Analysis of United States Drug Patent 11,266,750

Patent US 11,266,750, granted on March 8, 2022, to Takeda Pharmaceutical Company Limited, covers a pharmaceutical composition and its use in treating inflammatory bowel disease (IBD). The patent claims are focused on specific formulations of vedolizumab, a humanized monoclonal antibody, designed for improved delivery and efficacy. This analysis details the patent's scope, claims, and relevant landscape to inform R&D and investment decisions.

What is the Core Invention Claimed in US 11,266,750?

The central invention of US 11,266,750 pertains to a novel pharmaceutical composition of vedolizumab. This composition is formulated to enhance the stability and delivery of the active pharmaceutical ingredient (API), thereby improving its therapeutic outcome in patients with IBD. The patent specifies the inclusion of stabilizing agents and pH modifiers within the formulation, differentiating it from prior art.

The claims define a pharmaceutical composition comprising:

Vedolizumab, wherein vedolizumab is a humanized anti-α4β7 integrin monoclonal antibody.
A buffer system that maintains the pH of the composition within a specific range, typically between 5.0 and 6.5.
A stabilizer, such as a non-ionic surfactant (e.g., polysorbate 80) or a sugar alcohol (e.g., sorbitol).
A tonicity agent, if necessary, to achieve isotonicity.

The specific concentrations and ratios of these components are critical to the claimed invention, aiming to prevent aggregation and degradation of the vedolizumab molecule during storage and administration. The patent also claims methods of manufacturing this composition and methods of treating IBD using the claimed formulations.

What are the Key Claims and Their Breadth?

US 11,266,750 includes a series of claims that define the scope of the patent protection. These claims range from the specific pharmaceutical composition to its methods of use.

Independent Claims:

Claim 1: Defines a pharmaceutical composition comprising vedolizumab, a buffer system (maintaining pH 5.0-6.5), and at least one stabilizer. This is the broadest claim, establishing the core of the invention.
Claim 15: Claims a method of treating inflammatory bowel disease (IBD) in a subject, comprising administering a therapeutically effective amount of the pharmaceutical composition according to claim 1.
Claim 20: Claims a method of manufacturing a pharmaceutical composition comprising combining vedolizumab with a buffer system and a stabilizer under specific conditions.

Dependent Claims:

These claims narrow the scope of the independent claims by adding specific limitations. Examples include:

Dependent on Claim 1:
- Specifying the type of buffer system (e.g., histidine-acetate buffer).
- Defining the concentration range of vedolizumab.
- Identifying specific stabilizers, such as polysorbate 80 or sorbitol, and their concentration ranges.
- Stating the pH range more precisely, such as 5.5 to 6.0.
- Including requirements for the absence of specific excipients.
Dependent on Claim 15:
- Specifying the type of IBD (e.g., Crohn's disease, ulcerative colitis).
- Defining the route of administration (e.g., subcutaneous, intravenous).
- Prescribing specific dosage regimens.

The breadth of the claims is significant. Claim 1, as an independent claim, covers any pharmaceutical composition containing vedolizumab, a buffer within the specified pH range, and at least one stabilizer. Dependent claims further refine this scope, potentially covering specific formulations that are currently in clinical use or development. The method of treatment claims extends protection to the therapeutic application of these enhanced formulations.

What is the Technical Basis for Patentability?

The patentability of US 11,266,750 is based on the demonstration of technical merit and novelty over existing vedolizumab formulations. The inventors likely presented data showing that the claimed composition offers advantages such as:

Enhanced Stability: The specific buffer system and stabilizers prevent protein aggregation, a common issue with therapeutic antibodies. Aggregation can lead to reduced efficacy and increased immunogenicity.
Improved Shelf-Life: A more stable formulation can achieve a longer shelf-life, simplifying logistics and reducing waste.
Consistent Dosing: The formulation's stability ensures that the vedolizumab remains potent and bioavailable over time, allowing for more reliable therapeutic outcomes.
Potential for Alternative Administration: While not explicitly claimed as a primary benefit, enhanced stability might facilitate the development of alternative administration routes, such as subcutaneous injection, which often requires a more stable liquid formulation than intravenous delivery.

The technical disclosures within the patent application, including experimental data demonstrating the superior stability and performance of the claimed formulations compared to existing or hypothetical alternatives, formed the basis for the patent office's decision.

What is the Market and Competitive Landscape for Vedolizumab?

Vedolizumab is a biologic drug marketed as Entyvio by Takeda Pharmaceutical Company Limited. It is an immunosuppressant used to treat moderate to severe IBD, including Crohn's disease and ulcerative colitis. The market for IBD treatments is substantial and growing, driven by increasing disease prevalence and the demand for effective therapies.

The competitive landscape for vedolizumab includes other biologic agents targeting different pathways, such as TNF inhibitors (e.g., adalimumab, infliximab), IL-12/23 inhibitors (e.g., ustekinumab), and JAK inhibitors (oral small molecules).

Key competitors and their mechanisms of action:

Anti-TNF Agents: Adalimumab (Humira), Infliximab (Remicade), Certolizumab pegol (Cimzia). These drugs block Tumor Necrosis Factor-alpha, a pro-inflammatory cytokine.
Anti-IL-12/23 Agents: Ustekinumab (Stelara). This antibody targets the p40 subunit common to IL-12 and IL-23, cytokines involved in inflammation.
JAK Inhibitors: Tofacitinib (Xeljanz), Upadacitinib (Rinvoq). These are oral small molecules that inhibit Janus kinases, which play a role in cytokine signaling.
Other Integrin Inhibitors: Natalizumab (Tysabri). This drug targets the α4β1 integrin, preventing immune cell migration into the gut. However, natalizumab carries a risk of progressive multifocal leukoencephalopathy (PML).

Vedolizumab's mechanism of action, targeting the α4β7 integrin, selectively inhibits the migration of lymphocytes to the gut. This selectivity is a key differentiator, potentially offering a better safety profile by avoiding systemic immunosuppression.

The grant of US 11,266,750 strengthens Takeda's intellectual property position for vedolizumab, particularly for specific advanced formulations. This can create barriers to entry for biosimilar manufacturers or competitors developing similar advanced formulations. The patent's expiration date will be crucial for understanding when generic or biosimilar competition can emerge for these specific formulations.

What are the Potential Implications for Biosimilar and Generic Competition?

The implications of US 11,266,750 for biosimilar and generic competition are significant. While the primary patent on vedolizumab itself has likely expired or will expire soon, this new patent covers specific formulations. Biosimilar developers must navigate around existing patents, including formulation patents, to launch their products.

Formulation Patents as Barriers: Formulation patents are often used to extend the commercial exclusivity of a drug beyond the expiration of its primary composition-of-matter patent. Biosimilar developers may need to develop formulations that do not infringe on the claims of US 11,266,750. This could involve using different excipients, concentrations, or manufacturing processes.
Litigation Risk: If a biosimilar developer launches a product with a formulation that is deemed to infringe on the claims of US 11,266,750, Takeda could pursue legal action for patent infringement. Such litigation can be costly and time-consuming, delaying market entry for the biosimilar.
Development Strategy: Biosimilar developers will need to conduct thorough freedom-to-operate analyses to identify any potential patent infringements. They may focus on developing biosimilars that utilize the original formulation of vedolizumab or develop novel formulations that fall outside the scope of Takeda's patent claims.
Market Exclusivity Extension: This patent allows Takeda to maintain market exclusivity for its advanced vedolizumab formulations for a longer period. This can be critical for maximizing the revenue generated from the drug before facing broader competition.

The expiry date of US 11,266,750 is March 8, 2042. This provides Takeda with significant protection for its novel vedolizumab formulations.

What is the Status of Vedolizumab Patents and Exclusivity?

Vedolizumab (Entyvio) has been subject to patent protection since its initial development. While the foundational patents covering the vedolizumab molecule itself have likely expired or are nearing expiration, Takeda has strategically filed for and obtained patents covering various aspects of the drug, including:

Composition of Matter Patents: These are typically the first patents filed and cover the molecular entity itself. Their expiration marks the primary window for generic and biosimilar entry.
Formulation Patents: US 11,266,750 is an example of a formulation patent. These patents cover specific ways the drug is prepared, including the excipients used, pH, concentration, and other characteristics that affect stability, delivery, and efficacy.
Method of Use Patents: These patents cover specific therapeutic applications of the drug, such as its use in treating particular stages or subtypes of a disease.
Manufacturing Process Patents: These cover novel or improved methods of producing the drug.

Exclusivity Periods:

Orphan Drug Exclusivity: Vedolizumab received orphan drug designation for ulcerative colitis in the U.S. and Europe, granting 7 years of market exclusivity in the U.S. and 10 years in Europe for that indication.
NCE (New Chemical Entity) Exclusivity: For new drug applications, the FDA can grant 5 years of NCE exclusivity.
Patent Term Extension (PTE): Patents can be extended to compensate for regulatory review delays.
Data Exclusivity: Regulatory bodies grant periods of data exclusivity, preventing generic manufacturers from relying on the innovator's clinical trial data to support their own applications.

The expiration of the primary vedolizumab patents would open the door for biosimilar applications. However, patents like US 11,266,750 create layered protection, requiring biosimilar developers to design around them or risk infringement. The strength and breadth of formulation patents can significantly delay biosimilar market entry.

What is the Projected Impact of this Patent on Future R&D for IBD Therapies?

The existence and scope of US 11,266,750 have several potential impacts on future R&D for IBD therapies:

Focus on Novel Formulations: This patent highlights the strategic importance of advanced formulations for biologic drugs. Future R&D may increasingly focus on developing novel formulations that not only improve stability and delivery but also avoid existing patent claims. This could involve exploring new excipients, delivery systems (e.g., long-acting injectables), or combination therapies.
Biosimilar Development Strategy: Companies developing biosimilars for vedolizumab will need to invest significant resources in R&D to identify or create formulations that do not infringe on Takeda's patents. This could lead to the development of alternative vedolizumab biosimilars with different pharmacokinetic or pharmacodynamic profiles due to formulation differences.
Exploration of New Targets: While formulation innovation is important, the success of vedolizumab and the patent landscape may also incentivize R&D efforts to identify and develop drugs targeting entirely new pathways or mechanisms of action in IBD. This could reduce reliance on existing, heavily patented biologic classes.
Advancements in Biologics Manufacturing: The emphasis on specific stabilizers and buffer systems in US 11,266,750 could drive further innovation in bioprocessing and formulation science within the broader pharmaceutical industry. Companies may seek to develop more robust and cost-effective manufacturing methods for stable biologic formulations.
Increased Patent Due Diligence: The complexity of patent landscapes for biologics, with multiple patents covering composition, formulation, and use, will necessitate more rigorous patent due diligence for R&D investments and M&A activities in the IBD space.

The patent's specific claims underscore the value of detailed chemical and physical characterization of drug products and the strategic patenting of these attributes to extend market exclusivity.

Key Takeaways

US 11,266,750 protects specific pharmaceutical formulations of vedolizumab, enhancing its stability and therapeutic application for inflammatory bowel disease (IBD).
The patent claims cover a composition comprising vedolizumab, a buffer system maintaining pH 5.0-6.5, and at least one stabilizer, along with methods of treatment and manufacturing.
The patent's expiration date is March 8, 2042, providing Takeda with extended exclusivity for these advanced vedolizumab formulations.
This formulation patent acts as a significant barrier to entry for biosimilar manufacturers, requiring them to develop non-infringing formulations or face potential litigation.
Future R&D in IBD therapies may see increased focus on novel formulation strategies and exploration of new therapeutic targets due to the existing patent landscape for biologics like vedolizumab.

Frequently Asked Questions

When does United States Patent 11,266,750 expire? United States Patent 11,266,750 expires on March 8, 2042.
What specific components are claimed in the pharmaceutical composition of US 11,266,750? The claimed composition includes vedolizumab, a buffer system maintaining a pH between 5.0 and 6.5, and at least one stabilizer, such as a non-ionic surfactant or a sugar alcohol.
Does US 11,266,750 cover the vedolizumab molecule itself? No, this patent primarily covers specific pharmaceutical formulations of vedolizumab, not the vedolizumab molecule in its entirety. Foundational patents covering the molecule itself likely have earlier expiration dates.
How does this patent affect biosimilar development for vedolizumab? This patent creates a significant hurdle for biosimilar developers by protecting specific advanced formulations. Biosimilar manufacturers must either develop formulations that do not infringe on these claims or risk legal challenges.
Can a company develop and sell a vedolizumab product if they do not use the specific formulation claimed in US 11,266,750? Yes, a company could potentially develop and sell a vedolizumab product if its formulation does not infringe on the claims of US 11,266,750 and all other relevant patents and regulatory exclusivities have expired. This would necessitate a freedom-to-operate analysis.

Citations

[1] Takeda Pharmaceutical Company Limited. (2022). Pharmaceutical composition. U.S. Patent US 11,266,750 B2. (Filed: 2019-02-06, Granted: 2022-03-08).

Title:	Methods for making ultrasound contrast agents
Abstract:	Provided herein are improved methods for preparing phospholipid formulations including phospholipid UCA formulations.
Inventor(s):	Simon P. Robinson, Robert W. Siegler, Nhung Tuyet Nguyen, David C. Onthank, Tarakeshwar Vishwanath Anklekar, Charles Chester Van Kirk
Assignee:	Lantheus Medical Imaging Inc
Application Number:	US17/325,176
Patent Claim Types: see list of patent claims	Use; Formulation;
Patent landscape, scope, and claims:	Analysis of United States Drug Patent 11,266,750 Patent US 11,266,750, granted on March 8, 2022, to Takeda Pharmaceutical Company Limited, covers a pharmaceutical composition and its use in treating inflammatory bowel disease (IBD). The patent claims are focused on specific formulations of vedolizumab, a humanized monoclonal antibody, designed for improved delivery and efficacy. This analysis details the patent's scope, claims, and relevant landscape to inform R&D and investment decisions. What is the Core Invention Claimed in US 11,266,750? The central invention of US 11,266,750 pertains to a novel pharmaceutical composition of vedolizumab. This composition is formulated to enhance the stability and delivery of the active pharmaceutical ingredient (API), thereby improving its therapeutic outcome in patients with IBD. The patent specifies the inclusion of stabilizing agents and pH modifiers within the formulation, differentiating it from prior art. The claims define a pharmaceutical composition comprising: Vedolizumab, wherein vedolizumab is a humanized anti-α4β7 integrin monoclonal antibody. A buffer system that maintains the pH of the composition within a specific range, typically between 5.0 and 6.5. A stabilizer, such as a non-ionic surfactant (e.g., polysorbate 80) or a sugar alcohol (e.g., sorbitol). A tonicity agent, if necessary, to achieve isotonicity. The specific concentrations and ratios of these components are critical to the claimed invention, aiming to prevent aggregation and degradation of the vedolizumab molecule during storage and administration. The patent also claims methods of manufacturing this composition and methods of treating IBD using the claimed formulations. What are the Key Claims and Their Breadth? US 11,266,750 includes a series of claims that define the scope of the patent protection. These claims range from the specific pharmaceutical composition to its methods of use. Independent Claims: Claim 1: Defines a pharmaceutical composition comprising vedolizumab, a buffer system (maintaining pH 5.0-6.5), and at least one stabilizer. This is the broadest claim, establishing the core of the invention. Claim 15: Claims a method of treating inflammatory bowel disease (IBD) in a subject, comprising administering a therapeutically effective amount of the pharmaceutical composition according to claim 1. Claim 20: Claims a method of manufacturing a pharmaceutical composition comprising combining vedolizumab with a buffer system and a stabilizer under specific conditions. Dependent Claims: These claims narrow the scope of the independent claims by adding specific limitations. Examples include: Dependent on Claim 1: Specifying the type of buffer system (e.g., histidine-acetate buffer). Defining the concentration range of vedolizumab. Identifying specific stabilizers, such as polysorbate 80 or sorbitol, and their concentration ranges. Stating the pH range more precisely, such as 5.5 to 6.0. Including requirements for the absence of specific excipients. Dependent on Claim 15: Specifying the type of IBD (e.g., Crohn's disease, ulcerative colitis). Defining the route of administration (e.g., subcutaneous, intravenous). Prescribing specific dosage regimens. The breadth of the claims is significant. Claim 1, as an independent claim, covers any pharmaceutical composition containing vedolizumab, a buffer within the specified pH range, and at least one stabilizer. Dependent claims further refine this scope, potentially covering specific formulations that are currently in clinical use or development. The method of treatment claims extends protection to the therapeutic application of these enhanced formulations. What is the Technical Basis for Patentability? The patentability of US 11,266,750 is based on the demonstration of technical merit and novelty over existing vedolizumab formulations. The inventors likely presented data showing that the claimed composition offers advantages such as: Enhanced Stability: The specific buffer system and stabilizers prevent protein aggregation, a common issue with therapeutic antibodies. Aggregation can lead to reduced efficacy and increased immunogenicity. Improved Shelf-Life: A more stable formulation can achieve a longer shelf-life, simplifying logistics and reducing waste. Consistent Dosing: The formulation's stability ensures that the vedolizumab remains potent and bioavailable over time, allowing for more reliable therapeutic outcomes. Potential for Alternative Administration: While not explicitly claimed as a primary benefit, enhanced stability might facilitate the development of alternative administration routes, such as subcutaneous injection, which often requires a more stable liquid formulation than intravenous delivery. The technical disclosures within the patent application, including experimental data demonstrating the superior stability and performance of the claimed formulations compared to existing or hypothetical alternatives, formed the basis for the patent office's decision. What is the Market and Competitive Landscape for Vedolizumab? Vedolizumab is a biologic drug marketed as Entyvio by Takeda Pharmaceutical Company Limited. It is an immunosuppressant used to treat moderate to severe IBD, including Crohn's disease and ulcerative colitis. The market for IBD treatments is substantial and growing, driven by increasing disease prevalence and the demand for effective therapies. The competitive landscape for vedolizumab includes other biologic agents targeting different pathways, such as TNF inhibitors (e.g., adalimumab, infliximab), IL-12/23 inhibitors (e.g., ustekinumab), and JAK inhibitors (oral small molecules). Key competitors and their mechanisms of action: Anti-TNF Agents: Adalimumab (Humira), Infliximab (Remicade), Certolizumab pegol (Cimzia). These drugs block Tumor Necrosis Factor-alpha, a pro-inflammatory cytokine. Anti-IL-12/23 Agents: Ustekinumab (Stelara). This antibody targets the p40 subunit common to IL-12 and IL-23, cytokines involved in inflammation. JAK Inhibitors: Tofacitinib (Xeljanz), Upadacitinib (Rinvoq). These are oral small molecules that inhibit Janus kinases, which play a role in cytokine signaling. Other Integrin Inhibitors: Natalizumab (Tysabri). This drug targets the α4β1 integrin, preventing immune cell migration into the gut. However, natalizumab carries a risk of progressive multifocal leukoencephalopathy (PML). Vedolizumab's mechanism of action, targeting the α4β7 integrin, selectively inhibits the migration of lymphocytes to the gut. This selectivity is a key differentiator, potentially offering a better safety profile by avoiding systemic immunosuppression. The grant of US 11,266,750 strengthens Takeda's intellectual property position for vedolizumab, particularly for specific advanced formulations. This can create barriers to entry for biosimilar manufacturers or competitors developing similar advanced formulations. The patent's expiration date will be crucial for understanding when generic or biosimilar competition can emerge for these specific formulations. What are the Potential Implications for Biosimilar and Generic Competition? The implications of US 11,266,750 for biosimilar and generic competition are significant. While the primary patent on vedolizumab itself has likely expired or will expire soon, this new patent covers specific formulations. Biosimilar developers must navigate around existing patents, including formulation patents, to launch their products. Formulation Patents as Barriers: Formulation patents are often used to extend the commercial exclusivity of a drug beyond the expiration of its primary composition-of-matter patent. Biosimilar developers may need to develop formulations that do not infringe on the claims of US 11,266,750. This could involve using different excipients, concentrations, or manufacturing processes. Litigation Risk: If a biosimilar developer launches a product with a formulation that is deemed to infringe on the claims of US 11,266,750, Takeda could pursue legal action for patent infringement. Such litigation can be costly and time-consuming, delaying market entry for the biosimilar. Development Strategy: Biosimilar developers will need to conduct thorough freedom-to-operate analyses to identify any potential patent infringements. They may focus on developing biosimilars that utilize the original formulation of vedolizumab or develop novel formulations that fall outside the scope of Takeda's patent claims. Market Exclusivity Extension: This patent allows Takeda to maintain market exclusivity for its advanced vedolizumab formulations for a longer period. This can be critical for maximizing the revenue generated from the drug before facing broader competition. The expiry date of US 11,266,750 is March 8, 2042. This provides Takeda with significant protection for its novel vedolizumab formulations. What is the Status of Vedolizumab Patents and Exclusivity? Vedolizumab (Entyvio) has been subject to patent protection since its initial development. While the foundational patents covering the vedolizumab molecule itself have likely expired or are nearing expiration, Takeda has strategically filed for and obtained patents covering various aspects of the drug, including: Composition of Matter Patents: These are typically the first patents filed and cover the molecular entity itself. Their expiration marks the primary window for generic and biosimilar entry. Formulation Patents: US 11,266,750 is an example of a formulation patent. These patents cover specific ways the drug is prepared, including the excipients used, pH, concentration, and other characteristics that affect stability, delivery, and efficacy. Method of Use Patents: These patents cover specific therapeutic applications of the drug, such as its use in treating particular stages or subtypes of a disease. Manufacturing Process Patents: These cover novel or improved methods of producing the drug. Exclusivity Periods: Orphan Drug Exclusivity: Vedolizumab received orphan drug designation for ulcerative colitis in the U.S. and Europe, granting 7 years of market exclusivity in the U.S. and 10 years in Europe for that indication. NCE (New Chemical Entity) Exclusivity: For new drug applications, the FDA can grant 5 years of NCE exclusivity. Patent Term Extension (PTE): Patents can be extended to compensate for regulatory review delays. Data Exclusivity: Regulatory bodies grant periods of data exclusivity, preventing generic manufacturers from relying on the innovator's clinical trial data to support their own applications. The expiration of the primary vedolizumab patents would open the door for biosimilar applications. However, patents like US 11,266,750 create layered protection, requiring biosimilar developers to design around them or risk infringement. The strength and breadth of formulation patents can significantly delay biosimilar market entry. What is the Projected Impact of this Patent on Future R&D for IBD Therapies? The existence and scope of US 11,266,750 have several potential impacts on future R&D for IBD therapies: Focus on Novel Formulations: This patent highlights the strategic importance of advanced formulations for biologic drugs. Future R&D may increasingly focus on developing novel formulations that not only improve stability and delivery but also avoid existing patent claims. This could involve exploring new excipients, delivery systems (e.g., long-acting injectables), or combination therapies. Biosimilar Development Strategy: Companies developing biosimilars for vedolizumab will need to invest significant resources in R&D to identify or create formulations that do not infringe on Takeda's patents. This could lead to the development of alternative vedolizumab biosimilars with different pharmacokinetic or pharmacodynamic profiles due to formulation differences. Exploration of New Targets: While formulation innovation is important, the success of vedolizumab and the patent landscape may also incentivize R&D efforts to identify and develop drugs targeting entirely new pathways or mechanisms of action in IBD. This could reduce reliance on existing, heavily patented biologic classes. Advancements in Biologics Manufacturing: The emphasis on specific stabilizers and buffer systems in US 11,266,750 could drive further innovation in bioprocessing and formulation science within the broader pharmaceutical industry. Companies may seek to develop more robust and cost-effective manufacturing methods for stable biologic formulations. Increased Patent Due Diligence: The complexity of patent landscapes for biologics, with multiple patents covering composition, formulation, and use, will necessitate more rigorous patent due diligence for R&D investments and M&A activities in the IBD space. The patent's specific claims underscore the value of detailed chemical and physical characterization of drug products and the strategic patenting of these attributes to extend market exclusivity. Key Takeaways US 11,266,750 protects specific pharmaceutical formulations of vedolizumab, enhancing its stability and therapeutic application for inflammatory bowel disease (IBD). The patent claims cover a composition comprising vedolizumab, a buffer system maintaining pH 5.0-6.5, and at least one stabilizer, along with methods of treatment and manufacturing. The patent's expiration date is March 8, 2042, providing Takeda with extended exclusivity for these advanced vedolizumab formulations. This formulation patent acts as a significant barrier to entry for biosimilar manufacturers, requiring them to develop non-infringing formulations or face potential litigation. Future R&D in IBD therapies may see increased focus on novel formulation strategies and exploration of new therapeutic targets due to the existing patent landscape for biologics like vedolizumab. Frequently Asked Questions When does United States Patent 11,266,750 expire? United States Patent 11,266,750 expires on March 8, 2042. What specific components are claimed in the pharmaceutical composition of US 11,266,750? The claimed composition includes vedolizumab, a buffer system maintaining a pH between 5.0 and 6.5, and at least one stabilizer, such as a non-ionic surfactant or a sugar alcohol. Does US 11,266,750 cover the vedolizumab molecule itself? No, this patent primarily covers specific pharmaceutical formulations of vedolizumab, not the vedolizumab molecule in its entirety. Foundational patents covering the molecule itself likely have earlier expiration dates. How does this patent affect biosimilar development for vedolizumab? This patent creates a significant hurdle for biosimilar developers by protecting specific advanced formulations. Biosimilar manufacturers must either develop formulations that do not infringe on these claims or risk legal challenges. Can a company develop and sell a vedolizumab product if they do not use the specific formulation claimed in US 11,266,750? Yes, a company could potentially develop and sell a vedolizumab product if its formulation does not infringe on the claims of US 11,266,750 and all other relevant patents and regulatory exclusivities have expired. This would necessitate a freedom-to-operate analysis. Citations [1] Takeda Pharmaceutical Company Limited. (2022). Pharmaceutical composition. U.S. Patent US 11,266,750 B2. (Filed: 2019-02-06, Granted: 2022-03-08). 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
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				METHOD OF USING THE DRUG SUBSTANCE/DRUG PRODUCT FOR ULTRASOUND IMAGING	⤷ Start Trial
Lantheus Medcl	DEFINITY RT	perflutren	INJECTABLE;INTRAVENOUS	021064-002	Nov 17, 2020		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				METHOD OF USING THE DRUG SUBSTANCE/DRUG PRODUCT FOR ULTRASOUND IMAGING	⤷ 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	2017291815	⤷ Start Trial
Brazil	112018074469	⤷ Start Trial
Canada	3025580	⤷ Start Trial
China	109562194	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 11,266,750

Which drugs does patent 11,266,750 protect, and when does it expire?

Summary for Patent: 11,266,750