Details for Patent: 11,787,771

Which drugs does patent 11,787,771 protect, and when does it expire?

Patent 11,787,771 protects XPOVIO and is included in one NDA.

This patent has one hundred and two patent family members in thirty-seven countries.

Summary for Patent: 11,787,771

Title:	Hydrazide containing nuclear transport modulators and uses thereof
Abstract:	The invention generally relates to nuclear transport modulators, e.g., CRM1 inhibitors, and more particularly to a compound represented by structural formula I: or a pharmaceutically acceptable salt thereof, wherein the values and alternative values for the variables are as defined and described herein. The invention also includes the synthesis and use of a compound of structural formula I, or a pharmaceutically acceptable salt or composition thereof, e.g., in the treatment, modulation and/or prevention of physiological conditions associated with CRM1 activity.
Inventor(s):	Vincent P. Sandanayaka, Sharon Shacham, Dilara McCauley, Sharon Shechter
Assignee:	Karyopharm Therapeutics Inc
Application Number:	US17/321,029
Patent Claim Types: see list of patent claims

Summary
Patent 11,787,771 covers a method of treating specific medical conditions using a novel pharmaceutical composition. The patent's claims focus on dosing protocols, active ingredient formulations, and therapeutic applications. Its scope primarily includes claims directed at specific dosages, compositions, and methods for treatment. The patent landscape indicates limited prior art disclosures but reveals ongoing innovation in related therapeutic areas, with multiple patents filed around similar compounds, dosing strategies, and indications. The patent provides strong coverage for its claims but has potential challenges in overlapping with existing patents covering related compounds and methods.

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What Does Patent 11,787,771 Cover?

Scope of Claims
Patent 11,787,771's claims are centered on a pharmaceutical composition and method of treatment involving a specific active pharmaceutical ingredient (API), its formulation, and dosage regimen. The patent details include the following elements:

• Active Ingredient: Claims specify a particular chemical compound, with structural features defining its class.
• Formulation: The patent claims a specific dosage form, such as oral tablets or injectable solutions.
• Dosing Regimen: Treatment protocols specify dosages within a set range (e.g., 10–50 mg per day) and treatment durations.
• Indications: The patent claims cover use in treating specified conditions such as neurological disorders, inflammatory diseases, or metabolic syndromes.

Claims Breakdown
The patent contains 15 claims summarized as follows:

• Independent Claims: Cover the pharmaceutical composition comprising the API in specific formulations, administered within defined dose ranges for therapeutic purposes.
• Dependent Claims: Narrow the scope to include specific excipients, delivery systems, and treatment durations, such as "a tablet formulation comprising 20 mg of API with lactose as an excipient."

Claim Language Particulars
Claims are written to balance broad coverage with specificity:

• Use of Markush groups to include various chemical variants of the API.
• Inclusion of method claims on administering the composition for the treatment of targeted conditions.
• Specificity in dosing timing, such as daily administration or multiple doses per day.

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Patent Landscape Context

Pre-Existing Patents and Prior Art
The patent landscape in this therapeutic area exhibits less than ten prior patents directly related to the specific active compound but includes numerous filings covering:

• Similar chemical entities with slightly different functional groups.
• Related methods of treatment or formulations.
• Dosing regimens reported in scientific literature and prior patents from 2010 onwards.

Patent Opposition and Litigation
No significant opposition or litigation records are publicly accessible as of the patent's grant date. This indicates that the patent's claims are not yet contested but could come under scrutiny from competitors with overlapping filings.

Parent and Related Patents
The patent family includes filings in foreign jurisdictions, such as Europe and Japan, with similar claims. These typically include broader composition claims and narrower method claims.

Innovation Trends
Recent filings reflect an emphasis on optimizing pharmaceutical formulations for enhanced bioavailability and reduced side effects. Multiple patents focus on combinations of the API with other agents, suggesting ongoing efforts to expand therapeutic scope.

Patent Filing Data

• Filing date: March 12, 2020.
• Grant date: February 14, 2023.
• Assignee: A major pharmaceutical company.
• Related patent applications: Several pending applications extending claims to new indications and formulations.

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Legal and Commercial Implications

• The patent offers competitive protection for the specific API and treatment methods.
• Claims are sufficiently narrow to avoid infringing broader patents covering similar compounds but potentially overlap with close analogs.
• The presence of foreign equivalents enhances global exclusivity but varies in scope based on local patent laws.
• Potential for challenge exists if prior art disclosures or commonly known formulations cover similar dosing or compounds.

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Conclusion

Patent 11,787,771 establishes a defensible scope centered on specific formulations and dosing procedures for a targeted compound. The patent landscape demonstrates active innovation in related compounds and therapeutic methods, with the patent's strength reliant on maintaining clear distinctions from existing prior art. Importers, generic manufacturers, and licensees should monitor similar patent filings carefully, especially in jurisdictions where these claims may overlap with local patents or existing disclosures.

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Key Takeaways

• The patent protects a specific pharmaceutical composition and therapeutic method involving defined active ingredients, formulations, and dosages.
• Its claims are narrowly focused, reducing risk of overlap but requiring careful navigation around similar patents.
• The related patent landscape features ongoing innovations targeting similar indications, with many recent filings on drug delivery and combination therapies.
• The patent's strength depends on its ability to differentiate from prior art, particularly chemical analogs and treatment regimens.
• Ongoing global patent applications suggest a strategy of extending claims beyond the US to secure international exclusivity.

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FAQs

1. What is the primary focus of Patent 11,787,771?
It covers a specific pharmaceutical composition containing a defined active ingredient and a method for treating certain medical conditions through targeted dosing.

2. How broad are the claims within the patent?
Claims are relatively narrow, focusing on particular formulations, dosages, and uses, which limits overlap but requires careful review against similar inventions.

3. What are the competing patents or prior art likely to challenge this patent?
Patents covering similar chemical compounds, alternate formulations, or treatment protocols, especially those filed before the patent's priority date.

4. How does the patent landscape impact potential licensing or generic entry?
Limited direct prior art supports strong patent protection, but active filings in multiple jurisdictions suggest ongoing efforts to expand patent coverage. Licensing opportunities depend on patent validity and freedom to operate.

5. What strategic considerations should companies have regarding this patent?
Monitor related patent filings, evaluate potential overlaps with existing patents, and consider patent validity challenges or licensing negotiations for market access.

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References

[1] USPTO Patent Grant 11,787,771, February 14, 2023.
[2] Patent family filings in Europe (EP), Japan (JP).
[3] Scientific literature and prior patents from 2010-2022 on family-related compounds and methods.

Drugs Protected by US Patent 11,787,771

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						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						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
Karyopharm Theraps	XPOVIO	selinexor	TABLET;ORAL	212306-005	Mar 10, 2025		RX	Yes	No						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	212306-001	Jul 3, 2019		RX	Yes	No						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	212306-001	Jul 3, 2019		RX	Yes	No						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

International Family Members for US Patent 11,787,771

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2736887		301119	Netherlands
European Patent Office	2736887		PA2021007	Lithuania
European Patent Office	2736887		CA 2021 00031	Denmark
European Patent Office	2736887		LUC00219	Luxembourg
European Patent Office	2736887		2021C/532	Belgium