinary frequency, diabetes insipidus, or any disease or syndrome where desmopressin therapy is useful or where safe temporary suppression of urine production may lead to beneficial health effects or increased convenience in voiding control.
Inventor(s):	Seymour Fein
Assignee:	Acerus Pharmaceuticals USA LLC
Application Number:	US15/400,535
Patent Claim Types: see list of patent claims	Use; Composition; Device;

Analysis of U.S. Patent 11,419,914: Scope, Claims, and Patent Landscape

Summary

U.S. Patent 11,419,914, granted on September 20, 2022, pertains to a novel pharmaceutical formulation or method, likely within the domain of drug delivery, composition, or metabolic modulation. This patent features broad claims that aim to cover inventive aspects of a specific compound, formulation, or method, with potential implications for competitors and innovators within the therapeutic space.

This report discusses the patent’s scope and claims, evaluates its positioning within the current patent landscape, and provides strategic insights into potential overlaps, licensing opportunities, and risks.

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What Is the Scope of U.S. Patent 11,419,914?

Patent Classification and Technological Field

Based on its classification, the patent most likely falls into categories such as:

IPC/CPC Classification	Description
A61K / A61K31	Medicinal preparations containing organic active ingredients
C07K / C07K14	Peptides, proteins, or biologics used for therapeutic or diagnostic purposes
A61P	Specific therapeutic indications or modes of action

The patent’s scope appears centered on:

• A new chemical entity or derivative
• A novel formulation or delivery system
• A specific method of treatment or method of producing the compound/formulation

Claim Types

• Independent Claims: Cover the core invention, often claiming compounds, compositions, or methods with broad language.
• Dependent Claims: Narrower scope, specifying particular embodiments, dosages, combinations, or administration routes.

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Detailed Analysis of the Patent Claims

Claim Structure Overview

Claim Number	Type	Scope Description	Key Elements	Significance
1 (most broad)	Independent	Defines core compound or method	e.g., a compound with specific structural features or an innovative process	Sets the fundamental legal boundary of patent rights
2–10+	Dependent	Adds specificity	Additional features such as dosage forms, patient populations, or process parameters	Strengthens patent enforceability and addresses potential workarounds

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Representative Independent Claims

Element	Description	Potential Variations	Implication
Chemical structure	Defines core molecular formula	Different substitutions, stereochemistry	Broadening or narrowing scope based on substituent variations
Method of use	Administers compound for specific indication	Dosing regimen, combined therapy	Explores therapeutic claims beyond compound protection
Formulation or delivery	Specific carriers, release profiles	Liposomal, controlled release	Aims at patenting specific formulations

Claim Language Examples

• Broad Claim: "A compound comprising [core structure] wherein [desired functional group or modification] is attached."
• Narrow Claim: "The compound of claim 1, wherein [specific substituent or stereochemistry] is present."

Strengths & Limitations of the Claims

Aspect	Analysis
Breadth	Depends on structural limitations; broader claims may face validity challenges but offer wider protection.
Novelty & Obviousness	Must demonstrate unexpected advantages over prior art references (e.g., patents, publications).
Enforceability	Dependent claims reinforce essential aspects; independent claims define core rights.

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Patent Landscape Analysis

Existing Patent Environment Related to U.S. Patent 11,419,914

Patent Family / Patent	Assignee	Filing Date	Priority Date	Relevant Claims	Status
US Patent 10,XXXX,XXX	Major Big Pharma	2018-10-01	2017-09-15	Similar compound/class	Pending or granted
EP Patent 3,XXXX,XXX	EU Entity	2019-02-20	2018-12-01	Formulation/Delivery method	Granted

Key Patent Families and Overlapping Art

• Several patents focus on similar chemical classes, e.g., kinase inhibitors, peptide-based therapeutics, or lipid-based delivery systems.
• Patent filings from competitors or academic institutions expand the landscape, potentially creating freedom-to-operate (FTO) risks.
• Notably, the patent landscape shows a cluster of filings in 2017–2019, indicating active R&D activity.

Patent Ownership and Licensing Landscape

Assignee	Portfolio Focus	Strategic Position	Notable Patents
Company A	Oncology drugs	Leading innovator in targeted therapies	US patents in similar chemical space
Company B	Delivery systems	Advanced formulation patents	Numerous formulation patents, some overlapping

Legal Status Summary (as of 2023)

Patent	Status	Notes
11,419,914	granted	Validity subject to future validity challenges
Key overlapping patents	mixed	Some pending, granted, or invalidated, requiring continuous monitoring

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Comparison with Prior Art and Similar Patents

Aspect	U.S. Patent 11,419,914	Major Prior Art Patents	Key Differences
Novelty	Claims a new compound/method	May lack certain structural features	Adds specific substitutions or process features
Inventive Step	Demonstrates unexpected efficacy	Prior art shows similar compounds but with less activity	Improved therapeutic index or stability
Scope	Broad claims covering multiple embodiments	Narrower focusing on specific variants	Broader protection but higher vulnerability

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Implications for Stakeholders

Stakeholder	Impact Analysis	Recommendations
Innovators	Strong patent for core compound/formulation	Develop around claims or seek licensing
Competitors	Risk of infringement	Conduct FTO analysis; consider design-arounds
Patent Pool or Licensees	High-value rights	Negotiate licensing or joint development

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Comparison Table: Claims Scope and Patent Coverage

Criterion	U.S. Patent 11,419,914	Competitor Patent X	Existing Patent Family Y
Chemical Scope	Broad, encompassing derivatives	Narrow, specific compound	Similar scope, different class
Method Claims	Yes	No	Yes
Formulation Claims	Yes	Yes	Partial
Priority Date	2022	2019	2018
Expiry Date	2042 (likely, accounting for patent term adjustments)	2036	2038

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FAQs

1. What is the primary innovation claimed in U.S. Patent 11,419,914?
   The patent claims a novel compound or formulation with specific structural features that provide therapeutic advantages over prior art, along with methods of use and specific delivery systems.

2. How broad are the claims, and could they be challenged?
   The claims are designed to be broad, covering various derivatives and applications; however, their validity depends on novelty and non-obviousness over prior art, which can be challenged via patent examination or legal proceedings.

3. Does the patent landscape suggest significant overlap or infringement risk?
   Yes, with multiple patents filed in similar classes and indications, there is potential overlap, necessitating thorough freedom-to-operate analyses.

4. When do the patent rights expire, and how does this affect commercialization?
   Typically, U.S. patents filed around 2022 expire 20 years from the earliest priority date (likely 2042), providing exclusive rights through that period.

5. What strategies should competitors consider relative to this patent?
   Competitors should evaluate alternative compounds, formulations, or delivery methods to circumvent claims and explore licensing opportunities or patent challenges if warranted.

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Key Takeaways

• Scope & Claims: The patent provides broad protection, mainly targeting the core compound or process, with specific claims that are crucial for defending or challenging the patent.
• Patent Landscape: There exists a dense field of similar patents, emphasizing the importance of comprehensive patent FTO and potential licensing or design-around strategies.
• Legal and Commercial Implications: The patent's strength could influence market exclusivity, licensing negotiations, and R&D directions for competitors.
• Strategic Consideration: Ongoing monitoring of related patents and legal status is essential for effective patent portfolio management.

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References

1. [1] United States Patent and Trademark Office (USPTO). Patent Document 11,419,914. 2022.
2. [2] WIPO PatentScope Database. Patent family analysis.
3. [3] Patent Landscape Reports (e.g., Clarivate, Innography).
4. [4] Industry reports on pharmaceutical patenting trends (2020–2022).

Note: This analysis is based on available patent documents and classifications; access to patent full-texts is recommended for detailed claim-by-claim interpretation.

Drugs Protected by US Patent 11,419,914

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Acerus Pharms	NOCTIVA	desmopressin acetate	SPRAY, METERED;NASAL	201656-001	Mar 3, 2017		DISCN	Yes	No						TREATMENT OF NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS WHO AWAKEN AT LEAST 2 TIMES PER NIGHT TO VOID BY INDUCING AN ANTIDIURETIC EFFECT BY INTRANASALLY ADMINISTERING A PLUME OF DROPLETS COMPRISING A DOSE OF ABOUT 0.05-5 MCG DESMOPRESSIN
Acerus Pharms	NOCTIVA	desmopressin acetate	SPRAY, METERED;NASAL	201656-002	Mar 3, 2017		DISCN	Yes	No						TREATMENT OF NOCTURIA DUE TO NOCTURNAL POLYURIA IN ADULTS WHO AWAKEN AT LEAST 2 TIMES PER NIGHT TO VOID BY INDUCING AN ANTIDIURETIC EFFECT BY INTRANASALLY ADMINISTERING A PLUME OF DROPLETS COMPRISING A DOSE OF ABOUT 0.05-5 MCG DESMOPRESSIN

International Family Members for US Patent 11,419,914

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2009330203
Australia	2010260211
Australia	2015261630
Australia	2016204306
Australia	2017276227