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Last Updated: March 28, 2024

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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. One supplier is listed 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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Drug patent expirations by year for ZURAGARD
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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 one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ZURAGARD is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Antimicrobial compositions and methods of use
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Catheter lock solution comprising citrate and a paraben
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

Medical skin applicator apparatus
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE AS AN ANTISEPTIC FOR THE PREPARATION OF A PATIENT'S SKIN PRIOR TO SURGERY

FDA Regulatory Exclusivity protecting ZURAGARD

ADDITION OF INFORMATION TO THE LABEL REGARDING A CLEAR PRODUCT PRESENTATION AND 26 ML VOLUME PRODUCTS
Exclusivity Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zurex Pharma ZURAGARD isopropyl alcohol SOLUTION;TOPICAL 210872-001 Apr 26, 2019 OTC Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Zurex Pharma ZURAGARD isopropyl alcohol SOLUTION;TOPICAL 210872-001 Apr 26, 2019 OTC Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zurex Pharma ZURAGARD isopropyl alcohol SOLUTION;TOPICAL 210872-001 Apr 26, 2019 OTC Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zurex Pharma ZURAGARD isopropyl alcohol SOLUTION;TOPICAL 210872-001 Apr 26, 2019 OTC Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Zurex Pharma ZURAGARD isopropyl alcohol SOLUTION;TOPICAL 210872-001 Apr 26, 2019 OTC Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Zurex Pharma ZURAGARD isopropyl alcohol SOLUTION;TOPICAL 210872-001 Apr 26, 2019 OTC Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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: ⤷  Try a Trial

Brazil

Patent: 0913086
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 24784
Estimated Expiration: ⤷  Try a Trial

China

Patent: 2105055
Estimated Expiration: ⤷  Try a Trial

Patent: 6466319
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 93668
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 93668
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 9507
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 34848
Estimated Expiration: ⤷  Try a Trial

Patent: 11520960
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 3841
Estimated Expiration: ⤷  Try a Trial

Patent: 10012739
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 93668
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 19038
Estimated Expiration: ⤷  Try a Trial

Patent: 48456
Estimated Expiration: ⤷  Try a Trial

Patent: 10152555
Estimated Expiration: ⤷  Try a Trial

Patent: 14111445
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1008713
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 23909
Estimated Expiration: ⤷  Try a Trial

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
Austria E453415 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2009142760 ⤷  Try a Trial
Russian Federation 2015149468 МЕДИЦИНСКОЕ АППЛИКАТОРНОЕ УСТРОЙСТВО ДЛЯ КОЖИ ⤷  Try a Trial
Russian Federation 2010152555 АНТИМИКРОБНЫЕ КОМПОЗИЦИИ И СПОСОБЫ ПРИМЕНЕНИЯ ⤷  Try a Trial
Portugal 1688154 ⤷  Try a Trial
Russian Federation 2669465 МЕДИЦИНСКОЕ АППЛИКАТОРНОЕ УСТРОЙСТВО ДЛЯ КОЖИ (MEDICAL SKIN APPLICATOR APPARATUS) ⤷  Try a Trial
Japan 6396993 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ZURAGARD

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1448186 29/2010 Austria ⤷  Try a Trial PRODUCT NAME: "(-)-EPIGALLOCATECHIN GALLAT MIT ISOPROPYLMYRISTAT"; NAT. REGISTRATION NO/DATE: 1-29000 20100217; FIRST REGISTRATION: DE 73486.00.00 (MITTEILUNG) 20090908
1448186 C300550 Netherlands ⤷  Try a Trial 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 ⤷  Try a Trial 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
1448186 2012C/051 Belgium ⤷  Try a Trial 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
2447254 2018015 Norway ⤷  Try a Trial PRODUCT NAME: 2-4-(N-(5,6-DIFENYLPYRAZIN-2- YL)-N- ISOPROPYLAMINO)BUTYLOKSY-N-; REG. NO/DATE: EU/1/15/1083 20160530
2203462 2014029 Norway ⤷  Try a Trial PRODUCT NAME: SOFOSBUVIR. (S)-ISOPROPYL 2-; NAT. REG. NO/DATE: EU/1/13/894 20140116; FIRST REG. NO/DATE: (001-002) 20140117
0289349 SPC/GB04/007 United Kingdom ⤷  Try a Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.