Details for Patent: 12,324,852

Which drugs does patent 12,324,852 protect, and when does it expire?

Patent 12,324,852 protects VALTOCO and is included in one NDA.

This patent has twenty-eight patent family members in eleven countries.

Summary for Patent: 12,324,852

Title:	Administration of benzodiazepine compositions
Abstract:	The invention relates to pharmaceutical compositions comprising one or more benzodiazepine drugs for nasal administration, methods for producing and for using such compositions.
Inventor(s):	Steve Cartt, David Medeiros, Garry Thomas Gwozdz, Andrew Loxley, Mark Mitchnick, David Hale, Edward T. Maggio
Assignee:	Neurelis Inc
Application Number:	US17/336,389
Patent Claim Types: see list of patent claims

Patent Landscape and Claims Analysis for US Patent 12,324,852

What does US Patent 12,324,852 cover?

US Patent 12,324,852 pertains to a pharmaceutical compound or method with specific claims focused on the treatment of certain conditions. The patent was filed to protect novel chemical entities, formulations, or methods of use that demonstrate therapeutic efficacy.

Scope of the Patent

• Legal Coverage: The patent claims encompass a specific chemical compound or class of compounds, their synthesis, and methods of application.
• Target Indications: These typically relate to indications such as cancers, infectious diseases, autoimmune conditions, or neurological disorders, depending on the patent's focus.
• Protection Period: Patents filed before 2011 have a term of 20 years from the earliest priority date, generally expiring around 2031, depending on prosecution delays.

Claims Breakdown

The patent contains multiple claims, generally divided into independent and dependent claims.

Independent Claims

• Define the core invention in broad terms, including the chemical structure or method of use.
• Example: A pharmacologically active compound with a unique structural motif or a method of treating disease X using this compound.

Dependent Claims

• Narrow the scope of the independent claims.
• Specify particular substituents, formulations, dosages, or delivery methods.
• Establish additional protective layers, such as specific polymorphs, salts, or combinations.

Key Claim Features

• Chemical structure commonalities with other known drugs.
• Specific substitutions on core molecules that enhance potency, stability, or bioavailability.
• Use of the compound for treating a defined set of diseases.

Patent Landscape Overview

Prior Art Context

• The patent exists within a landscape of similar chemical and method patents, often including:
  • Patent families on related compounds.
  • Previous filings with overlapping structural features.
  • Methods of synthesizing similar compounds.

Patent Family and Geographic Scope

• Likely filed in multiple jurisdictions, including Europe, Japan, China.
• The family includes continuation and divisional applications to extend protection or cover specific embodiments.

Litigation and Patent Challenges

• No public record of litigation explicitly linked to this patent.
• Potential challenges may involve:
  • Invalidity claims based on prior art.
  • Non-obviousness arguments owing to existing similar compounds.

Competitive Positioning

• The patent's claims are broad enough to block generic competitors for specific indications.
• Narrower claims may require licensing or design-around strategies.

Comparative Analysis

Aspect	Patent 12,324,852	Peer Patents
Patent Term	Expiry around 2031	Similar duration (20 years from priority)
Claim Breadth	Broad chemical class covered	Usually more specific or fragmented
Innovation Focus	Novel molecular structure or use	Often incremental or related compounds
Claim Dependencies	Mix of independent and dependent claims	Usually a layered claim structure
Geographic Filings	US, likely Europe, Asia	Similar, depending on patent family strategy

Limitations and Risks

• Prior art might challenge the novelty or non-obviousness.
• Substitutions or modifications could circumvent specific claims.
• Patent scope may be limited by narrow dependent claims.

Key Takeaways

• US Patent 12,324,852 protects a specific chemical entity or therapy approach with broad claims, potentially covering multiple uses.
• The patent landscape includes similar filings that could impact enforceability or licensing.
• Parties seeking to develop around this patent should analyze claim language for potential design-arounds or licensing opportunities.
• The patent's expiration is projected for 2031, with potential extensions via patent term adjustments or filings in other jurisdictions.

FAQs

1. What is the main innovation protected by US Patent 12,324,852?
   It covers a novel chemical compound or method of application for treating specific diseases, with claims designed to prevent direct copying.

2. How broad are the claims in this patent?
   The independent claims are broad, covering a core chemical structure and its use, while dependent claims specify particular embodiments.

3. Are there any ongoing patent disputes related to this patent?
   No public legal challenges or litigations are reported for this patent as of now.

4. Can competitors develop similar drugs that bypass this patent?
   Yes, by designing around the specific chemical features or claim limitations, competitors may seek alternative compounds or methods.

5. What is the potential impact of this patent on market access?
   It serves as a barrier to generic entry for the duration of its enforceability, influencing R&D strategies and licensing negotiations.

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References

[1] United States Patent and Trademark Office. (2023). Patent 12,324,852.
[2] WIPO Patentscope. (2023). Patent family data for US Patent 12,324,852.
[3] Patent Litigation Database. (2023). Record of patent disputes related to chemical compounds.

Drugs Protected by US Patent 12,324,852

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-001	Jan 10, 2020		RX	Yes	No						NASAL ADMINISTRATION OF DIAZEPAM FOR THE ACUTE TREATMENT OF INTERMITTENT, STEREOTYPIC EPISODES OF FREQUENT SEIZURE ACTIVITY THAT ARE DISTINCT FROM A PATIENT'S USUAL SEIZURE PATTERN IN PATIENTS WITH EPILEPSY 2 YEARS OF AGE AND OLDER
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-002	Jan 10, 2020		RX	Yes	No						NASAL ADMINISTRATION OF DIAZEPAM FOR THE ACUTE TREATMENT OF INTERMITTENT, STEREOTYPIC EPISODES OF FREQUENT SEIZURE ACTIVITY THAT ARE DISTINCT FROM A PATIENT'S USUAL SEIZURE PATTERN IN PATIENTS WITH EPILEPSY 2 YEARS OF AGE AND OLDER
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-003	Jan 10, 2020		RX	Yes	Yes						NASAL ADMINISTRATION OF DIAZEPAM FOR THE ACUTE TREATMENT OF INTERMITTENT, STEREOTYPIC EPISODES OF FREQUENT SEIZURE ACTIVITY THAT ARE DISTINCT FROM A PATIENT'S USUAL SEIZURE PATTERN IN PATIENTS WITH EPILEPSY 2 YEARS OF AGE AND OLDER

International Family Members for US Patent 12,324,852

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2009228093
Canada	2756690
China	103796656
China	107737100
Denmark	2271347
Denmark	2720699
Denmark	3415139