zuragard Drug Patent Profile
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Which patents cover Zuragard, and when can generic versions of Zuragard launch?
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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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: | 2,929 |
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 ⤷ 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 |
---|---|---|---|
European Patent Office | 3711791 | APPAREIL APPLICATEUR CUTANÉ MÉDICAL (MEDICAL SKIN APPLICATOR APPARATUS) | ⤷ Sign Up |
Brazil | PI0606969 | solução de bloqueio de cateter compreendendo citrato e um parabeno | ⤷ Sign Up |
European Patent Office | 2986333 | ⤷ Sign Up | |
Mexico | 353841 | COMPOSICIONES ANTIMICROBIANAS Y METODOS DE USO. (ANTIMICROBIAL COMPOSITIONS AND METHODS OF USE.) | ⤷ Sign Up |
Canada | 2724784 | COMPOSITIONS ANTIMICROBIENNES ET LEURS PROCEDES D'UTILISATION (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 |
---|---|---|---|---|
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 |
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 |
2447254 | 2018015 | Norway | ⤷ Sign Up | PRODUCT NAME: 2-4-(N-(5,6-DIFENYLPYRAZIN-2- YL)-N- ISOPROPYLAMINO)BUTYLOKSY-N-; REG. NO/DATE: EU/1/15/1083 20160530 |
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 |
1448186 | C300550 | Netherlands | ⤷ Sign Up | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |