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Last Updated: December 22, 2024

Details for Patent: 10,519,139

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Which drugs does patent 10,519,139 protect, and when does it expire?

Patent 10,519,139 protects XPOVIO and is included in one NDA.

This patent has thirty-three patent family members in eighteen countries.

Summary for Patent: 10,519,139

Title:	Polymorphs of Selinexor
Abstract:	The present invention relates to crystalline forms of the compound represented by Structural Formula I, and compositions comprising crystalline forms of the compound represented by Structural Formula I described herein. The crystalline forms of the compound of Structural Formula I and compositions comprising the crystalline forms of the compound of Structural Formula I provided herein, in particular, single crystalline Form A, can be incorporated into pharmaceutical compositions, which can be used to treat various disorders associated with CRM1 activity, including cancer. Also described herein are methods for preparing the compound of Structural Formula I and its single crystalline forms.
Inventor(s):	Austad; Brian C. (Tewksbury, MA), Roe; David G. (Rockwood, CA)
Assignee:	Karyopharm Therapeutics Inc. (Newton, MA)
Application Number:	15/503,319
Patent Claim Types: see list of patent claims	Use; Composition; Compound;
Patent landscape, scope, and claims:	Detailed Analysis of the Scope and Claims of United States Patent 10,519,139 Introduction United States Patent 10,519,139, titled "Polymorphs of Selinexor," is a significant patent held by Karyopharm Therapeutics Inc. This patent is crucial for the protection and utilization of Selinexor, a drug used in the treatment of multiple myeloma and other cancers. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention. Background of Selinexor Selinexor, also known by its brand name Xpovio, is a selective inhibitor of nuclear export (SINE) compound that targets the nuclear export protein Exportin-1 (CRM1). It is used in combination with other drugs for the treatment of multiple myeloma in adult patients who have received at least one prior therapy[4]. Patent Overview Issuance and Expiration The patent was issued on December 31, 2019, and is set to expire on August 14, 2035. This expiration date is consistent across several related patents, ensuring a prolonged period of exclusivity for Karyopharm Therapeutics Inc.[2][5]. Inventors and Assignee The inventors listed on the patent are Brian C. Austad and David G. Roe, with Karyopharm Therapeutics Inc. as the assignee. This indicates that the research and development of Selinexor's polymorphs were conducted under the auspices of Karyopharm Therapeutics[5]. Scope of the Patent Crystalline Forms The patent specifically relates to crystalline forms of the compound represented by Structural Formula I, which is Selinexor. It describes various crystalline forms, including single crystalline Form A, and compositions comprising these crystalline forms. These forms are critical for the stability, efficacy, and bioavailability of the drug[5]. Pharmaceutical Compositions The patent details methods for preparing the compound and its single crystalline forms, which can be incorporated into pharmaceutical compositions. These compositions are designed to treat various disorders associated with CRM1 activity, including cancer[5]. Claims of the Patent Independent Claims The patent includes independent claims that define the scope of the invention. These claims typically cover the specific crystalline forms of Selinexor, methods of preparation, and pharmaceutical compositions containing these forms. The independent claims are crucial as they set the boundaries of what is considered novel and non-obvious, thereby defining the patent's scope[5]. Dependent Claims Dependent claims further specify the invention by detailing particular aspects of the crystalline forms, such as their physical and chemical properties, and the methods for their preparation. These claims build upon the independent claims and provide additional protection for specific embodiments of the invention[5]. Patent Landscape Related Patents Several other patents are related to Selinexor and its uses, including patents for hydrazide-containing nuclear transport modulators and other aspects of the drug. These patents, such as US8999996, US9714226, and US11807629, cover different facets of Selinexor, including its chemical structure, dosage forms, and methods of administration. This comprehensive patent portfolio ensures broad protection for Karyopharm Therapeutics Inc.[2][5]. Patent Expiration Dates The expiration dates of these related patents vary, with some expiring as early as July 2032 and others in August 2035. This staggered expiration timeline provides a prolonged period of exclusivity for Karyopharm Therapeutics Inc., allowing them to maintain market dominance for Selinexor over the next decade[2][5]. Impact on Innovation and Competition Patent Scope and Quality The scope of the patent claims is a critical factor in determining patent quality. Narrower claims, as seen in this patent, are generally associated with a higher probability of grant and a shorter examination process. This suggests that the patent office has rigorously evaluated the claims, ensuring they are clear and specific, which can foster innovation by providing clear boundaries for competitors[3]. Exclusivity and Market Protection The exclusive rights granted by this patent and its related patents protect Karyopharm Therapeutics Inc. from generic competition until the expiration dates. This exclusivity period allows the company to recoup its investment in research and development and maintain a competitive edge in the market[5]. Practical Implications Manufacturing and Formulation The patent's focus on specific crystalline forms and their preparation methods is crucial for the manufacturing process. This ensures that any pharmaceutical compositions produced using these methods will meet the required standards of efficacy and stability[5]. Clinical Use For clinicians, the patent's protection of Selinexor's polymorphs ensures that the drug will be available in a consistent and reliable form, which is vital for patient treatment outcomes. The patent also supports ongoing research into the drug's efficacy and safety in various clinical settings[4]. Key Takeaways Patent Scope: The patent covers specific crystalline forms of Selinexor, methods of preparation, and pharmaceutical compositions. Expiration Date: The patent expires on August 14, 2035. Related Patents: Several other patents protect different aspects of Selinexor, ensuring broad protection. Impact on Innovation: The patent's clear and specific claims foster innovation by providing clear boundaries. Market Protection: The patent protects Karyopharm Therapeutics Inc. from generic competition until its expiration. FAQs Q: What is the primary focus of United States Patent 10,519,139? A: The primary focus is on the crystalline forms of Selinexor, a drug used in the treatment of multiple myeloma and other cancers. Q: Who are the inventors listed on the patent? A: The inventors are Brian C. Austad and David G. Roe. Q: What is the expiration date of the patent? A: The patent expires on August 14, 2035. Q: How does the patent protect Karyopharm Therapeutics Inc.? A: The patent grants exclusive rights to Karyopharm Therapeutics Inc., protecting them from generic competition until its expiration. Q: What are the implications of the patent for clinicians? A: The patent ensures that Selinexor will be available in a consistent and reliable form, which is vital for patient treatment outcomes. Sources US10519139B2 - Polymorphs of Selinexor - Google Patents Xpovio patent expiration - Pharsight Patent Claims and Patent Scope - Hoover Institution Selinexor: Uses, Interactions, Mechanism of Action - DrugBank Online Generic Xpovio Availability - Drugs.com More… ↓ ⤷ Subscribe

Drugs Protected by US Patent 10,519,139

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Karyopharm Theraps	XPOVIO	selinexor	TABLET;ORAL	212306-001	Jul 3, 2019		RX	Yes	No	⤷ Subscribe	⤷ Subscribe	Y	Y		XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES	⤷ Subscribe
Karyopharm Theraps	XPOVIO	selinexor	TABLET;ORAL	212306-001	Jul 3, 2019		RX	Yes	No	⤷ Subscribe	⤷ Subscribe	Y	Y		XPOVIO IS INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL), NOT OTHERWISE SPECIFIED, INCLUDING DLBCL ARISING FROM FOLLICULAR LYMPHOMA, AFTER AT LEAST 2 LINES OF SYSTEMIC THERAPY	⤷ Subscribe
Karyopharm Theraps	XPOVIO	selinexor	TABLET;ORAL	212306-001	Jul 3, 2019		RX	Yes	No	⤷ Subscribe	⤷ Subscribe	Y	Y		XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY	⤷ Subscribe
Karyopharm Theraps	XPOVIO	selinexor	TABLET;ORAL	212306-002	Apr 15, 2021		RX	Yes	No	⤷ Subscribe	⤷ Subscribe	Y	Y		XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES	⤷ Subscribe
Karyopharm Theraps	XPOVIO	selinexor	TABLET;ORAL	212306-002	Apr 15, 2021		RX	Yes	No	⤷ Subscribe	⤷ Subscribe	Y	Y		XPOVIO IS INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL), NOT OTHERWISE SPECIFIED, INCLUDING DLBCL ARISING FROM FOLLICULAR LYMPHOMA, AFTER AT LEAST 2 LINES OF SYSTEMIC THERAPY	⤷ Subscribe
Karyopharm Theraps	XPOVIO	selinexor	TABLET;ORAL	212306-002	Apr 15, 2021		RX	Yes	No	⤷ Subscribe	⤷ Subscribe	Y	Y		XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY	⤷ Subscribe
Karyopharm Theraps	XPOVIO	selinexor	TABLET;ORAL	212306-003	Apr 15, 2021		RX	Yes	No	⤷ Subscribe	⤷ Subscribe	Y	Y		XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Foreign Priority and PCT Information for Patent: 10,519,139

PCT Information
PCT Filed	August 14, 2015	PCT Application Number:	PCT/US2015/045395
PCT Publication Date:	February 18, 2016	PCT Publication Number:	WO2016/025904

International Family Members for US Patent 10,519,139

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Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015301484	⤷ Subscribe
Australia	2020203246	⤷ Subscribe
Australia	2021286266	⤷ Subscribe
Australia	2024202835	⤷ Subscribe
Canada	2957266	⤷ Subscribe
China	107072992	⤷ Subscribe
China	111481553	⤷ Subscribe
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

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