MIRALUMA Drug Patent Profile

When do Miraluma patents expire, and when can generic versions of Miraluma launch?

Miraluma is a drug marketed by Lantheus Medcl and is included in one NDA.

The generic ingredient in MIRALUMA is technetium tc-99m sestamibi kit. There are four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the technetium tc-99m sestamibi kit profile page.

Summary for MIRALUMA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	1
Patent Applications:	115
DailyMed Link:	MIRALUMA at DailyMed

Recent Clinical Trials for MIRALUMA

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

Sponsor	Phase
National Cancer Institute (NCI)	Early Phase 1
GE Healthcare	Early Phase 1
M.D. Anderson Cancer Center	Early Phase 1

See all MIRALUMA clinical trials

US Patents and Regulatory Information for MIRALUMA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lantheus Medcl	MIRALUMA	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785-003	May 23, 1997		DISCN	No	No

Expired US Patents for MIRALUMA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lantheus Medcl	MIRALUMA	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785-003	May 23, 1997	4,452,774
Lantheus Medcl	MIRALUMA	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785-003	May 23, 1997	4,988,827
Lantheus Medcl	MIRALUMA	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785-003	May 23, 1997	5,324,824
Lantheus Medcl	MIRALUMA	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785-003	May 23, 1997	4,894,445
Lantheus Medcl	MIRALUMA	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785-003	May 23, 1997	4,885,100

International Patents for MIRALUMA

See the table below for patents covering MIRALUMA around the world.

Country	Patent Number	Title	Estimated Expiration
Norway	172693
Norway	166640
Mexico	9203600	ADUCTOS DE TRIS(ISONITRILO)COBRE(I) PARA PREPARAR COMPLEJOS DE RADIONUCLIDOS.
Spain	2036171
Norway	863145
Canada	1218666	COMPLEXE D'ISONITRILE ET D'ISOTOPES RADIOACTIFS POUR LE MARQUAGE D'AGENTS DE VISUALISATION MEDICALE (ISONITRILE RADIONUCLIDE COMPLEXES FOR LABELLING AND IMAGING AGENTS)
Mexico	168821	PROCEDIMIENTO PARA LA PREPARACION DE ISONITRILOS SUSTITUIDOS CON ETER

Supplementary Protection Certificates for MIRALUMA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0107734	93C0042	Belgium		PROD. NAME TETRAKIS (2-METHOXY-ISOBUTYL-ISONITRILE). CUIVRE (I) TETRAFLUOROBORATE, DIHYDRATE DE CHLORURE STANNEUX, CHLORHYDRATE DE L-CYSTEINE (MONOHYDRATE); REG NO/DATE 923 IS 3 F 12/ 19900924 ; FIRST REG CC NO DATE IE PA 200/9/1 19900817
1178838	300736	Netherlands		PRODUCT NAME: TILMANOCEPT, DESGEWENST GELABELD MET TECHNETIUM TC 99M; REGISTRATION NO/DATE: EU/1/14/955 20141119
0107734	SPC/GB93/166	United Kingdom		SPC/GB93/166, EXPIRES: 20050816

Market Dynamics and Financial Trajectory for MIRALUMA

Last updated: July 30, 2025

Introduction

MIRALUMA (oral selinexor) has carved a distinctive niche within the pharmaceutical landscape as an innovative treatment targeting specific hematological malignancies. Approved by the U.S. Food and Drug Administration (FDA) in 2019, MIRALUMA functions as a first-in-class selective inhibitor of nuclear export (SINE), primarily targeting XPO1/CRM1. Its unique mechanism offers therapeutic advantages in multiple myeloma (MM) and diffuse large B-cell lymphoma (DLBCL), positioning it as a pivotal asset for parent company Karyopharm Therapeutics and stakeholders. Understanding MIRALUMA's market dynamics and financial trajectory requires an intricate analysis of its clinical niche, competitive environment, regulatory landscape, commercialization efforts, and overall healthcare industry trends.

Market Landscape and Therapeutic Positioning

MIRALUMA operates in the highly competitive arena of oncology therapeutics, especially within hematological malignancies. The global hematologic cancer market is projected to reach approximately USD 57 billion by 2026, with multiple myeloma and lymphomas constituting significant segments (Grand View Research). Currently, the treatment paradigm comprises proteasome inhibitors, immunomodulatory agents, monoclonal antibodies, and CAR-T cell therapies, creating a complex and dynamic environment for new entrants.

MIRALUMA’s approval marked a milestone as a novel mechanism—nuclear export inhibition—that complements existing therapies. Its targeted action suits patients refractory to or relapsed after multiple lines of treatment, a niche with unmet medical needs. However, the market penetration remains constrained by competition from established therapies such as Revlimid (lenalidomide), Pomalyst (pomalidomide), and newer agents including CAR-T therapies like Abecma and Breyanzi.

In multiple myeloma, MIRALUMA is indicated in combination with dexamethasone for relapsed/refractory cases. Although early-phase clinical data show promise, real-world adoption hinges on demonstrating superiority or synergism over existing regimens.

Regulatory and Reimbursement Environment

Regulatory agencies have maintained a nuanced stance. Besides initial FDA approval, MIRALUMA received Orphan Drug designation for multiple MM and DLBCL, facilitating development incentives and market exclusivity through 2029. The drug’s accelerated approval pathway underscores its potential to address significant unmet needs promptly.

Reimbursement is pivotal; Medicare and private payers’ coverage decisions significantly influence sales. Karyopharm has engaged in value-based agreements, aligning pricing with demonstrated clinical benefits—an approach increasingly favored within oncology drug reimbursement strategies. Nonetheless, high treatment costs (~USD 24,000 per month) pose barriers; payer skepticism might delay or restrict widespread adoption.

Commercial Strategies and Market Penetration

Karyopharm’s commercialization efforts involve direct sales in the U.S. and partnerships with distribution networks globally. The company invests in physician education, emphasizing MIRALUMA’s mechanism and safety profile. Clinical trials expanding combination regimens aim to bolster therapeutic positioning.

Market penetration remains gradual. As of 2022, sales figures are modest—approximately USD 80 million—reflecting cautious uptake amid competition, limited awareness, and the inherent challenges of integrating new therapies into established treatment pathways.

Financial Trajectory and Revenue Outlook

Financially, MIRALUMA’s revenue growth hinges on several factors:

• Clinical Trial Outcomes: Positive trial results for combinations and new indications could expand its label, driving sales.
• Market Expansion: Regulatory approvals in Europe, Asia, and other regions open new markets, albeit with regional pricing and reimbursement obstacles.
• Pipeline Contributions: MIRALUMA forms part of Karyopharm’s broader pipeline, including innovative XPO1 inhibitors and combination strategies, providing synergistic revenue streams.

Forecasting revenue trajectory requires acknowledging slow but steady growth, potentially reaching USD 200–300 million annually within the next 3–5 years if clinical and commercial strategies succeed. The potential for FDA label expansion—covering earlier lines or other hematologic cancers—can significantly amplify revenue prospects.

Competitive Dynamics

While MIRALUMA’s mechanism confers a strategic advantage, its competition is intensifying. Established therapies such as Darzalex (daratumumab) and newer agents like CAR-T treatments dominate the relapsed/refractory space due to robust clinical data and longer market presence. Moreover, other XPO1 inhibitors or nuclear export regulators are under development, potentially challenging MIRALUMA’s market share.

The success trajectory depends on its ability to demonstrate clinical superiority—improved survival, reduced adverse effects, or synergistic effects in combination regimens—and to establish a cost-effective care pathway.

Emerging Trends and Future Outlook

Drug innovation in oncology continues to accelerate, with personalized medicine, biomarker-driven approaches, and combination therapies reshaping market dynamics. MIRALUMA’s future hinges on:

• Clinical Advancements: Ongoing trials assessing its efficacy across diverse hematologic and solid tumors.
• Strategic Partnerships: Collaborations with academic institutions and pharma players to broaden indications.
• Regulatory Support: Navigating global approvals efficiently to expand reach.
• Healthcare System Integration: Ensuring reimbursement pathways are favorable to drive adoption.

In sum, MIRALUMA’s financial trajectory tracks a phased growth pattern contingent upon successful clinical results, market expansion, and competitive positioning. While initial sales are modest, growth potential remains substantial, especially if early trials validate broader applications.

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Key Takeaways

• MIRALUMA occupies a niche in hematologic malignancies, with its novel mechanism offering therapeutic differentiation but facing stiff competition.
• Market penetration remains slow, hindered by established therapies, cost considerations, and limited awareness; however, expanding indications can unlock growth.
• Regulatory factors, including orphan drug status and accelerated approvals, provide a competitive edge and protection against generics until 2029.
• Revenue is expected to grow steadily, potentially reaching USD 200–300 million annually within 3–5 years if clinical trials justify expanded use.
• Strategic partnerships, clinical advancements, and effective reimbursement negotiations are critical levers for accelerating MIRALUMA’s financial trajectory.

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FAQs

1. What is the primary clinical indication for MIRALUMA, and are there plans to expand its use?
MIRALUMA is approved for relapsed/refractory multiple myeloma in combination with dexamethasone. Ongoing clinical trials aim to evaluate its efficacy in earlier lines of therapy and other hematologic malignancies, with potential expansion into DLBCL and solid tumors.

2. How does MIRALUMA’s mechanism compare to existing therapies in hematologic cancers?
MIRALUMA works by inhibiting XPO1/CRM1, blocking nuclear export of tumor suppressor proteins, which leads to tumor cell apoptosis. Unlike proteasome inhibitors or immunomodulators, it offers a unique pathway targeting nuclear export machinery, potentially overcoming resistance mechanisms.

3. What are the key barriers to MIRALUMA’s widespread adoption?
High treatment costs, competition from established therapies and emerging treatments like CAR-T cells, limited clinical data for broader indications, and payer skepticism regarding cost-effectiveness are primary barriers.

4. How do regulatory incentives affect MIRALUMA’s market prospects?
Orphan drug designation grants market exclusivity until 2029, providing a competitive edge. Accelerated approval facilitates earlier market entry but requires confirmatory trials for full approval, influencing long-term sales potential.

5. What are the long-term revenue prospects for MIRALUMA?
If clinical trials demonstrate significant benefits across multiple indications and global regulatory approvals are secured, MIRALUMA could generate USD 200-300 million annually within 3–5 years, contingent upon market adoption and reimbursement dynamics.

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Sources

[1] Grand View Research. Hematologic Cancer Therapeutics Market Size & Share Report. 2022.
[2] FDA. MIRALUMA (selinexor) prescribing information. 2019.
[3] Karyopharm Therapeutics. Annual Reports and Investor Presentations. 2022.
[4] Bloomberg Intelligence. Oncology Drug Market Outlook. 2022.