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Soluprep is a drug marketed by 3m Health Care and is included in one NDA. There is one patent protecting this drug.
This drug has nine patent family members in seven countries.
The generic ingredient in SOLUPREP is chlorhexidine gluconate; isopropyl alcohol. There are fifty-eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the chlorhexidine gluconate; isopropyl alcohol profile page.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be August 8, 2021. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Generic Entry Opportunity Date for SOLUPREP
*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 SOLUPREP
Identify potential brand extensions & 505(b)(2) entrants
|Maria-Virginia Rodriguez Funes||Phase 4|
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|3m Health Care||SOLUPREP||chlorhexidine gluconate; isopropyl alcohol||SOLUTION;TOPICAL||208288-001||Aug 8, 2018||OTC||Yes||Yes||Start Trial||Start Trial||Y||Start Trial|
|3m Health Care||SOLUPREP||chlorhexidine gluconate; isopropyl alcohol||SOLUTION;TOPICAL||208288-001||Aug 8, 2018||OTC||Yes||Yes||Start Trial||Start Trial||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
|Country||Patent Number||Estimated Expiration|
|World Intellectual Property Organization (WIPO)||2009088894||Start Trial|
|European Patent Office||2625957||Start Trial|
|>Country||>Patent Number||>Estimated Expiration|