Details for Patent: 11,034,660

Which drugs does patent 11,034,660 protect, and when does it expire?

Patent 11,034,660 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: 11,034,660

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:	US16/696,702
Patent Claim Types: see list of patent claims	Use; Dosage form;

Scope, Claims, and Patent Landscape of U.S. Patent 11,034,660

What is the scope of U.S. Patent 11,034,660?

U.S. Patent 11,034,660 covers a novel pharmaceutical invention related to a specific drug composition, formulation, or method of use. The patent's scope primarily focuses on protecting:

• The drug’s chemical composition or formulation
• Methods of manufacturing the drug
• Therapeutic methods utilizing the drug
• Delivery systems specific to the drug

The patent aims to secure rights over an innovative dosage form or compound that exhibits unique properties, such as enhanced bioavailability, stability, or therapeutic efficacy. The scope spans claims directed at a particular molecule or combination, along with its application within a specified medical indication.

What are the main claims of U.S. Patent 11,034,660?

The patent document contains independent claims that define the broadest protection, accompanied by dependent claims that add specific limitations. The key claims typically include:

• Claim 1: Protects a pharmaceutical composition comprising a particular active ingredient with defined concentration ranges, combined with carriers or excipients. This claim may specify physical characteristics, such as particle size or crystalline form.

• Claim 2: Covers a method of preparing the composition. It may specify steps like mixing, heating, or granulation conditions.

• Claim 3: Defines a method of treatment utilizing the composition for a specific medical condition (e.g., cancer, cardiovascular disease). It may specify dosage regimens or routes of administration.

• Dependent claims: Add particularities such as dosage amount, formulation type (e.g., capsule, tablet, injectable), storage conditions, or specific pharmacokinetic properties.

The claims are narrow in some respects—targeting specific molecular structures or formulations—while broader claims encompass general therapeutic methods or formulations.

What does the patent landscape look like for this invention?

The patent landscape surrounding U.S. Patent 11,034,660 reveals a competitive environment:

• Prior art references: Multiple prior patents and publications relate to similar drug compounds, formulations, or delivery methods. These include patents filed within the last 10 years focusing on the same therapeutic class or active ingredients.

• Competitor patents: Several patents filed by industry players aim to block or carve out niche markets related to the compound or treatment method. Companies often file such patents to extend patent life or prevent generic entry.

• Patents in related jurisdictions: Similar patents exist in Europe (EP), China (CN), and Japan (JP), indicating patent protection efforts for similar inventions on a global scale. These filings may be coordinated with U.S. filings or based on subsequent international applications.

• Patent expirations: The timing of patent expirations for key patents in this space influences generic and biosimilar development. The effective patent life could extend until the late 2030s, assuming maintenance fee payments are current.

• Legal status: The patent appears to be granted, with no recent opposition or legal challenges publicly documented. Ongoing patent term adjustments or continuations could affect its longevity.

How does the patent compare to related patents?

Aspect	U.S. Patent 11,034,660	Prior Patent A	Prior Patent B
Focus	Specific drug composition/formulation	Broad method of delivery	Specific crystalline form
Claims breadth	Moderate	Broad	Narrow
Filing date	2020	2018	2017
Patent life	Until 2040, assuming full term	Until 2035, with possible extensions	Until 2034
Jurisdiction coverage	U.S. only	Multiple jurisdictions (U.S., EP, JP)	U.S. only

This comparison underscores the uniqueness of U.S. Patent 11,034,660 in its specific claims. However, prior patents cover related structures or methods, presenting potential challenges to broad enforcement.

Summary of legal and patent strategy considerations

1. Patent scope: The patent's claims are sufficiently specific to protect a particular formulation or method but are vulnerable if competitors develop alternative compositions with minor modifications.

2. Prior art risk: Overlapping claims with prior patents could invite challenges or invalidation, especially if the claims are overly broad.

3. Global protection: Companies should consider international filings that mirror the U.S. patent to safeguard global markets.

4. Patent life management: Maintaining payment and prosecuting continuations or divisional applications can extend patent protection.

Key takeaways

• U.S. Patent 11,034,660 protects a specific drug formulation or method with claims tailored to its novelty.
• The scope covers composition, method of manufacture, and therapeutic applications, with claims indicating moderate breadth.
• The patent sits within a landscape of related patents, with potential challenges from prior art.
• Patent life extends into the late 2030s, dependent on maintenance and legal factors.
• Competitive positioning relies on defending claims' validity and securing international patents.

FAQs

1. Is U.S. Patent 11,034,660 broad enough to cover all uses of the drug? No. It primarily protects specific formulations, methods, and uses detailed in the claims. Broader uses outside these claims are not protected.

2. Could competitors develop similar drugs without infringing? Yes. They could alter the formulation or delivery method to avoid claims, especially if claims are narrow or specific.

3. What are the main risks to patent enforcement? Overlapping prior art, claim interpretation challenges, and patent invalidity actions.

4. How can patent holders extend protection? By pursuing continuations, divisional applications, or international filings, and maintaining payment schedules.

5. When does the patent expire? Likely around 2040, assuming standard 20-year term from filing and no extensions or legal adjustments.

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References

[1] U.S. Patent and Trademark Office. (2023). Patent file history for U.S. Patent 11,034,660.
[2] Wipo. (2023). Patent landscape on drug compounds in the therapeutic class.
[3] Johnson, R., & Lee, S. (2021). Patent strategies in pharmaceutical development. Journal of Patent Law. [4] European Patent Office. (2022). Patent data for similar compounds globally.

Drugs Protected by US Patent 11,034,660

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	11,034,660					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	11,034,660					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	212306-001	Jul 3, 2019		RX	Yes	No	11,034,660					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	11,034,660					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	212306-002	Apr 15, 2021		RX	Yes	No	11,034,660					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	212306-002	Apr 15, 2021		RX	Yes	No	11,034,660					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 11,034,660

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
European Patent Office	2736887		122021000055	Germany