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Last Updated: May 26, 2022

ZURAGARD Drug Patent Profile


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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

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Summary for ZURAGARD
International Patents:65
US Patents:7
Applicants:1
NDAs:1
Clinical Trials: 1
Formulation / Manufacturing:see details
DailyMed Link:ZURAGARD at DailyMed
Drug patent expirations by year for ZURAGARD
DrugPatentWatch® Estimated Generic Entry Opportunity Date for ZURAGARD
Generic Entry Date for ZURAGARD*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Zurex Pharma, Inc.Phase 3

See all ZURAGARD clinical trials

US Patents and Regulatory Information for ZURAGARD

ZURAGARD is protected by seven US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ZURAGARD is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Patents protecting ZURAGARD

Medical skin applicator apparatus
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE AS AN ANTISEPTIC FOR THE PREPARATION OF A PATIENT'S SKIN PRIOR TO SURGERY

Catheter lock solution comprising citrate and a paraben
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Antimicrobial compositions and methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE AS AN ANTISEPTIC FOR THE PREPARATION OF A PATIENT'S SKIN PRIOR TO SURGERY

Antimicrobial compositions and methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Catheter lock solution comprising citrate and a paraben
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Antimicrobial compositions and methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE AS AN ANTISEPTIC FOR THE PREPARATION OF A PATIENT'S SKIN PRIOR TO SURGERY

Medical skin applicator apparatus
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE AS AN ANTISEPTIC FOR THE PREPARATION OF A PATIENT'S SKIN PRIOR TO SURGERY

FDA Regulatory Exclusivity protecting ZURAGARD

NEW PRODUCT
Exclusivity Expiration: See Plans and Pricing

ADDITION OF INFORMATION TO THE LABEL REGARDING A CLEAR PRODUCT PRESENTATION AND 26 ML VOLUME PRODUCTS
Exclusivity Expiration: See Plans and Pricing

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 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Zurex Pharma ZURAGARD isopropyl alcohol SOLUTION;TOPICAL 210872-001 Apr 26, 2019 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Zurex Pharma ZURAGARD isopropyl alcohol SOLUTION;TOPICAL 210872-001 Apr 26, 2019 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Zurex Pharma ZURAGARD isopropyl alcohol SOLUTION;TOPICAL 210872-001 Apr 26, 2019 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Patent: 09249541
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0913086
Estimated Expiration: See Plans and Pricing

Canada

Patent: 24784
Estimated Expiration: See Plans and Pricing

China

Patent: 2105055
Estimated Expiration: See Plans and Pricing

Patent: 6466319
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 93668
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 93668
Estimated Expiration: See Plans and Pricing

Israel

Patent: 9507
Estimated Expiration: See Plans and Pricing

Japan

Patent: 34848
Estimated Expiration: See Plans and Pricing

Patent: 11520960
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 3841
Estimated Expiration: See Plans and Pricing

Patent: 10012739
Estimated Expiration: See Plans and Pricing

Poland

Patent: 93668
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 19038
Estimated Expiration: See Plans and Pricing

Patent: 48456
Estimated Expiration: See Plans and Pricing

Patent: 10152555
Estimated Expiration: See Plans and Pricing

Patent: 14111445
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1008713
Estimated Expiration: See Plans and Pricing

Spain

Patent: 23909
Estimated Expiration: See Plans and Pricing

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
Russian Federation 2669465 МЕДИЦИНСКОЕ АППЛИКАТОРНОЕ УСТРОЙСТВО ДЛЯ КОЖИ (MEDICAL SKIN APPLICATOR APPARATUS) See Plans and Pricing
Japan 2016515461 医療用皮膚塗布器装置 See Plans and Pricing
Mexico 2019008119 APARATO MEDICO APLICADOR PARA PIEL. (MEDICAL SKIN APPLICATOR APPARATUS.) See Plans and Pricing
Poland 1688154 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ZURAGARD

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0289349 SPC/GB04/007 United Kingdom See Plans and Pricing 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 2012C/051 Belgium See Plans and Pricing 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
1920764 2012/033 Ireland See Plans and Pricing 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
1448186 29/2010 Austria See Plans and Pricing PRODUCT NAME: "(-)-EPIGALLOCATECHIN GALLAT MIT ISOPROPYLMYRISTAT"; NAT. REGISTRATION NO/DATE: 1-29000 20100217; FIRST REGISTRATION: DE 73486.00.00 (MITTEILUNG) 20090908
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

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Merck
Johnson and Johnson
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Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.