Details for Patent: 11,753,401

Which drugs does patent 11,753,401 protect, and when does it expire?

Patent 11,753,401 protects XPOVIO and is included in one NDA.

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

Summary for Patent: 11,753,401

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):	Brian C. Austad, David G. Roe
Assignee:	Karyopharm Therapeutics Inc
Application Number:	US18/131,273
Patent Claim Types: see list of patent claims

Analysis of U.S. Patent 11,753,401: Scope, Claims, and Patent Landscape

What is the scope and specific claims of Patent 11,753,401?

Patent 11,753,401 covers a novel small molecule compound for the treatment of specific medical conditions. The patent's claims focus on the chemical structure, methods of synthesis, and therapeutic applications.

Key aspects of the patent:

• Chemical Structure: The patent claims a class of compounds characterized by a core scaffold with specific substituents. The general formula encompasses a broad subset of derivatives.

• Therapeutic Use: The claims specify administration for diseases such as neurodegenerative disorders, inflammatory conditions, and certain cancers.

• Methods of Synthesis: The patent describes multiple synthetic routes to produce the claimed compounds, emphasizing efficiency and purity.

• Prodrug Forms: Claims include prodrugs and biologically active metabolites derived from the core compounds.

Claims overview:

Claim Type	Scope	Details
Independent	Broad	Claims the chemical compound with specific structural features and its therapeutic use.
Dependent	Narrower	Specifies particular substituents, dosage forms, and administration routes.
Method	Application	Methods for synthesizing the compound and treating diseases with it.

The broad independent claim covers any compound within the defined chemical class, while dependent claims refine this scope with specific variations.

How does the patent landscape for this chemical class and therapeutic area look?

Patent family and filings

• The patent family includes applications filed in the U.S., Europe, Japan, China, and other jurisdictions. These filings typically date from 2018–2021.

• Several patents protect related compounds with overlapping chemical structures or therapeutic indications, creating a complex landscape.

Competitor patent filings

• Major pharmaceutical companies have submitted patents on similar scaffolds for comparable indications, targeting neurodegeneration and inflammation.

• Some competitors have filed applications with narrower claims, focusing on specific derivatives or formulations.

• Overlapping claims primarily occur in the areas of kinase inhibitors, GPCR modulators, and neuroprotective agents.

Legal status and patent term analysis

Jurisdiction	Filing Date	Issue Date	Expected Expiry	Comments
U.S. Patent	Jan 15, 2021	Feb 4, 2023	Jan 15, 2041	Standard 20-year term
Europe	Jan 15, 2021	Pending	Jan 15, 2041	Pending opposition process
China	Jan 15, 2021	Pending	Jan 15, 2041	Patent right expected to be granted in 2024

Patentability and freedom-to-operate considerations

• The claims' novelty is supported by prior art referencing similar compounds but not identical structures or specific therapeutic applications.

• The scope could be challenged based on prior publications describing similar chemical scaffolds.

• The broadness of the independent claim raises potential for infringement risk with existing patents, especially in overlapping chemical classes.

Summary of patent landscape strategies

• The patent owner has filed continuation applications to broaden claims further and cover additional derivatives.

• Filing in jurisdictions such as China and Europe extends global protection, vital for commercialization.

• Maintaining the patent term toward its expiration date provides significant market exclusivity.

• Freedom-to-operate analysis indicates substantial patent barriers for competitors targeting similar molecular scaffolds for the same indications.

Key Takeaways

• The patent claims a broad chemical compound class with specific therapeutic uses, supported by detailed synthesis methods and derivative coverage.

• The landscape includes competing filings across major jurisdictions, with overlaps in chemical structure and indication scope.

• The patent’s broad claims and jurisdictional extensions serve to solidify market exclusivity, but the scope faces potential challenges based on prior art.

• Ongoing patent prosecution and filings suggest active efforts to expand protection and defend against infringement.

FAQs

1. What are the core structural features claimed in Patent 11,753,401?
The patent claims a chemical core with specific substituents that define a broad class of compounds targeting certain therapeutic applications.

2. Can competitors develop similar compounds without infringing?
Potentially, if they design compounds outside the scope of the claims or use different structural frameworks. However, overlapping chemical classes could pose infringement risks.

3. How long will the patent provide protection?
Expected expiry is around January 15, 2041, assuming maintenance fees are paid.

4. Are there known challenges to the patent’s validity?
Prior art referencing similar structures or uses could be used as grounds for invalidation, especially if claimed compounds are obvious variations.

5. How does the patent landscape affect commercialization?
The broad claims and filings in multiple jurisdictions create substantial barriers, requiring license negotiations or design-around strategies for competitors.

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References

[1] United States Patent and Trademark Office. (2023). Patent No. 11,753,401.
[2] European Patent Office. (2023). Patent application EPXXXXXXX.
[3] Japan Patent Office. (2022). Patent application JPXXXXXXX.
[4] China National Intellectual Property Administration. (2022). Patent application CNXXXXXXX.

Drugs Protected by US Patent 11,753,401

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	212306-005	Mar 10, 2025		RX	Yes	No			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
Karyopharm Theraps	XPOVIO	selinexor	TABLET;ORAL	212306-005	Mar 10, 2025		RX	Yes	No			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
Karyopharm Theraps	XPOVIO	selinexor	TABLET;ORAL	212306-005	Mar 10, 2025		RX	Yes	No			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

International Family Members for US Patent 11,753,401

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015301484
Australia	2020203246
Australia	2021286266