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. Forty-one 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:	2
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	PHASE2
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
Japan	H03505882
Japan	3064010
European Patent Office	0738141	FORMULATIONS D'N-DOCOSANOL A BASE D'ESTER DE SUCROSE (SUCROSE ESTER AND N-DOCOSANOL FORMULATIONS)
Japan	3064009
Germany	69435067
Hong Kong	120497	Use of C-22 to C-26 aliphatic alcohols in the treatment of inflammatory and viral skin diseases
Austria	399004

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

Market Dynamics and Financial Trajectory for ABREVA

Last updated: December 29, 2025

Executive Summary

ABREVA (docosanol 10%) is a topical antiviral pharmaceutical approved by the U.S. Food and Drug Administration (FDA) in 2000 for the treatment of herpes labialis (cold sores). This comprehensive analysis assesses its market environment, growth drivers, competitive landscape, financial trajectory, and future opportunities. Despite its age, ABREVA maintains relevance due to persistent demand, evolving consumer preferences, and strategic positioning within the herpes treatment segment.

Market Overview

Product Profile

• Active Ingredient: Docosanol 10%
• Indications: Herpes labialis (cold sores)
• Formulation: Over-the-counter (OTC) topical cream
• Approval Date: 2000 (FDA)
• Manufacturer: Historically, they have been marketed under the brand ABREVA (GlaxoSmithKline initially, now marketed through specific licensing)

Market Size & Segments

The global herpes simplex virus (HSV) treatment market was valued at approximately USD 4.2 billion in 2022[1]. ABREVA competes primarily within the OTC segment, which accounted for roughly 60% of the market, driven largely by consumer demand for accessible, immediate treatments.

Segment	Market Share (2022)	Description
Prescription drugs	40%	Includes systemic antivirals (acyclovir, valacyclovir)
OTC products (e.g., ABREVA)	60%	Includes topical creams like ABREVA

Key Market Drivers

• Increasing HSV prevalence: Globally, approximately 67% of the population aged 0-49 have HSV-1 globally[2], fueling OTC demand.
• Consumer shift to OTC medications: Preference for accessible, self-managed treatments.
• Product familiarity and brand loyalty: ABREVA's established presence and recognition among consumers.
• Regulatory environment: Supportive policies for OTC drug expansion for cold sore treatments.

Competitive Landscape

Major Competitors

Product	Brand	Formulation	Market Position	Price Range (USD)	Notes
Zovirax	Acyclovir	Prescription	Dominant systemic	USD 15–30 (per package)	Requires prescription
Abreva	Docosanol	OTC Topical	Leading OTC	USD 14–20 (per 2g tube)	Unique OTC approval
Herpecin-L	Herbal	OTC	Niche alternative	USD 7–12	Natural ingredients focus
Generic OTC creams	Various	OTC	Competitive	USD 5–10	Lower efficacy claims

Strengths & Weaknesses

Aspect	ABREVA	Competitors
Strengths	FDA-approved OTC, fast symptom relief, trusted brand	Lower price, natural formulations, broader distribution
Weaknesses	Higher price point, limited efficacy evidence	Limited brand recognition, regulatory constraints

Financial Trajectory and Market Performance

Revenue Streams

• Product Sales: Dominated by over-the-counter sales, with estimated revenues surpassing USD 150 million annually globally[3].
• Licensing & Royalties: Revenue from licensing agreements, especially in non-U.S. markets.

Historical Financial Data

While specific company financials are proprietary, public data suggest:

• Pre-2020, ABREVA enjoyed steady sales growth driven by increasing HSV prevalence and OTC cold sore prevalence.
• 2020-2022 Trend: Slight decline in unit sales attributed to market saturation and competition from natural remedies. However, premium positioning and brand loyalty maintained stable revenues.

Growth Projections

• Compound Annual Growth Rate (CAGR): Forecasted at 2–3% from 2023 to 2030[4], driven by demographic shifts, increased awareness, and new formulations.
• Market Expansion Opportunities: Emerging markets in Asia, Latin America, and Africa present sizable opportunities due to rising HSV awareness and increasing OTC drug acceptance.

Regulatory & Policy Impact

Policy/Regulation	Effect on ABREVA	Year Implemented
OTC Monograph for Cold Sore Treatments	Facilitates market access	2002
Patent Expirations	Opened door to generics, risking revenue	2017
International Approvals	Expanding licensing agreements	Ongoing

The expiration of initial patent protections in 2017, while not impacting ABREVA directly, facilitated the emergence of generics and OTC competitors, intensifying competitive pressures.

Market Challenges & Opportunities

Challenges

• Price Competition: Entry of generics and store brands reduce market share.
• Consumer Awareness: Competing for consumers' attention against natural remedies and alternative treatments.
• Evolving Patient Preferences: Increasing demand for natural, holistic product options.

Opportunities

• New Formulations: Development of combination products (e.g., topical gels with soothing agents).
• Digital & Direct-to-Consumer Marketing: Leveraging online platforms for targeted advertising.
• Global Expansion: Exploiting emerging markets where OTC cold sore treatments are underpenetrated.
• Research & Development: Innovating compounds that accelerate healing or reduce latency.

Comparative Analysis

Parameter	ABREVA	Zovirax	Herpecin-L	Natural Remedies
FDA Status	Yes (OTC)	Yes (Prescription)	No	No
Efficacy	Fast symptom relief	Systemic, high efficacy	Mild	Variable
Cost	USD 14–20	USD 15–30 (per Rx)	USD 7–12	USD 5–10
Consumer Trust	Well-established	Market leader	Niche	Variable

Key Market Trends & Industry Insights

• Shift Towards Self-Care: Growing consumer preference for OTC and natural remedies.
• Technological Integration: Telemedicine and online pharmacy platforms increase access.
• Regulatory trajectories: Encouraging new OTC approvals for herpes treatments and combination products.

Future Outlook & Financial Trajectory

Projection Metric	2023–2030 Outlook
Market Growth Rate	2–3% CAGR globally
Revenue Potential	USD 180–200 million annually by 2030
Innovation Drivers	Formulation enhancements, digital marketing
Geographic Focus	Asia-Pacific, Latin America, Africa

Key Takeaways

• ABREVA remains a significant player in the OTC herpes treatment segment, with steady demand driven by HSV prevalence and consumer preferences.
• Market competition has intensified post-patent expiry, resulting in increased focus on branding, formulations, and market penetration strategies.
• Emerging markets exhibit substantial growth potential, especially with targeted regulatory approvals and consumer awareness campaigns.
• Innovators should explore combination therapies, digital channels, and natural formulations to maintain competitiveness.
• Strategic licensing and partnerships could further extend ABREVA’s reach internationally.

Frequently Asked Questions (FAQs)

Q1: What factors have historically influenced ABREVA’s market share?
A: Consumer trust, FDA approval as an OTC drug, brand recognition, pricing, and the availability of alternatives like natural remedies or generics.

Q2: How does ABREVA compare to prescription antivirals like Zovirax?
A: ABREVA offers topical, OTC symptom relief with quicker accessibility, but prescription drugs like Zovirax provide systemic, often more potent, antiviral effects for recurrent or severe cases.

Q3: What are the key challenges facing ABREVA’s growth?
A: Price competition from generics, consumer shift towards natural remedies, and limited innovation since its initial approval.

Q4: What opportunities exist for expanding ABREVA’s market presence internationally?
A: Regulatory approvals in emerging markets, tailored marketing strategies, and licensing agreements.

Q5: Can ABREVA’s formulation be improved to boost demand?
A: Yes; potential exists for combining docosanol with soothing or healing agents, or developing longer-lasting formulations, enhancing efficacy and user experience.

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References

[1] Global Herpes Treatment Market Report, 2022.
[2] World Health Organization (WHO). Herpes simplex virus factsheet, 2021.
[3] Company sales estimates, public filings, 2022.
[4] MarketResearch.com. Herpes Treatment Market Forecast, 2023–2030.