United States Patent 10,806,710: Scope, Claims, and Landscape Analysis

What is the Core Invention of Patent 10,806,710?

United States Patent 10,806,710, titled "METHODS AND COMPOSITIONS FOR TREATING OR PREVENTING DISEASES," claims methods and compositions for treating or preventing diseases using a specific pharmaceutical agent. The patent primarily focuses on the therapeutic applications of a compound, identified as GLPG0454, and its use in treating inflammatory bowel diseases (IBD), including Crohn's disease and ulcerative colitis [1]. The invention describes methods of administering GLPG0454 to a subject to achieve a therapeutic effect, along with pharmaceutical compositions containing GLPG0454.

What are the Key Claims of Patent 10,806,710?

The patent contains a series of claims that define the protected invention. These claims are crucial for understanding the patent's scope and enforceability.

Claim 1 describes a method for treating inflammatory bowel disease. This method involves administering to a subject an effective amount of a compound defined by its chemical structure or as "GLPG0454." The disease treated is specifically identified as inflammatory bowel disease, encompassing Crohn's disease and ulcerative colitis. The claim specifies the dosage and frequency of administration, detailing a dose of about 10 mg to about 200 mg, administered once a day or once every other day [1].
Claim 17 pertains to a pharmaceutical composition. This composition comprises GLPG0454 and a pharmaceutically acceptable carrier. The claim further specifies that GLPG0454 is in a specific crystalline form, designated as Form I, with defined X-ray powder diffraction (XRPD) peaks [1]. This specific polymorphic form is a critical aspect of the claim, potentially impacting the manufacturing and bioavailability of the drug.
Claim 20 reiterates the method of Claim 1 but specifies the administration of GLPG0454 in the crystalline Form I [1]. This links the therapeutic method directly to the specific solid-state form of the active pharmaceutical ingredient.
Claim 21 further refines the method by specifying the inflammatory bowel disease as Crohn's disease [1]. This narrows the scope of the therapeutic application.
Claim 22 narrows the method to ulcerative colitis as the treated inflammatory bowel disease [1].

The patent also includes claims related to specific dosage ranges and administration schedules, as well as the inclusion of specific excipients within the pharmaceutical composition. The emphasis on crystalline Form I of GLPG0454 is a key differentiator, suggesting that this particular solid-state form may offer advantages in terms of stability, manufacturability, or therapeutic efficacy.

What is the Pharmaceutical Agent Central to Patent 10,806,710?

The central pharmaceutical agent in Patent 10,806,710 is GLPG0454. This compound is an investigational drug developed by Galapagos NV. GLPG0454 is a selective sphingosine-1-phosphate receptor 1 (S1P1) receptor modulator. S1P1 modulators are a class of drugs that can be used to treat inflammatory and autoimmune diseases by affecting lymphocyte trafficking. By modulating S1P1 receptors, these drugs can trap lymphocytes in lymph nodes, thereby reducing their migration to inflamed tissues [2]. This mechanism of action is directly relevant to treating inflammatory bowel diseases like Crohn's disease and ulcerative colitis, where immune cell infiltration plays a significant role in pathogenesis.

What is the Target Indication for GLPG0454 as Described in the Patent?

The primary target indication for GLPG0454 as described in Patent 10,806,710 is inflammatory bowel disease (IBD). This encompasses both Crohn's disease and ulcerative colitis [1]. IBD is a chronic inflammatory condition of the gastrointestinal tract, characterized by periods of active disease and remission. The patent details methods for treating these conditions using GLPG0454, suggesting the compound's potential to reduce inflammation and alleviate symptoms associated with IBD.

What are the Specific Dosages and Administration Regimens Claimed?

The patent outlines specific dosage and administration parameters for GLPG0454.

Dosage Range: The claimed dosage range for GLPG0454 is about 10 mg to about 200 mg [1]. This range provides flexibility in treatment regimens.
Administration Frequency: The methods claim administration once a day or once every other day [1]. This bimodal frequency suggests the compound may have a sufficiently long half-life to allow for less frequent dosing.

These specific parameters are crucial for defining the scope of protection and for guiding potential generic manufacturers in designing non-infringing products.

What is the Significance of Crystalline Form I of GLPG0454 in the Patent?

The patent's focus on crystalline Form I of GLPG0454 is significant for several reasons. Polymorphism, the ability of a solid material to exist in more than one crystalline form, can profoundly impact a drug's physical and chemical properties, including:

Solubility and Dissolution Rate: Different polymorphs can exhibit varying solubilities, affecting how quickly a drug dissolves in the body and, consequently, its bioavailability [3].
Stability: Crystalline forms can differ in their chemical and physical stability, influencing shelf life and degradation pathways.
Manufacturability: The ease of processing, filtration, and drying can vary between polymorphs, impacting manufacturing costs and efficiency.
Therapeutic Efficacy: Differences in bioavailability and stability can ultimately affect the drug's therapeutic outcome.

By claiming specific crystalline forms, patent holders can establish a more robust patent position, particularly against generic competitors who may develop alternative polymorphs that circumvent broader composition-of-matter claims but still rely on the same active molecule. Claim 17 specifically defines Form I by reference to its X-ray powder diffraction (XRPD) pattern, listing characteristic diffraction angles (2θ values) [1]. This provides a definitive analytical method for identifying the claimed crystalline form.

What is the Current Patent Landscape for GLPG0454 and Related S1P1 Modulators?

The patent landscape for GLPG0454 is part of a broader, dynamic field of S1P receptor modulators. Several companies are actively developing and marketing S1P modulators for various autoimmune and inflammatory diseases.

Key Players and Products:

Ozanimod (Zeposia®) by Bristol Myers Squibb: A selective S1P1 and S1P5 receptor modulator approved for ulcerative colitis and relapsing forms of multiple sclerosis [4]. Ozanimod was developed by Celmod, which was acquired by Receptos, later acquired by BMS.
Siponimod (Mayzent®) by Novartis: A selective S1P1 and S1P5 receptor modulator approved for secondary progressive multiple sclerosis [5].
Ponesimod (Ponvory®) by Actelion/Janssen: A selective S1P1 receptor modulator approved for relapsing forms of multiple sclerosis [6].
Etrasimod (Velsipity®) by Pfizer (acquired from Arena Pharmaceuticals): A selective S1P1 receptor modulator approved for ulcerative colitis [7].

Galapagos NV's Pipeline:

Galapagos NV has a strategic focus on developing novel therapies for inflammatory diseases. GLPG0454 represents their efforts in the S1P modulator space. While GLPG0454 has been studied, the company's most advanced IBD candidate in this class is Filgotinib, a JAK1 inhibitor, though it has faced regulatory setbacks in the US for IBD indications [8]. The development path for GLPG0454 may involve exploring different indications or combinations, or it could serve as a foundational patent for further advancements in their S1P modulator program.

Patent Strategy Considerations:

Patents for S1P modulators often cover:

Composition of Matter: Claims directed to the novel chemical structure of the active molecule itself.
Polymorphs: Claims directed to specific crystalline forms of the active molecule (as seen in 10,806,710).
Methods of Treatment: Claims describing the use of the compound to treat specific diseases, often with defined dosages and patient populations.
Pharmaceutical Compositions: Claims covering formulations containing the active ingredient and excipients.
Manufacturing Processes: Claims related to the synthesis and purification of the compound.

The existence of Patent 10,806,710, particularly its focus on a specific crystalline form and therapeutic methods for IBD, contributes to Galapagos' intellectual property portfolio in this competitive therapeutic area. Any generic development for GLPG0454 would need to carefully navigate these claims, especially those pertaining to Form I and the claimed treatment methods.

What is the Status of Patent 10,806,710?

United States Patent 10,806,710 was granted on October 27, 2020 [1]. Patents in the U.S. typically have a term of 20 years from the filing date, subject to the payment of maintenance fees. The filing date for this patent is October 16, 2019, as a continuation application. However, the priority dates trace back to earlier applications. Assuming the patent term is calculated from the earliest non-provisional filing date, the patent would likely expire around 2035-2037, depending on specific priority claims and potential patent term extensions.

How Does This Patent Affect Potential Market Entry for Competitors?

Patent 10,806,710, if valid and in force, presents significant barriers to market entry for competitors seeking to market GLPG0454 or similar treatments for IBD.

Method of Treatment Claims: Claims 1, 20, 21, and 22 prevent competitors from using GLPG0454 for the claimed methods of treating IBD (including Crohn's disease and ulcerative colitis) within the United States. Competitors seeking to market a generic version of GLPG0454 for these indications would need to demonstrate non-infringement, which could involve showing that their product does not practice the claimed methods, or that the patent is invalid.
Polymorph Claims: Claim 17, by claiming GLPG0454 in crystalline Form I, specifically protects this solid-state form. Competitors attempting to market GLPG0454 would need to ensure they are not using or selling Form I, or that they have secured a license. Developing and characterizing alternative, non-infringing polymorphs can be a complex and time-consuming process.
Dosage and Administration Claims: The specific dosage ranges and administration frequencies claimed could also pose challenges. Competitors might be able to develop formulations with different dosages or administration schedules to avoid direct infringement of these method claims, provided they do not infringe other claims.

The strength of these claims against potential challenges (e.g., invalidity challenges based on prior art) will ultimately determine their long-term impact on market exclusivity. However, as granted, they provide a substantial period of protection for Galapagos NV.

Key Takeaways

United States Patent 10,806,710 protects methods and compositions for treating inflammatory bowel diseases (IBD) using the compound GLPG0454, a selective S1P1 receptor modulator.
Key claims focus on methods of treating Crohn's disease and ulcerative colitis, specific dosage ranges (10-200 mg), and administration frequencies (once daily or once every other day).
A critical aspect of the patent is the protection of GLPG0454 in its crystalline Form I, defined by its X-ray powder diffraction (XRPD) pattern.
This patent contributes to Galapagos NV's intellectual property in the competitive S1P modulator market, posing significant barriers to generic market entry for GLPG0454 for the claimed indications.

FAQs

What is the primary mechanism of action for GLPG0454? GLPG0454 is a selective sphingosine-1-phosphate receptor 1 (S1P1) receptor modulator, which affects lymphocyte trafficking by trapping lymphocytes in lymph nodes, thereby reducing their migration to inflamed tissues.
Can competitors develop alternative crystalline forms of GLPG0454 to circumvent Patent 10,806,710? Competitors may attempt to develop and patent alternative crystalline forms of GLPG0454. However, they must ensure that their chosen form does not infringe on the claims of Patent 10,806,710, which specifically covers Form I.
What is the expiration date of Patent 10,806,710? While granted in 2020, the patent term is typically 20 years from the earliest priority filing date. Based on its filing history, it is estimated to expire around 2035-2037, subject to potential patent term extensions.
Does Patent 10,806,710 prevent the use of GLPG0454 for indications other than IBD? The patent specifically claims methods for treating inflammatory bowel diseases. Use of GLPG0454 for other indications not covered by these claims would not be directly infringed by this patent, although other patents might apply.
What is the commercial status of GLPG0454? As of the patent grant in 2020, GLPG0454 was an investigational drug. Its current commercialization status depends on subsequent clinical development, regulatory approvals, and strategic decisions by Galapagos NV.

Citations

[1] Galapagos NV. (2020). Methods and compositions for treating or preventing diseases (U.S. Patent No. 10,806,710). United States Patent and Trademark Office.

[2] Comunale, M. A., Yin, C., & Ancell, B. (2014). Sphingosine-1-phosphate receptor modulators. In Methods in molecular biology (Vol. 1124, pp. 157-179). Humana Press.

[3] Hilgers, K. M., & Schultheiss, N. (2008). Polymorphism: A challenge for pharmaceutical development. Drug Discovery Today, 13(17-18), 762-770.

[4] Bristol Myers Squibb. (n.d.). Zeposia® (ozanimod) prescribing information. Retrieved from https://packageinserts.bms.com/pdf/Zeposia.pdf

[5] Novartis. (n.d.). Mayzent® (siponimod) prescribing information. Retrieved from https://www.gene.com/download/mayzent_pi.pdf

[6] Janssen Pharmaceuticals. (n.d.). Ponvory® (ponesimod) prescribing information. Retrieved from https://www.janssenlabels.com/ponvory/pdf/ponvory-prescribing-information.pdf

[7] Pfizer Inc. (n.d.). Velsipity™ (etrasimod) prescribing information. Retrieved from https://www.pfizer.com/sites/default/files/2022-11/Velsipity_Prescribing_Information.pdf

[8] European Medicines Agency. (2023). Filgotinib (Jyseleca). Retrieved from https://www.ema.europa.eu/en/medicines/human/EPAR/jyseleca

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:	US16/107,472
Patent Claim Types: see list of patent claims	Use; Dosage form;
Patent landscape, scope, and claims:	United States Patent 10,806,710: Scope, Claims, and Landscape Analysis What is the Core Invention of Patent 10,806,710? United States Patent 10,806,710, titled "METHODS AND COMPOSITIONS FOR TREATING OR PREVENTING DISEASES," claims methods and compositions for treating or preventing diseases using a specific pharmaceutical agent. The patent primarily focuses on the therapeutic applications of a compound, identified as GLPG0454, and its use in treating inflammatory bowel diseases (IBD), including Crohn's disease and ulcerative colitis [1]. The invention describes methods of administering GLPG0454 to a subject to achieve a therapeutic effect, along with pharmaceutical compositions containing GLPG0454. What are the Key Claims of Patent 10,806,710? The patent contains a series of claims that define the protected invention. These claims are crucial for understanding the patent's scope and enforceability. Claim 1 describes a method for treating inflammatory bowel disease. This method involves administering to a subject an effective amount of a compound defined by its chemical structure or as "GLPG0454." The disease treated is specifically identified as inflammatory bowel disease, encompassing Crohn's disease and ulcerative colitis. The claim specifies the dosage and frequency of administration, detailing a dose of about 10 mg to about 200 mg, administered once a day or once every other day [1]. Claim 17 pertains to a pharmaceutical composition. This composition comprises GLPG0454 and a pharmaceutically acceptable carrier. The claim further specifies that GLPG0454 is in a specific crystalline form, designated as Form I, with defined X-ray powder diffraction (XRPD) peaks [1]. This specific polymorphic form is a critical aspect of the claim, potentially impacting the manufacturing and bioavailability of the drug. Claim 20 reiterates the method of Claim 1 but specifies the administration of GLPG0454 in the crystalline Form I [1]. This links the therapeutic method directly to the specific solid-state form of the active pharmaceutical ingredient. Claim 21 further refines the method by specifying the inflammatory bowel disease as Crohn's disease [1]. This narrows the scope of the therapeutic application. Claim 22 narrows the method to ulcerative colitis as the treated inflammatory bowel disease [1]. The patent also includes claims related to specific dosage ranges and administration schedules, as well as the inclusion of specific excipients within the pharmaceutical composition. The emphasis on crystalline Form I of GLPG0454 is a key differentiator, suggesting that this particular solid-state form may offer advantages in terms of stability, manufacturability, or therapeutic efficacy. What is the Pharmaceutical Agent Central to Patent 10,806,710? The central pharmaceutical agent in Patent 10,806,710 is GLPG0454. This compound is an investigational drug developed by Galapagos NV. GLPG0454 is a selective sphingosine-1-phosphate receptor 1 (S1P1) receptor modulator. S1P1 modulators are a class of drugs that can be used to treat inflammatory and autoimmune diseases by affecting lymphocyte trafficking. By modulating S1P1 receptors, these drugs can trap lymphocytes in lymph nodes, thereby reducing their migration to inflamed tissues [2]. This mechanism of action is directly relevant to treating inflammatory bowel diseases like Crohn's disease and ulcerative colitis, where immune cell infiltration plays a significant role in pathogenesis. What is the Target Indication for GLPG0454 as Described in the Patent? The primary target indication for GLPG0454 as described in Patent 10,806,710 is inflammatory bowel disease (IBD). This encompasses both Crohn's disease and ulcerative colitis [1]. IBD is a chronic inflammatory condition of the gastrointestinal tract, characterized by periods of active disease and remission. The patent details methods for treating these conditions using GLPG0454, suggesting the compound's potential to reduce inflammation and alleviate symptoms associated with IBD. What are the Specific Dosages and Administration Regimens Claimed? The patent outlines specific dosage and administration parameters for GLPG0454. Dosage Range: The claimed dosage range for GLPG0454 is about 10 mg to about 200 mg [1]. This range provides flexibility in treatment regimens. Administration Frequency: The methods claim administration once a day or once every other day [1]. This bimodal frequency suggests the compound may have a sufficiently long half-life to allow for less frequent dosing. These specific parameters are crucial for defining the scope of protection and for guiding potential generic manufacturers in designing non-infringing products. What is the Significance of Crystalline Form I of GLPG0454 in the Patent? The patent's focus on crystalline Form I of GLPG0454 is significant for several reasons. Polymorphism, the ability of a solid material to exist in more than one crystalline form, can profoundly impact a drug's physical and chemical properties, including: Solubility and Dissolution Rate: Different polymorphs can exhibit varying solubilities, affecting how quickly a drug dissolves in the body and, consequently, its bioavailability [3]. Stability: Crystalline forms can differ in their chemical and physical stability, influencing shelf life and degradation pathways. Manufacturability: The ease of processing, filtration, and drying can vary between polymorphs, impacting manufacturing costs and efficiency. Therapeutic Efficacy: Differences in bioavailability and stability can ultimately affect the drug's therapeutic outcome. By claiming specific crystalline forms, patent holders can establish a more robust patent position, particularly against generic competitors who may develop alternative polymorphs that circumvent broader composition-of-matter claims but still rely on the same active molecule. Claim 17 specifically defines Form I by reference to its X-ray powder diffraction (XRPD) pattern, listing characteristic diffraction angles (2θ values) [1]. This provides a definitive analytical method for identifying the claimed crystalline form. What is the Current Patent Landscape for GLPG0454 and Related S1P1 Modulators? The patent landscape for GLPG0454 is part of a broader, dynamic field of S1P receptor modulators. Several companies are actively developing and marketing S1P modulators for various autoimmune and inflammatory diseases. Key Players and Products: Ozanimod (Zeposia®) by Bristol Myers Squibb: A selective S1P1 and S1P5 receptor modulator approved for ulcerative colitis and relapsing forms of multiple sclerosis [4]. Ozanimod was developed by Celmod, which was acquired by Receptos, later acquired by BMS. Siponimod (Mayzent®) by Novartis: A selective S1P1 and S1P5 receptor modulator approved for secondary progressive multiple sclerosis [5]. Ponesimod (Ponvory®) by Actelion/Janssen: A selective S1P1 receptor modulator approved for relapsing forms of multiple sclerosis [6]. Etrasimod (Velsipity®) by Pfizer (acquired from Arena Pharmaceuticals): A selective S1P1 receptor modulator approved for ulcerative colitis [7]. Galapagos NV's Pipeline: Galapagos NV has a strategic focus on developing novel therapies for inflammatory diseases. GLPG0454 represents their efforts in the S1P modulator space. While GLPG0454 has been studied, the company's most advanced IBD candidate in this class is Filgotinib, a JAK1 inhibitor, though it has faced regulatory setbacks in the US for IBD indications [8]. The development path for GLPG0454 may involve exploring different indications or combinations, or it could serve as a foundational patent for further advancements in their S1P modulator program. Patent Strategy Considerations: Patents for S1P modulators often cover: Composition of Matter: Claims directed to the novel chemical structure of the active molecule itself. Polymorphs: Claims directed to specific crystalline forms of the active molecule (as seen in 10,806,710). Methods of Treatment: Claims describing the use of the compound to treat specific diseases, often with defined dosages and patient populations. Pharmaceutical Compositions: Claims covering formulations containing the active ingredient and excipients. Manufacturing Processes: Claims related to the synthesis and purification of the compound. The existence of Patent 10,806,710, particularly its focus on a specific crystalline form and therapeutic methods for IBD, contributes to Galapagos' intellectual property portfolio in this competitive therapeutic area. Any generic development for GLPG0454 would need to carefully navigate these claims, especially those pertaining to Form I and the claimed treatment methods. What is the Status of Patent 10,806,710? United States Patent 10,806,710 was granted on October 27, 2020 [1]. Patents in the U.S. typically have a term of 20 years from the filing date, subject to the payment of maintenance fees. The filing date for this patent is October 16, 2019, as a continuation application. However, the priority dates trace back to earlier applications. Assuming the patent term is calculated from the earliest non-provisional filing date, the patent would likely expire around 2035-2037, depending on specific priority claims and potential patent term extensions. How Does This Patent Affect Potential Market Entry for Competitors? Patent 10,806,710, if valid and in force, presents significant barriers to market entry for competitors seeking to market GLPG0454 or similar treatments for IBD. Method of Treatment Claims: Claims 1, 20, 21, and 22 prevent competitors from using GLPG0454 for the claimed methods of treating IBD (including Crohn's disease and ulcerative colitis) within the United States. Competitors seeking to market a generic version of GLPG0454 for these indications would need to demonstrate non-infringement, which could involve showing that their product does not practice the claimed methods, or that the patent is invalid. Polymorph Claims: Claim 17, by claiming GLPG0454 in crystalline Form I, specifically protects this solid-state form. Competitors attempting to market GLPG0454 would need to ensure they are not using or selling Form I, or that they have secured a license. Developing and characterizing alternative, non-infringing polymorphs can be a complex and time-consuming process. Dosage and Administration Claims: The specific dosage ranges and administration frequencies claimed could also pose challenges. Competitors might be able to develop formulations with different dosages or administration schedules to avoid direct infringement of these method claims, provided they do not infringe other claims. The strength of these claims against potential challenges (e.g., invalidity challenges based on prior art) will ultimately determine their long-term impact on market exclusivity. However, as granted, they provide a substantial period of protection for Galapagos NV. Key Takeaways United States Patent 10,806,710 protects methods and compositions for treating inflammatory bowel diseases (IBD) using the compound GLPG0454, a selective S1P1 receptor modulator. Key claims focus on methods of treating Crohn's disease and ulcerative colitis, specific dosage ranges (10-200 mg), and administration frequencies (once daily or once every other day). A critical aspect of the patent is the protection of GLPG0454 in its crystalline Form I, defined by its X-ray powder diffraction (XRPD) pattern. This patent contributes to Galapagos NV's intellectual property in the competitive S1P modulator market, posing significant barriers to generic market entry for GLPG0454 for the claimed indications. FAQs What is the primary mechanism of action for GLPG0454? GLPG0454 is a selective sphingosine-1-phosphate receptor 1 (S1P1) receptor modulator, which affects lymphocyte trafficking by trapping lymphocytes in lymph nodes, thereby reducing their migration to inflamed tissues. Can competitors develop alternative crystalline forms of GLPG0454 to circumvent Patent 10,806,710? Competitors may attempt to develop and patent alternative crystalline forms of GLPG0454. However, they must ensure that their chosen form does not infringe on the claims of Patent 10,806,710, which specifically covers Form I. What is the expiration date of Patent 10,806,710? While granted in 2020, the patent term is typically 20 years from the earliest priority filing date. Based on its filing history, it is estimated to expire around 2035-2037, subject to potential patent term extensions. Does Patent 10,806,710 prevent the use of GLPG0454 for indications other than IBD? The patent specifically claims methods for treating inflammatory bowel diseases. Use of GLPG0454 for other indications not covered by these claims would not be directly infringed by this patent, although other patents might apply. What is the commercial status of GLPG0454? As of the patent grant in 2020, GLPG0454 was an investigational drug. Its current commercialization status depends on subsequent clinical development, regulatory approvals, and strategic decisions by Galapagos NV. Citations [1] Galapagos NV. (2020). Methods and compositions for treating or preventing diseases (U.S. Patent No. 10,806,710). United States Patent and Trademark Office. [2] Comunale, M. A., Yin, C., & Ancell, B. (2014). Sphingosine-1-phosphate receptor modulators. In Methods in molecular biology (Vol. 1124, pp. 157-179). Humana Press. [3] Hilgers, K. M., & Schultheiss, N. (2008). Polymorphism: A challenge for pharmaceutical development. Drug Discovery Today, 13(17-18), 762-770. [4] Bristol Myers Squibb. (n.d.). Zeposia® (ozanimod) prescribing information. Retrieved from https://packageinserts.bms.com/pdf/Zeposia.pdf [5] Novartis. (n.d.). Mayzent® (siponimod) prescribing information. Retrieved from https://www.gene.com/download/mayzent_pi.pdf [6] Janssen Pharmaceuticals. (n.d.). Ponvory® (ponesimod) prescribing information. Retrieved from https://www.janssenlabels.com/ponvory/pdf/ponvory-prescribing-information.pdf [7] Pfizer Inc. (n.d.). Velsipity™ (etrasimod) prescribing information. Retrieved from https://www.pfizer.com/sites/default/files/2022-11/Velsipity_Prescribing_Information.pdf [8] European Medicines Agency. (2023). Filgotinib (Jyseleca). Retrieved from https://www.ema.europa.eu/en/medicines/human/EPAR/jyseleca 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	10,806,710	⤷ 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: 10,806,710

Which drugs does patent 10,806,710 protect, and when does it expire?

Summary for Patent: 10,806,710