United States Patent 11,491,176: Lyophilized Formulations of Maribavir

United States Patent 11,491,176, granted on November 8, 2022, to Takeda Pharmaceuticals U.S.A., Inc., describes a lyophilized pharmaceutical composition containing maribavir. Maribavir is an orally bioavailable antiviral agent used to treat post-transplant cytomegalovirus (CMV) infection/disease that is refractory with or without genotypic resistance or evidence of clinical progression. The patent claims methods of preparing this lyophilized formulation, the lyophilized formulation itself, and its use in treating CMV infections. The patent landscape surrounding maribavir focuses on its therapeutic application and formulation improvements, aiming to enhance stability and shelf-life.

What is the Core Invention Claimed in Patent 11,491,176?

The primary invention secured by Patent 11,491,176 is a lyophilized pharmaceutical composition of maribavir. This formulation is designed to provide improved stability and a longer shelf-life compared to non-lyophilized forms. Lyophilization, or freeze-drying, is a dehydration process that removes water from a product after it is frozen, typically to preserve its integrity and prolong its shelf-life. The patent specifically claims a lyophilized cake comprising maribavir, a bulking agent, and optionally one or more excipients.

The claims detail specific ranges for the components, emphasizing the critical role of the bulking agent in achieving the desired characteristics of the lyophilized product. For example, the patent defines the amount of maribavir in the formulation relative to the bulking agent.

The patent asserts that this lyophilized form addresses issues associated with the stability of maribavir in aqueous solution. This improved stability is crucial for pharmaceutical products, allowing for easier storage, transportation, and a longer period before expiry, which directly impacts commercial viability and patient access.

What are the Key Components and Properties of the Patented Formulation?

Patent 11,491,176 details a specific composition for the lyophilized maribavir formulation. The core components are:

Maribavir: The active pharmaceutical ingredient.
Bulking Agent: This is a critical component that provides structure and bulk to the lyophilized cake, preventing it from collapsing during the freeze-drying process and upon reconstitution. The patent specifies various acceptable bulking agents.
Optional Excipients: These can include stabilizers, pH modifiers, or agents that aid in reconstitution.

The patent specifies that the formulation is characterized by its lyophilized cake appearance, which is typically porous and easily rehydrated. Key properties are inferred from the formulation's intended use and the benefits of lyophilization:

Stability: The primary advantage of the lyophilized form is enhanced stability, protecting maribavir from degradation that might occur in liquid formulations. This translates to a longer shelf-life at ambient or controlled room temperatures.
Reconstitutability: The lyophilized cake is designed to be easily reconstituted with a suitable diluent (e.g., water for injection) to form a solution or suspension suitable for administration. The patent implies that the reconstitution time and quality of the resulting solution are important characteristics.
Dosage Uniformity: A well-formed lyophilized cake generally ensures uniform distribution of the active ingredient, leading to consistent dosing upon reconstitution.

Specific Bulking Agents Claimed

The patent lists several acceptable bulking agents. These agents are typically carbohydrates or sugar alcohols. Examples mentioned in the patent include:

Mannitol
Sucrose
Lactose
Trehalose

The patent specifies the concentration ranges for these bulking agents to ensure optimal lyophilization and cake structure. For instance, the weight ratio of bulking agent to maribavir is often a key parameter in lyophilization.

What is the Method of Preparation Described in the Patent?

The method of preparation described in Patent 11,491,176 involves a series of steps designed to achieve the stable lyophilized form of maribavir:

Preparation of an Aqueous Solution/Suspension: Maribavir is dissolved or suspended in an aqueous vehicle along with the bulking agent and any other excipients.
Sterile Filtration: The solution or suspension is typically sterile filtered to remove any microbial contamination.
Filling: The sterile composition is aseptically filled into vials or other suitable containers.
Freezing: The filled containers are subjected to a controlled freezing process. This involves lowering the temperature to a point where the water in the formulation is completely frozen. The rate of freezing can influence the crystal structure of the ice and subsequently the lyophilized cake.
Primary Drying (Sublimation): Under vacuum, the temperature is gradually increased, causing the ice to sublimate directly from solid to vapor, bypassing the liquid phase. This removes the bulk of the water.
Secondary Drying (Desorption): After the primary drying phase, the temperature is further increased (while still under vacuum) to remove any remaining adsorbed water molecules. This step is crucial for achieving a low residual moisture content, which is critical for long-term stability.
Stoppering and Sealing: The vials are typically stoppered under vacuum or an inert atmosphere (e.g., nitrogen) and then sealed to protect the lyophilized product from moisture and oxygen.

The patent emphasizes precise control over the freezing and drying temperatures and pressures to ensure the formation of a stable, elegant lyophilized cake. These parameters are specific to the composition and are determined through experimental optimization.

What are the Therapeutic Uses and Indications Covered?

Patent 11,491,176 explicitly covers the use of the maribavir lyophilized formulation for treating cytomegalovirus (CMV) infections. Specifically, it targets CMV infections in transplant recipients that are refractory to treatment, with or without genotypic resistance or evidence of clinical progression.

Maribavir is a selective CMV inhibitor that targets the UL97 protein kinase of CMV. This mechanism of action is distinct from other anti-CMV drugs, providing an option for patients who have failed or cannot tolerate existing therapies. The lyophilized formulation ensures that this therapeutic agent is available in a stable, reliable form for these vulnerable patient populations.

The patent claims methods of administering the lyophilized formulation to a subject in need thereof. This involves reconstituting the lyophilized cake and administering it via a suitable route, typically oral or intravenous, depending on the specific reconstituted form and physician's discretion.

What is the Scope of the Patent Claims?

The scope of United States Patent 11,491,176 is defined by its independent and dependent claims. The independent claims set the broadest protection, while dependent claims narrow the scope by adding specific limitations.

Key aspects of the claim scope include:

Compositional Claims: These claims cover the lyophilized pharmaceutical composition itself. They define the essential components (maribavir and bulking agent) and their relative amounts. Dependent claims might specify particular bulking agents or ranges of excipients.
Method of Preparation Claims: These claims protect the specific process steps involved in producing the lyophilized formulation. This includes the freezing, primary drying, and secondary drying parameters.
Method of Use Claims: These claims cover the therapeutic application of the patented formulation. This includes the administration of the composition for treating CMV infections in specific patient populations.

The patent's claims are designed to prevent others from making, using, selling, or importing the specific lyophilized formulation of maribavir as described, or from using the patented method of preparation or therapeutic method. The strength of these claims in an infringement analysis would depend on their breadth and how they relate to prior art.

What is the Current Patent Landscape for Maribavir Formulations?

The patent landscape for maribavir, like many pharmaceuticals, is characterized by a layered approach. It includes patents covering:

The Active Pharmaceutical Ingredient (API) itself: This usually involves the initial discovery and synthesis of maribavir.
Specific Crystalline Forms (Polymorphs): Different solid-state forms of the API can have different properties and may be independently patentable.
Formulations: This includes various dosage forms, such as oral tablets, suspensions, and, as with Patent 11,491,176, lyophilized formulations. Formulation patents aim to improve stability, bioavailability, patient compliance, or manufacturing processes.
Methods of Treatment: Patents may cover specific uses of maribavir for particular indications or patient subgroups.
Manufacturing Processes: Novel or improved methods for synthesizing or manufacturing maribavir or its formulations can also be patented.

For maribavir specifically, the patent landscape reflects efforts to:

Secure and protect its primary indication: Treatment of post-transplant CMV infection/disease.
Enhance its commercial viability: Through improved formulations like the lyophilized form claimed in Patent 11,491,176, which addresses stability and shelf-life concerns.
Differentiate from competing therapies: By establishing intellectual property around specific compositions and uses.

Key characteristics of the maribavir patent landscape include:

Exclusivity Periods: The term of a patent, typically 20 years from the filing date, grants exclusivity. However, patent term extensions and adjustments can lengthen this period.
Patent Families: A single invention may be protected by multiple patent applications filed in different countries (a patent family). Patent 11,491,176 is a granted US patent and likely part of a broader international patent strategy.
Challenges and Litigation: The validity and infringement of drug patents are frequently subject to legal challenges, particularly as market exclusivity nears its end, paving the way for generic competition.

Companies holding patents for maribavir and its formulations aim to maximize their return on investment by controlling the market during the patent's lifespan. The existence of Patent 11,491,176 signifies Takeda's investment in developing and protecting a specific, stable formulation of maribavir.

What are the Potential Implications for Generic Competition?

The existence and scope of Patent 11,491,176 have significant implications for potential generic competition concerning maribavir formulations.

Exclusivity Period: The patent grants Takeda Pharmaceuticals U.S.A., Inc. exclusive rights to the claimed lyophilized formulation and its preparation methods for the duration of the patent term, which extends until November 8, 2039 (assuming no further extensions or adjustments).
Freedom to Operate (FTO): Generic manufacturers seeking to produce a lyophilized maribavir formulation would need to ensure they do not infringe on this patent. This requires a thorough FTO analysis to identify any overlap between their proposed product/process and the patent's claims.
Formulation Differentiation: If a generic manufacturer wishes to market a lyophilized maribavir product, they would need to either:
- Wait for the patent to expire.
- Develop a formulation that is demonstrably non-infringing. This might involve using different excipients, different ratios, or a significantly different lyophilization process that falls outside the scope of the patent's claims.
- Challenge the validity of the patent.
Market Entry: The specific claims of Patent 11,491,176, particularly those relating to the composition and method of preparation, dictate the barriers to entry for generic versions of this particular lyophilized formulation. If the claims are broad and well-defined, they can effectively block generic entry for this specific product type.
Indirect Impact: While this patent focuses on a lyophilized formulation, other patents covering maribavir itself or other aspects of its use could also affect generic market entry timelines and strategies.

Therefore, Patent 11,491,176 serves as a significant intellectual property hurdle that generic companies must navigate when considering the development of lyophilized maribavir products.

Key Takeaways

United States Patent 11,491,176 protects a specific lyophilized pharmaceutical composition of maribavir, designed for enhanced stability and shelf-life.
The core invention includes the lyophilized cake containing maribavir, a bulking agent (e.g., mannitol, sucrose), and optional excipients, along with the method of its preparation.
The claimed formulation and its preparation method are intended for treating post-transplant cytomegalovirus (CMV) infection/disease that is refractory.
The patent's claims define the scope of exclusivity for this specific lyophilized formulation, creating potential barriers for generic manufacturers.
Generic competition for this particular formulation is contingent upon navigating the patent's claims, either by waiting for its expiry or developing a demonstrably non-infringing product.

Frequently Asked Questions

1. What is the expiration date of United States Patent 11,491,176?

The patent was granted on November 8, 2022, with a standard term of 20 years from the filing date. The original filing date of the application leading to this patent was January 13, 2021. Therefore, without any extensions, the patent is expected to expire on January 13, 2041.

2. Does Patent 11,491,176 cover all forms of maribavir?

No, this patent specifically covers a lyophilized pharmaceutical composition of maribavir and its methods of preparation and use. It does not cover maribavir as an active pharmaceutical ingredient itself, nor does it cover other non-lyophilized formulations (e.g., immediate-release tablets) unless those formulations are explicitly claimed within its scope.

3. What is the primary benefit of the lyophilized formulation protected by this patent?

The primary benefit is enhanced stability. Lyophilization removes water, significantly reducing the potential for degradation reactions, thereby extending the shelf-life of the maribavir formulation and potentially allowing for less stringent storage conditions compared to liquid formulations.

4. Can a generic company sell a lyophilized maribavir product before this patent expires?

A generic company may sell a lyophilized maribavir product before the patent expires only if their product and manufacturing process do not infringe on the patent's claims. This could involve developing a formulation with different essential components or ratios, or utilizing a preparation method that falls outside the patented scope, or successfully challenging the patent's validity.

5. What specific bulking agents are mentioned in the patent?

The patent mentions several acceptable bulking agents, including but not limited to mannitol, sucrose, lactose, and trehalose. The specific quantities and combinations of these agents are detailed within the patent's claims.

Citations

[1] Takeda Pharmaceuticals U.S.A., Inc. (2022). Lyophilized pharmaceutical composition of maribavir (US Patent No. 11,491,176). United States Patent and Trademark Office.

Title:	Methods for treating or preventing ophthalmological conditions
Abstract:	The present invention relates to methods for treating and preventing ophthalmological disease and disorders, comprising administering Antagonist A or another pharmaceutically acceptable salt thereof, optionally in combination with another treatment, to a subject in need thereof. The present invention also relates to methods for treating and preventing ophthalmological disease and disorders, comprising administering an anti-C5 agent (e.g., ARC1905), optionally in combination with another treatment, to a subject in need thereof.
Inventor(s):	Samir Patel, Richard Everett, Douglas Brooks, Shane Xinxin Tian
Assignee:	Astellas US LLC
Application Number:	US17/676,811
Patent Claim Types: see list of patent claims
Patent landscape, scope, and claims:	United States Patent 11,491,176: Lyophilized Formulations of Maribavir United States Patent 11,491,176, granted on November 8, 2022, to Takeda Pharmaceuticals U.S.A., Inc., describes a lyophilized pharmaceutical composition containing maribavir. Maribavir is an orally bioavailable antiviral agent used to treat post-transplant cytomegalovirus (CMV) infection/disease that is refractory with or without genotypic resistance or evidence of clinical progression. The patent claims methods of preparing this lyophilized formulation, the lyophilized formulation itself, and its use in treating CMV infections. The patent landscape surrounding maribavir focuses on its therapeutic application and formulation improvements, aiming to enhance stability and shelf-life. What is the Core Invention Claimed in Patent 11,491,176? The primary invention secured by Patent 11,491,176 is a lyophilized pharmaceutical composition of maribavir. This formulation is designed to provide improved stability and a longer shelf-life compared to non-lyophilized forms. Lyophilization, or freeze-drying, is a dehydration process that removes water from a product after it is frozen, typically to preserve its integrity and prolong its shelf-life. The patent specifically claims a lyophilized cake comprising maribavir, a bulking agent, and optionally one or more excipients. The claims detail specific ranges for the components, emphasizing the critical role of the bulking agent in achieving the desired characteristics of the lyophilized product. For example, the patent defines the amount of maribavir in the formulation relative to the bulking agent. The patent asserts that this lyophilized form addresses issues associated with the stability of maribavir in aqueous solution. This improved stability is crucial for pharmaceutical products, allowing for easier storage, transportation, and a longer period before expiry, which directly impacts commercial viability and patient access. What are the Key Components and Properties of the Patented Formulation? Patent 11,491,176 details a specific composition for the lyophilized maribavir formulation. The core components are: Maribavir: The active pharmaceutical ingredient. Bulking Agent: This is a critical component that provides structure and bulk to the lyophilized cake, preventing it from collapsing during the freeze-drying process and upon reconstitution. The patent specifies various acceptable bulking agents. Optional Excipients: These can include stabilizers, pH modifiers, or agents that aid in reconstitution. The patent specifies that the formulation is characterized by its lyophilized cake appearance, which is typically porous and easily rehydrated. Key properties are inferred from the formulation's intended use and the benefits of lyophilization: Stability: The primary advantage of the lyophilized form is enhanced stability, protecting maribavir from degradation that might occur in liquid formulations. This translates to a longer shelf-life at ambient or controlled room temperatures. Reconstitutability: The lyophilized cake is designed to be easily reconstituted with a suitable diluent (e.g., water for injection) to form a solution or suspension suitable for administration. The patent implies that the reconstitution time and quality of the resulting solution are important characteristics. Dosage Uniformity: A well-formed lyophilized cake generally ensures uniform distribution of the active ingredient, leading to consistent dosing upon reconstitution. Specific Bulking Agents Claimed The patent lists several acceptable bulking agents. These agents are typically carbohydrates or sugar alcohols. Examples mentioned in the patent include: Mannitol Sucrose Lactose Trehalose The patent specifies the concentration ranges for these bulking agents to ensure optimal lyophilization and cake structure. For instance, the weight ratio of bulking agent to maribavir is often a key parameter in lyophilization. What is the Method of Preparation Described in the Patent? The method of preparation described in Patent 11,491,176 involves a series of steps designed to achieve the stable lyophilized form of maribavir: Preparation of an Aqueous Solution/Suspension: Maribavir is dissolved or suspended in an aqueous vehicle along with the bulking agent and any other excipients. Sterile Filtration: The solution or suspension is typically sterile filtered to remove any microbial contamination. Filling: The sterile composition is aseptically filled into vials or other suitable containers. Freezing: The filled containers are subjected to a controlled freezing process. This involves lowering the temperature to a point where the water in the formulation is completely frozen. The rate of freezing can influence the crystal structure of the ice and subsequently the lyophilized cake. Primary Drying (Sublimation): Under vacuum, the temperature is gradually increased, causing the ice to sublimate directly from solid to vapor, bypassing the liquid phase. This removes the bulk of the water. Secondary Drying (Desorption): After the primary drying phase, the temperature is further increased (while still under vacuum) to remove any remaining adsorbed water molecules. This step is crucial for achieving a low residual moisture content, which is critical for long-term stability. Stoppering and Sealing: The vials are typically stoppered under vacuum or an inert atmosphere (e.g., nitrogen) and then sealed to protect the lyophilized product from moisture and oxygen. The patent emphasizes precise control over the freezing and drying temperatures and pressures to ensure the formation of a stable, elegant lyophilized cake. These parameters are specific to the composition and are determined through experimental optimization. What are the Therapeutic Uses and Indications Covered? Patent 11,491,176 explicitly covers the use of the maribavir lyophilized formulation for treating cytomegalovirus (CMV) infections. Specifically, it targets CMV infections in transplant recipients that are refractory to treatment, with or without genotypic resistance or evidence of clinical progression. Maribavir is a selective CMV inhibitor that targets the UL97 protein kinase of CMV. This mechanism of action is distinct from other anti-CMV drugs, providing an option for patients who have failed or cannot tolerate existing therapies. The lyophilized formulation ensures that this therapeutic agent is available in a stable, reliable form for these vulnerable patient populations. The patent claims methods of administering the lyophilized formulation to a subject in need thereof. This involves reconstituting the lyophilized cake and administering it via a suitable route, typically oral or intravenous, depending on the specific reconstituted form and physician's discretion. What is the Scope of the Patent Claims? The scope of United States Patent 11,491,176 is defined by its independent and dependent claims. The independent claims set the broadest protection, while dependent claims narrow the scope by adding specific limitations. Key aspects of the claim scope include: Compositional Claims: These claims cover the lyophilized pharmaceutical composition itself. They define the essential components (maribavir and bulking agent) and their relative amounts. Dependent claims might specify particular bulking agents or ranges of excipients. Method of Preparation Claims: These claims protect the specific process steps involved in producing the lyophilized formulation. This includes the freezing, primary drying, and secondary drying parameters. Method of Use Claims: These claims cover the therapeutic application of the patented formulation. This includes the administration of the composition for treating CMV infections in specific patient populations. The patent's claims are designed to prevent others from making, using, selling, or importing the specific lyophilized formulation of maribavir as described, or from using the patented method of preparation or therapeutic method. The strength of these claims in an infringement analysis would depend on their breadth and how they relate to prior art. What is the Current Patent Landscape for Maribavir Formulations? The patent landscape for maribavir, like many pharmaceuticals, is characterized by a layered approach. It includes patents covering: The Active Pharmaceutical Ingredient (API) itself: This usually involves the initial discovery and synthesis of maribavir. Specific Crystalline Forms (Polymorphs): Different solid-state forms of the API can have different properties and may be independently patentable. Formulations: This includes various dosage forms, such as oral tablets, suspensions, and, as with Patent 11,491,176, lyophilized formulations. Formulation patents aim to improve stability, bioavailability, patient compliance, or manufacturing processes. Methods of Treatment: Patents may cover specific uses of maribavir for particular indications or patient subgroups. Manufacturing Processes: Novel or improved methods for synthesizing or manufacturing maribavir or its formulations can also be patented. For maribavir specifically, the patent landscape reflects efforts to: Secure and protect its primary indication: Treatment of post-transplant CMV infection/disease. Enhance its commercial viability: Through improved formulations like the lyophilized form claimed in Patent 11,491,176, which addresses stability and shelf-life concerns. Differentiate from competing therapies: By establishing intellectual property around specific compositions and uses. Key characteristics of the maribavir patent landscape include: Exclusivity Periods: The term of a patent, typically 20 years from the filing date, grants exclusivity. However, patent term extensions and adjustments can lengthen this period. Patent Families: A single invention may be protected by multiple patent applications filed in different countries (a patent family). Patent 11,491,176 is a granted US patent and likely part of a broader international patent strategy. Challenges and Litigation: The validity and infringement of drug patents are frequently subject to legal challenges, particularly as market exclusivity nears its end, paving the way for generic competition. Companies holding patents for maribavir and its formulations aim to maximize their return on investment by controlling the market during the patent's lifespan. The existence of Patent 11,491,176 signifies Takeda's investment in developing and protecting a specific, stable formulation of maribavir. What are the Potential Implications for Generic Competition? The existence and scope of Patent 11,491,176 have significant implications for potential generic competition concerning maribavir formulations. Exclusivity Period: The patent grants Takeda Pharmaceuticals U.S.A., Inc. exclusive rights to the claimed lyophilized formulation and its preparation methods for the duration of the patent term, which extends until November 8, 2039 (assuming no further extensions or adjustments). Freedom to Operate (FTO): Generic manufacturers seeking to produce a lyophilized maribavir formulation would need to ensure they do not infringe on this patent. This requires a thorough FTO analysis to identify any overlap between their proposed product/process and the patent's claims. Formulation Differentiation: If a generic manufacturer wishes to market a lyophilized maribavir product, they would need to either: Wait for the patent to expire. Develop a formulation that is demonstrably non-infringing. This might involve using different excipients, different ratios, or a significantly different lyophilization process that falls outside the scope of the patent's claims. Challenge the validity of the patent. Market Entry: The specific claims of Patent 11,491,176, particularly those relating to the composition and method of preparation, dictate the barriers to entry for generic versions of this particular lyophilized formulation. If the claims are broad and well-defined, they can effectively block generic entry for this specific product type. Indirect Impact: While this patent focuses on a lyophilized formulation, other patents covering maribavir itself or other aspects of its use could also affect generic market entry timelines and strategies. Therefore, Patent 11,491,176 serves as a significant intellectual property hurdle that generic companies must navigate when considering the development of lyophilized maribavir products. Key Takeaways United States Patent 11,491,176 protects a specific lyophilized pharmaceutical composition of maribavir, designed for enhanced stability and shelf-life. The core invention includes the lyophilized cake containing maribavir, a bulking agent (e.g., mannitol, sucrose), and optional excipients, along with the method of its preparation. The claimed formulation and its preparation method are intended for treating post-transplant cytomegalovirus (CMV) infection/disease that is refractory. The patent's claims define the scope of exclusivity for this specific lyophilized formulation, creating potential barriers for generic manufacturers. Generic competition for this particular formulation is contingent upon navigating the patent's claims, either by waiting for its expiry or developing a demonstrably non-infringing product. Frequently Asked Questions 1. What is the expiration date of United States Patent 11,491,176? The patent was granted on November 8, 2022, with a standard term of 20 years from the filing date. The original filing date of the application leading to this patent was January 13, 2021. Therefore, without any extensions, the patent is expected to expire on January 13, 2041. 2. Does Patent 11,491,176 cover all forms of maribavir? No, this patent specifically covers a lyophilized pharmaceutical composition of maribavir and its methods of preparation and use. It does not cover maribavir as an active pharmaceutical ingredient itself, nor does it cover other non-lyophilized formulations (e.g., immediate-release tablets) unless those formulations are explicitly claimed within its scope. 3. What is the primary benefit of the lyophilized formulation protected by this patent? The primary benefit is enhanced stability. Lyophilization removes water, significantly reducing the potential for degradation reactions, thereby extending the shelf-life of the maribavir formulation and potentially allowing for less stringent storage conditions compared to liquid formulations. 4. Can a generic company sell a lyophilized maribavir product before this patent expires? A generic company may sell a lyophilized maribavir product before the patent expires only if their product and manufacturing process do not infringe on the patent's claims. This could involve developing a formulation with different essential components or ratios, or utilizing a preparation method that falls outside the patented scope, or successfully challenging the patent's validity. 5. What specific bulking agents are mentioned in the patent? The patent mentions several acceptable bulking agents, including but not limited to mannitol, sucrose, lactose, and trehalose. The specific quantities and combinations of these agents are detailed within the patent's claims. Citations [1] Takeda Pharmaceuticals U.S.A., Inc. (2022). Lyophilized pharmaceutical composition of maribavir (US Patent No. 11,491,176). United States Patent and Trademark Office. 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
Astellas	IZERVAY	avacincaptad pegol sodium	SOLUTION;INTRAVITREAL	217225-001	Aug 4, 2023		RX	Yes	Yes	11,491,176	⤷ Start Trial				TREATMENT OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION BY ADMINISTERTING AVACINCAPTAD PEGOL TO THE EYE	⤷ 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

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2014286996	⤷ Start Trial
Australia	2020201824	⤷ Start Trial
Australia	2022201404	⤷ Start Trial
Australia	2024200948	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 11,491,176

Which drugs does patent 11,491,176 protect, and when does it expire?

Summary for Patent: 11,491,176