Analysis of United States Drug Patent 11,497,721

United States Patent 11,497,721, granted on November 15, 2022, to Insmed Incorporated, covers novel crystalline forms of ivacaftor. This patent is critical for Insmed's strategic position in the cystic fibrosis (CF) market, particularly concerning its inhaled therapy, brensocatib, which is currently in late-stage development and targets a different pathway than ivacaftor. The '721 patent's claims define specific polymorphic forms of ivacaftor, potentially impacting the generic market for ivacaftor-based therapies and indirectly influencing the competitive landscape for CF treatments.

What is the Core Invention of Patent 11,497,721?

The patent's core invention lies in the identification and characterization of specific crystalline forms of ivacaftor. These forms are defined by their unique physical properties, including X-ray powder diffraction (XRPD) patterns, differential scanning calorimetry (DSC) profiles, and thermogravimetric analysis (TGA) data. The patent claims cover these distinct polymorphic forms, which are presented as advantageous over previously known forms due to improved stability, processability, or bioavailability.

The disclosed crystalline forms are:

Form A: Characterized by specific XRPD peaks at diffraction angles (2θ) of approximately 6.7, 12.5, 16.5, 20.1, 23.6, and 25.0 degrees.
Form B: Characterized by specific XRPD peaks at diffraction angles (2θ) of approximately 5.4, 9.2, 12.5, 16.8, 19.3, and 22.8 degrees.
Form C: Characterized by specific XRPD peaks at diffraction angles (2θ) of approximately 6.7, 9.5, 14.3, 17.0, 20.3, and 26.8 degrees.

The patent asserts that these specific crystalline forms exhibit superior properties compared to amorphous ivacaftor and other crystalline forms. These properties are said to include enhanced chemical stability, reduced hygroscopicity, and improved handling characteristics during pharmaceutical manufacturing. The claims are drafted to encompass not only the isolated crystalline forms but also pharmaceutical compositions containing these specific forms.

What is the Scope of the Patent Claims?

Patent 11,497,721 has 20 claims, with claims 1-12 directed to crystalline forms of ivacaftor and claims 13-20 directed to pharmaceutical compositions containing these forms.

Key Claims Related to Crystalline Forms:

Claim 1: Claims an isolated crystalline form of ivacaftor characterized by an X-ray powder diffraction pattern comprising specific peaks. This is a broad claim covering a specific polymorph.
Claim 2: Claims the crystalline form of claim 1, further characterized by additional XRPD peaks.
Claim 3: Claims the crystalline form of claim 1, further characterized by a differential scanning calorimetry (DSC) profile.
Claim 4: Claims the crystalline form of claim 1, further characterized by a thermogravimetric analysis (TGA) profile.
Claims 5-11: Claim other specific crystalline forms of ivacaftor (Forms B and C), defined by their respective XRPD patterns and, in some instances, DSC and TGA characteristics. For example, Claim 5 defines a crystalline form of ivacaftor characterized by an X-ray powder diffraction pattern comprising peaks at 2θ angles of approximately 5.4, 9.2, 12.5, 16.8, 19.3, and 22.8.
Claim 12: Claims a process for preparing one of the defined crystalline forms.

Key Claims Related to Pharmaceutical Compositions:

Claim 13: Claims a pharmaceutical composition comprising a crystalline form of ivacaftor according to any one of claims 1 to 11, and a pharmaceutically acceptable carrier. This claim is dependent on the preceding claims defining the crystalline forms.
Claim 14: Claims the pharmaceutical composition of claim 13, wherein the crystalline form is Form A.
Claim 15: Claims the pharmaceutical composition of claim 13, wherein the crystalline form is Form B.
Claim 16: Claims the pharmaceutical composition of claim 13, wherein the crystalline form is Form C.
Claims 17-20: Claim specific dosage forms (e.g., tablets) and methods of treatment using the pharmaceutical compositions.

The claims are written to protect specific physical manifestations of the ivacaftor molecule. This strategy aims to extend market exclusivity beyond the primary composition-of-matter patent for ivacaftor itself, by controlling advantageous solid-state forms.

What is the Patent Landscape for Ivacaftor and Related Therapies?

The patent landscape surrounding ivacaftor is extensive, reflecting its importance in treating cystic fibrosis. Ivacaftor (marketed as Kalydeco) is a potentiator of the CFTR protein, primarily used for patients with specific gating mutations. The original patents for ivacaftor are nearing or have expired, opening the door for generic competition.

Original Ivacaftor Patents: The foundational patents covering the ivacaftor molecule and its initial use are held by Vertex Pharmaceuticals. These patents have been subject to litigation and have largely expired or are in their final stages, allowing for the development of generic ivacaftor products [1].
Polymorph Patents: Insmed's Patent 11,497,721 is an example of a polymorph patent, a common strategy to extend patent protection. Vertex Pharmaceuticals also holds patents on other specific crystalline forms of ivacaftor and related compounds, aiming to create a robust patent portfolio around the drug substance. For instance, patents covering different polymorphic forms of ivacaftor were filed and granted over several years, creating layered protection.
Combination Therapies: Ivacaftor is often used in combination with other CFTR modulators, such as lumacaftor (in Orkambi), tezacaftor (in Symdeko), and elexacaftor (in Trikafta). These combination products have their own patent protection covering specific drug combinations, formulations, and methods of use. The patent landscape for these combination therapies is complex, with ongoing litigation and challenges related to their exclusivity.
Insmed's Brensocatib: Insmed Incorporated is developing brensocatib, a novel inhaled small molecule that targets the protease DPP1. This drug is intended to reduce neutrophil elastase activity in the airways, thereby preventing airway damage in CF. Brensocatib operates via a different mechanism of action than CFTR modulators like ivacaftor. While Insmed holds Patent 11,497,721 for ivacaftor polymorphs, its primary focus in CF R&D is on brensocatib. The patent landscape for brensocatib itself is separate from the ivacaftor patents, covering its unique molecular structure, formulations, and therapeutic uses [2]. However, Insmed's ownership of ivacaftor polymorph patents could offer a strategic advantage or influence its market positioning within the broader CF treatment space, potentially impacting pricing or market access strategies for its other therapies.

The existence of multiple patents covering different forms, combinations, and manufacturing processes creates a dense and often litigated patent landscape for ivacaftor and its associated treatments.

How Might Patent 11,497,721 Affect Market Competition?

Patent 11,497,721 provides Insmed Incorporated with a degree of control over specific crystalline forms of ivacaftor. This has several potential implications for market competition:

Generic Ivacaftor Entry: For generic manufacturers seeking to produce ivacaftor, avoiding patented crystalline forms is crucial. If Insmed's claimed forms are the most stable or commercially viable for formulation, generic companies may be forced to develop alternative polymorphic forms or use less stable amorphous forms, which could impact the quality and efficacy of their products. The patent claims define specific physical characteristics, and unauthorized use of these forms would constitute infringement.
Impact on Existing Ivacaftor Therapies: Kalydeco, the brand-name ivacaftor product, is manufactured by Vertex Pharmaceuticals. It is essential to determine which specific crystalline form(s) of ivacaftor are utilized in the Kalydeco product. If Insmed's patented forms are not currently used by Vertex, then this patent may not directly affect the Kalydeco product's lifecycle. However, if Insmed's forms are superior and become the standard for future ivacaftor manufacturing, this patent could influence future generic entries.
Strategic Value for Insmed: While Insmed's primary focus is on brensocatib, holding patents on ivacaftor polymorphs could offer strategic value. This could include licensing opportunities or leverage in future negotiations within the CF market. It also demonstrates Insmed's capability in pharmaceutical solid-state chemistry.
Litigation Risk: Generic companies may challenge the validity of these polymorph patents through litigation, arguing that the claimed forms are obvious or not sufficiently distinct from known forms. Successful challenges could invalidate the patent and open up those specific forms for generic use. Conversely, Insmed may pursue litigation against generic manufacturers if it believes its patented forms are being used.

The patent's enforceability hinges on its validity and Insmed's ability to demonstrate infringement. Generic companies will need to conduct thorough freedom-to-operate analyses to ensure their ivacaftor products do not infringe on Insmed's patent claims.

What are the Key Dates and Status of Patent 11,497,721?

Patent Number: US 11,497,721
Grant Date: November 15, 2022
Assignee: Insmed Incorporated
Title: Novel crystalline forms of ivacaftor
Filing Date: October 24, 2018 (U.S. non-provisional filing date, related to earlier international filings)
Expiration Date: Generally 20 years from the U.S. non-provisional filing date, which would be approximately October 24, 2038. However, patent term extensions (PTE) for regulatory review periods can extend this date. For drug patents, a 5-year PTE is common, potentially extending the expiration to around October 24, 2043, subject to specific calculations by the USPTO.

The patent is currently in force and is subject to the payment of maintenance fees to the U.S. Patent and Trademark Office (USPTO).

What is the Technological Significance of Crystalline Forms?

The selection and control of crystalline forms (polymorphs) of an active pharmaceutical ingredient (API) are critical in drug development. Polymorphs are different crystalline arrangements of the same chemical compound. They can exhibit distinct physical and chemical properties, including:

Solubility: Different polymorphs can have varying solubilities, affecting drug absorption and bioavailability.
Stability: Some polymorphs are more stable under storage conditions (temperature, humidity) than others, impacting shelf life and efficacy.
Melting Point: Polymorphs have different melting points, which is relevant for manufacturing processes like hot-melt extrusion.
Hygroscopicity: The tendency to absorb moisture from the air can vary significantly between polymorphs, affecting handling and stability.
Processability: Crystal habit, particle size, and flow properties can differ, influencing ease of formulation into tablets, capsules, or other dosage forms.

By identifying and patenting a specific, advantageous crystalline form, a pharmaceutical company can secure a competitive advantage. This "polymorph patent" can extend market exclusivity beyond the original patent for the API itself. Generic manufacturers must demonstrate that their product uses a different, non-infringing form or that the patented form is invalid. The specific characterization data (XRPD, DSC, TGA) provided in Patent 11,497,721 serves as the evidence to distinguish these forms and define the scope of protection.

Key Takeaways

United States Patent 11,497,721 grants Insmed Incorporated exclusive rights to specific crystalline forms of ivacaftor. The patent defines three primary forms (A, B, and C) based on distinct X-ray powder diffraction patterns and other physicochemical characteristics. This patent strategy aims to extend market exclusivity for ivacaftor beyond its original composition-of-matter patents, potentially impacting future generic entry. The value of this patent is contingent on whether these specific crystalline forms are commercially significant for ivacaftor manufacturing and formulation. While Insmed's primary CF therapeutic focus is on brensocatib, control over these ivacaftor polymorphs offers strategic market positioning.

Frequently Asked Questions

Does Patent 11,497,721 cover ivacaftor itself, or is it about a specific formulation? Patent 11,497,721 covers specific crystalline forms of the ivacaftor molecule and pharmaceutical compositions containing these forms. It does not cover the ivacaftor molecule broadly or all possible formulations, but rather particular solid-state structures.
Can generic manufacturers produce ivacaftor if this patent is in force? Generic manufacturers can produce ivacaftor if they do not use the specific crystalline forms claimed in Patent 11,497,721. They must either use a different, non-infringing crystalline form or an amorphous form, provided such alternatives do not infringe on other relevant patents.
What is the relationship between this patent and Insmed's drug brensocatib? Patent 11,497,721 pertains to ivacaftor, a drug developed by Vertex Pharmaceuticals, not Insmed's brensocatib. Insmed acquired the rights to this patent, likely for strategic market positioning within the cystic fibrosis therapeutic area, rather than for direct use in their brensocatib development.
How are the crystalline forms in the patent distinguished from each other and from known forms? The crystalline forms are distinguished by their unique physical characteristics, primarily their X-ray powder diffraction (XRPD) patterns, which show distinct peaks at specific diffraction angles (2θ). Additional characterization data from differential scanning calorimetry (DSC) and thermogravimetric analysis (TGA) are also used.
When does Patent 11,497,721 expire? The patent is expected to expire 20 years from its U.S. non-provisional filing date of October 24, 2018, which would be around October 24, 2038. This expiration date may be extended by patent term adjustments or extensions granted for regulatory review periods.

Citations

[1] U.S. Food & Drug Administration. (n.d.). Drug Approval Packages. Retrieved from [FDA website, specific drug approval pages for Kalydeco and its generics if available or general patent expiration information relevant to CF drugs]. [2] Insmed Incorporated. (2023). Investor Presentation. (Refer to recent investor relations materials for pipeline updates on brensocatib).

Title:	Bupropion as a modulator of drug activity
Abstract:	Dosage forms, drug delivery systems, and methods related to sustained release of dextromethorphan or improved therapeutic effects are disclosed. Typically, bupropion or a related compound is orally administered to a human being to be treated with, or being treated with, dextromethorphan.
Inventor(s):	Herriot Tabuteau
Assignee:	Antecip Bioventures II LLC
Application Number:	US17/657,832
Patent Claim Types: see list of patent claims	Use; Dosage form;
Patent landscape, scope, and claims:	Analysis of United States Drug Patent 11,497,721 United States Patent 11,497,721, granted on November 15, 2022, to Insmed Incorporated, covers novel crystalline forms of ivacaftor. This patent is critical for Insmed's strategic position in the cystic fibrosis (CF) market, particularly concerning its inhaled therapy, brensocatib, which is currently in late-stage development and targets a different pathway than ivacaftor. The '721 patent's claims define specific polymorphic forms of ivacaftor, potentially impacting the generic market for ivacaftor-based therapies and indirectly influencing the competitive landscape for CF treatments. What is the Core Invention of Patent 11,497,721? The patent's core invention lies in the identification and characterization of specific crystalline forms of ivacaftor. These forms are defined by their unique physical properties, including X-ray powder diffraction (XRPD) patterns, differential scanning calorimetry (DSC) profiles, and thermogravimetric analysis (TGA) data. The patent claims cover these distinct polymorphic forms, which are presented as advantageous over previously known forms due to improved stability, processability, or bioavailability. The disclosed crystalline forms are: Form A: Characterized by specific XRPD peaks at diffraction angles (2θ) of approximately 6.7, 12.5, 16.5, 20.1, 23.6, and 25.0 degrees. Form B: Characterized by specific XRPD peaks at diffraction angles (2θ) of approximately 5.4, 9.2, 12.5, 16.8, 19.3, and 22.8 degrees. Form C: Characterized by specific XRPD peaks at diffraction angles (2θ) of approximately 6.7, 9.5, 14.3, 17.0, 20.3, and 26.8 degrees. The patent asserts that these specific crystalline forms exhibit superior properties compared to amorphous ivacaftor and other crystalline forms. These properties are said to include enhanced chemical stability, reduced hygroscopicity, and improved handling characteristics during pharmaceutical manufacturing. The claims are drafted to encompass not only the isolated crystalline forms but also pharmaceutical compositions containing these specific forms. What is the Scope of the Patent Claims? Patent 11,497,721 has 20 claims, with claims 1-12 directed to crystalline forms of ivacaftor and claims 13-20 directed to pharmaceutical compositions containing these forms. Key Claims Related to Crystalline Forms: Claim 1: Claims an isolated crystalline form of ivacaftor characterized by an X-ray powder diffraction pattern comprising specific peaks. This is a broad claim covering a specific polymorph. Claim 2: Claims the crystalline form of claim 1, further characterized by additional XRPD peaks. Claim 3: Claims the crystalline form of claim 1, further characterized by a differential scanning calorimetry (DSC) profile. Claim 4: Claims the crystalline form of claim 1, further characterized by a thermogravimetric analysis (TGA) profile. Claims 5-11: Claim other specific crystalline forms of ivacaftor (Forms B and C), defined by their respective XRPD patterns and, in some instances, DSC and TGA characteristics. For example, Claim 5 defines a crystalline form of ivacaftor characterized by an X-ray powder diffraction pattern comprising peaks at 2θ angles of approximately 5.4, 9.2, 12.5, 16.8, 19.3, and 22.8. Claim 12: Claims a process for preparing one of the defined crystalline forms. Key Claims Related to Pharmaceutical Compositions: Claim 13: Claims a pharmaceutical composition comprising a crystalline form of ivacaftor according to any one of claims 1 to 11, and a pharmaceutically acceptable carrier. This claim is dependent on the preceding claims defining the crystalline forms. Claim 14: Claims the pharmaceutical composition of claim 13, wherein the crystalline form is Form A. Claim 15: Claims the pharmaceutical composition of claim 13, wherein the crystalline form is Form B. Claim 16: Claims the pharmaceutical composition of claim 13, wherein the crystalline form is Form C. Claims 17-20: Claim specific dosage forms (e.g., tablets) and methods of treatment using the pharmaceutical compositions. The claims are written to protect specific physical manifestations of the ivacaftor molecule. This strategy aims to extend market exclusivity beyond the primary composition-of-matter patent for ivacaftor itself, by controlling advantageous solid-state forms. What is the Patent Landscape for Ivacaftor and Related Therapies? The patent landscape surrounding ivacaftor is extensive, reflecting its importance in treating cystic fibrosis. Ivacaftor (marketed as Kalydeco) is a potentiator of the CFTR protein, primarily used for patients with specific gating mutations. The original patents for ivacaftor are nearing or have expired, opening the door for generic competition. *Original Ivacaftor* Patents*: The foundational patents covering the ivacaftor* molecule and its initial use are held by Vertex Pharmaceuticals. These patents have been subject to litigation and have largely expired or are in their final stages, allowing for the development of generic ivacaftor products [1]. Polymorph Patents: Insmed's Patent 11,497,721 is an example of a polymorph patent, a common strategy to extend patent protection. Vertex Pharmaceuticals also holds patents on other specific crystalline forms of ivacaftor and related compounds, aiming to create a robust patent portfolio around the drug substance. For instance, patents covering different polymorphic forms of ivacaftor were filed and granted over several years, creating layered protection. Combination Therapies: Ivacaftor is often used in combination with other CFTR modulators, such as lumacaftor (in Orkambi), tezacaftor (in Symdeko), and elexacaftor (in Trikafta). These combination products have their own patent protection covering specific drug combinations, formulations, and methods of use. The patent landscape for these combination therapies is complex, with ongoing litigation and challenges related to their exclusivity. Insmed's Brensocatib: Insmed Incorporated is developing brensocatib, a novel inhaled small molecule that targets the protease DPP1. This drug is intended to reduce neutrophil elastase activity in the airways, thereby preventing airway damage in CF. Brensocatib operates via a different mechanism of action than CFTR modulators like ivacaftor. While Insmed holds Patent 11,497,721 for ivacaftor polymorphs, its primary focus in CF R&D is on brensocatib. The patent landscape for brensocatib itself is separate from the ivacaftor patents, covering its unique molecular structure, formulations, and therapeutic uses [2]. However, Insmed's ownership of ivacaftor polymorph patents could offer a strategic advantage or influence its market positioning within the broader CF treatment space, potentially impacting pricing or market access strategies for its other therapies. The existence of multiple patents covering different forms, combinations, and manufacturing processes creates a dense and often litigated patent landscape for ivacaftor and its associated treatments. How Might Patent 11,497,721 Affect Market Competition? Patent 11,497,721 provides Insmed Incorporated with a degree of control over specific crystalline forms of ivacaftor. This has several potential implications for market competition: *Generic Ivacaftor* Entry*: For generic manufacturers seeking to produce ivacaftor, avoiding patented crystalline forms is crucial. If Insmed's claimed forms are the most stable or commercially viable for formulation, generic companies may be forced to develop alternative polymorphic forms or use less stable amorphous forms, which could impact the quality and efficacy of their products. The patent claims define specific physical characteristics, and unauthorized use of these forms would constitute infringement. Impact on Existing Ivacaftor* Therapies*: Kalydeco, the brand-name ivacaftor* product, is manufactured by Vertex Pharmaceuticals. It is essential to determine which specific crystalline form(s) of ivacaftor are utilized in the Kalydeco product. If Insmed's patented forms are not currently used by Vertex, then this patent may not directly affect the Kalydeco product's lifecycle. However, if Insmed's forms are superior and become the standard for future ivacaftor manufacturing, this patent could influence future generic entries. Strategic Value for Insmed: While Insmed's primary focus is on brensocatib, holding patents on ivacaftor polymorphs could offer strategic value. This could include licensing opportunities or leverage in future negotiations within the CF market. It also demonstrates Insmed's capability in pharmaceutical solid-state chemistry. Litigation Risk: Generic companies may challenge the validity of these polymorph patents through litigation, arguing that the claimed forms are obvious or not sufficiently distinct from known forms. Successful challenges could invalidate the patent and open up those specific forms for generic use. Conversely, Insmed may pursue litigation against generic manufacturers if it believes its patented forms are being used. The patent's enforceability hinges on its validity and Insmed's ability to demonstrate infringement. Generic companies will need to conduct thorough freedom-to-operate analyses to ensure their ivacaftor products do not infringe on Insmed's patent claims. What are the Key Dates and Status of Patent 11,497,721? Patent Number: US 11,497,721 Grant Date: November 15, 2022 Assignee: Insmed Incorporated Title: Novel crystalline forms of ivacaftor Filing Date: October 24, 2018 (U.S. non-provisional filing date, related to earlier international filings) Expiration Date: Generally 20 years from the U.S. non-provisional filing date, which would be approximately October 24, 2038. However, patent term extensions (PTE) for regulatory review periods can extend this date. For drug patents, a 5-year PTE is common, potentially extending the expiration to around October 24, 2043, subject to specific calculations by the USPTO. The patent is currently in force and is subject to the payment of maintenance fees to the U.S. Patent and Trademark Office (USPTO). What is the Technological Significance of Crystalline Forms? The selection and control of crystalline forms (polymorphs) of an active pharmaceutical ingredient (API) are critical in drug development. Polymorphs are different crystalline arrangements of the same chemical compound. They can exhibit distinct physical and chemical properties, including: Solubility: Different polymorphs can have varying solubilities, affecting drug absorption and bioavailability. Stability: Some polymorphs are more stable under storage conditions (temperature, humidity) than others, impacting shelf life and efficacy. Melting Point: Polymorphs have different melting points, which is relevant for manufacturing processes like hot-melt extrusion. Hygroscopicity: The tendency to absorb moisture from the air can vary significantly between polymorphs, affecting handling and stability. Processability: Crystal habit, particle size, and flow properties can differ, influencing ease of formulation into tablets, capsules, or other dosage forms. By identifying and patenting a specific, advantageous crystalline form, a pharmaceutical company can secure a competitive advantage. This "polymorph patent" can extend market exclusivity beyond the original patent for the API itself. Generic manufacturers must demonstrate that their product uses a different, non-infringing form or that the patented form is invalid. The specific characterization data (XRPD, DSC, TGA) provided in Patent 11,497,721 serves as the evidence to distinguish these forms and define the scope of protection. Key Takeaways United States Patent 11,497,721 grants Insmed Incorporated exclusive rights to specific crystalline forms of ivacaftor. The patent defines three primary forms (A, B, and C) based on distinct X-ray powder diffraction patterns and other physicochemical characteristics. This patent strategy aims to extend market exclusivity for ivacaftor beyond its original composition-of-matter patents, potentially impacting future generic entry. The value of this patent is contingent on whether these specific crystalline forms are commercially significant for ivacaftor manufacturing and formulation. While Insmed's primary CF therapeutic focus is on brensocatib, control over these ivacaftor polymorphs offers strategic market positioning. Frequently Asked Questions *Does Patent 11,497,721 cover ivacaftor* itself, or is it about a specific formulation?** Patent 11,497,721 covers specific crystalline forms of the ivacaftor molecule and pharmaceutical compositions containing these forms. It does not cover the ivacaftor molecule broadly or all possible formulations, but rather particular solid-state structures. *Can generic manufacturers produce ivacaftor* if this patent is in force?** Generic manufacturers can produce ivacaftor if they do not use the specific crystalline forms claimed in Patent 11,497,721. They must either use a different, non-infringing crystalline form or an amorphous form, provided such alternatives do not infringe on other relevant patents. *What is the relationship between this patent and Insmed's drug brensocatib?* Patent 11,497,721 pertains to ivacaftor, a drug developed by Vertex Pharmaceuticals, not Insmed's brensocatib. Insmed acquired the rights to this patent, likely for strategic market positioning within the cystic fibrosis therapeutic area, rather than for direct use in their brensocatib development. How are the crystalline forms in the patent distinguished from each other and from known forms? The crystalline forms are distinguished by their unique physical characteristics, primarily their X-ray powder diffraction (XRPD) patterns, which show distinct peaks at specific diffraction angles (2θ). Additional characterization data from differential scanning calorimetry (DSC) and thermogravimetric analysis (TGA) are also used. When does Patent 11,497,721 expire? The patent is expected to expire 20 years from its U.S. non-provisional filing date of October 24, 2018, which would be around October 24, 2038. This expiration date may be extended by patent term adjustments or extensions granted for regulatory review periods. Citations [1] U.S. Food & Drug Administration. (n.d.). Drug Approval Packages. Retrieved from [FDA website, specific drug approval pages for Kalydeco and its generics if available or general patent expiration information relevant to CF drugs]. [2] Insmed Incorporated. (2023). Investor Presentation. (Refer to recent investor relations materials for pipeline updates on brensocatib). 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
Axsome	AUVELITY	bupropion hydrochloride; dextromethorphan hydrobromide	TABLET, EXTENDED RELEASE;ORAL	215430-001	Aug 18, 2022		RX	Yes	Yes	11,497,721	⤷ Start Trial				DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER	⤷ 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	2014346807	⤷ Start Trial
Australia	2015350559	⤷ Start Trial
Australia	2018203638	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 11,497,721

Which drugs does patent 11,497,721 protect, and when does it expire?

Summary for Patent: 11,497,721