ABREVA Drug Patent Profile

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

Abreva is a drug marketed by Haleon Us Holdings and is included in one NDA.

The generic ingredient in ABREVA is docosanol. There are five drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the docosanol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Abreva

A generic version of ABREVA was approved as docosanol by P AND L on November 19^th, 2018.

Summary for ABREVA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	122
Clinical Trials:	1
Drug Prices:	Drug price information for ABREVA
What excipients (inactive ingredients) are in ABREVA?	ABREVA excipients list
DailyMed Link:	ABREVA at DailyMed

See drug prices for ABREVA

See drug sales revenues for ABREVA

Recent Clinical Trials for ABREVA

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

Sponsor	Phase
University of Utah	Phase 2

See all ABREVA clinical trials

US Patents and Regulatory Information for ABREVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Haleon Us Holdings	ABREVA	docosanol	CREAM;TOPICAL	020941-001	Jul 25, 2000		OTC	Yes	Yes

Expired US Patents for ABREVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Haleon Us Holdings	ABREVA	docosanol	CREAM;TOPICAL	020941-001	Jul 25, 2000
Haleon Us Holdings	ABREVA	docosanol	CREAM;TOPICAL	020941-001	Jul 25, 2000

International Patents for ABREVA

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0594565
Japan	H03505882
European Patent Office	0469064	UTILISATION DES ALCOOLS ALIPHATIQUES C-20 A C-26 POUR L'OBTENTION D'UN MEDICAMENT DESTINE AU TRAITEMENT DES INFECTIONS VIRALES. (USE OF C-20 TO C-26 ALIPHATIC ALCOHOLS FOR THE MANUFACTURE OF A MEDICAMENT FOR THE TREATMENT OF VIRAL INFECTIONS.)
Denmark	0738141

Supplementary Protection Certificates for ABREVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0428642	300354	Netherlands		300354, 20100416, EXPIRES: 20150415
0428642	57/2007	Austria		PRODUCT NAME: DOCOSANOL; NAT. REGISTRATION NO/DATE: 1-27014 20070518; FIRST REGISTRATION: SE 18517 20031114
0428642	07C0081	France		PRODUCT NAME: DOCOSANOL; REGISTRATION NO/DATE IN FRANCE: NL 33457 DU 20070821; REGISTRATION NO/DATE AT EEC: 18517 DU 20031114

ABREVA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Abreva

Introduction to Abreva

Abreva, known for its distinctive diamond-studded lip design, is a prominent brand in the treatment of cold sores, which are caused by the herpes simplex virus type 1 (HSV-1). Here, we will delve into the market dynamics and financial trajectory of Abreva, a key player in the cold sore treatment market.

Market Size and Growth

The global cold sore treatment market, within which Abreva operates, is projected to grow significantly. As of 2024, the market is estimated to be valued at USD 1.02 billion and is expected to reach USD 1.57 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 6.3% during the forecast period[4].

Key Drivers of Market Growth

Several factors are driving the growth of the cold sore treatment market, and by extension, the demand for Abreva:

Rising Incidence of HSV-1 Infections

The World Health Organization (WHO) estimates that around 3.7 billion people under the age of 50, or 67% of the global population, have HSV-1 infections. This widespread prevalence is a significant driver of the market[4].

Increasing Adoption of OTC Medications

Over-the-counter (OTC) medications for cold sores are gaining popularity, contributing to market growth. Abreva, being an OTC antiviral drug, benefits from this trend[4].

Advancements in Topical Treatments

Topical antiviral drugs like Abreva, which contain docosanol, are preferred due to their fewer side effects compared to oral antivirals. The market is witnessing numerous product launches and innovations in topical treatments, further boosting demand[4].

Competitive Landscape

Abreva operates in a competitive market with several key players:

Market Players

Companies such as GSK Plc, Novartis AG, Teva Pharmaceutical US, Inc., AbbVie Inc, Merck & Co., Inc., Pfizer Inc., Sanofi, and others are active in the cold sore treatment market. Abreva, however, holds a unique position due to its U.S. FDA approval as the only antiviral drug for treating cold sores[4].

Recent Developments

In February 2024, Abreva introduced a distinctive diamond-studded lip design to promote confidence among cold sore sufferers, highlighting the brand's commitment to innovation and customer engagement[4].

Financial Performance and Revenue Streams

Revenue Contribution

Abreva is a significant contributor to the revenue of its parent company. For instance, Avanir Pharmaceuticals, which co-promotes Abreva, reported substantial revenue growth in the past. In the first quarter of fiscal 2014, Avanir's total net revenues were $26.7 million, with a notable portion coming from co-promotion revenues and royalty revenue from Abreva[5].

Market Penetration

The wide availability of Abreva in retail and online pharmacies enhances its market penetration. Online pharmacies, in particular, have seen rapid growth due to improved internet access and increased awareness about OTC products, although this growth has been somewhat impacted by the de-escalation of COVID-19 restrictions[1].

Regional Outlook

North America Dominance

North America, particularly the U.S. and Canada, is expected to hold a dominant position in the cold sore treatment market. This region's developed healthcare infrastructure and growing disease prevalence contribute to Abreva's strong market presence[4].

Challenges and Opportunities

Awareness and Education

Despite the growing market, there is a lack of awareness about treatment and symptoms of cold sores in low and middle-income countries. This presents both a challenge and an opportunity for Abreva to expand its reach through educational campaigns and strategic marketing[4].

Research and Development

The market is witnessing increasing research and development activities for novel drug formulations, such as combination therapies and long-acting formulations. Abreva can benefit from these advancements by innovating its product line to meet evolving consumer needs[4].

Key Takeaways

• Market Growth: The cold sore treatment market is expected to grow at a CAGR of 6.3% from 2024 to 2031.
• Topical Treatments: Abreva, as a topical antiviral drug, benefits from the preference for topical treatments due to fewer side effects.
• Competitive Landscape: Abreva operates in a competitive market but holds a unique position due to its FDA approval.
• Financial Performance: Abreva contributes significantly to the revenue of its parent company through co-promotion and royalty revenues.
• Regional Outlook: North America is a key region for Abreva, driven by developed healthcare infrastructure and growing disease prevalence.

FAQs

1. What is Abreva used for? Abreva is used for the treatment of cold sores caused by the herpes simplex virus type 1 (HSV-1).

2. What is the market size of the cold sore treatment market? The global cold sore treatment market is estimated to be valued at USD 1.02 billion in 2024 and is expected to reach USD 1.57 billion by 2031[4].

3. Who are the key players in the cold sore treatment market? Key players include GSK Plc, Novartis AG, Teva Pharmaceutical US, Inc., AbbVie Inc, Merck & Co., Inc., Pfizer Inc., Sanofi, and others[4].

4. Why is Abreva preferred over other treatments? Abreva is preferred due to its topical formulation, which has fewer side effects compared to oral antivirals[4].

5. What are the challenges faced by Abreva in the market? One of the main challenges is the lack of awareness about treatment and symptoms of cold sores in low and middle-income countries[4].

Cited Sources

1. Grand View Research: Herpes Simplex Virus Treatment Market Size Report, 2030.
2. AbbVie Investors: AbbVie Reports Full-Year and Fourth-Quarter 2023 Financial Results.
3. Baron Capital Group: A Multi-Billion-Dollar Drug Market.
4. GlobeNewswire: Cold Sore Treatment Market Size to Reach $1.57 Billion by 2031.
5. Avanir Pharmaceuticals: AVANIR Pharmaceuticals Reports Fiscal 2014 First Quarter Financial and Business Results.