NEURACEQ Drug Patent Profile

When do Neuraceq patents expire, and what generic alternatives are available?

Neuraceq is a drug marketed by Life Molecular and is included in one NDA. There is one patent protecting this drug.

This drug has thirty-five patent family members in twenty-seven countries.

The generic ingredient in NEURACEQ is florbetaben f-18. One supplier is listed for this compound. Additional details are available on the florbetaben f-18 profile page.

DrugPatentWatch^® Generic Entry Outlook for Neuraceq

Neuraceq was eligible for patent challenges on March 21, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 18, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for NEURACEQ

International Patents:	35
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	6
Patent Applications:	88
What excipients (inactive ingredients) are in NEURACEQ?	NEURACEQ excipients list
DailyMed Link:	NEURACEQ at DailyMed

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

NDA:

204677

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 NEURACEQ

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

Sponsor	Phase
Life Molecular Imaging GmbH	Phase 3
William Charles Kreisl	Phase 1/Phase 2
Ulsan University Hospital	N/A

See all NEURACEQ clinical trials

Pharmacology for NEURACEQ

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Positron Emitting Activity

US Patents and Regulatory Information for NEURACEQ

NEURACEQ is protected by one US patents.

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
Life Molecular	NEURACEQ	florbetaben f-18	SOLUTION;INTRAVENOUS	204677-001	Mar 19, 2014		RX	Yes	Yes			Y	Y

International Patents for NEURACEQ

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

Country	Patent Number	Title	Estimated Expiration
China	101151886
European Patent Office	2213652	Dérivés de stilbène et leur utilisation pour l'imagerie des plaques amyloïdes et leur liaison (Stilbene derivatives and their use for binding and imaging amyloid plaques)
Israel	183946	STILBENE DERIVATIVES AND THEIR USE FOR BINDING AND IMAGING AMYLOID PLAQUES
Mexico	2007007380	DERIVADOS DE ESTILBENO Y SU USO PARA ESTUDIOS DE UNION Y POR IMAGENES DE PLACAS AMILOIDES. (STILBENE DERIVATIVES AND THEIR USE FOR BINDING AND IMAGING AMYLOID PLAQUES.)
New Zealand	555942	Radiolabelled tilbene derivatives and their use for binding and imaging amyloid plaques
Portugal	2213652
World Intellectual Property Organization (WIPO)	2006066104

Supplementary Protection Certificates for NEURACEQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2213652	132015902339134	Italy		PRODUCT NAME: FLORBETABEN (18)(NEURACEQ); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/906, 20140224
2213652	2015/008	Ireland		PRODUCT NAME: FLORBETABEN (18F); REGISTRATION NO/DATE: EU/1/13/906/001 20140220
2213652	8/2015	Austria		PRODUCT NAME: FLORBETABEN (18 F); REGISTRATION NO/DATE: EU/1/13/906/001 (MITTEILUNG) 20140224
2213652	C20150010 00142	Estonia		PRODUCT NAME: FLORBETABEEN (18F);REG NO/DATE: EU/1/13/906 24.02.2014
2213652	C300719	Netherlands		PRODUCT NAME: FLORBETABEN (18F); REGISTRATION NO/DATE: EU/1/13/906 20140220
2213652	PA2015005	Lithuania		PRODUCT NAME: FLORBETABENUM (18F); REGISTRATION NO/DATE: EU/1/13/906/001 20140220
2213652	SPC/GB15/010	United Kingdom		PRODUCT NAME: FLORBETABEN (18F), WHICH IS (4-((E)-2-(4-(2-(2-(2-(1F)FLUOROETHOXY)ETHOXY)ETHOXY)PHENYL)ETHENYL)-N-METHYLANILINE); REGISTERED: UK EU/1/13/906/001 20140224

Market Dynamics and Financial Trajectory for Neuraceq

Introduction

Neuraceq, a radiotracer developed by Life Molecular Imaging (LMI), has been a pivotal player in the diagnosis and management of Alzheimer's disease and other neurodegenerative conditions. Here, we delve into the market dynamics and financial trajectory of Neuraceq, highlighting its significance, market trends, and financial performance.

What is Neuraceq?

Neuraceq is an FDA-approved imaging agent used for the detection of beta-amyloid plaques in the brains of adult patients with cognitive impairment. It is administered as part of a PET-CT scan, enabling the identification of amyloid proteins central to the diagnosis of Alzheimer's disease (AD)[1][4].

Market Demand and Growth

The demand for Neuraceq has been driven by several factors, including the increasing prevalence of dementia. Alzheimer's disease, which accounts for a significant proportion of dementia cases, is expected to affect 152 million people by 2050, up from 50 million in 2020. This growing patient population has fueled the need for accurate diagnostic tools like Neuraceq[1].

Clinical Trials and Therapeutic Use

Neuraceq has seen continued demand for its use in ongoing clinical trials for potential Alzheimer's drugs. The approval of Biogen's Aduhelm, an anti-amyloid therapy, has further increased the relevance of Neuraceq in diagnosing and monitoring patients eligible for such treatments. However, the clinical demand related to PET-CT scanning for patients starting Aduhelm treatment has been slow due to pending reimbursement and treatment pathways in the US[1].

Financial Performance

Revenue Growth

In 2021, LMI reported a significant increase in revenue, primarily driven by Neuraceq sales. The company's revenue grew to £19 million, a 25.4% increase from £15 million in 2020. This growth underscores the commercial success and market acceptance of Neuraceq[1].

Manufacturing and Distribution

To meet the increasing demand, LMI has expanded its manufacturing and distribution capabilities. For instance, the strategic partnership with SOFIE Biosciences has enabled the distribution of Neuraceq from SOFIE's radiopharmaceutical manufacturing site in Cleveland, Ohio. This expansion has improved supply capabilities and patient access to Neuraceq[4].

Market Trends

Radiopharmaceutical Market

The radiopharmaceutical market, within which Neuraceq operates, is expected to grow significantly. The market is projected to increase by USD 4.61 billion at a CAGR of 10.22% from 2023 to 2027, with North America contributing 42% to this growth. The demand for diagnostics using radioisotopes, particularly in chronic conditions like cancer and neurodegenerative diseases, is driving this expansion[3].

Outsourcing and Contract Manufacturing

The pharmaceutical industry's trend towards outsourcing and contract manufacturing is also beneficial for Neuraceq. Companies like Jubilant Pharma are expanding their capabilities to meet the complex production needs of biologics and personalized medicines, which includes radiopharmaceuticals like Neuraceq[3].

Competitive Landscape

Product Pipeline

LMI's product pipeline includes several other neurodegenerative and cardiovascular products, positioning the company for future growth beyond Neuraceq. This diversification strategy aims to address various diagnostic needs in the healthcare sector[1].

Challenges and Opportunities

Regulatory and Reimbursement

One of the challenges facing Neuraceq is the pending reimbursement for Aduhelm in the US. Until reimbursement pathways are finalized, the clinical demand for Neuraceq related to Aduhelm treatment is expected to remain low. However, once these hurdles are overcome, the demand is likely to increase significantly[1].

Technological Advancements

The adoption of advanced manufacturing technologies and the integration of emerging technologies are expected to enhance the production and distribution of Neuraceq. This could lead to improved supply chain efficiency and better patient access[3].

Quotes from Industry Experts

"Expanding Neuraceq manufacturing in Mobile in collaboration with Jubilant, further reinforces Life Molecular Imaging's commitment to meeting the increasing demand for amyloid detection to confirm eligibility for new therapies," said Colleen Ruby, US Country and Chief Operating Officer, Americas and APAC[3].

Illustrative Statistics

• Revenue Growth: £19 million in 2021, up 25.4% from £15 million in 2020[1].
• Market Projection: The radiopharmaceutical market is expected to increase by USD 4.61 billion at a CAGR of 10.22% from 2023 to 2027[3].
• Patient Impact: More than 6.2 million Americans are currently living with Alzheimer's disease[3].

Key Takeaways

• Neuraceq is a critical diagnostic tool for Alzheimer's disease, with growing demand driven by increasing dementia prevalence.
• The product has seen significant revenue growth, driven by its use in clinical trials and therapeutic applications.
• Market trends, including the growth of the radiopharmaceutical market and outsourcing in pharmaceutical manufacturing, favor Neuraceq's continued success.
• Regulatory and reimbursement challenges need to be addressed to fully realize the product's potential.

FAQs

What is Neuraceq used for?

Neuraceq is used for the detection of beta-amyloid plaques in the brains of adult patients with cognitive impairment, primarily for diagnosing Alzheimer's disease.

How has Neuraceq impacted LMI's revenue?

In 2021, Neuraceq sales drove LMI's revenue to £19 million, a 25.4% increase from £15 million in 2020.

What are the challenges facing Neuraceq's clinical demand?

The clinical demand for Neuraceq related to Aduhelm treatment is slow due to pending reimbursement and treatment pathways in the US.

How is the radiopharmaceutical market expected to grow?

The radiopharmaceutical market is expected to increase by USD 4.61 billion at a CAGR of 10.22% from 2023 to 2027.

What is the significance of Neuraceq in the pharmaceutical industry?

Neuraceq is a key imaging biomarker for the appropriate characterization of subjects assessed for treatment eligibility with newly approved anti-amyloid drugs and for enrollment in clinical trials to further support drug development in neurodegenerative diseases.

Sources

1. Life Healthcare Online: International business review | Integrated Report 2021
2. NeurAxis Inc.: NeurAxis Reports Fourth Quarter and Fiscal Year 2023 Financial
3. Synapse: Jubilant Pharma Ltd. - Drug pipelines, Patents, Clinical trials
4. PR Newswire: Life Molecular Imaging and SOFIE announce Neuraceq availability in Cleveland
5. Neurocrine Biosciences: Neurocrine Biosciences Reports Fourth Quarter and Fiscal 2022 Financial Results and Provides Financial Expectations for 2023