Orange Book product · Brand (NDA)
ZYCLARA
IMIQUIMOD
At a glance
Mar 25, 2010
Approved
Brand (NDA)
Application
AB
TE code
13
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 25, 2010
16 yr 6 mo ago
Today
Patent 10238645 expires
Listed method-of-use patent (U-172) expiration.
Aug 18, 2029
in 3 yr 3 mo
Patent 10238645 expires
Listed method-of-use patent (U-1455) expiration.
Aug 18, 2029
in 3 yr 3 mo
Patent 8598196 expires
Listed method-of-use patent (U-172) expiration.
Aug 18, 2029
in 3 yr 3 mo
Patent 8598196 expires
Listed method-of-use patent (U-1455) expiration.
Aug 18, 2029
in 3 yr 3 mo
Patent 10238644 expires
Listed method-of-use patent (U-68) expiration.
Dec 11, 2029
in 3 yr 6 mo
Patent 8236816 expires
Listed method-of-use patent (U-68) expiration.
Dec 11, 2029
in 3 yr 6 mo
Patent 8299109 expires
Listed method-of-use patent (U-68) expiration.
Dec 11, 2029
in 3 yr 6 mo
Patent 10918635 expires
Listed method-of-use patent (U-172) expiration.
Apr 30, 2030
in 3 yr 11 mo
Patent 10918635 expires
Listed method-of-use patent (U-1455) expiration.
Apr 30, 2030
in 3 yr 11 mo
Patent 11202752 expires
Listed method-of-use patent (U-1455) expiration.
Apr 30, 2030
in 3 yr 11 mo
Patent 11202752 expires
Listed method-of-use patent (U-172) expiration.
Apr 30, 2030
in 3 yr 11 mo
Patent 11850245 expires
Listed method-of-use patent (U-1455) expiration.
Apr 30, 2030
in 3 yr 11 mo
Patent 11850245 expires
Listed method-of-use patent (U-172) expiration.
Apr 30, 2030
in 3 yr 11 mo
Pharmaceutical detail
Active ingredient
IMIQUIMOD
Strength
3.75%
Dosage form
CREAM
Route
TOPICAL
TE code
AB
Application
NDA 022483
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 1997ALDARABrand (NDA)
NDA 020723 · BAUSCH
- 2021IMIQUIMODGeneric (ANDA)
ANDA 205971 · TARO
- 2014IMIQUIMODGeneric (ANDA)
ANDA 202002 · STRIDES PHARMA
- 2012IMIQUIMODGeneric (ANDA)
ANDA 091308 · APOTEX INC
- 2012IMIQUIMODGeneric (ANDA)
ANDA 201994 · GLENMARK PHARMS
- 2011IMIQUIMODGeneric (ANDA)
ANDA 200481 · COSETTE
- 2011IMIQUIMODGeneric (ANDA)
ANDA 200173 · TARO
- 2011IMIQUIMODGeneric (ANDA)
ANDA 091044 · ENCUBE
- 2010IMIQUIMODGeneric (ANDA)
ANDA 078837 · PADAGIS ISRAEL
- 2010IMIQUIMODGeneric (ANDA)
ANDA 078548 · FOUGERA PHARMS
Listed patents (13)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10238645 | Aug 18, 2029 | in 3 yr 3 mo | U-172 |
| 10238645 | Aug 18, 2029 | in 3 yr 3 mo | U-1455 |
| 8598196 | Aug 18, 2029 | in 3 yr 3 mo | U-172 |
| 8598196 | Aug 18, 2029 | in 3 yr 3 mo | U-1455 |
| 10238644 | Dec 11, 2029 | in 3 yr 6 mo | U-68 |
| 8236816 | Dec 11, 2029 | in 3 yr 6 mo | U-68 |
| 8299109 | Dec 11, 2029 | in 3 yr 6 mo | U-68 |
| 10918635 | Apr 30, 2030 | in 3 yr 11 mo | U-172 |
| 10918635 | Apr 30, 2030 | in 3 yr 11 mo | U-1455 |
| 11202752 | Apr 30, 2030 | in 3 yr 11 mo | U-1455 |
| 11202752 | Apr 30, 2030 | in 3 yr 11 mo | U-172 |
| 11850245 | Apr 30, 2030 | in 3 yr 11 mo | U-1455 |
| 11850245 | Apr 30, 2030 | in 3 yr 11 mo | U-172 |
