donepezil hydrochloride · Corium · NDA 212304

Adlarity

Earliest generic entry, as listed · earliest of 2 marketed strengths
11 Aug 2038

No marketed reference-listed strength; date taken from all listed strengths.

Blocked by patent: US 10966936.

Listed patents · 11 unexpired

PatentClaimsExpires
US 10966936drug product, use U-3334 · sets the listed date11 Aug 2038
US 10835499drug product, use U-333420 May 2038
US 11648214drug product, use U-333423 Sep 2037
US 10016372use U-333426 Jul 2037
US 10300025drug product26 Jul 2037
US 10307379drug product26 Jul 2037
US 11103463use U-333426 Jul 2037
US 9993466drug product26 Jul 2037
US 11679086use U-333426 May 2037
US 12161767drug substance, drug product, use U-333430 Dec 2036
US 12168075use U-333430 Dec 2036

Exclusivities · 0 unexpired

No unexpired exclusivities listed.

Paragraph IV certifications · 0

No Paragraph IV certification listed by FDA for this drug.

The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.

Event history

No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.

Products covered · 2

NDA · productFormStrengthListed expiry
212304 · 001 · RLD · discontinuedsystem, transdermal5MG/DAY11 Aug 2038
212304 · 002 · RLD · discontinuedsystem, transdermal10MG/DAY11 Aug 2038