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XPOVIO Drug Patent Profile

Which patents cover Xpovio, and what generic alternatives are available?

Xpovio is a drug marketed by Karyopharm Theraps and is included in one NDA. There are ten patents protecting this drug.

This drug has one hundred and thirty-one patent family members in thirty-eight countries.

The generic ingredient in XPOVIO is selinexor. One supplier is listed for this compound. Additional details are available on the selinexor profile page.

DrugPatentWatch^® Generic Entry Outlook for Xpovio

Xpovio was eligible for patent challenges on July 3, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 14, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for XPOVIO

International Patents:	131
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	47
Clinical Trials:	24
Patent Applications:	134
Drug Prices:	Drug price information for XPOVIO
What excipients (inactive ingredients) are in XPOVIO?	XPOVIO excipients list
DailyMed Link:	XPOVIO at DailyMed

See drug prices for XPOVIO

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for XPOVIO

Constraining patent/regulatory exclusivity:

10,519,139

NDA:

212306

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for XPOVIO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Miami	Phase 2
Xia Zhongjun	Phase 1/Phase 2
Li Zhiming	Phase 2

See all XPOVIO clinical trials

US Patents and Regulatory Information for XPOVIO

XPOVIO is protected by twenty-two US patents and seven FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 10,519,139.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Karyopharm Theraps	XPOVIO	selinexor	TABLET;ORAL	212306-003	Apr 15, 2021		RX	Yes	No	8,999,996		Y	Y
Karyopharm Theraps	XPOVIO	selinexor	TABLET;ORAL	212306-004	Apr 15, 2021		RX	Yes	Yes
Karyopharm Theraps	XPOVIO	selinexor	TABLET;ORAL	212306-002	Apr 15, 2021		RX	Yes	No	10,544,108
Karyopharm Theraps	XPOVIO	selinexor	TABLET;ORAL	212306-002	Apr 15, 2021		RX	Yes	No	11,746,102
Karyopharm Theraps	XPOVIO	selinexor	TABLET;ORAL	212306-002	Apr 15, 2021		RX	Yes	No
Karyopharm Theraps	XPOVIO	selinexor	TABLET;ORAL	212306-003	Apr 15, 2021		RX	Yes	No	11,787,771
Karyopharm Theraps	XPOVIO	selinexor	TABLET;ORAL	212306-002	Apr 15, 2021		RX	Yes	No

EU/EMA Drug Approvals for XPOVIO

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Stemline Therapeutics B.V.	Nexpovio	selinexor	EMEA/H/C/005127 NEXPOVIO is indicatedin combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.	Authorised	no	no	no	2021-03-26

International Patents for XPOVIO

When does loss-of-exclusivity occur for XPOVIO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

China

Colombia

Denmark

Eurasian Patent Organization

European Patent Office

Israel

Japan

Mexico

Morocco

New Zealand

Singapore

South Africa

South Korea

Spain

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering XPOVIO around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	20230042129	하이드라지드 함유 핵 수송 조절인자 및 이의 용도 (HYDRAZIDE CONTAINING NUCLEAR TRANSPORT MODULATORS AND USES THEREOF)
Colombia	2017001884	Polimorfos de selinexor
New Zealand	621520	Nuclear transport modulators and uses thereof
Hong Kong	1256745	含酰肼的核運輸調節劑及其用途 (HYDRAZIDE CONTAINING NUCLEAR TRANSPORT MODULATORS AND USES THEREOF)
European Patent Office	3333164	MODULATEURS DE TRANSPORT NUCLÉAIRE CONTENANT DE L'HYDRAZIDE ET LEURS UTILISATIONS (HYDRAZIDE CONTAINING NUCLEAR TRANSPORT MODULATORS AND USES THEREOF)
China	106083827	含酰肼的核运输调节剂及其用途 (Hydrazide Containing Nuclear Transport Modulators and Uses Thereof)
Chile	2015001257	Compuestos derivados de 3-(3-(3,5-bis(trifluorometil)fenil)-1h-1,2,4-triazol-1-il)-hidrazida; composicion farmaceutica; procedimiento para preprar precursores; procedimiento para tratar; uso para tratar trastornos asociados a crm1 tal como trastorno proliferativo, inflamatorio, entre otros (divisional de solicitud n° 225-2014).

Supplementary Protection Certificates for XPOVIO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2736887	C20210021 00403	Estonia		PRODUCT NAME: SELINEKSOOR;REG NO/DATE: EU/1/21/1537 29.03.2021
2736887	CR 2021 00031	Denmark		PRODUCT NAME: SELINEXOR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1537 20210329
2736887	LUC00219	Luxembourg		PRODUCT NAME: SELINEXOR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/21/1537 20210329
2736887	2021033	Norway		PRODUCT NAME: SELINEKSOR ELLER ET FARMASOEYTISK AKSEPTABELT SALT DERAV; REG. NO/DATE: EU/1/21/1537 20210408
2736887	2021C/532	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME
2736887	301119	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME
2736887	29/2021	Austria		PRODUCT NAME: SELINEXOR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1537 (MITTEILUNG) 20210329

XPOVIO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for XPOVIO

Introduction to XPOVIO

XPOVIO, also known as selinexor, is a groundbreaking drug developed by Karyopharm Therapeutics. It is the world's first orally available, selective inhibitor of the nuclear export protein XPO1, approved for various oncology indications including multiple myeloma, diffuse large B-cell lymphoma (DLBCL), and other hematological malignancies[4].

Mechanism of Action and Clinical Significance

XPOVIO functions by selectively binding to and inhibiting the nuclear export protein XPO1, which is crucial for the transport of proteins out of the nucleus. This mechanism of action offers a novel approach in cancer treatment, providing synergistic effects in combination regimens, a fast onset of action, and durable responses[4].

Market Performance: Recent Financial Results

2023 Financial Highlights

In 2023, Karyopharm reported total revenue of $146 million, with U.S. XPOVIO net product revenue of $112 million. Although this met the company's guidance, it was a slight decrease from the $120 million in U.S. XPOVIO net product revenue in 2022. The decline was attributed to increased utilization of the KaryForward Patient Assistance Program (PAP) and higher gross-to-net discounts due to 340B discounts and Medicaid rebates[1].

2024 Financial Performance

• Second Quarter 2024: U.S. XPOVIO net product revenue was $28.0 million, showing quarter-over-quarter growth in both new patient starts and refills. The community setting, which accounts for about 60% of overall net product revenues, saw over 10% growth. Despite competitive pressures, demand in the academic setting remained consistent[2].
• Third Quarter 2024: Net U.S. XPOVIO revenue was $29.5 million, with double-digit demand growth in the community setting. However, this was partially offset by higher gross-to-net discounts due to a higher proportion of 340B business[5].

Revenue Guidance and Projections

For 2024, Karyopharm has narrowed its total revenue guidance to $145 million to $155 million, with U.S. XPOVIO net product revenue expected to be in the range of $110 million to $115 million. This adjustment reflects the company's ongoing efforts to manage expenses and optimize revenue streams[5].

Key Factors Influencing Revenue

Patient Assistance Programs

Increased utilization of the KaryForward Patient Assistance Program (PAP) has impacted XPOVIO net product revenue. In 2023, this program contributed to about 10% of total demand, up from 5% in 2022, resulting in an estimated $6 million impact on revenue[1].

Competition and Discounts

Higher gross-to-net discounts, driven by increased 340B discounts and Medicaid rebates, have consistently affected XPOVIO net product revenue. This trend continued into 2024, with a notable impact on the third quarter's financial results[3][5].

Clinical Trials and Regulatory Approvals

Karyopharm is anticipating top-line data readouts from three pivotal Phase 3 trials in 2025, evaluating selinexor in endometrial cancer, myelofibrosis, and multiple myeloma. These trials are crucial for expanding XPOVIO's indications and enhancing its market position[1].

Global Expansion and Regulatory Approvals

XPOVIO has received regulatory approvals in 42 countries and regions, including recent approvals in Turkiye, South Korea, Thailand, and Malaysia. Favorable reimbursement decisions in France and Italy have also expanded global patient access[5].

Research and Development Highlights

Karyopharm continues to invest in R&D, with expenses projected to be in the range of $255 million to $265 million for 2024. This includes ongoing clinical trials and the development of selinexor in combination therapies for various diseases[5].

Intellectual Property and Patent Protection

The U.S. Patent and Trademark Office has issued patents related to the polymorphic form of selinexor, pharmaceutical compositions, and methods of treatment, which will expire in August 2035. This patent protection is vital for maintaining the drug's market exclusivity[1].

Cash Runway and Financial Sustainability

Karyopharm expects its existing cash, cash equivalents, and investments, along with revenue from XPOVIO sales and license agreements, to be sufficient to fund its operations into the first quarter of 2026. The company has also completed significant refinancing transactions and amended its royalty agreement to extend its financial runway[2][5].

Market Dynamics: Community vs. Academic Settings

XPOVIO has seen consistent growth in the community setting, which accounts for approximately 60% of overall net product revenues. However, the academic setting has faced competitive pressures, though demand for XPOVIO has continued to grow, particularly in its use preceding and following T-cell therapies[2][5].

Expert Insights and Market Potential

Richard Paulson, President and Chief Executive Officer of Karyopharm, highlighted the potential of selinexor to redefine the standard of care for patients with myelofibrosis and endometrial cancer, driven by its compelling clinical and preclinical data[2].

Key Takeaways

• Revenue Trends: XPOVIO's revenue has been impacted by patient assistance programs, higher gross-to-net discounts, and competitive pressures, but it continues to show growth in the community setting.
• Clinical Trials: Anticipated top-line data readouts from Phase 3 trials in 2025 are critical for expanding XPOVIO's indications.
• Global Expansion: Regulatory approvals and favorable reimbursement decisions have expanded global access to XPOVIO.
• Financial Sustainability: Karyopharm's financial management and refinancing transactions are expected to support operations into the first quarter of 2026.
• Market Potential: Selinexor's unique mechanism of action and growing clinical evidence position it for significant market impact.

Frequently Asked Questions

What is XPOVIO and how does it work?

XPOVIO, or selinexor, is an oral selective inhibitor of the nuclear export protein XPO1. It works by blocking the nuclear export protein, which is crucial for the transport of proteins out of the nucleus, offering a novel approach in cancer treatment[4].

What are the approved indications for XPOVIO?

XPOVIO is approved for multiple myeloma, diffuse large B-cell lymphoma (DLBCL), and other hematological malignancies. It is used in combination with other therapies or as a single agent in heavily pre-treated patients[1].

How has XPOVIO's revenue been affected in recent years?

XPOVIO's revenue has been impacted by increased utilization of patient assistance programs, higher gross-to-net discounts due to 340B discounts and Medicaid rebates, and competitive pressures in the academic setting[1][3][5].

What are the key upcoming milestones for XPOVIO?

Key upcoming milestones include top-line data readouts from three pivotal Phase 3 trials in 2025, evaluating selinexor in endometrial cancer, myelofibrosis, and multiple myeloma[1].

How is Karyopharm managing its financial sustainability?

Karyopharm has completed significant refinancing transactions, amended its royalty agreement, and is managing expenses to ensure its financial runway extends into the first quarter of 2026[2][5].

Cited Sources

1. Karyopharm Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Company Progress. Karyopharm Therapeutics.
2. Karyopharm Reports Second Quarter 2024 Financial Results and Highlights Recent Company Progress. PR Newswire.
3. Earnings call: Karyopharm Therapeutics reports on clinical and financial progress. Investing.com.
4. Antengene Announces Inclusion of XPOVIO® (selinexor) in 2023 China's National Reimbursement Drug List. PR Newswire.
5. Karyopharm Reports Third Quarter 2024 Financial Results and Highlights Recent Company Progress. Karyopharm Therapeutics.