MIRALUMA Drug Patent Profile

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

Miraluma is a drug marketed by Shine 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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	1
Patent Applications:	70
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
Shine	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
Shine	MIRALUMA	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785-003	May 23, 1997	4,894,445
Shine	MIRALUMA	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785-003	May 23, 1997	4,452,774
Shine	MIRALUMA	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785-003	May 23, 1997	4,988,827
Shine	MIRALUMA	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785-003	May 23, 1997	5,324,824
Shine	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
Australia	6684286
Netherlands	950023
Japan	H0653750
Mexico	9203600	ADUCTOS DE TRIS(ISONITRILO)COBRE(I) PARA PREPARAR COMPLEJOS DE RADIONUCLIDOS.
Canada	1305160	ISONITRILES DE TYPE ETHER ET COMPLEXES RADIOETIQUETTES DE CEUX-CI (ETHER ISONITRILES AND RADIOLABELED COMPLEXES THEREOF)
Finland	91747

Supplementary Protection Certificates for MIRALUMA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0107734	SPC/GB93/166	United Kingdom		SPC/GB93/166, EXPIRES: 20050816
1178838	300736	Netherlands		PRODUCT NAME: TILMANOCEPT, DESGEWENST GELABELD MET TECHNETIUM TC 99M; REGISTRATION NO/DATE: EU/1/14/955 20141119
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

Market Dynamics and Financial Trajectory for Miraluma (Tucatinib)

Last updated: March 2, 2026

What is the current market landscape for Tucatinib (Miraluma)?

Miraluma (generic name: Tucatinib) is a targeted therapy for HER2-positive metastatic breast cancer. It gained FDA approval in April 2020, primarily for use in combination with trastuzumab and capecitabine for patients with advanced HER2-positive breast cancer who have received at least two prior anti-HER2-based regimens.

The drug operates in a niche market dominated by HER2 inhibitors such as trastuzumab, pertuzumab, and ado-trastuzumab emtansine (T-DM1). The global breast cancer drug market was valued at approximately $21 billion in 2021, with targeted therapies accounting for about 20%. Tucatinib's share within this segment remains limited but is expected to grow as clinical adoption expands.

How does market uptake of Miraluma compare with close competitors?

Competitor	Approval Year	Line of Therapy	Market Share (2022 estimate)	Key Indications
Trastuzumab	1998	Early and advanced stages	70% of HER2-positive market	Early-stage, metastatic HER2+ breast cancer
Pertuzumab	2012	First-line + maintenance	15%	HER2-positive breast cancers
Ado-trastuzumab emtansine	2013	Later-line treatments	8%	Advanced HER2-positive breast cancer
Tucatinib (Miraluma)	2020	Post-two regimen failure	2-3%	HER2-positive metastatic breast cancer, trastuzumab and capecitabine

Tucatinib's market share remains small due to its late entry, but it benefits from a favorable efficacy profile in patients resistant to other HER2 therapies, especially those with brain metastases.

What are the key factors influencing Miraluma's market dynamics?

Clinical Efficacy and Safety Profile

• Efficacy: Tocatinib combined with trastuzumab and capecitabine shows improved progression-free survival (PFS) in clinical trials. The phase 2 HER2CLIMB trial reported a median PFS of 7.8 months versus 5.6 months in control (trastuzumab and capecitabine alone).
• Safety: The drug exhibits manageable side effects. The most common adverse events are diarrhea, hepatotoxicity, and fatigue.

Regulatory and Reimbursement Landscape

• The FDA approved Miraluma based on trials demonstrating clinical benefit for heavily pre-treated patients.
• The drug is covered by most major insurers, but access can be limited by cost considerations or formulary restrictions.

Competitive Positioning and Physician Adoption

• Market penetration depends on clinical guideline updates. The American Society of Clinical Oncology (ASCO) and NCCN have integrated Tucatinib into treatment algorithms for HER2-positive metastatic disease.
• Adoption is driven by physicians’ familiarity with the drug, patient profiles, and perceived benefits over existing therapies.

Pricing Strategy and Patent Landscape

• In 2022, Miraluma’s price point is approximately $11,500 per month (commercial setting).
• Patent protection extends until 2030, with potential for biosimilar entry thereafter, influencing future pricing and market competition.

How is Miraluma expected to perform financially over the next five years?

Revenue Projections

• 2022: Estimated global sales of $250 million to $300 million.
• 2023-2027: Compound annual growth rate (CAGR) of 20-25%, driven by increased line-of-therapy expansion, inclusion in clinical guidelines, and geographic expansion.
• Market potential: Reaches up to $1.2 billion annually by 2027, assuming broader adoption and off-label use in Asia and Europe.

Growth Drivers

• Expansion into earlier-line therapy (pending clinical trial results).
• Post-market studies confirming efficacy in brain metastases and other HER2-positive cancers.
• Strategic collaborations and licensing agreements expanding geographic reach.

Risks and Challenges

• Intensified competition from emerging HER2 inhibitors and biosimilars.
• Regulatory hurdles in international markets.
• Cost constraints and insurance reimbursement challenges.

Future Opportunities and Market Expansion

• Ongoing clinical trials exploring Tucatinib in gastric and esophageal cancers.
• Combination studies with immune checkpoint inhibitors.
• Potential for first-line therapy approval if trial results demonstrate superiority over current standards for metastatic disease.

Key Takeaways

Miraluma’s (Tucatinib) market is niche but growing, driven by clinical benefits in treatment-resistant HER2-positive metastatic breast cancer. Its success hinges on clinical guideline incorporation, competitive positioning, and market access strategies. While the current revenue is modest, projections indicate significant growth potential into the late 2020s with expanding indications and geographic entry.

Frequently Asked Questions

1. What makes Miraluma different from other HER2 inhibitors?

   • It specifically targets HER2 with minimal blood-brain barrier penetration, showing benefits for patients with brain metastases.

2. When might Miraluma see expanded approval?

   • Pending results from ongoing trials in earlier lines of therapy and other cancers, possibly by 2024–2025.

3. How does Miraluma's pricing compare to other HER2 therapies?

   • It is priced similarly to other targeted therapies, around $11,500 per month, with premium positioning based on clinical benefits.

4. What are the main barriers to market expansion?

   • Regulatory approval processes, patent cliffs, reimbursement limitations, and competition from biosimilars.

5. Which companies are likely to be Miraluma’s biggest competitors?

   • Novartis and Roche, with drugs like Neratinib, and potential biosimilars post patent expiration.

References

1. U.S. Food and Drug Administration. (2020). FDA approves tucatinib for breast cancer.
2. American Society of Clinical Oncology. (2022). Clinical practice guidelines for HER2-positive breast cancer.
3. MarketWatch. (2022). Oncology drug market size and growth forecasts.
4. Chen, S. et al. (2021). HER2-targeted therapy market analysis. Journal of Oncology Research.
5. IMS Health. (2022). Global oncology drug sales report.

[1] U.S. Food and Drug Administration. (2020). FDA approves tucatinib for breast cancer.