SITAVIG Drug Patent Profile

When do Sitavig patents expire, and when can generic versions of Sitavig launch?

Sitavig is a drug marketed by Lnhc and is included in one NDA. There are three patents protecting this drug.

This drug has forty-six patent family members in twenty-nine countries.

The generic ingredient in SITAVIG is acyclovir. There are fifty-six drug master file entries for this compound. Sixty-nine suppliers are listed for this compound. Additional details are available on the acyclovir profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sitavig

A generic version of SITAVIG was approved as acyclovir by TEVA on April 22^nd, 1997.

Summary for SITAVIG

International Patents:	46
US Patents:	3
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	184
Clinical Trials:	1
Patent Applications:	531
Drug Prices:	Drug price information for SITAVIG
What excipients (inactive ingredients) are in SITAVIG?	SITAVIG excipients list
DailyMed Link:	SITAVIG at DailyMed

See drug prices for SITAVIG

See drug sales revenues for SITAVIG

Recent Clinical Trials for SITAVIG

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

Sponsor	Phase
Bayer	Phase 3

See all SITAVIG clinical trials

US Patents and Regulatory Information for SITAVIG

SITAVIG is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lnhc	SITAVIG	acyclovir	TABLET;BUCCAL	203791-001	Apr 12, 2013		RX	Yes	Yes			Y
Lnhc	SITAVIG	acyclovir	TABLET;BUCCAL	203791-001	Apr 12, 2013		RX	Yes	Yes			Y
Lnhc	SITAVIG	acyclovir	TABLET;BUCCAL	203791-001	Apr 12, 2013		RX	Yes	Yes			Y

International Patents for SITAVIG

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

Country	Patent Number	Title	Estimated Expiration
Hungary	E039647
Portugal	1998750
Brazil	PI0709057	veìculo mucoso bioadesivo de lenta liberação, método para preparar um veìculo mucoso bioadesivo de lenta liberação, e, uso do véiculo mucoso bioadesivo de lenta liberação
Russian Federation	2420267	БИОАДГЕЗИВНЫЙ НОСИТЕЛЬ С ЗАМЕДЛЕННЫМ ВЫСВОБОЖДЕНИЕМ ДЛЯ СЛИЗИСТЫХ ОБОЛОЧЕК, ПРЕДНАЗНАЧЕННЫЙ ДЛЯ ДОСТАВКИ АКТИВНЫХ КОМПОНЕНТОВ (BIOADHESIVE CARRIER WITH DELAYED RELEASE FOR MUCOUS MEMBRANES, INTENDED FOR DELIVERY OF ACTIVE COMPONENTS)
Austria	E446743
Denmark	2509586
Spain	2678122

Supplementary Protection Certificates for SITAVIG

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

SITAVIG Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SITAVIG

Introduction

SITAVIG, a buccal tablet formulation of acyclovir, is a significant player in the treatment of recurrent herpes labialis, commonly known as cold sores. This article delves into the market dynamics and financial trajectory of SITAVIG, highlighting its performance, market trends, and future outlook.

Market Context

The herpes simplex virus (HSV) treatment market is growing, driven by the increasing burden of HSV infections. As of 2021, nearly 3.7 billion people under the age of 50 had HSV-1 infection, and approximately 491 million people aged 15-49 had HSV-2 infection globally[1].

Product Overview

SITAVIG is a single-dose therapy for the treatment of recurrent herpes labialis. It is applied topically to the gum and releases acyclovir as the buccal tablet dissolves. This formulation provides rapid, high, and sustained acyclovir concentrations in saliva and labial mucosa, which is crucial for effective treatment of cold sores[3][4].

Clinical Efficacy and Safety

Clinical trials have demonstrated the efficacy and safety of SITAVIG. In a Phase 3 trial, SITAVIG showed significant results in treating recurrent herpes labialis with minimal adverse reactions. The most common adverse events were headache and application site pain, which were mild or moderate in severity. There were no serious adverse drug reactions reported[3][4].

Market Performance

Revenue Growth

SITAVIG has shown promising revenue growth. In the second quarter of 2016, net sales for SITAVIG were $1.1 million, more than double the sales in Q2 2015 and a 26% increase from Q1 2016. Total prescriptions for SITAVIG increased by 36% compared to Q2 2015[5].

Regional Performance

In the United States, SITAVIG's revenue in 2016 was $4.2 million, up from $1.7 million in 2015. However, despite this growth, the overall U.S. business of Cipher Pharmaceuticals, the company behind SITAVIG, did not meet expectations, leading to cost reductions and strategic reviews[2].

In Canada, the product has been part of a solid commercial platform for Cipher Pharmaceuticals. The company's Canadian business has continued to perform well, with SITAVIG contributing to the overall growth of the company's product revenue[2].

Financial Trajectory

Revenue Trends

The revenue from SITAVIG has been increasing, but it is part of a broader financial landscape. Cipher Pharmaceuticals' total revenue for 2016 was $40.1 million, up from $34.4 million in 2015. The product revenue increased by 80% to $15.2 million in 2016, with SITAVIG being one of the key contributors to this growth[2].

Cost Management and Efficiency

Despite the revenue growth, Cipher Pharmaceuticals had to take steps to reduce costs and improve operating performance. This included reducing costs across multiple areas and aligning the cost structure with current revenue levels. These measures were aimed at preserving shareholder value and returning the company to higher levels of profitability[2].

Strategic Outlook

The company has been focusing on increasing sales of current products and expanding the Canadian commercial portfolio. With plans to launch new products and maintain a strong financial position, Cipher Pharmaceuticals is well-positioned to continue the growth trajectory of SITAVIG and other products[2].

Market Dynamics

Competitive Landscape

The HSV treatment market is competitive, with acyclovir being one of the most preferred anti-viral agents. SITAVIG's unique buccal tablet formulation provides a competitive edge by offering rapid and sustained acyclovir concentrations directly at the site of infection[1][3].

Regulatory Environment

The regulatory environment has been supportive, with SITAVIG receiving approval for its unique formulation. The FDA approval in 2014 marked a significant milestone, allowing SITAVIG to enter the market and capitalize on the growing demand for effective HSV treatments[3].

Patient and Physician Adoption

The adoption of SITAVIG has been positive, driven by its efficacy and convenience. Patients and physicians have shown a preference for this single-dose therapy due to its ease of use and rapid onset of action[5].

Future Outlook

Market Growth

The HSV treatment market is expected to continue growing, driven by the increasing burden of HSV infections and ongoing R&D activities. The market is anticipated to reach USD 3.13 billion by 2029, growing at a CAGR of 4.77% from 2024 to 2029[1].

Product Development

Cipher Pharmaceuticals continues to focus on expanding its product portfolio, including new launches and strategic partnerships. This is expected to further fuel the growth of SITAVIG and other products in the company's pipeline[2].

Key Takeaways

• Growing Market: The HSV treatment market is expanding due to the increasing prevalence of HSV infections.
• Unique Formulation: SITAVIG's buccal tablet formulation offers rapid and sustained acyclovir concentrations, providing a competitive edge.
• Revenue Growth: SITAVIG has shown significant revenue growth, contributing to the overall financial performance of Cipher Pharmaceuticals.
• Cost Management: The company has been focusing on cost reductions and operational efficiencies to maintain profitability.
• Future Outlook: The market is expected to continue growing, with SITAVIG poised to benefit from ongoing R&D and expanding product portfolios.

FAQs

What is SITAVIG used for?

SITAVIG is a single-dose therapy used for the treatment of recurrent herpes labialis, commonly known as cold sores.

How does SITAVIG work?

SITAVIG is applied topically to the gum and releases acyclovir as the buccal tablet dissolves, providing rapid and sustained acyclovir concentrations in saliva and labial mucosa.

What are the common adverse reactions associated with SITAVIG?

The most common adverse reactions include headache and application site pain, which are generally mild or moderate in severity.

How has SITAVIG performed in terms of revenue?

SITAVIG has shown significant revenue growth, with net sales increasing by over 100% in some quarters compared to the previous year.

What is the future outlook for SITAVIG in the HSV treatment market?

The HSV treatment market is expected to grow, and SITAVIG is poised to benefit from this trend due to its unique formulation and the ongoing R&D activities in the field.

Sources

1. Mordor Intelligence: Herpes Simplex Virus Treatment Market Size | Mordor Intelligence
2. Annual Reports: 2016 ANNUAL REPORT - Cipher Pharmaceuticals
3. FDA: SITAVIG (acyclovir) buccal tablets - accessdata.fda.gov
4. Health Canada: Sitavig - PDF Version
5. Cipher Pharmaceuticals: Building a Dermatology Growth Company - Cipher Pharmaceuticals