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. 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

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 and one FDA Regulatory Exclusivity.

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

FDA Regulatory Exclusivity protecting ZURAGARD

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
Zurex Pharma	ZURAGARD	isopropyl alcohol	SOLUTION;TOPICAL	210872-001	Apr 26, 2019		OTC	Yes	Yes			Y
Zurex Pharma	ZURAGARD	isopropyl alcohol	SOLUTION;TOPICAL	210872-001	Apr 26, 2019		OTC	Yes	Yes
Zurex Pharma	ZURAGARD	isopropyl alcohol	SOLUTION;TOPICAL	210872-001	Apr 26, 2019		OTC	Yes	Yes
Zurex Pharma	ZURAGARD	isopropyl alcohol	SOLUTION;TOPICAL	210872-001	Apr 26, 2019		OTC	Yes	Yes			Y
Zurex Pharma	ZURAGARD	isopropyl alcohol	SOLUTION;TOPICAL	210872-001	Apr 26, 2019		OTC	Yes	Yes			Y
Zurex Pharma	ZURAGARD	isopropyl alcohol	SOLUTION;TOPICAL	210872-001	Apr 26, 2019		OTC	Yes	Yes			Y

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
Canada	2909795	APPAREIL MEDICAL D'APPLICATION SUR LA PEAU (MEDICAL SKIN APPLICATOR APPARATUS)
European Patent Office	1688154	Solution de verrou pour cathéter contenant un citrate et un parabène (A catheter lock solution comprising citrate and a paraben)
Mexico	353841	COMPOSICIONES ANTIMICROBIANAS Y METODOS DE USO. (ANTIMICROBIAL COMPOSITIONS AND METHODS OF USE.)
Israel	209507	תכשירים אנטימיקרוביים ושיטות לשימוש בהם (Antimicrobial compositions and methods of use thereof)
Israel	185120	תמיסה מימית אנטימיקרוביאלית והתקן ערוי וערכה המכילים אותה (Aqueous antimicrobial solution and infusion device and kit containing the same)
Portugal	1688154
South Korea	101337312

Supplementary Protection Certificates for ZURAGARD

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1448186	29/2010	Austria		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		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		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		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		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		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		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