LUTATHERA Drug Patent Profile

Which patents cover Lutathera, and when can generic versions of Lutathera launch?

Lutathera is a drug marketed by Aaa Usa Inc and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-four patent family members in twenty-four countries.

The generic ingredient in LUTATHERA is lutetium lu 177 dotatate. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lutetium lu 177 dotatate profile page.

DrugPatentWatch^® Generic Entry Outlook for Lutathera

Lutathera was eligible for patent challenges on January 26, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 25, 2039. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for LUTATHERA

International Patents:	74
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	46
Drug Prices:	Drug price information for LUTATHERA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LUTATHERA
What excipients (inactive ingredients) are in LUTATHERA?	LUTATHERA excipients list
DailyMed Link:	LUTATHERA at DailyMed

See drug prices for LUTATHERA

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

Constraining patent/regulatory exclusivity:

10,596,278*PED

NDA:

208700

Dosage:

SOLUTION;INTRAVENOUS

^*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 LUTATHERA

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

Sponsor	Phase
University Hospital, Grenoble	PHASE3
Fundacin de investigacin HM	PHASE2
The Taylor Family 2010 Charitable Trust	PHASE2

See all LUTATHERA clinical trials

Paragraph IV (Patent) Challenges for LUTATHERA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LUTATHERA	Injection	lutetium lu 177 dotatate	10 mCi/mL	208700	1	2023-11-13

US Patents and Regulatory Information for LUTATHERA

LUTATHERA is protected by eight US patents and six FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 10,596,278.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aaa Usa Inc	LUTATHERA	lutetium lu 177 dotatate	SOLUTION;INTRAVENOUS	208700-001	Jan 26, 2018		RX	Yes	Yes	12,168,063		Y
Aaa Usa Inc	LUTATHERA	lutetium lu 177 dotatate	SOLUTION;INTRAVENOUS	208700-001	Jan 26, 2018		RX	Yes	Yes	12,161,732*PED				Y
Aaa Usa Inc	LUTATHERA	lutetium lu 177 dotatate	SOLUTION;INTRAVENOUS	208700-001	Jan 26, 2018		RX	Yes	Yes	12,151,003*PED				Y

International Patents for LUTATHERA

When does loss-of-exclusivity occur for LUTATHERA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Colombia

Croatia

Denmark

European Patent Office

Finland

Germany

Israel

Japan

Lithuania

Mexico

Poland

Portugal

Serbia

Singapore

Slovenia

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering LUTATHERA around the world.

Country	Patent Number	Title	Estimated Expiration
China	120860272	稳定的、浓缩的放射性核素络合物溶液
China	120860271	稳定的、浓缩的放射性核素络合物溶液
Finland	3826686

Supplementary Protection Certificates for LUTATHERA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
4095130	2490022-7	Sweden		PRODUCT NAME: LUTETIUM (177LU) VIPIVOTIDE TETRAXETAN; REG. NO/DATE: EU/1/22/1703 20221212
4095130	202440024	Slovenia		PRODUCT NAME: LUTETIUM (177LU) VIPIVOTIDE TETRAXETAN; NATIONAL AUTHORISATION NUMBER: EU/1/22/1703; DATE OF NATIONAL AUTHORISATION: 20221209; AUTHORITY FOR NATIONAL AUTHORISATION: EU
4095130	2024C/528	Belgium		PRODUCT NAME: LUTETIUM (177LU) VIPIVOTIDE TETRAXETAN; AUTHORISATION NUMBER AND DATE: EU/1/22/1703 20221212

Market Dynamics and Financial Trajectory for LUTATHERA (Lutetium Lu 177 Dotatate)

Last updated: November 20, 2025

Introduction

LUTATHERA (lutetium Lu 177 dotatate) has emerged as a pivotal therapy in the treatment of somatostatin receptor-positive neuroendocrine tumors (NETs), a niche yet significant segment of oncology. Approved by the FDA in January 2018, LUTATHERA represents a significant advancement in peptide receptor radionuclide therapy (PRRT), combining targeted radiation with neuroendocrine tumor management. This analysis evaluates the evolving market landscape, competitive environment, revenue potential, and future financial prospects of LUTATHERA, considering current trends and strategic factors impacting its trajectory.

Market Overview and Therapeutic Significance

Neuroendocrine tumors are rare, often indolent malignancies that pose diagnostic and therapeutic challenges. While surgical resection remains the mainstay, metastatic or inoperable cases demand systemic approaches. Historically, treatment options included somatostatin analogs and chemotherapy, but these offered limited efficacy. The advent of PRRT, especially with radiolabeled somatostatin analogs like LUTATHERA, has transformed the treatment paradigm, demonstrating improved progression-free survival (PFS) and quality-of-life metrics.

LUTATHERA specifically binds to somatostatin receptor subtype 2 (SSTR2), delivering targeted radiotherapy via lutetium-177. Clinical data from the NETTER-1 trial evidenced a substantial reduction in disease progression, elevating its status as a breakthrough therapy [1].

Market Dynamics

Growth Drivers

1. Unmet Medical Need: With limited efficacious options for advanced NETs, LUTATHERA addresses a significant therapeutic void, fostering strong clinical demand.
2. Regulatory Approvals and Payer Acceptance: Approval by major jurisdictions, led by the FDA (2018) and EMA (2017), facilitated market entry. Payer coverage expansions following positive trial outcomes enhance reimbursement prospects.
3. Clinical Evidence and Outcomes: The robustness of clinical data accelerates physician adoption. The NETTER-1 trial contributed to establishing LUTATHERA as a standard first-line PRRT.
4. Global Expansion: Beyond North America and Europe, emerging markets exhibit growing adoption potential, triggered by increasing neuroendocrine tumor prevalence and healthcare investments.

Market Challenges

1. Competition: Radionuclide therapies like Octreotide's long-acting formulations maintain a foothold, although they do not provide direct radiotherapeutic action. Upcoming or alternative therapies, such as peptide analogs labeled with alpha emitters (e.g., Actinium-225), threaten future dominance.
2. Operational and Logistical Constraints: PRRT requires specialized facilities, trained personnel, and isotope supply chains, potentially limiting widespread dissemination.
3. Pricing and Cost-Effectiveness: High upfront costs of PRRT limit uptake in price-sensitive markets, despite compelling clinical benefits.
4. Regulatory and Reimbursement Variability: Differing national policies and reimbursement frameworks impact accessibility.

Financial Trajectory and Revenue Projections

Initial Market Penetration

Since its launch, LUTATHERA has seen a steady increase in prescriptions, driven by growing physician familiarity and expanding indications. Its primary revenue stream stems from sales in the metastatic NET population, with estimates indicating approximately 60,000 to 70,000 eligible patients globally [2].

Revenue Growth Patterns

Analysts project compound annual growth rates (CAGR) of 15-20% over the next five years, leveraging several factors:

• Increasing Diagnosis Rates: Improved imaging and awareness contribute to earlier detection.
• Expanded Indications: Ongoing research may extend LUTATHERA's use to other somatostatin receptor-positive tumors.
• Dose Optimization and Re-treatment: Evolving protocols can increase use frequency and dosage, boosting revenue.

Market Share and Competitive Position

Despite competition, LUTATHERA maintains a robust share within the PRRT landscape, owing to its proven efficacy and regulatory endorsement. The emergence of novel radiopharmaceuticals threatens its dominance but provides incremental growth rather than immediate obsolescence.

Pricing Strategy and Reimbursement

Pricing varies globally, with the U.S. unit price estimated between $30,000 and $50,000 per treatment cycle. Reimbursement policies and access influence actual market penetration. Cost-effectiveness analyses favor LUTATHERA for eligible patients, which is instrumental in securing payer support.

Strategic Outlook and Long-Term Financial Prospects

The preliminary pipeline includes investigational uses for other neuroendocrine malignancies and combination therapies, which could propel further growth. Additionally, geographic expansion into emerging markets, with targeted marketing and infrastructure development, will be pivotal.

Investment in manufacturing capacity and supply chain robustness, especially considering the isotope's short half-life, underpins sustainability. Innovations in dosimetry and personalized treatment regimens could improve clinical outcomes and enable premium pricing models, improving margins.

Regulatory and Economic Considerations

Regulatory agencies are scrutinizing long-term safety profiles and quality controls, impacting approval timelines for new indications. Economic evaluations stress the value of LUTATHERA, especially for advanced NETs, supporting favorable reimbursement decisions.

Conclusion

LUTATHERA stands at the cusp of significant financial growth driven by ongoing demand for effective neuroendocrine tumor therapies. Market expansion hinges on addressing logistical challenges, broadening indications, and integrating cost-effective approaches. Its future trajectory appears promising, contingent on continued clinical validation and strategic market positioning.

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Key Takeaways

• Market Expansion: Increasing incidence and earlier diagnosis of NETs globally underpin sustained growth for LUTATHERA.
• Revenue Drivers: Efficacy demonstrated in pivotal trials, coupled with expanding indications and geographic reach, will further elevate sales.
• Competitive Edge: Proven clinical benefit keeps LUTATHERA competitive despite emerging therapies, though vigilance to innovation is necessary.
• Operational Challenges: Facility requirements and isotope supply chain logistics pose barriers to rapid adoption; investments synergize with market growth.
• Business Strategy: Partnerships, resource allocation for manufacturing, and targeted reimbursement negotiations are critical to maximizing financial potential.

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FAQs

1. What is the current market size for LUTATHERA?
   Approximately 60,000 to 70,000 patients globally are eligible for LUTATHERA therapy, translating into a multi-hundred-million-dollar market annually, considering pricing and utilization rates.

2. How does LUTATHERA compare economically to traditional treatments?
   While upfront costs are higher, clinical data show improved progression-free survival and quality of life, rendering LUTATHERA cost-effective in many healthcare settings, especially with supportive reimbursement policies.

3. What are the primary barriers to market expansion for LUTATHERA?
   Key hurdles include logistical challenges related to isotope supply and facility requirements, regulatory approvals for new indications, and payer reimbursement policies.

4. Are there promising competitors or alternatives to LUTATHERA?
   Emerging therapies with alpha emitters like actinium-225 are under investigation; however, they are not yet commercially dominant. The current landscape favors LUTATHERA’s established efficacy.

5. What future developments could influence LUTATHERA’s financial outlook?
   Advances in combination therapies, new indications, improved manufacturing, and broader international approval are poised to further expand market penetration and revenue.

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References

[1] Bodei, L., et al. (2017). Efficacy and safety of lutetium 177 dotatate in neuroendocrine tumors. The New England Journal of Medicine, 376(2), 154-165.

[2] Grand View Research. (2022). Peptide Receptor Radionuclide Therapy Market Size, Share & Trends Analysis.