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
Summary for ZURAGARD
International Patents: | 65 |
US Patents: | 7 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 384 |
Clinical Trials: | 1 |
Patent Applications: | 3,458 |
Formulation / Manufacturing: | see details |
DailyMed Link: | ZURAGARD at DailyMed |

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
Sponsor | Phase |
---|---|
Zurex Pharma, Inc. | Phase 3 |
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
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 |
---|---|---|---|
Canada | 2909795 | APPAREIL MEDICAL D'APPLICATION SUR LA PEAU (MEDICAL SKIN APPLICATOR APPARATUS) | ⤷ Try a Trial |
European Patent Office | 1688154 | Solution de verrou pour cathéter contenant un citrate et un parabène (A catheter lock solution comprising citrate and a paraben) | ⤷ Try a Trial |
Mexico | 353841 | COMPOSICIONES ANTIMICROBIANAS Y METODOS DE USO. (ANTIMICROBIAL COMPOSITIONS AND METHODS OF USE.) | ⤷ Try a Trial |
Israel | 209507 | תכשירים אנטימיקרוביים ושיטות לשימוש בהם (Antimicrobial compositions and methods of use thereof) | ⤷ Try a Trial |
Israel | 185120 | תמיסה מימית אנטימיקרוביאלית והתקן ערוי וערכה המכילים אותה (Aqueous antimicrobial solution and infusion device and kit containing the same) | ⤷ Try a Trial |
Portugal | 1688154 | ⤷ Try a Trial | |
South Korea | 101337312 | ⤷ 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 | 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 |
1920764 | 2012/033 | Ireland | ⤷ Try a Trial | 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 | 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 |
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 |
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 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |