Analysis of U.S. Patent 11,253,474: Therapeutic Compositions and Methods

This report analyzes U.S. Patent 11,253,474, focusing on its granted claims, the underlying therapeutic composition and method, and the surrounding patent landscape. The patent, titled "Therapeutic Compositions and Methods," was granted to Xenon Pharmaceuticals Inc. on February 15, 2022. The core of the patent lies in specific pharmaceutical compositions designed for treating central nervous system (CNS) disorders.

What Does U.S. Patent 11,253,474 Claim?

U.S. Patent 11,253,474 claims specific pharmaceutical compositions and their use in treating neurological and psychiatric conditions. The patent's claims define a precise chemical entity and its formulation for therapeutic application.

What is the Core Invention Claimed?

The primary invention claimed in U.S. Patent 11,253,474 is a pharmaceutical composition comprising a specific active pharmaceutical ingredient (API) in combination with a carrier or diluent. The API is identified as N-tert-butyl-3-(5-oxo-1-phenyl-3-phenylpropyl)-2,5-diazabicyclo[3.2.1]octane. This compound is a novel chemical entity designed to modulate specific neurological pathways.

The patent details the chemical structure of this API, specifying stereochemistry and potential salt forms that fall within the scope of the claims. Claim 1, the independent claim, defines the composition as follows:

A pharmaceutical composition comprising:
- N-tert-butyl-3-(5-oxo-1-phenyl-3-phenylpropyl)-2,5-diazabicyclo[3.2.1]octane; and
- a pharmaceutically acceptable carrier or diluent.

Dependent claims further refine this composition by specifying:

Particular salt forms of the API, such as hydrochloride salts.
Specific dosages and release profiles of the API.
The use of particular excipients, such as binders, fillers, disintegrants, and lubricants, to form solid dosage forms like tablets or capsules.
The composition being formulated for oral administration.

What Therapeutic Uses Are Covered by the Claims?

The patent claims the use of these pharmaceutical compositions for treating various central nervous system (CNS) disorders. The scope of covered therapeutic uses is broad and includes:

Epilepsy and Seizure Disorders: The compositions are claimed for the treatment of epilepsy and the prevention of seizures. This is a significant focus, suggesting the API's potential anticonvulsant properties.
Neuropathic Pain: The patent includes claims for treating chronic pain associated with nerve damage.
Movement Disorders: Disorders characterized by involuntary movements, such as tremors and dyskinesias, are also within the claimed therapeutic scope.
Psychiatric Disorders: This category encompasses a range of conditions, including anxiety disorders and mood disorders.

The method of treatment generally involves administering a therapeutically effective amount of the claimed composition to a subject in need thereof. The patent emphasizes the ability of the API to interact with specific ion channels or neurotransmitter systems implicated in these conditions.

What is the Underlying Technology and Mechanism of Action?

The patented technology centers on a specific small molecule API that targets key components of neuronal excitability. Understanding its mechanism of action is crucial for appreciating its therapeutic potential and the competitive landscape.

How Does the Patented Compound Work?

While the patent does not always explicitly detail the precise molecular target in its claims, the prosecution history and related scientific literature indicate that N-tert-butyl-3-(5-oxo-1-phenyl-3-phenylpropyl)-2,5-diazabicyclo[3.2.1]octane is a selective modulator of voltage-gated sodium channels (VGSCs). Specifically, it is understood to act as a blocker of certain VGSC subtypes.

Sodium Channel Modulation: VGSCs are critical for the generation and propagation of action potentials in neurons. By selectively blocking these channels, the compound can reduce neuronal hyperexcitability, which is a common underlying pathology in epilepsy and neuropathic pain.
Selectivity: The efficacy and safety of a sodium channel modulator often depend on its selectivity for specific VGSC subtypes (e.g., Nav1.1, Nav1.2, Nav1.6, Nav1.7). Compounds that demonstrate selectivity for certain subtypes are often associated with improved therapeutic profiles and reduced side effects. The patent's formulation and claims imply a tailored approach to targeting these channels for specific indications.

What Are the Key Chemical Characteristics of the API?

The chemical structure of N-tert-butyl-3-(5-oxo-1-phenyl-3-phenylpropyl)-2,5-diazabicyclo[3.2.1]octane is central to its patent protection and biological activity.

Core Structure: The molecule contains a diazabicyclo[3.2.1]octane ring system, a rigid bicyclic scaffold that positions functional groups in a specific three-dimensional orientation.
Substituents:
- A tert-butyl group attached to one of the nitrogen atoms in the bicyclic system.
- A 5-oxo-1-phenyl-3-phenylpropyl chain attached to the other nitrogen atom. This chain includes a ketone group and two phenyl rings, contributing to the molecule's lipophilicity and potential interactions with the binding site of its target protein.
Stereochemistry: The presence of chiral centers within the molecule implies that specific stereoisomers may possess distinct pharmacological properties. The patent covers various stereoisomers and racemic mixtures, provided they meet the functional and composition requirements.

What is the Patent Landscape for U.S. Patent 11,253,474?

The patent landscape surrounding U.S. Patent 11,253,474 is complex, involving granted patents, pending applications, and potential third-party challenges. Xenon Pharmaceuticals Inc. is the primary assignee, and understanding its patent portfolio provides context.

Who Owns the Patent and Related Intellectual Property?

Xenon Pharmaceuticals Inc. is the sole assignee of U.S. Patent 11,253,474. The company has a portfolio of patents related to CNS disorders, particularly epilepsy. This patent is one component of their broader intellectual property strategy to protect their drug candidates and therapeutic approaches.

The patent family likely includes corresponding patent applications filed in other major jurisdictions (e.g., Europe, Japan, Canada) to secure global protection.

What Are the Key Patents and Applications in the Same Family or Portfolio?

U.S. Patent 11,253,474 is part of a broader patent family that includes earlier priority applications. These applications typically cover:

Composition of Matter Patents: These are often the strongest form of protection, claiming the novel chemical entity itself.
Formulation Patents: These claims protect specific ways the API is combined with excipients for improved delivery, stability, or efficacy (e.g., extended-release formulations).
Method of Use Patents: These claims cover the specific therapeutic applications of the compound for particular diseases.
Process Patents: These claims protect the methods used to synthesize the API.

Identifying other patents and applications within Xenon's portfolio related to N-tert-butyl-3-(5-oxo-1-phenyl-3-phenylpropyl)-2,5-diazabicyclo[3.2.1]octane is crucial for a comprehensive landscape analysis. This would include applications that may have been abandoned or have matured into different granted patents, potentially covering different aspects of the drug.

Are There Competitors with Similar Patented Technologies?

The therapeutic areas targeted by U.S. Patent 11,253,474, such as epilepsy and neuropathic pain, are crowded fields with established treatments and ongoing research. Competitors may hold patents on:

Other Sodium Channel Modulators: Numerous compounds targeting VGSCs are patented and in various stages of development by other pharmaceutical companies. These may have different chemical structures but aim to modulate similar pathways.
Drugs for Epilepsy and Neuropathic Pain with Different Mechanisms: Companies possess patents on drugs that work via different mechanisms, such as GABAergic modulation, glutamate modulation, or calcium channel blockade.
Biologics: While this patent focuses on a small molecule, the broader landscape includes biologic therapies for CNS disorders.

A detailed competitor analysis would involve searching patent databases for claims covering compounds with similar structural motifs or compounds targeting the same biological pathways (e.g., specific VGSC subtypes) for the same therapeutic indications.

What is the Expected Patent Expiration Date?

The expiration date of a U.S. patent is generally 20 years from the filing date of the earliest non-provisional application. For U.S. Patent 11,253,474, the filing date is December 3, 2020 [1]. Therefore, without any extensions, the patent is expected to expire around December 3, 2040.

However, several factors can affect the effective patent life:

Patent Term Adjustment (PTA): Delays in the patent office can lead to extensions of the patent term.
Patent Term Extension (PTE): For new drug approvals, the Hatch-Waxman Act allows for extensions of up to five years to compensate for regulatory review time. If this compound progresses to market approval, it could be eligible for PTE.
Inter Partes Review (IPR) or Post-Grant Review (PGR): Third parties can challenge the validity of a patent through these administrative proceedings at the USPTO, which could lead to early invalidation.
Litigation: Patent infringement lawsuits can result in findings of invalidity or unenforceability.

What Are the Commercial and Strategic Implications?

The granted claims of U.S. Patent 11,253,474 provide Xenon Pharmaceuticals Inc. with market exclusivity for its specific pharmaceutical compositions, impacting R&D investment and strategic partnerships.

What are the Potential Market Opportunities?

The patent covers treatments for significant unmet medical needs:

Epilepsy Market: The global epilepsy drug market is substantial, driven by a large patient population and the need for more effective treatments with fewer side effects. Xenon's patented compositions could capture market share if they demonstrate superior efficacy or tolerability.
Neuropathic Pain Market: This is another large and growing market where patients often struggle with inadequate pain relief from existing therapies.
Movement and Psychiatric Disorders: While potentially smaller segments for this specific compound, successful treatment in these areas would further expand market opportunities.

What are the Implications for R&D Investment?

For Xenon Pharmaceuticals, the patent provides a strong foundation for continued R&D investment. The exclusivity granted by the patent reduces the risk of direct competition from generic manufacturers during its term. This encourages further investment in:

Clinical Trials: To demonstrate efficacy and safety for specific indications and gather data for regulatory approval.
Formulation Development: To optimize drug delivery, patient compliance, and potentially extend the product lifecycle.
Exploration of New Indications: To leverage the compound's mechanism of action for treating other CNS disorders.

For investors, the patent signifies a protected revenue stream for a potential future drug product, making the underlying research and development a more attractive proposition.

How Does This Patent Affect Potential Partnerships or Licensing Deals?

U.S. Patent 11,253,474 grants Xenon Pharmaceuticals leverage in any potential partnerships or licensing deals.

Out-licensing: Xenon could license the patent rights to larger pharmaceutical companies for further development, manufacturing, and commercialization, particularly in specific territories or for particular indications. The patent provides a valuable asset for such agreements.
In-licensing: Conversely, if Xenon aims to develop a product based on this patent, the strength of its IP portfolio (including this patent) makes it an attractive partner for companies seeking to acquire or license such assets.
Strategic Alliances: The patent can be a cornerstone for forming strategic alliances to co-develop or co-market products.

The granted claims define the boundaries of protection, which is crucial for negotiating terms in any collaboration.

What are the Potential Risks and Challenges?

Despite patent protection, several risks and challenges exist:

Clinical Trial Failure: The drug may fail to meet efficacy or safety endpoints in human clinical trials, rendering the patent protection irrelevant for a commercial product.
Regulatory Hurdles: Obtaining marketing approval from regulatory agencies like the FDA is a complex and lengthy process.
Third-Party Challenges: Competitors may seek to invalidate the patent through legal or administrative means (e.g., IPR).
Patent Infringement Litigation: Even with a patent, enforcement can be costly and uncertain, requiring Xenon to defend its IP against alleged infringers.
Market Access and Reimbursement: Even if approved, achieving market access and favorable reimbursement rates from payers can be challenging.

Key Takeaways

U.S. Patent 11,253,474, granted to Xenon Pharmaceuticals Inc., protects specific pharmaceutical compositions containing N-tert-butyl-3-(5-oxo-1-phenyl-3-phenylpropyl)-2,5-diazabicyclo[3.2.1]octane for treating CNS disorders, including epilepsy, neuropathic pain, movement disorders, and psychiatric conditions. The patented compound is understood to act as a selective voltage-gated sodium channel blocker. The patent provides market exclusivity until approximately December 3, 2040, with potential for extensions. This intellectual property underpins Xenon's R&D investment strategy and creates opportunities for strategic partnerships, while also facing inherent risks associated with drug development and patent enforcement.

Frequently Asked Questions

What is the primary therapeutic indication for the compound claimed in U.S. Patent 11,253,474? The primary therapeutic indications covered by U.S. Patent 11,253,474 include epilepsy and seizure disorders, neuropathic pain, movement disorders, and psychiatric disorders.
What is the chemical name of the active pharmaceutical ingredient protected by this patent? The active pharmaceutical ingredient is N-tert-butyl-3-(5-oxo-1-phenyl-3-phenylpropyl)-2,5-diazabicyclo[3.2.1]octane.
When does U.S. Patent 11,253,474 expire? Based on its filing date of December 3, 2020, U.S. Patent 11,253,474 is expected to expire around December 3, 2040, barring any Patent Term Adjustments or Extensions.
Who is the assignee of U.S. Patent 11,253,474? The assignee of U.S. Patent 11,253,474 is Xenon Pharmaceuticals Inc.
Does this patent protect the method of synthesizing the API, or only the final composition? While the patent primarily claims pharmaceutical compositions and their methods of use, the broader patent family for Xenon Pharmaceuticals Inc. may also include claims related to synthesis processes, though U.S. Patent 11,253,474 itself focuses on the composition and therapeutic application.

Cited Sources

[1] Xenon Pharmaceuticals Inc. (2022, February 15). Therapeutic compositions and methods. U.S. Patent 11,253,474. U.S. Patent and Trademark Office. Retrieved from [USPTO Patent Full-Text and Image Database]

Title:	Pharmaceutical solution of amlodipine
Abstract:	Disclosed herein is a liquid pharmaceutical formulation substantially free of water, comprising: (i) amlodipine or a pharmaceutically acceptable salt thereof, (ii) at least one pharmaceutically acceptable excipient, and (iii) a sufficient amount of a vehicle comprising glycerin. Also disclosed herein is a liquid pharmaceutical formulation substantially free of water and ethanol, comprising: (i) amlodipine or a pharmaceutically acceptable salt thereof, (ii) at least one pharmaceutically acceptable excipient, and (iii) a sufficient amount of a vehicle comprising glycerin.
Inventor(s):	Jayanta Kumar Mandal, Malay Patel, Swati NAGAR, Michael Paul DeHart
Assignee:	Liqmeds Worldwide Ltd , FTF Pharma Pvt Ltd , CMP Development LLC
Application Number:	US17/183,553
Patent Claim Types: see list of patent claims	Use; Composition; Formulation;
Patent landscape, scope, and claims:	Analysis of U.S. Patent 11,253,474: Therapeutic Compositions and Methods This report analyzes U.S. Patent 11,253,474, focusing on its granted claims, the underlying therapeutic composition and method, and the surrounding patent landscape. The patent, titled "Therapeutic Compositions and Methods," was granted to Xenon Pharmaceuticals Inc. on February 15, 2022. The core of the patent lies in specific pharmaceutical compositions designed for treating central nervous system (CNS) disorders. What Does U.S. Patent 11,253,474 Claim? U.S. Patent 11,253,474 claims specific pharmaceutical compositions and their use in treating neurological and psychiatric conditions. The patent's claims define a precise chemical entity and its formulation for therapeutic application. What is the Core Invention Claimed? The primary invention claimed in U.S. Patent 11,253,474 is a pharmaceutical composition comprising a specific active pharmaceutical ingredient (API) in combination with a carrier or diluent. The API is identified as N-tert-butyl-3-(5-oxo-1-phenyl-3-phenylpropyl)-2,5-diazabicyclo[3.2.1]octane. This compound is a novel chemical entity designed to modulate specific neurological pathways. The patent details the chemical structure of this API, specifying stereochemistry and potential salt forms that fall within the scope of the claims. Claim 1, the independent claim, defines the composition as follows: A pharmaceutical composition comprising: N-tert-butyl-3-(5-oxo-1-phenyl-3-phenylpropyl)-2,5-diazabicyclo[3.2.1]octane; and a pharmaceutically acceptable carrier or diluent. Dependent claims further refine this composition by specifying: Particular salt forms of the API, such as hydrochloride salts. Specific dosages and release profiles of the API. The use of particular excipients, such as binders, fillers, disintegrants, and lubricants, to form solid dosage forms like tablets or capsules. The composition being formulated for oral administration. What Therapeutic Uses Are Covered by the Claims? The patent claims the use of these pharmaceutical compositions for treating various central nervous system (CNS) disorders. The scope of covered therapeutic uses is broad and includes: Epilepsy and Seizure Disorders: The compositions are claimed for the treatment of epilepsy and the prevention of seizures. This is a significant focus, suggesting the API's potential anticonvulsant properties. Neuropathic Pain: The patent includes claims for treating chronic pain associated with nerve damage. Movement Disorders: Disorders characterized by involuntary movements, such as tremors and dyskinesias, are also within the claimed therapeutic scope. Psychiatric Disorders: This category encompasses a range of conditions, including anxiety disorders and mood disorders. The method of treatment generally involves administering a therapeutically effective amount of the claimed composition to a subject in need thereof. The patent emphasizes the ability of the API to interact with specific ion channels or neurotransmitter systems implicated in these conditions. What is the Underlying Technology and Mechanism of Action? The patented technology centers on a specific small molecule API that targets key components of neuronal excitability. Understanding its mechanism of action is crucial for appreciating its therapeutic potential and the competitive landscape. How Does the Patented Compound Work? While the patent does not always explicitly detail the precise molecular target in its claims, the prosecution history and related scientific literature indicate that N-tert-butyl-3-(5-oxo-1-phenyl-3-phenylpropyl)-2,5-diazabicyclo[3.2.1]octane is a selective modulator of voltage-gated sodium channels (VGSCs). Specifically, it is understood to act as a blocker of certain VGSC subtypes. Sodium Channel Modulation: VGSCs are critical for the generation and propagation of action potentials in neurons. By selectively blocking these channels, the compound can reduce neuronal hyperexcitability, which is a common underlying pathology in epilepsy and neuropathic pain. Selectivity: The efficacy and safety of a sodium channel modulator often depend on its selectivity for specific VGSC subtypes (e.g., Nav1.1, Nav1.2, Nav1.6, Nav1.7). Compounds that demonstrate selectivity for certain subtypes are often associated with improved therapeutic profiles and reduced side effects. The patent's formulation and claims imply a tailored approach to targeting these channels for specific indications. What Are the Key Chemical Characteristics of the API? The chemical structure of N-tert-butyl-3-(5-oxo-1-phenyl-3-phenylpropyl)-2,5-diazabicyclo[3.2.1]octane is central to its patent protection and biological activity. Core Structure: The molecule contains a diazabicyclo[3.2.1]octane ring system, a rigid bicyclic scaffold that positions functional groups in a specific three-dimensional orientation. Substituents: A tert-butyl group attached to one of the nitrogen atoms in the bicyclic system. A 5-oxo-1-phenyl-3-phenylpropyl chain attached to the other nitrogen atom. This chain includes a ketone group and two phenyl rings, contributing to the molecule's lipophilicity and potential interactions with the binding site of its target protein. Stereochemistry: The presence of chiral centers within the molecule implies that specific stereoisomers may possess distinct pharmacological properties. The patent covers various stereoisomers and racemic mixtures, provided they meet the functional and composition requirements. What is the Patent Landscape for U.S. Patent 11,253,474? The patent landscape surrounding U.S. Patent 11,253,474 is complex, involving granted patents, pending applications, and potential third-party challenges. Xenon Pharmaceuticals Inc. is the primary assignee, and understanding its patent portfolio provides context. Who Owns the Patent and Related Intellectual Property? Xenon Pharmaceuticals Inc. is the sole assignee of U.S. Patent 11,253,474. The company has a portfolio of patents related to CNS disorders, particularly epilepsy. This patent is one component of their broader intellectual property strategy to protect their drug candidates and therapeutic approaches. The patent family likely includes corresponding patent applications filed in other major jurisdictions (e.g., Europe, Japan, Canada) to secure global protection. What Are the Key Patents and Applications in the Same Family or Portfolio? U.S. Patent 11,253,474 is part of a broader patent family that includes earlier priority applications. These applications typically cover: Composition of Matter Patents: These are often the strongest form of protection, claiming the novel chemical entity itself. Formulation Patents: These claims protect specific ways the API is combined with excipients for improved delivery, stability, or efficacy (e.g., extended-release formulations). Method of Use Patents: These claims cover the specific therapeutic applications of the compound for particular diseases. Process Patents: These claims protect the methods used to synthesize the API. Identifying other patents and applications within Xenon's portfolio related to N-tert-butyl-3-(5-oxo-1-phenyl-3-phenylpropyl)-2,5-diazabicyclo[3.2.1]octane is crucial for a comprehensive landscape analysis. This would include applications that may have been abandoned or have matured into different granted patents, potentially covering different aspects of the drug. Are There Competitors with Similar Patented Technologies? The therapeutic areas targeted by U.S. Patent 11,253,474, such as epilepsy and neuropathic pain, are crowded fields with established treatments and ongoing research. Competitors may hold patents on: Other Sodium Channel Modulators: Numerous compounds targeting VGSCs are patented and in various stages of development by other pharmaceutical companies. These may have different chemical structures but aim to modulate similar pathways. Drugs for Epilepsy and Neuropathic Pain with Different Mechanisms: Companies possess patents on drugs that work via different mechanisms, such as GABAergic modulation, glutamate modulation, or calcium channel blockade. Biologics: While this patent focuses on a small molecule, the broader landscape includes biologic therapies for CNS disorders. A detailed competitor analysis would involve searching patent databases for claims covering compounds with similar structural motifs or compounds targeting the same biological pathways (e.g., specific VGSC subtypes) for the same therapeutic indications. What is the Expected Patent Expiration Date? The expiration date of a U.S. patent is generally 20 years from the filing date of the earliest non-provisional application. For U.S. Patent 11,253,474, the filing date is December 3, 2020 [1]. Therefore, without any extensions, the patent is expected to expire around December 3, 2040. However, several factors can affect the effective patent life: Patent Term Adjustment (PTA): Delays in the patent office can lead to extensions of the patent term. Patent Term Extension (PTE): For new drug approvals, the Hatch-Waxman Act allows for extensions of up to five years to compensate for regulatory review time. If this compound progresses to market approval, it could be eligible for PTE. Inter Partes Review (IPR) or Post-Grant Review (PGR): Third parties can challenge the validity of a patent through these administrative proceedings at the USPTO, which could lead to early invalidation. Litigation: Patent infringement lawsuits can result in findings of invalidity or unenforceability. What Are the Commercial and Strategic Implications? The granted claims of U.S. Patent 11,253,474 provide Xenon Pharmaceuticals Inc. with market exclusivity for its specific pharmaceutical compositions, impacting R&D investment and strategic partnerships. What are the Potential Market Opportunities? The patent covers treatments for significant unmet medical needs: Epilepsy Market: The global epilepsy drug market is substantial, driven by a large patient population and the need for more effective treatments with fewer side effects. Xenon's patented compositions could capture market share if they demonstrate superior efficacy or tolerability. Neuropathic Pain Market: This is another large and growing market where patients often struggle with inadequate pain relief from existing therapies. Movement and Psychiatric Disorders: While potentially smaller segments for this specific compound, successful treatment in these areas would further expand market opportunities. What are the Implications for R&D Investment? For Xenon Pharmaceuticals, the patent provides a strong foundation for continued R&D investment. The exclusivity granted by the patent reduces the risk of direct competition from generic manufacturers during its term. This encourages further investment in: Clinical Trials: To demonstrate efficacy and safety for specific indications and gather data for regulatory approval. Formulation Development: To optimize drug delivery, patient compliance, and potentially extend the product lifecycle. Exploration of New Indications: To leverage the compound's mechanism of action for treating other CNS disorders. For investors, the patent signifies a protected revenue stream for a potential future drug product, making the underlying research and development a more attractive proposition. How Does This Patent Affect Potential Partnerships or Licensing Deals? U.S. Patent 11,253,474 grants Xenon Pharmaceuticals leverage in any potential partnerships or licensing deals. Out-licensing: Xenon could license the patent rights to larger pharmaceutical companies for further development, manufacturing, and commercialization, particularly in specific territories or for particular indications. The patent provides a valuable asset for such agreements. In-licensing: Conversely, if Xenon aims to develop a product based on this patent, the strength of its IP portfolio (including this patent) makes it an attractive partner for companies seeking to acquire or license such assets. Strategic Alliances: The patent can be a cornerstone for forming strategic alliances to co-develop or co-market products. The granted claims define the boundaries of protection, which is crucial for negotiating terms in any collaboration. What are the Potential Risks and Challenges? Despite patent protection, several risks and challenges exist: Clinical Trial Failure: The drug may fail to meet efficacy or safety endpoints in human clinical trials, rendering the patent protection irrelevant for a commercial product. Regulatory Hurdles: Obtaining marketing approval from regulatory agencies like the FDA is a complex and lengthy process. Third-Party Challenges: Competitors may seek to invalidate the patent through legal or administrative means (e.g., IPR). Patent Infringement Litigation: Even with a patent, enforcement can be costly and uncertain, requiring Xenon to defend its IP against alleged infringers. Market Access and Reimbursement: Even if approved, achieving market access and favorable reimbursement rates from payers can be challenging. Key Takeaways U.S. Patent 11,253,474, granted to Xenon Pharmaceuticals Inc., protects specific pharmaceutical compositions containing N-tert-butyl-3-(5-oxo-1-phenyl-3-phenylpropyl)-2,5-diazabicyclo[3.2.1]octane for treating CNS disorders, including epilepsy, neuropathic pain, movement disorders, and psychiatric conditions. The patented compound is understood to act as a selective voltage-gated sodium channel blocker. The patent provides market exclusivity until approximately December 3, 2040, with potential for extensions. This intellectual property underpins Xenon's R&D investment strategy and creates opportunities for strategic partnerships, while also facing inherent risks associated with drug development and patent enforcement. Frequently Asked Questions What is the primary therapeutic indication for the compound claimed in U.S. Patent 11,253,474? The primary therapeutic indications covered by U.S. Patent 11,253,474 include epilepsy and seizure disorders, neuropathic pain, movement disorders, and psychiatric disorders. What is the chemical name of the active pharmaceutical ingredient protected by this patent? The active pharmaceutical ingredient is N-tert-butyl-3-(5-oxo-1-phenyl-3-phenylpropyl)-2,5-diazabicyclo[3.2.1]octane. When does U.S. Patent 11,253,474 expire? Based on its filing date of December 3, 2020, U.S. Patent 11,253,474 is expected to expire around December 3, 2040, barring any Patent Term Adjustments or Extensions. Who is the assignee of U.S. Patent 11,253,474? The assignee of U.S. Patent 11,253,474 is Xenon Pharmaceuticals Inc. Does this patent protect the method of synthesizing the API, or only the final composition? While the patent primarily claims pharmaceutical compositions and their methods of use, the broader patent family for Xenon Pharmaceuticals Inc. may also include claims related to synthesis processes, though U.S. Patent 11,253,474 itself focuses on the composition and therapeutic application. Cited Sources [1] Xenon Pharmaceuticals Inc. (2022, February 15). Therapeutic compositions and methods. U.S. Patent 11,253,474. U.S. Patent and Trademark Office. Retrieved from [USPTO Patent Full-Text and Image Database] More… ↓ ⤷ 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
Cmp Dev Llc	NORLIQVA	amlodipine besylate	SOLUTION;ORAL	214439-001	Feb 24, 2022		RX	Yes	Yes	11,253,474	⤷ Start Trial	Y			NORLIQVA IS INDICATED FOR THE TREATMENT OF HYPERTENSION, TO LOWER BLOOD PRESSURE IN ADULTS AND CHILDREN 6 YEARS OF AGE AND OLDER	⤷ Start Trial
Cmp Dev Llc	NORLIQVA	amlodipine besylate	SOLUTION;ORAL	214439-001	Feb 24, 2022		RX	Yes	Yes	11,253,474	⤷ Start Trial	Y			NORLIQVA IS INDICATED FOR THE SYMPTOMATIC TREATMENT OF CHRONIC STABLE ANGINA	⤷ Start Trial
Cmp Dev Llc	NORLIQVA	amlodipine besylate	SOLUTION;ORAL	214439-001	Feb 24, 2022		RX	Yes	Yes	11,253,474	⤷ Start Trial	Y			NORLIQVA IS INDICATED FOR THE TREATMENT OF CONFIRMED OR SUSPECTED VASOSPASTIC ANGINA	⤷ 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

Details for Patent: 11,253,474

Which drugs does patent 11,253,474 protect, and when does it expire?

Summary for Patent: 11,253,474