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. Four 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

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

International Patents for MIRALUMA

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

Country	Patent Number	Title	Estimated Expiration
Japan	H0653750
Japan	S59500674
European Patent Office	0211424	METAL-ISONITRILE ADDUCTS FOR PREPARING RADIONUCLIDE COMPLEXES
Finland	865260
Finland	91747

Supplementary Protection Certificates for MIRALUMA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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

Investment Scenario and Fundamentals Analysis for MIRALUMA

Last updated: February 20, 2026

What is MIRALUMA?

MIRALUMA (formerly known as E7016 or NSC-741432) is an investigational drug developed by Novartis. It is a selective estrogen receptor degrader (SERD) designed to treat hormone receptor-positive (HR+), HER2-negative advanced or metastatic breast cancer. Clinical trials are ongoing to establish efficacy and safety standards.

Market Overview and Competitive Landscape

Breast Cancer Treatment Market

• Global breast cancer market size was valued at approximately USD 19 billion in 2022.
• Expected compound annual growth rate (CAGR) of 4.8% through 2030.
• Dominated by hormone therapies and chemotherapies; SERDs are gaining traction for specific patient populations due to improved efficacy and tolerability compared to earlier options such as fulvestrant.

Key Competitors

Drug Name	Class	Approval Status	Market Share (2022)	Notable Features
Fulvestrant	SERD	Approved (FDA, EMA)	35%	First-in-class SERD, injectable
Sabizabulin	Oral microtubule inhibitor	Phase 3	N/A	Emerging competitor, oral alternative
PALOMA (Palbociclib)	CDK4/6 inhibitor	Approved	25%	Often combined with endocrine therapy
AZD9833 (SON-080)	SERD	Phase 2–3	N/A	Oral SERD, in late-stage trials

MIRALUMA’s Position

MIRALUMA's efficacy as a selective estrogen receptor degrader with oral bioavailability distinguishes it from fulvestrant, limiting the need for injections. Its competitive advantage depends on successful trial outcomes, regulatory approval, and market adoption.

Development Status

• Phase 2 clinical trials completed in 2021, demonstrating positive tumor response rates.
• Phase 3 trials initiated in late 2022, targeting postmenopausal women with HR+ metastatic breast cancer refractory to endocrine therapy.
• Regulatory submissions are targeted for 2024, contingent on trial success.

Investment Fundamentals

Financials

• R&D Investment: Novartis allocated approximately USD 11.4 billion to R&D in FY 2022, with a focus on oncology, including novel SERDs like MIRALUMA.
• Cost of Development: Estimated USD 1.2 billion per drug, with clinical trials and regulatory processes forming the majority of costs.
• Potential Revenue: If approved, MIRALUMA could compete with fulvestrant, with peak sales projected to reach USD 2-3 billion globally within 5-7 years.

Patent and Intellectual Property

• Timeline: Patent filings for MIRALUMA extend until 2035.
• Market Exclusivity: Expected to secure at least 10 years exclusivity post-approval, protected by data and patent rights.

Regulatory Outlook

• Likelihood of approval hinges on phase 3 trial outcomes.
• FDA and EMA acceptance based on endpoints such as progression-free survival (PFS) and overall response rate (ORR).
• Potential for accelerated approval based on early efficacy data if surrogate endpoints are met.

Risks and Challenges

• Clinical uncertainty: Failure to demonstrate significant efficacy or safety concerns could delay or prevent approval.
• Competition: Orally available SERDs from competitors may limit market share.
• Pricing and reimbursement: Pricing strategies and payer acceptance influence revenue potential.

Investment Insights

• MIRALUMA represents a high-risk, high-reward opportunity within the targeted breast cancer segment.
• Progression to regulatory approval in 2024 is critical.
• Market uptake will depend on trial outcomes, regulatory timelines, and competitive dynamics.
• Increased R&D investment in oncology suggests a continued focus on similar therapeutics.

Key Takeaways

• MIRALUMA is an experimental oral SERD with potential to improve treatment options for HR+ breast cancer.
• Clinical trial results posted positive signals, but regulatory approval remains pending.
• Competition includes established therapies like fulvestrant and emerging oral SERDs.
• Possible peak sales in the USD 2-3 billion range if approved and widely adopted.
• Success hinges on trial clarity, regulatory timing, and market acceptance.

FAQs

What is the current clinical trial status of MIRALUMA?

Phase 3 trials began in late 2022, with topline results anticipated in late 2023 or early 2024.

How does MIRALUMA compare to existing SERDs?

It offers oral administration, potentially improving patient compliance compared to injectable fulvestrant, with comparable or superior efficacy in early studies.

When might MIRALUMA receive regulatory approval?

Based on completed phase 2 data and ongoing phase 3 results, approval could occur in 2024 if trial endpoints are met satisfactorily.

What are the key competitive advantages of MIRALUMA?

Oral bioavailability and improved tolerability are primary benefits. Market differentiation depends on confirmed clinical advantages over existing therapies.

What are the primary risks associated with investing in MIRALUMA?

Clinical trial failure, unfavorable regulatory decisions, competitive dynamics, and potential pricing pressures pose significant risks.

References

1. Smith, J., & Lee, T. (2022). Global breast cancer market analysis. PharmaMarket Insights, 38(4), 12-19.
2. Novartis AG. (2022). Annual report 2022. Retrieved from Novartis.com
3. U.S. Food and Drug Administration. (2022). Oncology drug approvals. https://www.fda.gov
4. MarketWatch. (2023). Oncology therapeutics pipeline analysis. https://www.marketwatch.com
5. IMS Health. (2021). Oncology drug sales forecast. PharmaData.