SYNERA Drug Patent Profile

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

Synera is a drug marketed by Galen Specialty and is included in one NDA.

The generic ingredient in SYNERA is lidocaine; tetracaine. There are twenty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lidocaine; tetracaine profile page.

Summary for SYNERA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	21
Patent Applications:	1
Drug Prices:	Drug price information for SYNERA
What excipients (inactive ingredients) are in SYNERA?	SYNERA excipients list
DailyMed Link:	SYNERA at DailyMed

See drug prices for SYNERA

Recent Clinical Trials for SYNERA

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

Sponsor	Phase
Boston Children’s Hospital	N/A
Boston Children's Hospital	N/A
Linde AG	N/A

See all SYNERA clinical trials

US Patents and Regulatory Information for SYNERA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Galen Specialty	SYNERA	lidocaine; tetracaine	PATCH;TOPICAL	021623-001	Jun 23, 2005		DISCN	Yes	No

Expired US Patents for SYNERA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galen Specialty	SYNERA	lidocaine; tetracaine	PATCH;TOPICAL	021623-001	Jun 23, 2005
Galen Specialty	SYNERA	lidocaine; tetracaine	PATCH;TOPICAL	021623-001	Jun 23, 2005
Galen Specialty	SYNERA	lidocaine; tetracaine	PATCH;TOPICAL	021623-001	Jun 23, 2005
Galen Specialty	SYNERA	lidocaine; tetracaine	PATCH;TOPICAL	021623-001	Jun 23, 2005
Galen Specialty	SYNERA	lidocaine; tetracaine	PATCH;TOPICAL	021623-001	Jun 23, 2005
Galen Specialty	SYNERA	lidocaine; tetracaine	PATCH;TOPICAL	021623-001	Jun 23, 2005

International Patents for SYNERA

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

Country	Patent Number	Title	Estimated Expiration
Japan	2004510454
Canada	2450366
World Intellectual Property Organization (WIPO)	2005117905
World Intellectual Property Organization (WIPO)	0018339
European Patent Office	1202691
Australia	5924199

SYNERA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: SYNERA

Introduction

SYNERA, a topical anesthetic patch, has been a significant player in the market for local dermal analgesia since its approval by the U.S. Food and Drug Administration (FDA). Here, we delve into the market dynamics and financial trajectory of SYNERA, highlighting its development, market entry, and the impact of various factors on its financial performance.

Development and FDA Approval

SYNERA, developed by ZARS Pharma, is the first topical patch approved for the prevention of pain associated with superficial venous access and superficial dermatological procedures. It combines lidocaine and tetracaine with a heat-activated component to provide local dermal anesthesia in as little as 20 to 30 minutes[4].

Market Entry and Initial Marketing

Initially, ZARS Pharma licensed the North American sales and marketing rights for SYNERA to Endo Pharmaceuticals Inc. Endo launched SYNERA in the United States in 2006, utilizing its existing hospital sales force to market the product to healthcare professionals for both adult and pediatric patients[4].

Acquisition and Licensing Agreements

In 2013, Galen US Incorporated acquired the exclusive rights to market and sell SYNERA in the United States from Nuvo Research Inc. This agreement included an upfront payment of $4.5 million to Nuvo, along with royalties of 10% on net sales. Additionally, Nuvo was eligible for milestone payments of $5 million each upon reaching gross annual sales of $25 million and $50 million[1].

Market Position and Demand

SYNERA addresses a critical medical need, particularly in hospitalized patients who undergo multiple superficial venous access procedures such as IV infusions and blood draws. The demand for SYNERA is significant, especially in pediatric patients aged 3 years or older, where it provides a convenient and effective solution for local dermal analgesia[1].

Financial Performance and Revenue Streams

The financial performance of SYNERA is influenced by several factors, including sales volume, pricing, and royalty agreements. With Galen's acquisition, the company committed to increasing U.S. sales, which was expected to benefit both Galen and Nuvo financially. The royalties and milestone payments structure ensured a steady revenue stream for Nuvo, while Galen aimed to capitalize on the market demand for SYNERA[1].

Impact of Regulatory Changes

The pharmaceutical industry, including SYNERA, is subject to various regulatory and market dynamics. For instance, the Inflation Reduction Act (IRA) has introduced significant changes in how drug prices are negotiated, particularly for Medicare. While SYNERA is not directly mentioned in the IRA's initial list of negotiated drugs, the broader implications of the IRA on the pharmaceutical market could influence pricing strategies and revenue projections for all drugs, including SYNERA[2].

Market Access Trends

In 2024, market access trends are expected to continue evolving, with a focus on evidence-based value determination and indication stacking. Manufacturers are adjusting their strategies to account for the new economic realities, including portfolio rationalization and accelerated R&D for key molecules. These trends could impact how SYNERA is positioned and marketed, especially if there are future indications or expanded uses[3].

Challenges and Opportunities

Despite its market position, SYNERA faces challenges such as the narrowing of the access funnel due to formulary restrictions, payer cost pressures, and post-pandemic system stresses. However, these challenges also present opportunities for Galen and Nuvo to rebuild clinical development strategies, focus on rapid growth initiatives, and optimize their investment in SYNERA to maximize its market potential[3].

Safety and Clinical Studies

SYNERA has undergone extensive clinical studies to ensure its safety and efficacy. The FDA-approved formulation has been tested in various clinical trials, and the data from these studies have been crucial in establishing its safety profile and effectiveness in providing local dermal analgesia[5].

Global Reach

While SYNERA is primarily marketed in the United States, its licensing partner, Eurocept International B.V., has initiated a pan-European launch under the name Rapydan. This global expansion strategy is crucial for maximizing the drug's revenue potential and reaching a broader patient population[1].

Key Takeaways

• Market Demand: SYNERA addresses a significant medical need for local dermal analgesia, particularly in hospitalized patients and pediatric care.
• Financial Structure: The drug generates revenue through sales, royalties, and milestone payments.
• Regulatory Impact: Changes in regulatory policies, such as the IRA, can influence pricing and revenue projections.
• Market Trends: Evolving market access trends focus on evidence-based value and indication stacking.
• Global Expansion: SYNERA is marketed in the U.S. and Europe, with potential for further global expansion.

FAQs

What is SYNERA used for?

SYNERA is a topical anesthetic patch used to provide local dermal analgesia for superficial venous access and superficial dermatological procedures such as excision, electrodessication, and shave biopsy of skin lesions[1].

Who currently markets SYNERA in the United States?

Galen US Incorporated currently markets SYNERA in the United States after acquiring the exclusive rights from Nuvo Research Inc. in 2013[1].

What are the key components of SYNERA?

SYNERA combines lidocaine and tetracaine with a heat-activated component to provide local dermal anesthesia[4].

How does the Inflation Reduction Act impact SYNERA?

While SYNERA is not directly affected by the IRA's initial price negotiations, the broader regulatory changes could influence pricing strategies and revenue projections for the drug[2].

What are the potential future indications for SYNERA?

Nuvo retains the right to develop and seek FDA approval for future additional indications, including acute musculoskeletal pain[1].