imiquimod · Bausch · NDA 022483

Zyclara

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

11 Dec 2029

Other strengths are listed to 30 Apr 2030.

Blocked by patent: US 10238644, US 11318130, US 8222270, US 8236816, US 8299109. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

Listed patents · 10 unexpired

15 Orange Book listing rows for 10 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

Patent	Claims	Expires	Notes
US 10918635	use U-1455, U-172	30 Apr 2030	2 listing rows
US 10918635 listing row	use U-1455	30 Apr 2030	listed 3 Mar 2021
US 10918635 listing row	use U-172	30 Apr 2030	listed 3 Mar 2021
US 11202752	use U-1455, U-172	30 Apr 2030	2 listing rows
US 11202752 listing row	use U-1455	30 Apr 2030	listed 19 Jan 2022
US 11202752 listing row	use U-172	30 Apr 2030	listed 19 Jan 2022
US 11850245	use U-1455, U-172	30 Apr 2030	2 listing rows
US 11850245 listing row	use U-1455	30 Apr 2030	listed 12 Jan 2024
US 11850245 listing row	use U-172	30 Apr 2030	listed 12 Jan 2024
US 10238644	use U-68 · sets the listed date	11 Dec 2029	listed 11 Apr 2019
US 11318130	use U-68 · sets the listed date	11 Dec 2029	listed 20 May 2022
US 8222270	use U-68 · sets the listed date	11 Dec 2029	listed 18 Jul 2012
US 8236816	use U-68 · sets the listed date	11 Dec 2029	listed 8 Aug 2012
US 8299109	use U-68 · sets the listed date	11 Dec 2029	listed 1 Nov 2012
US 10238645	use U-1455, U-172	18 Aug 2029	2 listing rows
US 10238645 listing row	use U-1455	18 Aug 2029	listed 11 Apr 2019
US 10238645 listing row	use U-172	18 Aug 2029	listed 11 Apr 2019
US 8598196	use U-1455, U-172	18 Aug 2029	2 listing rows
US 8598196 listing row	use U-1455	18 Aug 2029	listed 11 Dec 2013
US 8598196 listing row	use U-172	18 Aug 2029	listed 11 Dec 2013

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 · product	Form	Strength	Approved	Listed expiry
022483 · 001 · RLD	cream, topical	3.75%	25 Mar 2010	30 Apr 2030
022483 · 002 · RLD	cream, topical	2.5%	15 Jul 2011	11 Dec 2029