ABLAVAR Drug Patent Profile

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

Ablavar is a drug marketed by Lantheus Medcl and is included in one NDA.

The generic ingredient in ABLAVAR is gadofosveset trisodium. Additional details are available on the gadofosveset trisodium profile page.

Summary for ABLAVAR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	9
Clinical Trials:	9
Patent Applications:	217
DailyMed Link:	ABLAVAR at DailyMed

Recent Clinical Trials for ABLAVAR

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

Sponsor	Phase
Paul Finn	Phase 4
Maastricht University Medical Center	Phase 4
Maastricht University Medical Center

See all ABLAVAR clinical trials

US Patents and Regulatory Information for ABLAVAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lantheus Medcl	ABLAVAR	gadofosveset trisodium	SOLUTION;INTRAVENOUS	021711-001	Dec 22, 2008		DISCN	No	No
Lantheus Medcl	ABLAVAR	gadofosveset trisodium	SOLUTION;INTRAVENOUS	021711-002	Dec 22, 2008		DISCN	No	No

Expired US Patents for ABLAVAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lantheus Medcl	ABLAVAR	gadofosveset trisodium	SOLUTION;INTRAVENOUS	021711-001	Dec 22, 2008	8,394,356
Lantheus Medcl	ABLAVAR	gadofosveset trisodium	SOLUTION;INTRAVENOUS	021711-001	Dec 22, 2008	5,362,475
Lantheus Medcl	ABLAVAR	gadofosveset trisodium	SOLUTION;INTRAVENOUS	021711-002	Dec 22, 2008	7,060,250
Lantheus Medcl	ABLAVAR	gadofosveset trisodium	SOLUTION;INTRAVENOUS	021711-002	Dec 22, 2008	7,011,815

EU/EMA Drug Approvals for ABLAVAR

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
TMC Pharma Services Ltd.	Ablavar (previously Vasovist)	gadofosveset trisodium	EMEA/H/C/000601 This medicinal product is for diagnostic use only.Ablavar is indicated for contrast-enhanced magnetic resonance angiography (CE-MRA) for visualisation of abdominal or limb vessels in adults only, with suspected or known vascular disease.	Withdrawn	no	no	no	2005-10-03

International Patents for ABLAVAR

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

Country	Patent Number	Title	Estimated Expiration
Sweden	512863	Diagnostisk komposition innehållande minst ett fysiologiskt fördragbart komplexsalt
Australia	1018688
Japan	4950110
Australia	4654396

Supplementary Protection Certificates for ABLAVAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0806968	SPC/GB07/011	United Kingdom		PRODUCT NAME: GADOFOSVESET TRISODIUM; REGISTERED: UK EU/1/05/313/001 20051003; UK EU/1/05/313/002 20051003; UK EU/1/05/313/003 20051003; UK EU/1/05/313/004 20051003; UK EU/1/05/313/005 20051003; UK EU/1/05/313/006 20051003; UK EU/1/05/313/007 20051003; UK EU/1/05/313/008 20051003; UK EU/1/05/313/009 20051003
0806968	300253	Netherlands		300253, 20160116, EXPIRES: 20201002
0806968	PA2007003	Lithuania		PRODUCT NAME: GADOFOSVESETUM TRINATRICUM; REG NO/DATE: EU/1/05/313/001-009 20051005
0071564	SPC/GB93/060	United Kingdom

ABLAVAR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ABLAVAR

Introduction

ABLAVAR (gadofosveset trisodium injection) is a unique, injectable magnetic resonance angiography (MRA) blood pool imaging agent developed by Lantheus Medical Imaging, Inc. This article delves into the market dynamics and financial trajectory of ABLAVAR, highlighting its launch, indications, market impact, and financial performance.

Launch and Global Expansion

ABLAVAR was launched in the United States in January 2010, marking a significant milestone as the first and only FDA-approved contrast agent for use with MRA to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease (PVD)[4].

Following its U.S. launch, Lantheus expanded ABLAVAR's availability to Canada in October 2010, as part of its international growth strategy to increase access to innovative diagnostic imaging tools[1].

Indications and Clinical Use

ABLAVAR is clinically proven to produce high-resolution MRA images, combining both dynamic (first pass) and steady-state imaging. It is specifically indicated for evaluating AIOD, a type of PVD that can lead to severe complications such as pain, infection, and even loss of limbs if left untreated[4].

The agent's ability to provide comprehensive, three-dimensional diagnostic information has been praised by clinicians for improving patient treatment decisions and care[4].

Market Impact

The introduction of ABLAVAR has significantly impacted the diagnostic imaging market, particularly in the radiology and peripheral vascular disease segments. It has extended Lantheus's presence into MRI, in addition to its existing portfolio of SPECT, PET, and echocardiography imaging modalities[4].

Competitive Landscape

ABLAVAR's unique approval for MRA indications sets it apart from other contrast agents. Its use in nearly 90,000 patients across 37 countries outside the U.S. underscores its global acceptance and clinical utility[4].

Patient and Clinician Benefits

For patients, ABLAVAR offers a more accurate and detailed diagnostic tool, which can lead to better treatment outcomes. For clinicians, it provides a valuable addition to the existing diagnostic arsenal, enhancing their ability to evaluate and manage vascular diseases[4].

Financial Performance

Revenue Contribution

ABLAVAR has been a solid contributor to Lantheus's revenue. The company's annual reports indicate that ABLAVAR, along with other products, has provided a stable base of recurring revenue. In 2010, ABLAVAR was expected to be a key factor in the company's long-term growth due to its attractive product attributes and potential market demand[5].

Market Growth Potential

The financial trajectory of ABLAVAR is tied to the growing demand for advanced diagnostic imaging agents. The market for diagnostic imaging agents is expanding, driven by the increasing prevalence of vascular diseases and the need for accurate diagnostic tools. Lantheus's strategy to expand ABLAVAR's availability globally aligns with this market trend, positioning the company for continued growth[1][4].

Safety and Contraindications

While ABLAVAR has been well-received, it is not without contraindications. A history of a prior allergic reaction to a gadolinium-based contrast agent is a significant contraindication. This highlights the need for careful patient selection and monitoring to ensure safe use[1][4].

Regulatory and Patent Landscape

Lantheus acquired exclusive rights for ABLAVAR in the United States, Canada, and Australia in April 2009 and later purchased the balance of the worldwide rights in July 2010. The company's patent portfolio for ABLAVAR has been deemed recoverable, indicating a strong intellectual property position that supports its long-term growth strategy[1][5].

Future Outlook

The future outlook for ABLAVAR remains positive, driven by its unique clinical benefits and the expanding need for advanced diagnostic imaging. As Lantheus continues to invest in research and development and expands its global presence, ABLAVAR is expected to remain a key product in the company's portfolio.

Market Trends

The diagnostic imaging market is influenced by trends such as the increasing use of MRI and the demand for more accurate and detailed diagnostic tools. These trends are likely to continue driving the adoption of ABLAVAR and other advanced imaging agents[4].

Key Takeaways

• Launch and Expansion: ABLAVAR was launched in the U.S. in January 2010 and later in Canada, marking significant milestones in its global expansion.
• Clinical Use: It is indicated for evaluating aortoiliac occlusive disease in adults with known or suspected peripheral vascular disease.
• Market Impact: ABLAVAR has extended Lantheus's presence into the MRI segment and provided a valuable diagnostic tool for clinicians.
• Financial Performance: It has been a solid contributor to Lantheus's revenue and is expected to continue driving growth.
• Safety and Contraindications: Careful patient selection is necessary due to contraindications related to allergic reactions to gadolinium-based contrast agents.
• Regulatory and Patent Landscape: Lantheus holds strong intellectual property rights for ABLAVAR, supporting its long-term growth strategy.

FAQs

What is ABLAVAR used for?

ABLAVAR is used as a contrast agent in magnetic resonance angiography (MRA) to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease.

When was ABLAVAR launched in the United States?

ABLAVAR was launched in the United States in January 2010.

What sets ABLAVAR apart from other contrast agents?

ABLAVAR is the first and only FDA-approved contrast agent for use with MRA to evaluate AIOD, providing both dynamic and steady-state imaging.

What are the contraindications for ABLAVAR?

A history of a prior allergic reaction to a gadolinium-based contrast agent is a significant contraindication for ABLAVAR.

How has ABLAVAR impacted the diagnostic imaging market?

ABLAVAR has extended Lantheus's presence into the MRI segment and provided a valuable diagnostic tool for clinicians, enhancing the evaluation and management of vascular diseases.

Sources

1. Lantheus Medical Imaging, Inc. Launches ABLAVAR® in Canada - Lantheus Holdings.
2. AbbVie Reports Full-Year and Fourth-Quarter 2023 Financial Results - AbbVie.
3. Drug Bioavailability Enhancement Market - Roots Analysis - Roots Analysis.
4. Lantheus Medical Imaging, Inc. Launches ABLAVAR™ (Gadofosveset Trisodium) - Lantheus Medical Imaging, Inc.
5. Lantheus Medical Imaging, Inc. - Annual Reports - Annual Reports.