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Last Updated: May 2, 2024

Details for Patent: 10,016,372


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Summary for Patent: 10,016,372
Title:Transdermal delivery systems with pharmacokinetics bioequivalent to oral delivery
Abstract: A method for delivering a therapeutic agent to a subject from a transdermal delivery system is described, where the therapeutic agent (i) has a half-life in the blood when delivered orally of greater than about 48 hours and (ii) is for the treatment of a chronic condition. The transdermal delivery system achieves transdermal delivery of the therapeutic agent at steady state that is bioequivalent to administration of the therapeutic agent orally, wherein bioequivalency is established by (a) a 90% confidence interval of the relative mean Cmax and AUC of the therapeutic agent administered from the transdermal delivery system and via oral delivery between 0.70 and 1.43 or between 0.80 and 1.25, or (b) a 90% confidence interval of the ratios for AUC and Cmax of the therapeutic agent administered from the transdermal delivery system and via oral delivery between 0.70 and 1.43 or between 0.80 and 1.25.
Inventor(s): Singh; Parminder (Union City, CA), Lee; Eun Soo (Redwood City, CA), Jain; Amit K. (Milpitas, CA)
Assignee: Corium International, Inc. (Menlo Park, CA)
Application Number:15/660,933
Patent Claim Types:
see list of patent claims
Use; Composition; Delivery;

Drugs Protected by US Patent 10,016,372

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Corium ADLARITY donepezil hydrochloride SYSTEM;TRANSDERMAL 212304-001 Mar 11, 2022 RX Yes No ⤷  Try a Trial ⤷  Try a Trial A METHOD OF TRANSDERMAL DELIVERY OF DONEPEZIL FOR TREATING MILD, MODERATE AND SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE ⤷  Try a Trial
Corium ADLARITY donepezil hydrochloride SYSTEM;TRANSDERMAL 212304-002 Mar 11, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial A METHOD OF TRANSDERMAL DELIVERY OF DONEPEZIL FOR TREATING MILD, MODERATE AND SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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