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:	4
Clinical Trials:	1
Patent Applications:	36
DailyMed Link:	MIRALUMA at DailyMed

Recent Clinical Trials for MIRALUMA

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

Sponsor	Phase
GE Healthcare	Early Phase 1
M.D. Anderson Cancer Center	Early Phase 1
National Cancer Institute (NCI)	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	5,324,824
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	4,885,100
Lantheus Medcl	MIRALUMA	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785-003	May 23, 1997	4,894,445

International Patents for MIRALUMA

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

Country	Patent Number	Title	Estimated Expiration
Ireland	863353
Mexico	168821	PROCEDIMIENTO PARA LA PREPARACION DE ISONITRILOS SUSTITUIDOS CON ETER
European Patent Office	0211424	METAL-ISONITRILE ADDUCTS FOR PREPARING RADIONUCLIDE COMPLEXES
Greece	3000681
World Intellectual Property Organization (WIPO)	8303761
Denmark	174300
Portugal	83136	PROCESSO PARA A PREPARACAO DE COMPLEXOS DE RADIONUCLIDEOS MEDIANTE UTILIZACAO DE ADUCTOS DE METAL-ISONITRILO

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

MIRALUMA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Miraluma (Technetium Tc99m Sestamibi)

Introduction

Miraluma, also known as Technetium Tc99m Sestamibi, is a diagnostic agent primarily used for breast imaging to evaluate breast lesions. Here, we will delve into the market dynamics and financial trajectory of this drug, exploring its current status, trends, and future outlook.

Market Overview

Miraluma is part of the broader nuclear medicine market, which has seen steady growth driven by advancements in diagnostic technologies and increasing demand for precise diagnostic tools.

Current Market Size and Growth

While specific financial data for Miraluma alone is not readily available, the nuclear medicine market, of which Miraluma is a part, has been growing steadily. The overall diagnostic imaging market, including nuclear medicine, is influenced by factors such as the aging population, increased incidence of diseases, and technological advancements[3].

Key Applications and Uses

Miraluma is used for breast imaging, particularly for evaluating breast lesions. Its application in this niche area makes it a valuable tool in the early detection and diagnosis of breast cancer.

Market Trends

Technological Advancements

Advancements in nuclear medicine and diagnostic imaging technologies are driving the market forward. Innovations in imaging techniques and the development of new radiopharmaceuticals are expected to continue supporting the growth of the market[3].

Regulatory Environment

Regulatory changes and approvals play a crucial role in the market dynamics of diagnostic agents like Miraluma. Strict regulatory frameworks ensure the safety and efficacy of these products, which can impact their adoption and market performance.

Healthcare Spending

The overall trend in healthcare spending, including diagnostic imaging, has been influenced by factors such as reimbursement policies, patient affordability, and the impact of generic and biosimilar drugs. While total drug spending has grown below medical inflation in recent years, diagnostic imaging has seen more stable growth due to its essential role in healthcare[3].

Financial Trajectory

Revenue Streams

The revenue generated by Miraluma is part of the larger revenue streams from diagnostic imaging agents. These revenues are influenced by the number of procedures performed, the cost per procedure, and reimbursement rates.

Cost and Pricing

The cost of Miraluma, like other diagnostic agents, is subject to various factors including production costs, regulatory approvals, and market competition. Pricing strategies are often balanced between ensuring profitability and maintaining patient affordability.

Challenges and Opportunities

Competition

Miraluma faces competition from other diagnostic imaging agents and emerging technologies. The market is dynamic, with new products and technologies continually being developed, which can pose both challenges and opportunities for existing products.

Patent and Exclusivity

Unlike therapeutic drugs, diagnostic agents like Miraluma may not have the same level of patent protection. However, exclusivity periods and regulatory approvals can still provide a competitive edge.

Regional Market Analysis

Global Market

The global market for diagnostic imaging agents is diverse, with different regions having varying levels of demand and market penetration. Developed markets like North America and Europe tend to have higher adoption rates due to better healthcare infrastructure and higher per capita healthcare expenditure[4].

Emerging Markets

Emerging markets, particularly in Asia Pacific and Latin America, are seeing increased demand for diagnostic imaging agents due to growing awareness, improving healthcare access, and rising healthcare spending. These regions offer significant growth opportunities for Miraluma and similar products[4].

Future Outlook

Technological Innovations

The future of Miraluma and similar diagnostic agents is closely tied to technological innovations in nuclear medicine and diagnostic imaging. Advances in imaging techniques and the development of new radiopharmaceuticals are expected to drive growth.

Regulatory and Reimbursement Changes

Changes in regulatory frameworks and reimbursement policies will continue to influence the market. For instance, any changes in Medicare or Medicaid reimbursement rates in the U.S. could significantly impact the financial trajectory of Miraluma.

Key Takeaways

• Market Growth: The market for diagnostic imaging agents, including Miraluma, is expected to grow driven by technological advancements and increasing demand.
• Technological Innovations: Continued innovations in nuclear medicine and diagnostic imaging will be crucial for the future growth of Miraluma.
• Regulatory Environment: Regulatory changes and approvals will play a significant role in shaping the market dynamics.
• Financial Trajectory: The financial performance of Miraluma will be influenced by factors such as production costs, market competition, and reimbursement rates.

FAQs

Q: What is Miraluma used for? A: Miraluma (Technetium Tc99m Sestamibi) is used for breast imaging to evaluate breast lesions.

Q: How does the regulatory environment impact Miraluma? A: The regulatory environment ensures the safety and efficacy of Miraluma, influencing its adoption and market performance through strict approvals and guidelines.

Q: What are the key drivers of the market for diagnostic imaging agents like Miraluma? A: Key drivers include technological advancements, increasing demand for precise diagnostic tools, and changes in healthcare spending and reimbursement policies.

Q: How does competition affect Miraluma in the market? A: Miraluma faces competition from other diagnostic imaging agents and emerging technologies, which can pose both challenges and opportunities.

Q: What is the outlook for Miraluma in emerging markets? A: Emerging markets, particularly in Asia Pacific and Latin America, offer significant growth opportunities due to growing awareness, improving healthcare access, and rising healthcare spending.

Sources

1. The Business Research Company: Global Multiple Myeloma Drugs Market Report 2024
2. RxList: Miraluma (Technetium Tc99m sestamibi): Side Effects, Uses ...
3. IQVIA: Drug Expenditure Dynamics 1995-2020: Understanding Medicine Spending in Context U.S Detail
4. Coherent Market Insights: Lenalidomide Drug Market Size & Share Analysis - Growth Trends