HEMANGEOL Drug Patent Profile

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

Hemangeol is a drug marketed by Pierre 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 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:	128
Clinical Trials:	4
Patent Applications:	4,440
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
University of Missouri-Columbia	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	HEMANGEOL	propranolol hydrochloride	SOLUTION;ORAL	205410-001	Mar 14, 2014		RX	Yes	Yes	8,338,489
Pierre	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
Taiwan	200932207	Use of a beta blocker for the manufacture of a medicament for the treatment of hemangiomas
Canada	2701953
World Intellectual Property Organization (WIPO)	2009050567
Russian Federation	2471500	ПРИМЕНЕНИЕ БЕТА-БЛОКАТОРА ДЛЯ ИЗГОТОВЛЕНИЯ ЛЕКАРСТВЕННОГО СРЕДСТВА ДЛЯ ЛЕЧЕНИЯ ГЕМАНГИОМ (USE OF BETA BLOCKER FOR PREPARING DRUG FOR TREATING HEMANGIOMAS)
Argentina	068927
South Korea	20100087012	USE OF A BETA BLOCKER FOR THE MANUFACTURE OF A MEDICAMENT FOR THE TREATMENT OF HEMANGIOMAS
Austria	E512661

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: HEMANGEOL

Last updated: July 27, 2025

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Introduction

The pharmaceutical landscape is continually evolving, driven by innovative therapies, regulatory shifts, and unmet medical needs. Among these, HEMANGEOL—a branded formulation of propranolol—has carved a niche owing to its unique clinical application in pediatric hemangiomas. Understanding the market dynamics and financial trajectory surrounding HEMANGEOL is crucial for stakeholders, including investors, healthcare providers, and competitors, to navigate this specialized segment effectively.

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Product Overview and Indications

HEMANGEOL (propranolol hydrochloride) is a prescription medication approved primarily for the treatment of infantile hemangiomas, a common vascular tumor in neonates and infants. Since its FDA approval in 2014, HEMANGEOL has gained prominence as the first systemic therapy specifically indicated for problematic hemangiomas requiring pharmacologic intervention, offering an alternative to invasive procedures and corticosteroids. Its efficacy in shrinking hemangiomas, combined with a manageable safety profile, has driven clinical adoption.

Market Drivers

1. Growing Incidence of Infantile Hemangiomas

The global incidence of infantile hemangiomas ranges from 4% to 5% among infants, with higher prevalence in females and preterm infants [1]. The growing awareness among pediatricians about early diagnosis and intervention fuels demand for targeted therapies like HEMANGEOL.

2. Clinical Efficacy and Safety Profile

HEMANGEOL demonstrates a high success rate in reducing tumor size, with fewer side effects compared to traditional corticosteroid treatments [2]. These benefits foster its acceptance as the first-line therapy and expand its use in various clinical settings.

3. Regulatory Adaptations and Expanding Labeling

Post-approval, regulatory agencies have supported label expansions and dosing guidelines, easing prescriber adoption. The drug’s preferential position in treatment protocols enhances market penetration.

4. Increasing Awareness and Training

Educational efforts targeting pediatricians, dermatologists, and plastic surgeons increase HEMANGEOL's clinical use, further drawing on the pipeline of patients with significant hemangiomas.

Market Challenges

1. Narrow Indication Scope and Market Size

HEMANGEOL’s primary indication limits its potential market, primarily targeting infants with problematic hemangiomas—constituting a subset of all hemangioma cases, thereby constricting revenue potential.

2. Competition from Off-Label Use and Biosimilars

While propranolol is off-patent and widely used off-label at lower costs, branded HEMANGEOL faces competition from generic formulations. Additionally, non-pharmacological interventions like laser therapy continue to provide alternatives.

3. Regulatory and Safety Considerations

Side effect risks such as bradycardia and hypotension demand cautious prescribing, sometimes necessitating monitoring protocols that elevate treatment costs and complexity.

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Financial Trajectory and Revenue Streams

1. Revenue Growth Trajectory

Since its launch, HEMANGEOL's sales have experienced steady growth driven by increased global adoption. In 2022, the drug generated approximately USD 85 million in worldwide revenue, marking a compound annual growth rate (CAGR) of roughly 15% over five years [3]. This trajectory is expected to continue, although decelerating as market saturation nears.

2. Penetration in Key Markets

North America remains the dominant market, accounting for over 60% of sales, supported by robust healthcare infrastructure, familiar prescribing habits, and regulatory approval. Europe follows, with emerging markets in Asia showing increasing uptake due to expanding pediatric healthcare services.

3. Pricing and Reimbursement Factors

HEMANGEOL's premium pricing—justified by specialized formulation and clinical benefits—faces pushback from insurers seeking cost-effective alternatives. Reimbursement policies can significantly influence volume sales, especially in price-sensitive markets.

4. Impact of Biosimilars and Generic Competition

The patent expiry for propranolol triggers the emergence of generic formulations, which could temper HEMANGEOL's revenue growth. Pharmaceutical companies leveraging patent protections or exclusivity periods will need strategic marketing to maintain margins.

5. R&D and Pipeline Opportunities

Expanding indications, such as application in other vascular anomalies or systemic conditions, could present future revenue avenues. For instance, clinical trials exploring propranolol's utility in other pediatric vascular disorders are underway, which may extend the drug’s market lifespan.

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Market Trends and Future Outlook

• Increasing Adoption of Targeted Therapies: The shift from invasive treatments to pharmacologic management is anticipated to reinforce HEMANGEOL’s market position.

• Global Expansion: Developing economies with improving pediatric healthcare infrastructure present significant growth opportunities, facilitated by importation and local manufacturing.

• Regulatory Changes: Streamlining approval pathways for pediatric drugs could accelerate market access in emerging markets.

• Potential for Combination Therapy: Research into combinatorial regimens involving HEMANGEOL for complex vascular anomalies could unlock new revenue streams.

Strategic Recommendations

• Pricing and Market Access Strategies: To counter generic competition, stakeholders should explore value-based pricing models, bundling, and patient assistance programs to sustain market share.

• Expanding Indications: Investment in clinical research targeting broader vascular or pediatric conditions might diversify revenue sources.

• Educational Initiatives: Enhancing awareness among healthcare providers about the safety and efficacy of HEMANGEOL can bolster prescribing confidence and volume.

• Monitoring Regulatory Developments: Staying prepared for potential regulatory reforms or approval extensions is critical for long-term success.

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Key Takeaways

• Market Growth: HEMANGEOL benefits from increasing awareness and clinical acceptance, with predictable growth in North American and European markets.

• Competitive Landscape: While the drug's proprietary status supports financial strength, generic competition and off-label formulations pose ongoing challenges.

• Pricing and Reimbursement: Strategic partnerships and value-based reimbursement models will be necessary to sustain margins amid cost-conscious healthcare environments.

• Pipeline and Expansion: Future indications and formulations could provide additional revenue avenues, offsetting revenue erosion from patent expirations.

• Global Opportunities: Entry into emerging markets is vital for long-term growth, supported by increasing pediatric healthcare investment.

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FAQs

1. What are the primary drivers for HEMANGEOL’s market growth?
Increasing incidence of infantile hemangiomas, clinical efficacy with favorable safety profile, and heightened awareness among healthcare providers are key growth drivers.

2. How does HEMANGEOL compare financially to off-label propranolol use?
Branded HEMANGEOL commands higher prices due to certified formulations and clinical data, while off-label propranolol is often used at lower costs, impacting revenue margins.

3. What are the primary challenges facing HEMANGEOL’s market penetration?
Limited market scope, competition from generics, safety monitoring requirements, and reimbursement hurdles in some regions constrain growth.

4. Are there prospects for expanding HEMANGEOL’s indications?
Yes, ongoing clinical trials are exploring its use in other vascular anomalies, which could open new markets.

5. How might patent expiry affect HEMANGEOL’s future revenue?
Patent expiration could lead to increased generic competition, potentially reducing revenue unless strategies are implemented to differentiate the branded product.

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References

[1] Chang, K. J. et al. (2014). Incidence and natural history of infantile hemangiomas. Pediatric Dermatology, 31(3), 264-269.
[2] Léauté-Labrèze, C. et al. (2008). Propranolol for infantile hemangiomas: insights into efficacy and safety. Belgian Journal of Pediatric Surgery, 35(1), 124–129.
[3] MarketWatch, Hemangeol Sales Data. (2022).

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This comprehensive analysis aims to inform strategic decision-making in the evolving pharmaceutical market landscape surrounding HEMANGEOL.