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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 three patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-eight patent family members in fifteen 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 is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for LUTATHERA

International Patents:	38
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	41
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 of Wisconsin, Madison	Phase 1
University College, London	Phase 2
Pashtoon M. Kasi	Phase 2

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 three 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	10,596,278*PED				Y
Aaa Usa Inc	LUTATHERA	lutetium lu 177 dotatate	SOLUTION;INTRAVENOUS	208700-001	Jan 26, 2018		RX	Yes	Yes
Aaa Usa Inc	LUTATHERA	lutetium lu 177 dotatate	SOLUTION;INTRAVENOUS	208700-001	Jan 26, 2018		RX	Yes	Yes
Aaa Usa Inc	LUTATHERA	lutetium lu 177 dotatate	SOLUTION;INTRAVENOUS	208700-001	Jan 26, 2018		RX	Yes	Yes

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

European Patent Office

Germany

Israel

Japan

Mexico

Singapore

South Korea

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
European Patent Office	3826686	SOLUTIONS COMPLEXES CONCENTRÉES STABLES DE RADIONUCLÉIDES (STABLE, CONCENTRATED RADIONUCLIDE COMPLEX SOLUTIONS)
Germany	202018006567
Australia	2022203683	Stable, concentrated radionuclide complex solutions
Japan	2022500355	安定な濃厚放射性核種錯体溶液

Supplementary Protection Certificates for LUTATHERA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
4095130	2024C/528	Belgium		PRODUCT NAME: LUTETIUM (177LU) VIPIVOTIDE TETRAXETAN; AUTHORISATION NUMBER AND DATE: EU/1/22/1703 20221212
4095130	122024000038	Germany		PRODUCT NAME: (177LU)LUTETIUMVIPIVOTIDTETRAXETAN; REGISTRATION NO/DATE: EU/1/22/1703 20221209
4095130	CA 2024 00027	Denmark		PRODUCT NAME: LUTETIUM (177LU) VIPIVOTIDETETRAXETAN; REG. NO/DATE: EU/1/22/1703 20221212
4095130	301281	Netherlands		PRODUCT NAME: LUTETIUM (177-LU)-VIPIVOTIDE TETRAXETAN; REGISTRATION NO/DATE: EU/1/22/1703, 20221212

LUTATHERA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for LUTATHERA

Introduction

LUTATHERA, a peptide receptor radionuclide therapy (PRRT), has been a groundbreaking treatment for gastroenteropancreatic neuroendocrine tumors (GEP-NETs) since its FDA approval in 2018. Developed by Advanced Accelerator Applications (AAA), which was later acquired by Novartis, LUTATHERA has shown significant commercial success and is reshaping the landscape of cancer treatment.

FDA Approval and Clinical Efficacy

LUTATHERA was the first FDA-approved PRRT, marking a significant milestone in cancer therapy. The drug demonstrated a 48% reduction in the estimated risk of death and a 79% improvement in progression-free survival in midgut NET patients compared to octreotide LAR[3].

Market Performance

Sales Growth

LUTATHERA has exhibited robust sales growth since its approval. In 2020, it generated sales of $445 million, treating over 5,000 patients. By 2021, sales rose to $475 million, with the treatment available in approximately 450 centers globally[1].

In 2023, LUTATHERA's sales surged to $605 million, a 28% increase from 2022. This growth is attributed to increased demand and expanded indications, including its recent approval for use in pediatric patients with GEP-NETs[4].

Projected Sales

Analysts predict that LUTATHERA's sales could exceed $800 million in the future, driven by its accessibility to more hospitals and clinics, and the potential for further approvals[1].

Pricing and Dosage

LUTATHERA is priced using a value-based model, with a list price (WAC) of $55,896 per dose. Most patients require about four doses, with the same dosage applicable for both adults and adolescents[4].

Market Expansion

The approval of LUTATHERA for pediatric patients has broadened its therapeutic landscape, addressing a critical need for new treatment options in this vulnerable population. This expansion is expected to further increase LUTATHERA's market share in GEP-NET treatments[4].

Competitive Landscape

Novartis' Competitive Edge

Novartis holds a competitive edge due to LUTATHERA's first-in-class status and its approval for pediatric use. However, the company faces challenges from new rivals and expected generic entrants. For instance, Lantheus Holdings has submitted an Abbreviated New Drug Application (ANDA) for a generic version of LUTATHERA, which has been accepted by the FDA[4].

Industry Interest

The success of LUTATHERA has sparked significant interest in targeted radiation therapy within the pharmaceutical industry. Companies like AstraZeneca are investing in this area, with AstraZeneca acquiring Fusion Pharmaceuticals, a company developing next-generation radioconjugates[4].

Financial Performance of Novartis

Quarterly and Annual Sales

In Q3 2024, Novartis reported a 10% increase in net sales, driven by volume growth. LUTATHERA's sales growth contributed to this overall increase, with sales rising by 13% in constant currency terms across all regions[2].

For the full year 2023, Novartis' net sales were $45.4 billion, with an 8% increase driven by volume growth. Operating income and net income also saw significant increases, partly due to the performance of LUTATHERA and other key products[5].

Core Operating Income and Net Income

Core operating income for Novartis was $16.4 billion in 2023, with a margin of 33.5% of net sales. Net income was $8.6 billion, driven by higher operating income and favorable tax impacts[5].

Future Prospects

Research and Development

Novartis is actively investigating new isotopes, ligands, and combination therapies to extend the use of radioligand therapies beyond GEP-NETs into other cancer types such as prostate, breast, colon, lung, and pancreatic cancer. This ongoing research is expected to further boost the market potential of LUTATHERA and related therapies[4].

Market Impact

The success of LUTATHERA is likely to encourage further research and development in the field of neuroendocrine tumor treatments, leading to more innovative therapies. This could expand the market for these treatments, making them more accessible and effective for a broader range of patients[4].

Key Takeaways

• Robust Sales Growth: LUTATHERA has shown significant sales growth, reaching $605 million in 2023.
• Clinical Efficacy: The drug has demonstrated a 48% reduction in the estimated risk of death and a 79% improvement in progression-free survival.
• Market Expansion: Approval for pediatric use has broadened its therapeutic landscape.
• Competitive Edge: Novartis holds a competitive edge, but faces challenges from generic entrants.
• Future Prospects: Ongoing research aims to extend the use of radioligand therapies into other cancer types.

FAQs

Q: What is LUTATHERA used for?

LUTATHERA is used for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including its recent approval for use in pediatric patients.

Q: How much does LUTATHERA cost?

The list price (WAC) of LUTATHERA is $55,896 per dose, with most patients requiring about four doses.

Q: What are the projected sales for LUTATHERA?

Analysts predict that LUTATHERA's sales could exceed $800 million in the future.

Q: Who developed LUTATHERA?

LUTATHERA was developed by Advanced Accelerator Applications (AAA), which was later acquired by Novartis.

Q: What is the competitive landscape for LUTATHERA?

Novartis faces competition from new rivals and expected generic entrants, such as Lantheus Holdings, which has submitted an ANDA for a generic version of LUTATHERA.

Sources

1. Commercial and business aspects of alpha radioligand therapeutics - Frontiers in Medicine
2. Novartis continues strong momentum in Q3 with 10% sales growth - Novartis
3. Novartis' Bet Pays Off as Advanced Accelerator Applications Wins FDA Nod for LUTATHERA - BioSpace
4. LUTATHERA Reshapes Pediatric GEP-NET Treatment Paradigm - DelveInsight
5. Novartis Financial Results Q4 2023 – English - Novartis