XERESE Drug Patent Profile

When do Xerese patents expire, and what generic alternatives are available?

Xerese is a drug marketed by Bausch and is included in one NDA.

The generic ingredient in XERESE is acyclovir; hydrocortisone. There are fifty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the acyclovir; hydrocortisone profile page.

Summary for XERESE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	1
Patent Applications:	1
Drug Prices:	Drug price information for XERESE
What excipients (inactive ingredients) are in XERESE?	XERESE excipients list
DailyMed Link:	XERESE at DailyMed

See drug prices for XERESE

Recent Clinical Trials for XERESE

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

Sponsor	Phase
TKL Research, Inc.	Phase 3
Meda Pharmaceuticals	Phase 3

See all XERESE clinical trials

Pharmacology for XERESE

Drug Class	Corticosteroid Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor
Mechanism of Action	Corticosteroid Hormone Receptor Agonists DNA Polymerase Inhibitors

US Patents and Regulatory Information for XERESE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	XERESE	acyclovir; hydrocortisone	CREAM;TOPICAL	022436-001	Jul 31, 2009		RX	Yes	Yes

Expired US Patents for XERESE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	XERESE	acyclovir; hydrocortisone	CREAM;TOPICAL	022436-001	Jul 31, 2009	6,514,980
Bausch	XERESE	acyclovir; hydrocortisone	CREAM;TOPICAL	022436-001	Jul 31, 2009	7,223,387
Bausch	XERESE	acyclovir; hydrocortisone	CREAM;TOPICAL	022436-001	Jul 31, 2009	RE39264

International Patents for XERESE

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

Country	Patent Number	Title	Estimated Expiration
Canada	2244268	ANALOGUES DE NUCLEOSIDES UTILISES DANS UNE THERAPIE COMBINEECONTRE DES INFECTIONS DUES A L'HERPES SIMPLEX (NUCLEOSIDE ANALOGS IN COMBINATION THERAPY OF HERPES SIMPLEX INFECTIONS)
Japan	2007284452	NEW PHARMACEUTICAL COMPOSITION
Slovenia	876146
South Korea	100431042
Canada	2351463	FORMULATIONS ANTIVIRALES RENFERMANT DU PROPYLENE GLYCOL ET UN ESTER ACIDE ALKANOIQUE D'ISOPROPYLE (ANTIVIRAL FORMULATIONS COMPRISING PROPYLENE GLYCOL AND AN ISOPROPYL ALKANOIC ACID ESTER)

Supplementary Protection Certificates for XERESE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0809498	10C0038	France		PRODUCT NAME: ACYCLOVIR ET HYDROCORTISONE; NAT. REGISTRATION NO/DATE: NL 36 826 20100420; FIRST REGISTRATION: SK - 2108/08467-R 20091026
0809498	SPC/GB10/012	United Kingdom		PRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112
0809498	CA 2010 00009	Denmark

XERESE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Xerese

Introduction

Xerese, a topical combination product of 5% acyclovir and 1% hydrocortisone, is a significant player in the herpes labialis treatment market. Here, we delve into the market dynamics and financial trajectory of Xerese, highlighting its launch, market positioning, and future prospects.

Market Launch and Approval

Xerese was launched in the United States in March 2011, following FDA marketing approval. This product is unique in its formulation, combining an antiviral (acyclovir) and an anti-inflammatory (hydrocortisone) in a single cream vehicle, which differentiates it from other topical cold sore treatments[1].

Market Size and Potential

The U.S. market for cold sore products was valued at approximately USD 230 million in 2011. With Meda's strong commercial presence and deep understanding of the U.S. market dynamics, Xerese was anticipated to be a successful entrant in this market. Medivir granted Meda the exclusive rights to market, sell, and distribute Xerese in the United States, Canada, and Mexico[1].

Clinical Efficacy and Differentiation

Xerese demonstrated greater efficacy compared to 5% acyclovir alone in the same cream vehicle, particularly when treated early. It reduced the likelihood of progression to ulceration, making it a preferred choice for patients and healthcare providers[1].

Partnership and Distribution

Medivir partnered with Meda AB for the North American, Canadian, and Mexican markets, and with GlaxoSmithKline for the European, Japanese, and Russian markets. This strategic partnership ensured a broad reach and strong commercial support for Xerese[1].

Financial Arrangements

Medivir received funding for the commercial development of Xerese, including up-front and pre-launch milestones totaling USD 5 million. Additionally, Medivir was set to receive double-digit royalties on sales of Xerese, providing a significant revenue stream[1].

Market Growth Drivers

The herpes labialis treatment market has been growing steadily, with a CAGR of 4.2% between 2018 and 2022. Factors driving this growth include increasing patient awareness, advancements in treatment options, and the introduction of generic treatments in developing countries[4].

Regional Market Performance

In Europe, Germany held a significant share of the herpes labialis treatment market, driven by a growing patient population and improved healthcare facilities. In Asia Pacific, China accounted for a substantial share, with the market expected to expand at a CAGR of 6.1% from 2023 to 2033, partly due to government investments in healthcare infrastructure[4].

Distribution Channels

Hospitals play a crucial role in the distribution of herpes labialis treatments, holding a 35.4% market share in 2022. The availability of comprehensive treatment options, expert medical personnel, and inclusion in insurance coverage plans contribute to the dominance of hospitals in this market[4].

Competitive Landscape

The market for herpes labialis treatments is competitive, with several players including Bausch Health, GlaxoSmithKline, and generic manufacturers. Partnerships and acquisitions, such as GlaxoSmithKline's acquisition of TESARO Inc., are common strategies to diversify product portfolios and increase market share[4].

Future Prospects

Given its differentiated profile and strong clinical data, Xerese is well-positioned for continued growth. The increasing demand for effective herpes labialis treatments, especially in regions like China, presents opportunities for expansion. Additionally, the growing awareness of the benefits of acyclovir in treating herpes labialis is expected to further drive the demand for Xerese[4].

Key Takeaways

• Unique Formulation: Xerese combines 5% acyclovir and 1% hydrocortisone, offering superior efficacy and differentiation in the market.
• Strong Partnerships: Medivir's partnerships with Meda AB and GlaxoSmithKline ensure broad market reach and commercial support.
• Growing Market: The herpes labialis treatment market is expanding, driven by increasing patient awareness and advancements in treatment options.
• Regional Opportunities: Significant growth potential exists in regions like China and Europe, driven by government investments in healthcare and growing patient populations.
• Financial Trajectory: Medivir benefits from double-digit royalties on Xerese sales, providing a stable revenue stream.

FAQs

What is Xerese and how is it different from other cold sore treatments?

Xerese is a topical combination product of 5% acyclovir and 1% hydrocortisone. It is unique because it combines an antiviral and an anti-inflammatory in a single cream vehicle, which differentiates it from other topical cold sore treatments.

Who are the key partners for Xerese in different markets?

Medivir partnered with Meda AB for the North American, Canadian, and Mexican markets, and with GlaxoSmithKline for the European, Japanese, and Russian markets.

What is the current market size for herpes labialis treatments?

The herpes labialis treatment market was valued at USD 1.13 billion in 2023 and is expected to reach USD 1.79 billion by 2033, growing at a CAGR of 4.7%[4].

How does the distribution of herpes labialis treatments vary by channel?

Hospitals hold a significant share of the distribution market, accounting for 35.4% in 2022, due to their comprehensive treatment options and inclusion in insurance coverage plans[4].

What are the key drivers of growth in the herpes labialis treatment market?

Key drivers include increasing patient awareness, advancements in treatment options, introduction of generic treatments in developing countries, and government investments in healthcare infrastructure[4].