FLORBETABEN F-18 - Generic Drug Details

What are the generic drug sources for florbetaben f-18 and what is the scope of patent protection?

Florbetaben f-18 is the generic ingredient in one branded drug marketed by Life Molecular and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Florbetaben f-18 has thirty-five patent family members in twenty-seven countries.

One supplier is listed for this compound.

Summary for FLORBETABEN F-18

International Patents:	35
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	24
Patent Applications:	239
DailyMed Link:	FLORBETABEN F-18 at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for FLORBETABEN F-18

Constraining patent/regulatory exclusivity:

7,807,135

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 FLORBETABEN F-18

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

Sponsor	Phase
National Institutes of Health (NIH)	Phase 3
University of Pennsylvania	Phase 3
Life Molecular Imaging GmbH	Phase 3

See all FLORBETABEN F-18 clinical trials

Pharmacology for FLORBETABEN F-18

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Positron Emitting Activity

US Patents and Regulatory Information for FLORBETABEN F-18

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	7,807,135		Y	Y

International Patents for FLORBETABEN F-18

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1838298	Dérivés du stilbène et leur utilisation pour l'imagerie des plaques amyloïdes et pour se lier à elles (STILBENE DERIVATIVES AND THEIR USE FOR BINDING AND IMAGING AMYLOID PLAQUES)
France	15C0012
Eurasian Patent Organization	200701299	ПРОИЗВОДНЫЕ СТИЛЬБЕНА И ИХ ПРИМЕНЕНИЕ ДЛЯ СВЯЗЫВАНИЯ И ВИЗУАЛИЗАЦИИ АМИЛОИДНЫХ БЛЯШЕК
Ukraine	91996	ПРОИЗВОДНЫЕ СТИЛЬБЕНА И ИХ ПРИМЕНЕНИЕ ДЛЯ СВЯЗЫВАНИЯ И ВИЗУАЛИЗАЦИИ АМИЛОИДНЫХ БЛЯШЕК;ПОХІДНІ СТИЛЬБЕНУ ТА ЇХ ЗАСТОСУВАННЯ ДЛЯ ЗВ'ЯЗУВАННЯ ТА ВІЗУАЛІЗАЦІЇ АМІЛОЇДНИХ БЛЯШОК (STILBENE DERIVATIVES AND THEIR USE FOR BINDING AND IMAGING AMYLOID PLAQUES)

Supplementary Protection Certificates for FLORBETABEN F-18

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2213652	2015/008	Ireland		PRODUCT NAME: FLORBETABEN (18F); REGISTRATION NO/DATE: EU/1/13/906/001 20140220
2213652	504	Finland
2213652	PA2015005	Lithuania		PRODUCT NAME: FLORBETABENUM (18F); REGISTRATION NO/DATE: EU/1/13/906/001 20140220
2213652	122015000018	Germany		PRODUCT NAME: FLORBETABEN (18F); REGISTRATION NO/DATE: EU/1/13/906/001 20140220

FLORBETABEN F-18 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Florbetaben F-18

Introduction to Florbetaben F-18

Florbetaben F-18, also known by its trade name Neuraceq, is a radiopharmaceutical diagnostic agent used in Positron Emission Tomography (PET) imaging to detect β-amyloid neuritic plaques in the brain. This is crucial for the diagnosis and evaluation of Alzheimer's Disease (AD) and other cognitive impairments[4].

Regulatory Approval and Market Impact

In September 2023, Florbetaben F-18 received regulatory approval from the National Medical Products Administration (NMPA) in China, marking it as the first Aβ-PET imaging radiotracer approved for AD diagnosis in the country. This approval fills a significant market gap in the field of Aβ-PET diagnostic imaging agents in China[1][2].

Clinical Significance and Market Demand

The approval of Florbetaben F-18 is pivotal for early, accurate, and non-invasive diagnosis of AD. Early detection of β-amyloid plaques can occur 15-20 years before the onset of dementia symptoms, significantly improving diagnostic and therapeutic outcomes. The IDEAS study, involving 16,000 subjects, demonstrated that Aβ-PET diagnosis enhances clinical diagnostic confidence and reduces healthcare costs[1].

Financial Trajectory

Financing and Investment

The nuclear medicine sector, particularly the development of radiopharmaceuticals like Florbetaben F-18, has seen significant financial backing. In 2022, the annual cumulative financing in the nuclear medicine field in China amounted to nearly RMB 900 million. Sinotau, the company behind Florbetaben F-18, announced a new round of financing of over RMB 1.1 billion in July 2023, which will be used for research, development, and clinical applications of diagnostic and therapeutic radiopharmaceuticals[2].

Market Potential

The approval of Florbetaben F-18 opens a new chapter in AD diagnosis in China, a market that was previously devoid of such diagnostic tools. This new approval is expected to drive growth in the nuclear medicine sector, enhancing the competitiveness of Sinotau and contributing to the development of China’s nuclear drug industry[2].

Economic and Socioeconomic Value

Healthcare Cost Reduction

Early diagnosis using Aβ-PET imaging with Florbetaben F-18 can significantly reduce healthcare and care costs. The Aβ-PET Pharmacoeconomics Study showed that early diagnosis with Aβ-PET shortens the time to clinical confirmation of a patient’s diagnosis, reduces hospital admission risks by approximately 12%, and enhances physicians’ confidence in diagnosing the disease[1].

Socioeconomic Impact

The socioeconomic value of Florbetaben F-18 extends beyond healthcare costs. It improves the clinical care of patients and has a positive impact on societal well-being by enabling early intervention and potentially slowing disease progression[1].

Industry Trends and Future Outlook

Growing Demand for Nuclear Medicine

The nuclear medicine sector is experiencing a surge in interest and investment, particularly in China. The continuous financing and the high percentage of over 100 million financing events in this field indicate a strong market demand for innovative diagnostic and therapeutic radiopharmaceuticals[2].

Competitive Landscape

Sinotau’s successful approval of Florbetaben F-18 positions the company as a leader in the field of nuclear drugs in China. This approval enhances the company’s competitiveness and is expected to drive further innovation and development in the sector[2].

Challenges and Opportunities

Regulatory Hurdles

While Florbetaben F-18 has received approval in China, its path to approval in other countries, such as the United States, has been more complex. For instance, the FDA required additional clinical re-read studies before considering approval[3].

Market Expansion

The approval in China presents an opportunity for Sinotau to expand its market presence. As the first Aβ-PET imaging radiotracer approved in China, Florbetaben F-18 is poised to capture a significant share of the growing nuclear medicine market[1][2].

Expert Insights and Industry Reaction

"The successful approval of Florbetaben F 18 means that Sinotau has waded a new path for independent innovation through its own efforts, which will further enhance the competitiveness of the enterprise in the field of nuclear drugs and have a positive impact on the future development of its business." - Mrs. Yanmin Tang, Co-President of Sinotau[2].

Key Takeaways

• Regulatory Approval: Florbetaben F-18 is the first Aβ-PET imaging radiotracer approved for AD diagnosis in China.
• Market Impact: Fills a significant market gap in Aβ-PET diagnostic imaging agents in China.
• Financial Trajectory: Significant financing in the nuclear medicine sector, with Sinotau receiving over RMB 1.1 billion in funding.
• Economic and Socioeconomic Value: Reduces healthcare costs, shortens diagnosis time, and enhances clinical care.
• Industry Trends: Growing demand for nuclear medicine, particularly in China.
• Competitive Landscape: Positions Sinotau as a leader in nuclear drugs in China.

FAQs

Q: What is Florbetaben F-18 used for? A: Florbetaben F-18 is used for PET imaging of the brain to detect β-amyloid neuritic plaques, aiding in the diagnosis and evaluation of Alzheimer's Disease and other cognitive impairments[4].

Q: What is the significance of Florbetaben F-18's approval in China? A: The approval fills a significant market gap in Aβ-PET diagnostic imaging agents in China, enabling early, accurate, and non-invasive AD diagnosis[1][2].

Q: How does Florbetaben F-18 reduce healthcare costs? A: Early diagnosis with Aβ-PET imaging shortens the time to clinical confirmation, reduces hospital admission risks, and enhances physicians’ confidence in diagnosing the disease[1].

Q: What are the financial implications of Florbetaben F-18's approval? A: The approval has led to significant financing in the nuclear medicine sector, with Sinotau receiving over RMB 1.1 billion in funding for further research and development[2].

Q: What is the competitive position of Sinotau following the approval of Florbetaben F-18? A: Sinotau is now a leader in the field of nuclear drugs in China, enhancing its competitiveness and contributing to the development of China’s nuclear drug industry[2].

Sources

1. Sinotau - First Beta-Amyloid PET Tracer Florbetaben F-18 Injection Received Regulatory Approval in China.
2. Sinotau - Press Conference on the Regulatory Approval of Florbetaben F18 Injection.
3. FDA - 204677Orig1s000 ClinPharmR.pdf.
4. DrugBank - Florbetaben F-18: Uses, Interactions, Mechanism of Action.