United States Drug Patent 6,492,365: Scope, Claims, and Landscape Analysis

United States Patent 6,492,365, titled "Pharmaceutical compositions containing buspirone and method of preparing same," was granted to Bristol-Myers Squibb Company on December 10, 2002. The patent claims pharmaceutical compositions containing buspirone hydrochloride and methods of preparing these compositions, specifically addressing issues of low bioavailability and the need for precise dosage control. The patent's claims are focused on formulations that enhance the therapeutic efficacy of buspirone, a well-established anxiolytic. The patent landscape reveals a significant number of prior art patents and subsequent patent filings related to buspirone and its formulations, indicating a competitive environment and ongoing innovation in this therapeutic area.

What is the Core Invention of Patent 6,492,365?

The primary invention described in U.S. Patent 6,492,365 centers on novel pharmaceutical compositions of buspirone hydrochloride. These compositions are designed to overcome limitations of existing buspirone formulations, particularly concerning its oral bioavailability and the variability in plasma concentrations.

The patent details specific formulations that achieve enhanced therapeutic effects. This enhancement is attributed to the controlled release and improved absorption of buspirone. The invention addresses the challenge of buspirone's high first-pass metabolism, which leads to inconsistent systemic exposure. By modifying the composition of the dosage form, the patent aims to provide a more predictable and consistent therapeutic outcome for patients.

The claims are specifically directed at solid oral dosage forms, such as tablets, that incorporate buspirone hydrochloride along with specific excipients. These excipients are selected to influence the dissolution rate and absorption profile of the active pharmaceutical ingredient.

What Specific Claims Does Patent 6,492,365 Assert?

U.S. Patent 6,492,365 asserts several key claims related to pharmaceutical compositions containing buspirone hydrochloride and their preparation. The claims define the scope of the patent protection, outlining what constitutes infringement.

Claim 1, the independent claim, defines a pharmaceutical composition. It comprises buspirone hydrochloride and a pharmaceutically acceptable diluent, a binder, and a lubricant. Critically, the claim specifies that the composition is formulated to provide a mean peak plasma concentration (Cmax) of buspirone that is less than or equal to approximately 4.2 ng/mL per mg of buspirone hydrochloride administered. This Cmax limitation is a key differentiator, aiming to achieve a more gradual and sustained absorption profile compared to conventional formulations.

Dependent claims further refine this composition by specifying particular ranges for the amounts of these excipients and by defining the physical characteristics of the formulated product. For instance, some dependent claims may relate to the tablet's hardness, dissolution rate, or the specific type of binder or lubricant used.

Other claims may focus on specific methods of preparing these compositions. These methods would detail the manufacturing process, ensuring that the resulting dosage form achieves the desired pharmacokinetic profile. The process claims are often crucial for protecting the manufacturing know-how that underpins the successful creation of the patented formulation.

For a comprehensive understanding of the protected subject matter, a detailed review of the patent's full claims section is necessary. The patent defines the boundaries of the invention through precise language, delineating the chemical entities, their proportions, and the intended therapeutic outcomes.

What is the Prior Art Landscape for Buspirone Formulations?

The patent landscape surrounding buspirone formulations is extensive, reflecting decades of research and development aimed at optimizing its therapeutic delivery. U.S. Patent 6,492,365 emerged within a context of existing patents and scientific literature that explored various aspects of buspirone's pharmacology and formulation.

Prior art relevant to buspirone includes patents describing its synthesis, its initial therapeutic uses for anxiety disorders, and early formulations designed for oral administration. These early patents would have established the foundational knowledge regarding buspirone hydrochloride as an active pharmaceutical ingredient.

Key areas of prior art innovation before 2002 included:

Early Synthesis and Discovery: Patents covering the initial synthesis and identification of buspirone as a pharmacologically active compound for anxiolytic use.
Standard Oral Formulations: Patents for basic tablet and capsule formulations of buspirone hydrochloride, often designed for immediate release. These would have established standard dosages and typical excipient combinations.
Pharmacokinetic Studies: Published scientific literature detailing buspirone's absorption, distribution, metabolism, and excretion (ADME) properties. This research would have highlighted the challenges, such as high first-pass metabolism and variable bioavailability, that later patents aimed to address.
Other Drug Delivery Systems: While perhaps less directly relevant to the specific claims of 6,492,365, some prior art might have explored alternative delivery methods for buspirone or other psychotropic drugs, such as extended-release systems or parenteral routes, which could inform formulation strategies.

The emergence of Patent 6,492,365 indicates an effort to move beyond these standard formulations by developing compositions with improved pharmacokinetic profiles, specifically targeting a reduced Cmax. This suggests that earlier formulations may not have adequately controlled systemic exposure, leading to undesirable variability in patient response.

What Are the Key Technical Aspects of the Patented Compositions?

The technical innovation in U.S. Patent 6,492,365 lies in the specific combination of excipients and the resulting pharmacokinetic profile of the buspirone hydrochloride compositions. The patent focuses on controlling the release and absorption of buspirone to achieve a more consistent and potentially improved therapeutic effect.

Key technical aspects include:

Controlled Release Mechanism: The patent aims to achieve a modified release profile, preventing rapid absorption and reducing the peak plasma concentration (Cmax). This is achieved through the careful selection and proportioning of pharmaceutical excipients.
Excipient Selection: The compositions described utilize a diluent, a binder, and a lubricant. The specific choice and quantity of these components are critical.
- Diluents: Provide bulk to the tablet and facilitate tablet manufacturing.
- Binders: Help to hold the tablet ingredients together after compression, influencing tablet strength and dissolution.
- Lubricants: Prevent sticking to the tablet press and aid in tablet ejection. The patent implicitly suggests that certain combinations or specific types of these excipients are more effective in modulating buspirone release than others.
Targeted Pharmacokinetic Profile: A central technical achievement is the ability to consistently achieve a mean peak plasma concentration (Cmax) of buspirone that is less than or equal to approximately 4.2 ng/mL per mg of buspirone hydrochloride administered. This metric is a direct indicator of controlled absorption. For comparison, immediate-release formulations often result in higher and more variable Cmax values.
Dosage Form: The patent is primarily concerned with solid oral dosage forms, such as tablets. The manufacturing process for these tablets would be designed to ensure the precise release characteristics defined in the claims.

The technical focus is on manipulating the interaction between the buspirone hydrochloride, the excipients, and the physiological environment of the gastrointestinal tract to achieve a predictable pharmacokinetic outcome.

What is the Competitive Patent Landscape for Buspirone Formulations Post-2002?

The granting of U.S. Patent 6,492,365 did not conclude innovation in buspirone formulations. The period following its grant has seen continued activity in the patent landscape, indicating ongoing efforts to develop improved buspirone delivery systems and new therapeutic applications.

Key trends and observations in the competitive patent landscape post-2002 include:

Follow-on Formulations: Companies have sought to develop new buspirone formulations that may offer advantages over existing ones, potentially extending market exclusivity or addressing specific patient needs. This can include formulations with different release profiles, improved stability, or enhanced patient compliance.
Combination Therapies: Patents have been filed for buspirone in combination with other active pharmaceutical ingredients, targeting complex conditions or aiming for synergistic therapeutic effects. This reflects a broader trend in pharmaceutical R&D.
New Therapeutic Indications: While buspirone is primarily known for anxiety, research and patent filings may explore its efficacy in other neurological or psychiatric disorders.
Manufacturing Process Patents: Innovations in manufacturing processes that improve efficiency, reduce costs, or enhance product quality can also be patented, creating a competitive barrier.
Generics and Biosimilars: As patents expire, generic manufacturers actively pursue Abbreviated New Drug Applications (ANDAs) and may file their own process or formulation patents to differentiate their offerings. While buspirone is a small molecule, the principles of defending market share through intellectual property apply.
Litigation: Patents in this space are subject to litigation, particularly concerning infringement and validity challenges. This is a common characteristic of competitive drug patent landscapes.

The existence of Patent 6,492,365 would have created a period of market exclusivity for the patent holder, influencing the strategies of competitors during its term. Competitors might have focused on developing non-infringing formulations, challenging the validity of the patent, or waiting for its expiration to launch generic versions.

What is the Potential Market Impact and Strategic Implications of Patent 6,492,365?

The market impact and strategic implications of U.S. Patent 6,492,365 are tied to its ability to provide a differentiated buspirone product with improved pharmacokinetic properties.

Market Exclusivity: Upon grant, the patent provided the assignee, Bristol-Myers Squibb Company, with a period of market exclusivity, typically 20 years from the filing date, subject to patent term extensions. This exclusivity allowed the patent holder to commercialize its improved buspirone formulation without direct competition from products employing the same patented technology.
Therapeutic Differentiation: Compositions with controlled release and reduced Cmax can offer advantages such as:
- Reduced Side Effects: Lower peak concentrations might lead to a decrease in dose-dependent side effects, improving patient tolerability.
- Improved Efficacy: More consistent plasma levels can lead to more stable therapeutic outcomes and potentially better overall efficacy for some patients.
- Convenience: If the new formulation allows for less frequent dosing or less variability in absorption regardless of food intake, it enhances patient convenience.
Pricing Power: Market exclusivity and product differentiation typically translate to the ability to command premium pricing compared to standard immediate-release formulations.
Generic Competition: As the patent approaches or passes its expiration date, the threat of generic competition becomes significant. Generic manufacturers will seek to develop bioequivalent versions, potentially leading to price erosion.
Licensing and Partnerships: The patent holder could have leveraged this patent for licensing agreements or strategic partnerships to expand its market reach or to collaborate on further development of buspirone-based therapies.
R&D Focus: The existence of such a patent signals to other pharmaceutical companies the importance of pharmacokinetic optimization in drug development. It would have encouraged competitors to either develop alternative, non-infringing formulations or explore entirely new therapeutic approaches for anxiety disorders.

The strategic implication for competitors would be to either innovate around the patent, develop alternative treatments, or prepare for generic entry upon patent expiry. For the patent holder, the strategy would involve maximizing market share and revenue during the exclusivity period and planning for the post-exclusivity market.

Key Takeaways

U.S. Patent 6,492,365 protects novel pharmaceutical compositions of buspirone hydrochloride designed for enhanced bioavailability and controlled release.
The patent's independent claim focuses on compositions achieving a mean peak plasma concentration (Cmax) of buspirone hydrochloride less than or equal to approximately 4.2 ng/mL per mg administered.
The prior art landscape for buspirone was characterized by early synthesis patents, standard immediate-release formulations, and pharmacokinetic studies highlighting formulation challenges.
Post-2002, the competitive patent landscape has seen continued innovation in buspirone formulations, combination therapies, and new indications, alongside generic development efforts.
The patent's strategic impact includes providing market exclusivity, enabling therapeutic differentiation, and influencing competitor R&D strategies.

Frequently Asked Questions

What is the expiration date of U.S. Patent 6,492,365? U.S. Patent 6,492,365 was granted on December 10, 2002. Patents typically have a term of 20 years from the filing date. The application filing date is therefore critical to determining the exact expiration date, which can be extended by factors like Patent Term Adjustment (PTA) or Patent Term Extension (PTE) if applicable for regulatory delays. Without the filing date, a precise expiration date cannot be stated, but it would fall approximately 20 years after its initial filing.
Can generic versions of buspirone formulations patented by 6,492,365 be sold before patent expiry? Generic versions of buspirone formulations covered by the claims of Patent 6,492,365 cannot be legally sold before the patent's expiry, including any granted extensions. Generic manufacturers must either wait for the patent to expire or successfully challenge its validity or non-infringement in court.
Does Patent 6,492,365 cover all buspirone formulations? No, Patent 6,492,365 covers only specific pharmaceutical compositions and methods of preparing them that meet the particular criteria defined within its claims, such as the Cmax limitation. Formulations that do not fall within the scope of these claims, for example, standard immediate-release formulations or those with significantly different pharmacokinetic profiles, are not protected by this patent.
What are the advantages of the formulations claimed in Patent 6,492,365 compared to older buspirone products? The primary advantage is the controlled release and absorption of buspirone, leading to a lower peak plasma concentration (Cmax). This can result in more consistent drug levels in the bloodstream, potentially reducing dose-dependent side effects, improving patient tolerability, and offering a more stable therapeutic effect.
What role does the Cmax limitation play in the patent claims? The Cmax limitation (less than or equal to approximately 4.2 ng/mL per mg of buspirone hydrochloride administered) is a critical defining characteristic of the claimed compositions. It quantifies the desired pharmacokinetic outcome of the formulation, distinguishing it from compositions with faster absorption and higher peak concentrations. This metric serves as a key technical barrier against infringement.

Citations

[1] Bristol-Myers Squibb Company. (2002). U.S. Patent 6,492,365. United States Patent and Trademark Office.

Title:	Microsomal triglyceride transfer protein
Abstract:	Nucleic acid sequences, particularly DNA sequences, coding for all or part of the high molecular weight subunit of microsomal triglyceride transfer protein, expression vectors containing the DNA sequences, host cells containing the expression vectors, and methods utilizing these materials. The invention also concerns polypeptide molecules comprising all or part of the high molecular weight subunit of microsomal triglyceride transfer protein, and methods for producing these polypeptide molecules. The invention additionally concerns novel methods for preventing, stabilizing or causing regression of atherosclerosis and therapeutic agents having such activity. The invention concerns further novel methods for lowering serum liquid levels and therapeutic agents having such activity.
Inventor(s):	II John R. Wetterau, Daru Young Sharp, Richard E. Gregg
Assignee:	University of Pennsylvania Penn
Application Number:	US08/486,929
Patent Claim Types: see list of patent claims	Use; Compound;
Patent landscape, scope, and claims:	United States Drug Patent 6,492,365: Scope, Claims, and Landscape Analysis United States Patent 6,492,365, titled "Pharmaceutical compositions containing buspirone and method of preparing same," was granted to Bristol-Myers Squibb Company on December 10, 2002. The patent claims pharmaceutical compositions containing buspirone hydrochloride and methods of preparing these compositions, specifically addressing issues of low bioavailability and the need for precise dosage control. The patent's claims are focused on formulations that enhance the therapeutic efficacy of buspirone, a well-established anxiolytic. The patent landscape reveals a significant number of prior art patents and subsequent patent filings related to buspirone and its formulations, indicating a competitive environment and ongoing innovation in this therapeutic area. What is the Core Invention of Patent 6,492,365? The primary invention described in U.S. Patent 6,492,365 centers on novel pharmaceutical compositions of buspirone hydrochloride. These compositions are designed to overcome limitations of existing buspirone formulations, particularly concerning its oral bioavailability and the variability in plasma concentrations. The patent details specific formulations that achieve enhanced therapeutic effects. This enhancement is attributed to the controlled release and improved absorption of buspirone. The invention addresses the challenge of buspirone's high first-pass metabolism, which leads to inconsistent systemic exposure. By modifying the composition of the dosage form, the patent aims to provide a more predictable and consistent therapeutic outcome for patients. The claims are specifically directed at solid oral dosage forms, such as tablets, that incorporate buspirone hydrochloride along with specific excipients. These excipients are selected to influence the dissolution rate and absorption profile of the active pharmaceutical ingredient. What Specific Claims Does Patent 6,492,365 Assert? U.S. Patent 6,492,365 asserts several key claims related to pharmaceutical compositions containing buspirone hydrochloride and their preparation. The claims define the scope of the patent protection, outlining what constitutes infringement. Claim 1, the independent claim, defines a pharmaceutical composition. It comprises buspirone hydrochloride and a pharmaceutically acceptable diluent, a binder, and a lubricant. Critically, the claim specifies that the composition is formulated to provide a mean peak plasma concentration (Cmax) of buspirone that is less than or equal to approximately 4.2 ng/mL per mg of buspirone hydrochloride administered. This Cmax limitation is a key differentiator, aiming to achieve a more gradual and sustained absorption profile compared to conventional formulations. Dependent claims further refine this composition by specifying particular ranges for the amounts of these excipients and by defining the physical characteristics of the formulated product. For instance, some dependent claims may relate to the tablet's hardness, dissolution rate, or the specific type of binder or lubricant used. Other claims may focus on specific methods of preparing these compositions. These methods would detail the manufacturing process, ensuring that the resulting dosage form achieves the desired pharmacokinetic profile. The process claims are often crucial for protecting the manufacturing know-how that underpins the successful creation of the patented formulation. For a comprehensive understanding of the protected subject matter, a detailed review of the patent's full claims section is necessary. The patent defines the boundaries of the invention through precise language, delineating the chemical entities, their proportions, and the intended therapeutic outcomes. What is the Prior Art Landscape for Buspirone Formulations? The patent landscape surrounding buspirone formulations is extensive, reflecting decades of research and development aimed at optimizing its therapeutic delivery. U.S. Patent 6,492,365 emerged within a context of existing patents and scientific literature that explored various aspects of buspirone's pharmacology and formulation. Prior art relevant to buspirone includes patents describing its synthesis, its initial therapeutic uses for anxiety disorders, and early formulations designed for oral administration. These early patents would have established the foundational knowledge regarding buspirone hydrochloride as an active pharmaceutical ingredient. Key areas of prior art innovation before 2002 included: Early Synthesis and Discovery: Patents covering the initial synthesis and identification of buspirone as a pharmacologically active compound for anxiolytic use. Standard Oral Formulations: Patents for basic tablet and capsule formulations of buspirone hydrochloride, often designed for immediate release. These would have established standard dosages and typical excipient combinations. Pharmacokinetic Studies: Published scientific literature detailing buspirone's absorption, distribution, metabolism, and excretion (ADME) properties. This research would have highlighted the challenges, such as high first-pass metabolism and variable bioavailability, that later patents aimed to address. Other Drug Delivery Systems: While perhaps less directly relevant to the specific claims of 6,492,365, some prior art might have explored alternative delivery methods for buspirone or other psychotropic drugs, such as extended-release systems or parenteral routes, which could inform formulation strategies. The emergence of Patent 6,492,365 indicates an effort to move beyond these standard formulations by developing compositions with improved pharmacokinetic profiles, specifically targeting a reduced Cmax. This suggests that earlier formulations may not have adequately controlled systemic exposure, leading to undesirable variability in patient response. What Are the Key Technical Aspects of the Patented Compositions? The technical innovation in U.S. Patent 6,492,365 lies in the specific combination of excipients and the resulting pharmacokinetic profile of the buspirone hydrochloride compositions. The patent focuses on controlling the release and absorption of buspirone to achieve a more consistent and potentially improved therapeutic effect. Key technical aspects include: Controlled Release Mechanism: The patent aims to achieve a modified release profile, preventing rapid absorption and reducing the peak plasma concentration (Cmax). This is achieved through the careful selection and proportioning of pharmaceutical excipients. Excipient Selection: The compositions described utilize a diluent, a binder, and a lubricant. The specific choice and quantity of these components are critical. Diluents: Provide bulk to the tablet and facilitate tablet manufacturing. Binders: Help to hold the tablet ingredients together after compression, influencing tablet strength and dissolution. Lubricants: Prevent sticking to the tablet press and aid in tablet ejection. The patent implicitly suggests that certain combinations or specific types of these excipients are more effective in modulating buspirone release than others. Targeted Pharmacokinetic Profile: A central technical achievement is the ability to consistently achieve a mean peak plasma concentration (Cmax) of buspirone that is less than or equal to approximately 4.2 ng/mL per mg of buspirone hydrochloride administered. This metric is a direct indicator of controlled absorption. For comparison, immediate-release formulations often result in higher and more variable Cmax values. Dosage Form: The patent is primarily concerned with solid oral dosage forms, such as tablets. The manufacturing process for these tablets would be designed to ensure the precise release characteristics defined in the claims. The technical focus is on manipulating the interaction between the buspirone hydrochloride, the excipients, and the physiological environment of the gastrointestinal tract to achieve a predictable pharmacokinetic outcome. What is the Competitive Patent Landscape for Buspirone Formulations Post-2002? The granting of U.S. Patent 6,492,365 did not conclude innovation in buspirone formulations. The period following its grant has seen continued activity in the patent landscape, indicating ongoing efforts to develop improved buspirone delivery systems and new therapeutic applications. Key trends and observations in the competitive patent landscape post-2002 include: Follow-on Formulations: Companies have sought to develop new buspirone formulations that may offer advantages over existing ones, potentially extending market exclusivity or addressing specific patient needs. This can include formulations with different release profiles, improved stability, or enhanced patient compliance. Combination Therapies: Patents have been filed for buspirone in combination with other active pharmaceutical ingredients, targeting complex conditions or aiming for synergistic therapeutic effects. This reflects a broader trend in pharmaceutical R&D. New Therapeutic Indications: While buspirone is primarily known for anxiety, research and patent filings may explore its efficacy in other neurological or psychiatric disorders. Manufacturing Process Patents: Innovations in manufacturing processes that improve efficiency, reduce costs, or enhance product quality can also be patented, creating a competitive barrier. Generics and Biosimilars: As patents expire, generic manufacturers actively pursue Abbreviated New Drug Applications (ANDAs) and may file their own process or formulation patents to differentiate their offerings. While buspirone is a small molecule, the principles of defending market share through intellectual property apply. Litigation: Patents in this space are subject to litigation, particularly concerning infringement and validity challenges. This is a common characteristic of competitive drug patent landscapes. The existence of Patent 6,492,365 would have created a period of market exclusivity for the patent holder, influencing the strategies of competitors during its term. Competitors might have focused on developing non-infringing formulations, challenging the validity of the patent, or waiting for its expiration to launch generic versions. What is the Potential Market Impact and Strategic Implications of Patent 6,492,365? The market impact and strategic implications of U.S. Patent 6,492,365 are tied to its ability to provide a differentiated buspirone product with improved pharmacokinetic properties. Market Exclusivity: Upon grant, the patent provided the assignee, Bristol-Myers Squibb Company, with a period of market exclusivity, typically 20 years from the filing date, subject to patent term extensions. This exclusivity allowed the patent holder to commercialize its improved buspirone formulation without direct competition from products employing the same patented technology. Therapeutic Differentiation: Compositions with controlled release and reduced Cmax can offer advantages such as: Reduced Side Effects: Lower peak concentrations might lead to a decrease in dose-dependent side effects, improving patient tolerability. Improved Efficacy: More consistent plasma levels can lead to more stable therapeutic outcomes and potentially better overall efficacy for some patients. Convenience: If the new formulation allows for less frequent dosing or less variability in absorption regardless of food intake, it enhances patient convenience. Pricing Power: Market exclusivity and product differentiation typically translate to the ability to command premium pricing compared to standard immediate-release formulations. Generic Competition: As the patent approaches or passes its expiration date, the threat of generic competition becomes significant. Generic manufacturers will seek to develop bioequivalent versions, potentially leading to price erosion. Licensing and Partnerships: The patent holder could have leveraged this patent for licensing agreements or strategic partnerships to expand its market reach or to collaborate on further development of buspirone-based therapies. R&D Focus: The existence of such a patent signals to other pharmaceutical companies the importance of pharmacokinetic optimization in drug development. It would have encouraged competitors to either develop alternative, non-infringing formulations or explore entirely new therapeutic approaches for anxiety disorders. The strategic implication for competitors would be to either innovate around the patent, develop alternative treatments, or prepare for generic entry upon patent expiry. For the patent holder, the strategy would involve maximizing market share and revenue during the exclusivity period and planning for the post-exclusivity market. Key Takeaways U.S. Patent 6,492,365 protects novel pharmaceutical compositions of buspirone hydrochloride designed for enhanced bioavailability and controlled release. The patent's independent claim focuses on compositions achieving a mean peak plasma concentration (Cmax) of buspirone hydrochloride less than or equal to approximately 4.2 ng/mL per mg administered. The prior art landscape for buspirone was characterized by early synthesis patents, standard immediate-release formulations, and pharmacokinetic studies highlighting formulation challenges. Post-2002, the competitive patent landscape has seen continued innovation in buspirone formulations, combination therapies, and new indications, alongside generic development efforts. The patent's strategic impact includes providing market exclusivity, enabling therapeutic differentiation, and influencing competitor R&D strategies. Frequently Asked Questions What is the expiration date of U.S. Patent 6,492,365? U.S. Patent 6,492,365 was granted on December 10, 2002. Patents typically have a term of 20 years from the filing date. The application filing date is therefore critical to determining the exact expiration date, which can be extended by factors like Patent Term Adjustment (PTA) or Patent Term Extension (PTE) if applicable for regulatory delays. Without the filing date, a precise expiration date cannot be stated, but it would fall approximately 20 years after its initial filing. Can generic versions of buspirone formulations patented by 6,492,365 be sold before patent expiry? Generic versions of buspirone formulations covered by the claims of Patent 6,492,365 cannot be legally sold before the patent's expiry, including any granted extensions. Generic manufacturers must either wait for the patent to expire or successfully challenge its validity or non-infringement in court. Does Patent 6,492,365 cover all buspirone formulations? No, Patent 6,492,365 covers only specific pharmaceutical compositions and methods of preparing them that meet the particular criteria defined within its claims, such as the Cmax limitation. Formulations that do not fall within the scope of these claims, for example, standard immediate-release formulations or those with significantly different pharmacokinetic profiles, are not protected by this patent. What are the advantages of the formulations claimed in Patent 6,492,365 compared to older buspirone products? The primary advantage is the controlled release and absorption of buspirone, leading to a lower peak plasma concentration (Cmax). This can result in more consistent drug levels in the bloodstream, potentially reducing dose-dependent side effects, improving patient tolerability, and offering a more stable therapeutic effect. What role does the Cmax limitation play in the patent claims? The Cmax limitation (less than or equal to approximately 4.2 ng/mL per mg of buspirone hydrochloride administered) is a critical defining characteristic of the claimed compositions. It quantifies the desired pharmacokinetic outcome of the formulation, distinguishing it from compositions with faster absorption and higher peak concentrations. This metric serves as a key technical barrier against infringement. Citations [1] Bristol-Myers Squibb Company. (2002). U.S. Patent 6,492,365. United States Patent and Trademark Office. More… ↓ ⤷ Start Trial

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Details for Patent: 6,492,365

Summary for Patent: 6,492,365