SELINEXOR - Generic Drug Details

What are the generic sources for selinexor and what is the scope of freedom to operate?

Selinexor is the generic ingredient in one branded drug marketed by Karyopharm Theraps and is included in one NDA. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for SELINEXOR

International Patents:	131
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	47
Clinical Trials:	138
Patent Applications:	405
What excipients (inactive ingredients) are in SELINEXOR?	SELINEXOR excipients list
DailyMed Link:	SELINEXOR at DailyMed

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

Constraining patent/regulatory exclusivity:

10,519,139

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 SELINEXOR

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

Sponsor	Phase
AbbVie	Phase 3
Ruijin Hospital	Phase 2
Kathleen Dorritie	Phase 1/Phase 2

See all SELINEXOR clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for SELINEXOR

L01XX	Other antineoplastic agents
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for SELINEXOR

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	212306-004	Apr 15, 2021		RX	Yes	Yes	9,079,865
Karyopharm Theraps	XPOVIO	selinexor	TABLET;ORAL	212306-003	Apr 15, 2021		RX	Yes	No	11,807,629		Y	Y
Karyopharm Theraps	XPOVIO	selinexor	TABLET;ORAL	212306-004	Apr 15, 2021		RX	Yes	Yes

EU/EMA Drug Approvals for SELINEXOR

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 SELINEXOR

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

Supplementary Protection Certificates for SELINEXOR

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

SELINEXOR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Selinexor

Introduction to Selinexor

Selinexor, marketed as XPOVIO, is a cancer drug developed by Karyopharm Therapeutics. It has been approved for use in relapsed or refractory multiple myeloma and diffuse large B-cell lymphoma. Here, we delve into the market dynamics and financial trajectory of selinexor, highlighting key milestones, challenges, and future prospects.

Current Market Position

Revenue Performance

In 2023, Karyopharm reported total revenue of $146 million, with U.S. XPOVIO net product revenue of $112 million, meeting the company's guidance. However, this represented a slight decline from the $120 million in U.S. net product revenue in 2022, primarily due to increased competition in the academic setting and higher gross-to-net discounts driven by 340B discounts and Medicaid rebates[1][3].

Geographical Expansion

Selinexor has seen positive momentum in ex-U.S. markets, with continued regulatory and reimbursement approvals. This expansion is crucial for the drug's global market penetration and revenue growth[2].

Clinical Pipeline and Trials

Pivotal Phase 3 Trials

Karyopharm is conducting several pivotal Phase 3 trials evaluating selinexor in endometrial cancer, myelofibrosis, and multiple myeloma. Top-line data readouts from these trials are expected in 2025, which will be pivotal in determining the drug's future market potential[1][3].

Endometrial Cancer Trials

Despite initial setbacks, such as the failure of the SIENDO trial to yield clinically meaningful results, there is potential for selinexor in a subgroup of patients with TP53 wild-type cancer. The final endometrial cancer trial results will significantly influence Karyopharm's direction over the next few years[4].

Myelofibrosis and Multiple Myeloma Trials

The Phase 3 SENTRY trial for myelofibrosis has received favorable regulatory updates, with top-line data expected in the second half of 2025. Additionally, the company is evaluating an oral combination of selinexor, pomalidomide, and dexamethasone in patients with previously treated multiple myeloma, with enrollment expected to complete in the second half of 2024[1][5].

Challenges and Hurdles

Competition and Market Dynamics

Selinexor faces significant competition in the multiple myeloma space, with existing treatments offering similar or slightly better efficacy. The drug's median overall survival rate of 8.6 months in the Phase IIb STORM trial, while sufficient for FDA approval, may not be enough to secure uninterrupted market success[4].

Gross-to-Net Discounts and Patient Assistance Programs

Increased utilization of the KaryForward Patient Assistance Program and higher gross-to-net discounts due to 340B discounts and Medicaid rebates have adversely impacted XPOVIO net product revenue. This has resulted in an estimated impact of around $6 million in 2023[1][3].

Financial Outlook and Guidance

2024 Revenue Guidance

Karyopharm has provided a full-year 2024 total revenue guidance of $140 million to $160 million, including U.S. XPOVIO net product revenue guidance of $100 million to $120 million. The company has sufficient cash to continue operations through Q1 2026[1][3].

Recent Financial Performance

In Q3 2024, Karyopharm reported revenues of $38.8 million, with a slight decrease in XPOVIO net product revenue from the previous year. The company has narrowed its 2024 revenue guidance to $145 million to $155 million[5].

Intellectual Property and Regulatory Strength

Patent Protection

The U.S. Patent and Trademark Office has issued patents directed toward the polymorphic form of selinexor, pharmaceutical compositions, and methods of treatment, which will expire in August 2035. This provides a significant protective barrier for the drug's market exclusivity[1][3].

Operational Objectives and Catalysts

Clinical Data and Presentations

Karyopharm plans to present updated exploratory subgroup analysis results and additional data on selinexor's impact on T-cell fitness and combinability with multiple agents in 2024. These presentations are crucial for demonstrating the drug's efficacy and potential in various cancer types[1][3].

Commercial Foundation and Global Launches

The company is focused on maintaining its commercial foundation in the competitive multiple myeloma marketplace and driving increased XPOVIO revenues. Global launches and reimbursement approvals by partners in ex-U.S. territories are also key objectives[1][2].

Future Prospects and Market Potential

Potential in New Indications

Selinexor shows potential as a novel maintenance therapy in endometrial cancer, with top-line data from the ECO-042 trial expected in early 2026. The drug's success in myelofibrosis and endometrial cancer could significantly expand its market share[5].

Market Research and Physician Support

Strong connections with treating physicians and positive market research support selinexor's potential success upon approval. This indicates a favorable market reception if the upcoming trials yield positive results[5].

Key Takeaways

• Revenue Performance: Selinexor's revenue has been impacted by competition and gross-to-net discounts but remains a significant contributor to Karyopharm's total revenue.
• Clinical Pipeline: Pivotal Phase 3 trials in endometrial cancer, myelofibrosis, and multiple myeloma are critical for the drug's future market potential.
• Financial Outlook: Karyopharm has a narrowed revenue guidance for 2024 and sufficient cash to continue operations through Q1 2026.
• Regulatory Strength: Patent protection until 2035 provides market exclusivity for selinexor.
• Future Prospects: Success in new indications such as endometrial cancer and myelofibrosis could significantly expand the drug's market share.

FAQs

What is the current market position of selinexor?

Selinexor, marketed as XPOVIO, has a current market position with total revenue of $146 million in 2023, though it faced a slight decline in U.S. net product revenue due to increased competition and higher gross-to-net discounts.

What are the key clinical trials for selinexor?

Key clinical trials include the Phase 3 trials evaluating selinexor in endometrial cancer, myelofibrosis, and multiple myeloma, with top-line data readouts expected in 2025.

How does selinexor's intellectual property protect its market?

Selinexor's market is protected by patents issued by the U.S. Patent and Trademark Office, which will expire in August 2035, providing market exclusivity.

What are the financial challenges faced by Karyopharm?

Karyopharm faces challenges such as increased gross-to-net discounts, higher 340B utilization, and Medicaid rebates, which have impacted XPOVIO net product revenue. The company also has an operating income margin of -84.86%, indicating significant challenges in achieving profitability.

What are the future prospects for selinexor in new indications?

Selinexor shows potential as a novel maintenance therapy in endometrial cancer and has favorable regulatory updates for the Phase 3 SENTRY trial in myelofibrosis. Success in these indications could significantly expand its market share.

Citations

1. Karyopharm Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Company Progress. Karyopharm.
2. Karyopharm Reports Second Quarter 2024 Financial Results and Highlights Recent Company Progress. PR Newswire.
3. Karyopharm Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Company Progress. PR Newswire.
4. Despite Early Success, Karyopharm's Selinexor Faces Uncertain Path to Expansion. BioSpace.
5. Earnings call: Karyopharm Therapeutics reports on clinical and financial progress. Investing.com.