ZURAGARD Drug Patent Profile

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

Zuragard is a drug marketed by Zurex Pharma and is included in one NDA. There are seven patents protecting this drug.

This drug has sixty-five patent family members in twenty-two countries.

The generic ingredient in ZURAGARD is isopropyl alcohol. There are thirty-one drug master file entries for this compound. Additional details are available on the isopropyl alcohol profile page.

DrugPatentWatch^® Generic Entry Outlook for Zuragard

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 23, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ZURAGARD

International Patents:	65
US Patents:	7
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	384
Clinical Trials:	1
Patent Applications:	3,146
DailyMed Link:	ZURAGARD at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ZURAGARD

Constraining patent/regulatory exclusivity:

8,703,828

NDA:

210872

Dosage:

SOLUTION;TOPICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ZURAGARD

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

Sponsor	Phase
Zurex Pharma, Inc.	Phase 3

See all ZURAGARD clinical trials

US Patents and Regulatory Information for ZURAGARD

ZURAGARD is protected by seven US patents.

This potential generic entry date is based on patent 8,703,828.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zurex Pharma	ZURAGARD	isopropyl alcohol	SOLUTION;TOPICAL	210872-001	Apr 26, 2019		OTC	Yes	Yes	9,629,368
Zurex Pharma	ZURAGARD	isopropyl alcohol	SOLUTION;TOPICAL	210872-001	Apr 26, 2019		OTC	Yes	Yes	8,703,828		Y
Zurex Pharma	ZURAGARD	isopropyl alcohol	SOLUTION;TOPICAL	210872-001	Apr 26, 2019		OTC	Yes	Yes	8,389,583
Zurex Pharma	ZURAGARD	isopropyl alcohol	SOLUTION;TOPICAL	210872-001	Apr 26, 2019		OTC	Yes	Yes	9,844,654		Y
Zurex Pharma	ZURAGARD	isopropyl alcohol	SOLUTION;TOPICAL	210872-001	Apr 26, 2019		OTC	Yes	Yes	10,688,291		Y
Zurex Pharma	ZURAGARD	isopropyl alcohol	SOLUTION;TOPICAL	210872-001	Apr 26, 2019		OTC	Yes	Yes	8,226,971		Y
Zurex Pharma	ZURAGARD	isopropyl alcohol	SOLUTION;TOPICAL	210872-001	Apr 26, 2019		OTC	Yes	Yes	9,011,897		Y

Expired US Patents for ZURAGARD

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Zurex Pharma	ZURAGARD	isopropyl alcohol	SOLUTION;TOPICAL	210872-001	Apr 26, 2019	8,226,971
Zurex Pharma	ZURAGARD	isopropyl alcohol	SOLUTION;TOPICAL	210872-001	Apr 26, 2019	9,011,897

International Patents for ZURAGARD

When does loss-of-exclusivity occur for ZURAGARD?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Denmark

European Patent Office

Israel

Japan

Mexico

Poland

Russian Federation

South Africa

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ZURAGARD around the world.

Country	Patent Number	Title	Estimated Expiration
China	102105055	Antimicrobial compositions and methods of use
Russian Federation	2007133649	РАСТВОР ЗАМКА КАТЕТОРА, СОДЕРЖАЩИЙ ЦИТРАТ И ПАРАБЕН
Brazil	112015026482	aparelho aplicador cutâneo médico
Mexico	353841	COMPOSICIONES ANTIMICROBIANAS Y METODOS DE USO. (ANTIMICROBIAL COMPOSITIONS AND METHODS OF USE.)
World Intellectual Property Organization (WIPO)	2014172200
Japan	5101019
China	101442956	Catheter lock solution comprising citrate and paraben

Supplementary Protection Certificates for ZURAGARD

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1448186	2012C/051	Belgium		PRODUCT NAME: MELANGE DE CATECHOLS ISOLES D'UN EXTRAIT DE THE (CAMELLIA SINENSIS (L.) O. KUNTZE) AVEC DU MYRISTATE D'ISOPROPYLE; AUTHORISATION NUMBER AND DATE: BE424383 20120719
0289349	SPC/GB04/007	United Kingdom		PRODUCT NAME: ISOPROPYL(+)-(Z)-7-((1R,2R,3R,5S)-3,5-DIHYDROXY-2-(3-OXODECYL)CYCLOPENTYL)-5-HEPTENOATE; REGISTERED: CH 55634 01 20010329; UK PL00101/0667 20031112
1448186	C300550	Netherlands		PRODUCT NAME: MENGSEL VAN CATECHOLEN GEISOLEERD UIT EEN EXTRACT VAN GROENE THEE, CAMELLIA SINENSIS, L. O. KUNTZE MET ISOPROPYLMYRISTAAT; NATL. REGISTRATION NO/DATE: RVG 110904 20120920; FIRST REGISTRATION: DE 73486.00.00 20090831
0364417	SPC/GB97/014	United Kingdom		PRODUCT NAME: LATANOPROST (I.E. 13,14-DIHYDRO-17-PHENYL-18,19,20-TRINOR-PGF-ALPHA-ISOPROPYLESTER); NAT. REGISTRATION NO/DATE: 00032/0220 19961216; FIRST REGISTRATION: SE 12716 19960718; SPC EXTENSION AUTHORISATION: PL00057/1057-008 20101216
2447254	2018015	Norway		PRODUCT NAME: 2-4-(N-(5,6-DIFENYLPYRAZIN-2- YL)-N- ISOPROPYLAMINO)BUTYLOKSY-N-; REG. NO/DATE: EU/1/15/1083 20160530
1920764	2012/033	Ireland		PRODUCT NAME: TRAVOPROST (ALSO CALLED FLUPROSTENOL ISOPROPYL ESTER); NAT REGISTRATION NO/DATE: EU/1/01/199/001-002 20011129; FIRST REGISTRATION NO/DATE: EU/1/01/199/001-002 20011129; PAEDIATRIC INVESTIGATION PLAN: P/0298/2013 PROCEEDINGS UNDER SECTION 37 OF THE PATENTS ACT, 1992 RESTORATION ORDER DATED 12TH JANUARY 2016, WAS MADE RESTORING THE PATENT MENTIONED BELOW S85583 PAUL DOYLE A RE-USABLE BAG SYSTEM RESTORATION ORDERS DATED 16TH FEBRUARY 2016, WERE MADE RESTORING THE PATENTS MENTIONED BELOW S86133 MERVYN GREENE MULTI PURPOSE TANK STAND WITH COMPLEX LOCKING MECHANISM 86119 MPC GREEN LIMITED ANEW BIN
2203462	2014029	Norway		PRODUCT NAME: SOFOSBUVIR. (S)-ISOPROPYL 2-; NAT. REG. NO/DATE: EU/1/13/894 20140116; FIRST REG. NO/DATE: (001-002) 20140117

Market Dynamics and Financial Trajectory for ZURAGARD

Introduction

ZURAGARD, a skin preparation solution, is a product that has garnered attention for its effectiveness in reducing skin bacteria and preventing infections. To understand its market dynamics and financial trajectory, it is crucial to delve into various aspects such as its development, regulatory approvals, market competition, and financial performance.

Development and Clinical Trials

ZURAGARD was developed by Ash Access, a company focused on improving medical devices and solutions. The product is a skin preparation solution containing components of isopropyl alcohol and other antibacterial agents. Clinical trials have shown that ZURAGARD is more effective than existing solutions like Chloroprep® in decreasing skin bacteria[2].

Regulatory Approvals

The regulatory journey for ZURAGARD has been significant. While the product has shown promising results in clinical trials, it has faced some challenges in gaining full regulatory approval. For instance, a related product, Zuragen®, which is a catheter lock with antibacterial functions, was not approved by the FDA due to its classification as a drug rather than a device[2].

Market Launch and Adoption

Despite the regulatory hurdles, ZURAGARD has been successfully marketed and is currently undergoing beta site testing. Its adoption is expected to grow as it demonstrates superior efficacy in clinical settings. The product's success can be attributed to its ability to address a critical need in infection prevention, a key area of concern in healthcare[2].

Market Competition

The market for skin preparation solutions and infection prevention products is competitive. ZURAGARD competes with established products like Chloroprep®, which has a strong market presence. However, ZURAGARD's superior clinical outcomes and unique formulation position it favorably in the market. The growing demand for effective infection prevention solutions, especially in hospitals and healthcare facilities, provides a fertile ground for ZURAGARD's growth[5].

Financial Performance

The financial performance of ZURAGARD is closely tied to its market adoption and sales. Given its recent market entry, the product is in the early stages of generating significant revenue. However, the positive clinical trial results and ongoing beta testing indicate a promising financial trajectory.

Revenue Projections

While exact revenue figures for ZURAGARD are not publicly available, the broader market trends suggest a positive outlook. The pharmaceutical drug delivery market, which includes infection prevention solutions, is expected to grow significantly, driven by increasing demand for effective treatments and government initiatives to support healthcare innovation[3].

Cost and Pricing

The pricing strategy for ZURAGARD will be crucial in determining its financial success. The product's cost-effectiveness compared to competitors will be a key factor. Given the pressure on pharmaceutical companies to reduce costs and the increasing acceptance of lower-priced medications, ZURAGARD's pricing will need to balance profitability with market competitiveness[3].

Market Dynamics

Regional Market Insights

The market for ZURAGARD is expected to be strong in regions with high healthcare spending and a focus on infection prevention. North America, with its significant healthcare expenditure and stringent infection control protocols, is likely to be a key market. Europe, with its robust pharmaceutical sector, is also expected to be a major market for ZURAGARD[3].

Impact of Regulatory Policies

Regulatory policies play a critical role in the pharmaceutical industry. For ZURAGARD, the FDA's approval process and classification of the product as a drug or device will significantly impact its market dynamics. Policies that support innovation and reduce regulatory barriers can enhance the product's adoption and financial performance[1][4].

Industry Trends and Challenges

Generic and Biosimilar Competition

While ZURAGARD is not a generic or biosimilar product, the broader pharmaceutical market is influenced by these categories. The entry of generic and biosimilar drugs can impact the pricing and market share of branded products. However, ZURAGARD's unique formulation and clinical efficacy are expected to maintain its market position[4].

Cost-Cutting Pressures

The pharmaceutical industry is under significant pressure to reduce costs. This trend is driven by governments, insurers, and patients seeking lower-priced treatments. ZURAGARD's financial trajectory will need to navigate these cost-cutting pressures while maintaining profitability[3].

Key Takeaways

• Clinical Efficacy: ZURAGARD has demonstrated superior clinical outcomes in reducing skin bacteria.
• Regulatory Journey: The product has faced regulatory challenges but is currently being marketed and tested.
• Market Competition: ZURAGARD competes in a competitive market but has a unique selling proposition.
• Financial Performance: The product is in its early stages of revenue generation but has a promising financial trajectory.
• Market Dynamics: Regional market insights and regulatory policies will significantly impact ZURAGARD's success.

FAQs

Q: What is ZURAGARD used for?

A: ZURAGARD is a skin preparation solution used to reduce skin bacteria and prevent infections.

Q: Has ZURAGARD received FDA approval?

A: While ZURAGARD itself has not faced significant FDA approval issues, a related product, Zuragen®, was classified as a drug and not approved as a device.

Q: How does ZURAGARD compare to competitors?

A: ZURAGARD has shown superior efficacy compared to existing products like Chloroprep® in clinical trials.

Q: What are the key market regions for ZURAGARD?

A: North America and Europe are expected to be key markets due to their significant healthcare expenditure and focus on infection prevention.

Q: How will cost-cutting pressures in the pharmaceutical industry affect ZURAGARD?

A: ZURAGARD will need to balance its pricing strategy to remain competitive while navigating the cost-cutting pressures in the industry.

Sources

1. Comparing New Prescription Drug Availability and Launch Timing in the United States and Other Countries - ASPE.
2. Success Is Just Running Out of Mistakes - IU Health.
3. Pharmaceutical Drug Delivery Market: Industry Analysis - Maximize Market Research.
4. Generic Drug Industry Dynamics - Federal Trade Commission.
5. A Clinical Study Comparing the Skin Antisepsis and Safety of ChloraPrep 70 Isopropyl Alcohol and 2 Aqueous Chlorhexidine - ResearchGate.

Last updated: 2024-12-16