HEMANGEOL Drug Patent Profile

Which patents cover Hemangeol, and what generic alternatives are available?

Hemangeol is a drug marketed by Pierre Fabre and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has forty-seven patent family members in thirty-one countries.

The generic ingredient in HEMANGEOL is propranolol hydrochloride. There are twenty-two drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the propranolol hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Hemangeol

A generic version of HEMANGEOL was approved as propranolol hydrochloride by INNOGENIX on October 22^nd, 1985.

Summary for HEMANGEOL

International Patents:	47
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	156
Clinical Trials:	4
Patent Applications:	4,079
Drug Prices:	Drug price information for HEMANGEOL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for HEMANGEOL
What excipients (inactive ingredients) are in HEMANGEOL?	HEMANGEOL excipients list
DailyMed Link:	HEMANGEOL at DailyMed

See drug prices for HEMANGEOL

Recent Clinical Trials for HEMANGEOL

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

Sponsor	Phase
Christiana Care Health Services	Phase 1
Columbia University	Phase 2
United States Department of Defense	Early Phase 1

See all HEMANGEOL clinical trials

Pharmacology for HEMANGEOL

Drug Class	beta-Adrenergic Blocker
Mechanism of Action	Adrenergic beta-Antagonists

Paragraph IV (Patent) Challenges for HEMANGEOL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
HEMANGEOL	Oral Solution	propranolol hydrochloride	4.28 mg/mL	205410	1	2022-07-21

US Patents and Regulatory Information for HEMANGEOL

HEMANGEOL is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pierre Fabre	HEMANGEOL	propranolol hydrochloride	SOLUTION;ORAL	205410-001	Mar 14, 2014		RX	Yes	Yes	8,338,489
Pierre Fabre	HEMANGEOL	propranolol hydrochloride	SOLUTION;ORAL	205410-001	Mar 14, 2014		RX	Yes	Yes	8,987,262

International Patents for HEMANGEOL

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

Country	Patent Number	Title	Estimated Expiration
Slovenia	2233135
Hong Kong	1140530	USE OF A BETA BLOCKER FOR THE MANUFACTURE OF A MEDICAMENT FOR THE TREATMENT OF HEMANGIOMAS
European Patent Office	2233135	Utilisation de bêtabloquants pour la fabrication d'un médicament pour le traitement d'hémangiomes (Use of a beta blocker for the manufacture of a medicament for the treatment of hemangiomas)
Taiwan	I531365
European Patent Office	2050441	Utilisation de bêtabloquants pour la fabrication d'un médicament pour le traitement d'hémangiomes (Use of beta blocker for the manufacture of a medicament for the treatment of hemangiomas)
Chile	2008003083	Uso de un beta bloqueador seleccionado de un beta bloqueador no selectivo y/o un beta bloqueador selectivo beta-1 para preparar un medicamento util para el tratamiento de los hemangiomas.

HEMANGEOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for HEMANGEOL

Introduction to HEMANGEOL

HEMANGEOL, a pediatric formulation of propranolol hydrochloride, is specifically designed for the treatment of infantile hemangiomas. Approved by the U.S. Food and Drug Administration (FDA) in March 2014, it has revolutionized the management of this common childhood condition[5].

Market Growth and Projections

The market for HEMANGEOL is experiencing robust growth, driven by several key factors:

Increasing Prevalence of Infantile Hemangiomas

The rising cases of infantile hemangiomas are a significant driver for the market. Infantile hemangiomas are the most common tumors of childhood, and their treatment is becoming increasingly important[5].

Market Size and Forecast

The Hemangeol Sales Market is projected to see substantial expansion from 2023 to 2031. The market size is expected to grow significantly, with the forecast period indicating robust growth rates. The market is categorized by type (oral solution, injectable) and application (infantile hemangioma, cardiovascular diseases), with geographical regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa contributing to its growth[1].

Geographical Segmentation

The market is segmented geographically, with North America and Europe being key regions due to advanced healthcare infrastructure and higher healthcare expenditure. The Asia-Pacific region is also showing significant growth, driven by economic development and increasing healthcare spending[1][4].

Key Drivers

Rising Healthcare Expenditure

Increased healthcare expenditure in developed countries is a major driver. For instance, in the U.S., healthcare expenditure has seen a significant rise, with a total expenditure of USD 3.3 trillion in 2016, indicating a strong financial backing for healthcare services and products[4].

Early Detection and Awareness

Growing rates of early detection and awareness of infantile hemangiomas are fueling the market. Early assessment and treatment can mitigate complications associated with these tumors, leading to increased demand for effective treatments like HEMANGEOL[5].

Research Funding and Innovations

Rising research funding and the development of innovative products are also driving the market. Companies like Pierre Fabre S.A. are continuously developing and marketing new pharmaceutical products, including HEMANGEOL, to address various medical conditions[4].

Competitive Landscape

Key Players

The Hemangeol Sales Market is dominated by several prominent players, including Pierre Fabre Group, Vifor Pharma, Sun Pharmaceutical Industries Ltd., Novartis AG, Pfizer Inc., GlaxoSmithKline plc, Abbott Laboratories, Bayer AG, Sanofi SA, and Boehringer Ingelheim International GmbH. These companies are actively involved in the development and marketing of HEMANGEOL and other related treatments[1].

Market Competition

The market is highly competitive, with various existing and new players entering the scene. Companies are focusing on innovative products and treatments to control infantile hemangiomas, which is driving market competition and growth[4].

Financial Performance

Revenue Projections

The Hemangeol Sales Market is expected to achieve significant revenue growth throughout the forecast period. The market size is projected to expand substantially, with the value measured in USD million across various segments[1].

Cost and Pricing

The cost of treatment with HEMANGEOL is a critical factor. While the drug is effective, it is important to balance the cost with the benefits. The market report provides detailed information on product pricing and the extent of product penetration at national and regional levels[1].

Challenges and Restraints

Side Effects and Efficacy

Despite the positive growth, the market faces challenges such as the side effects of HEMANGEOL. Common adverse reactions include sleep disorders, respiratory tract infections, diarrhea, and vomiting. Severe side effects like bradycardia and hypotension can also occur, which may impact market growth[3].

High Cost of Alternative Treatments

The high cost of alternative treatments, such as laser therapy, is another restraint. The estimated physician fee for laser skin resurfacing is about USD 3,361, which can be a significant barrier for some patients[4].

Mechanism of Action and Efficacy

Clinical Trials and Outcomes

HEMANGEOL has shown significant efficacy in clinical trials. A pivotal Phase II/III clinical trial demonstrated that 60% of infants treated with HEMANGEOL achieved complete or nearly complete resolution of infantile hemangioma, compared to 4% in the placebo group[3].

Mechanism of Action

The mechanism of action of HEMANGEOL involves local hemodynamic effects, anti-angiogenic effects, and apoptosis triggering effects on capillary endothelial cells. This multi-faceted approach contributes to its effectiveness in treating infantile hemangiomas[3].

Safety Profile

Monitoring and Adverse Reactions

The safety profile of HEMANGEOL requires careful monitoring. Healthcare providers must monitor heart rate and blood pressure after treatment initiation or dose increases. Common adverse reactions include sleep disorders, respiratory tract infections, and gastrointestinal issues. Severe reactions like bradycardia and hypotension necessitate immediate medical attention[2].

Dosing and Administration

Convenience and Safety

HEMANGEOL is administered twice daily for 6 months, with dosing adjusted periodically based on the child’s weight. It is crucial to administer the drug during or right after feeding to reduce the risk of hypoglycemia. The dosing calculator is a valuable tool for healthcare professionals to determine the recommended dosing volume[2].

Key Takeaways

• The Hemangeol Sales Market is expected to experience robust growth from 2023 to 2031.
• Key drivers include rising healthcare expenditure, early detection and awareness, and research funding.
• The market is highly competitive with prominent players like Pierre Fabre Group and Novartis AG.
• HEMANGEOL has shown significant efficacy in treating infantile hemangiomas, but it also comes with potential side effects.
• Careful monitoring and proper dosing are essential for safe administration.

Frequently Asked Questions (FAQs)

1. What is HEMANGEOL used for?

HEMANGEOL is used for the treatment of infantile hemangiomas requiring systemic therapy. It is specifically designed for infants aged 5 weeks to 5 months with proliferating infantile hemangiomas[2].

2. How is HEMANGEOL administered?

HEMANGEOL is administered twice daily for 6 months, with the dose adjusted periodically based on the child’s weight. It should be given during or right after feeding to reduce the risk of hypoglycemia[2].

3. What are the common side effects of HEMANGEOL?

Common side effects include sleep disorders, respiratory tract infections, diarrhea, and vomiting. Severe side effects can include bradycardia and hypotension[3].

4. What is the mechanism of action of HEMANGEOL?

The mechanism of action involves local hemodynamic effects, anti-angiogenic effects, and apoptosis triggering effects on capillary endothelial cells[3].

5. Who are the key players in the Hemangeol Sales Market?

Key players include Pierre Fabre Group, Vifor Pharma, Sun Pharmaceutical Industries Ltd., Novartis AG, Pfizer Inc., and others[1].

Cited Sources:

1. Market Research Intellect. Hemangeol Sales Market Size, Scope And Forecast Report. November 2024.
2. Hemangeol. Dosing & Administration - Hemangeol.
3. Hemangeol. About Hemangeol | Discovery of Propranolol.
4. Market Research Future. Hemangioma Market Projected to Grow Radiantly by 2030. January 2022.
5. Effective Healthcare. Strategies to Treat and Manage Infantile Hemangioma.