Details for New Drug Application (NDA): 210872
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NDA 210872 describes ZURAGARD, which is a drug marketed by Zurex Pharma and is included in one NDA. There are five patents protecting this drug. Additional details are available on the ZURAGARD profile page.
The generic ingredient in ZURAGARD is isopropyl alcohol. There are thirty-one drug master file entries for this compound. Additional details are available on the isopropyl alcohol profile page.
The generic ingredient in ZURAGARD is isopropyl alcohol. There are thirty-one drug master file entries for this compound. Additional details are available on the isopropyl alcohol profile page.
Summary for 210872
| Tradename: | ZURAGARD |
| Applicant: | Zurex Pharma |
| Ingredient: | isopropyl alcohol |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 210872
Generic Entry Date for 210872*:
Constraining patent/regulatory exclusivity:
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.
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SOLUTION;TOPICAL | Strength | 70% | ||||
| Approval Date: | Apr 26, 2019 | TE: | RLD: | Yes | |||||
| Patent: | 10,688,291 | Patent Expiration: | Dec 20, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | USE AS AN ANTISEPTIC FOR THE PREPARATION OF A PATIENT'S SKIN PRIOR TO SURGERY | ||||||||
| Patent: | 8,389,583 | Patent Expiration: | Aug 9, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | USE AS AN ANTISEPTIC FOR THE PREPARATION OF A PATIENT'S SKIN PRIOR TO SURGERY | ||||||||
| Patent: | 8,703,828 | Patent Expiration: | May 23, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 210872
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Zurex Pharma | ZURAGARD | isopropyl alcohol | SOLUTION;TOPICAL | 210872-001 | Apr 26, 2019 | 8,226,971 | ⤷ Start Trial |
| Zurex Pharma | ZURAGARD | isopropyl alcohol | SOLUTION;TOPICAL | 210872-001 | Apr 26, 2019 | 9,011,897 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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