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Last Updated: July 19, 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 ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Antimicrobial compositions and methods of use
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Catheter lock solution comprising citrate and a paraben
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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

Medical skin applicator apparatus
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zurex Pharma ZURAGARD isopropyl alcohol SOLUTION;TOPICAL 210872-001 Apr 26, 2019 OTC Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Zurex Pharma ZURAGARD isopropyl alcohol SOLUTION;TOPICAL 210872-001 Apr 26, 2019 OTC Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zurex Pharma ZURAGARD isopropyl alcohol SOLUTION;TOPICAL 210872-001 Apr 26, 2019 OTC Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zurex Pharma ZURAGARD isopropyl alcohol SOLUTION;TOPICAL 210872-001 Apr 26, 2019 OTC Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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
Patent: Antimicrobial compositions and methods of use
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0913086
Patent: Composições antimicrobianas e métodos de uso
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 24784
Patent: COMPOSITIONS ANTIMICROBIENNES ET LEURS PROCEDES D'UTILISATION (ANTIMICROBIAL COMPOSITIONS AND METHODS OF USE)
Estimated Expiration: ⤷  Sign Up

China

Patent: 2105055
Patent: Antimicrobial compositions and methods of use
Estimated Expiration: ⤷  Sign Up

Patent: 6466319
Patent: 抗微生物组合物和使用方法 (Antimicrobial compositions and methods of use)
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 93668
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 93668
Patent: COMPOSITIONS ANTIMICROBIENNES ET LEURS PROCÉDÉS D'UTILISATION (ANTIMICROBIAL COMPOSITIONS AND METHODS OF USE)
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 9507
Patent: תכשירים אנטימיקרוביים ושיטות לשימוש בהם (Antimicrobial compositions and methods of use thereof)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 34848
Estimated Expiration: ⤷  Sign Up

Patent: 11520960
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 3841
Patent: COMPOSICIONES ANTIMICROBIANAS Y METODOS DE USO. (ANTIMICROBIAL COMPOSITIONS AND METHODS OF USE.)
Estimated Expiration: ⤷  Sign Up

Patent: 10012739
Patent: COMPOSICIONES ANTIMICROBIANAS Y MÉTODOS DE USO. (ANTIMICROBIAL COMPOSITIONS AND METHODS OF USE.)
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 93668
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 19038
Patent: АНТИМИКРОБНЫЕ КОМПОЗИЦИИ И СПОСОБЫ ПРИМЕНЕНИЯ (ANTIMICROBIAL COMPOSITIONS AND METHODS OF USING THEM)
Estimated Expiration: ⤷  Sign Up

Patent: 48456
Patent: АНТИМИКРОБНЫЕ КОМПОЗИЦИИ И СПОСОБЫ ПРИМЕНЕНИЯ (ANTIMICROBIAL COMPOSITIONS AND METHODS OF USE)
Estimated Expiration: ⤷  Sign Up

Patent: 10152555
Patent: АНТИМИКРОБНЫЕ КОМПОЗИЦИИ И СПОСОБЫ ПРИМЕНЕНИЯ
Estimated Expiration: ⤷  Sign Up

Patent: 14111445
Patent: АНТИМИКРОБНЫЕ КОМПОЗИЦИИ И СПОСОБЫ ПРИМЕНЕНИЯ
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1008713
Patent: ANTIMICROBIAL COMPOSITIONS AND METHODS OF USE
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 23909
Estimated Expiration: ⤷  Sign Up

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
South Korea 101337312 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2006086250 ⤷  Sign Up
South Africa 200707348 A catheter lock solution comprising citrate and a paraben ⤷  Sign Up
Mexico 2019008119 APARATO MEDICO APLICADOR PARA PIEL. (MEDICAL SKIN APPLICATOR APPARATUS.) ⤷  Sign Up
Russian Federation 2648456 АНТИМИКРОБНЫЕ КОМПОЗИЦИИ И СПОСОБЫ ПРИМЕНЕНИЯ (ANTIMICROBIAL COMPOSITIONS AND METHODS OF USE) ⤷  Sign Up
>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 ⤷  Sign Up 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 29/2010 Austria ⤷  Sign Up PRODUCT NAME: "(-)-EPIGALLOCATECHIN GALLAT MIT ISOPROPYLMYRISTAT"; NAT. REGISTRATION NO/DATE: 1-29000 20100217; FIRST REGISTRATION: DE 73486.00.00 (MITTEILUNG) 20090908
2203462 2014029 Norway ⤷  Sign Up PRODUCT NAME: SOFOSBUVIR. (S)-ISOPROPYL 2-; NAT. REG. NO/DATE: EU/1/13/894 20140116; FIRST REG. NO/DATE: (001-002) 20140117
1920764 2012/033 Ireland ⤷  Sign Up 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 2012C/051 Belgium ⤷  Sign Up 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
>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.