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Accenture
McKesson
US Army
AstraZeneca
Merck
Argus Health
Medtronic
McKinsey
Teva

Generated: July 15, 2018

DrugPatentWatch Database Preview

Imiquimod - Generic Drug Details

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What are the generic drug sources for imiquimod and what is the scope of imiquimod freedom to operate?

Imiquimod
is the generic ingredient in three branded drugs marketed by Medicis, Apotex Inc, Fougera Pharms, G And W Labs Inc, Glenmark Generics, Perrigo Israel, Strides Pharma, Taro, and Tolmar, and is included in ten NDAs. There are five patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Imiquimod has twenty-two patent family members in seventeen countries.

There are fourteen drug master file entries for imiquimod. Nine suppliers are listed for this compound.
Pharmacology for imiquimod
Synonyms for imiquimod
(non-labelled)Imiquimod-d9
011I026
1-(2-methylpropyl)-1H-imidazo[4,5-c]-quinolin-4-amine
1-(2-methylpropyl)-1H-imidazo[4,5-c]quinolin-4-amine
1-(2-methylpropyl)-1H-imidazo[4,5-c]quinolin-4-amine;
1-(2-Methylpropyl)-1H-imidazole[4,5-c]quinoline-4-amine
1-(2-methylpropyl)-1Himidazo[4,5-c]quinolin-4-amine
1-(2-methylpropyl)-4-imidazo[4,5-c]quinolinamine
1-(2-methylpropyl)imidazo[4,5-c]quinolin-4-amine
1-isobutyl-1H-imidazo [4,5-c]quinolin-4-amine
1-isobutyl-1H-imidazo(4,5-c)quinolin-4-amine
1-isobutyl-1H-imidazo[4,5-c]quinolin-4-amine
1-Isobutyl-1H-imidazo[4,5-c]quinolin-4-ylamine
1-isobutyl-1H-imidazo[4,5-c]quinoline-4-amine
1-isobutylimidazo[4,5-c]quinolin-4-amine
1H-Imidazo(4,5-c)quinolin-4-amine, 1-(2-methylpropyl)-
1H-Imidazo[4, 1-(2-methylpropyl)-
1H-Imidazo[4,5-c]quinolin-4-amine, 1-(2-methylpropyl)-
3M Brand of Imiquimod
4-Amino- 1-isobutyl-1H-imidazo[4,5-c]quinoline; 1-(2-Methylpropyl)-1H-imidazo[4,5-C]quinolin-4-amine
4-Amino-1-isobutyl-1H-imidazo(4,5-c)quinoline
4-Amino-1-isobutyl-1H-imidazo[4,5-c]quinoline
6T0
9050-31-1
99011-02-6
A845945
AB00399298_08
AB00399298_09
AB00399298-05
AB00399298-06
AB00399298-07
AC-529
AC1L1N2I
AC1Q4YO9
ACMC-209stx
AK209015
AKOS005507352
Aldara
Aldara (TN)
Aldara, Imiquimod
Aldara|||Beselna
AN-15735
ANW-41635
AOB6939
API0002986
BB_SC-2107
BBL010772
BC205676
BDBM50240849
Beselna
Beselna (TN)
BG0561
BIDD:GT0859
BRD-K26657438-001-13-7
C-14410
CAS-99011-02-6
CC-23827
CCG-208015
CHEBI:36704
CHEMBL1282
CJ-16235
CS-2058
CTK8B3025
D02500
D06CTE
DB00724
DOUYETYNHWVLEO-UHFFFAOYSA-N
DR000569
DSSTox_CID_21047
DSSTox_GSID_41047
DSSTox_RID_79617
DTXSID7041047
DZ-2636
EBD27815
FT-0080222
FT-0602727
GP9049
GTPL5003
HMS2090M14
HMS2232G07
HMS3373B13
HY-B0180
I06-0624
I0747
Imiquimod / 1-(2-METHYLPROPYL)-1H-IMIDAZO[4,5-C]Q
Imiquimod - Aldara
Imiquimod (JAN/USAN/INN)
Imiquimod [USAN:INN]
Imiquimod acetate
Imiquimod, >=98% (HPLC), solid
Imiquimod, United States Pharmacopeia (USP) Reference Standard
Imiquimodum
J10325
KB-52632
KS-000002KB
KS-5218
LS-178395
MCULE-9421195760
MFCD00866946
MLS000083577
MolPort-002-507-845
MTD-39
NCGC00070736-02
NCGC00070736-03
NCGC00070736-04
NSC-369100
NSC-759651
NSC369100
NSC759651
P1QW714R7M
Pharmakon1600-01502351
PL019867
PL076468
PubChem21071
R 837
R-837
S 26308
S-26308
s1211
SC-17224
SCHEMBL26136
SMR000048307
SR-01000611320
SR-01000611320-2
STK583860
SY017571
TL8006059
TMX 101
TMX-101
Tox21_110985
Tox21_110985_1
TR-038644
TRA0092888
UNII-P1QW714R7M
Vyloma
Z-4416
Zartra
ZINC19632912
ZLA0010
zlchem 9
Zyclara
Zyclara (TN)

US Patents and Regulatory Information for imiquimod

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Medicis ZYCLARA imiquimod CREAM;TOPICAL 022483-001 Mar 25, 2010 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
G And W Labs Inc IMIQUIMOD imiquimod CREAM;TOPICAL 200481-001 Apr 18, 2011 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Taro IMIQUIMOD imiquimod CREAM;TOPICAL 200173-001 Apr 15, 2011 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Tolmar IMIQUIMOD imiquimod CREAM;TOPICAL 091044-001 Feb 28, 2011 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for imiquimod

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,835,394 Treatment for basal cell carcinoma ➤ Sign Up
9,370,509 2.times.2.times.2 week dosing regimen for treating actinic keratosis with pharmaceutical compositions formulated with 3.75 % imiquimod ➤ Sign Up
9,271,973 Methods of treating dermatological disorders and inducing interferon biosynthesis with shorter durations of imiquimod therapy ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for imiquimod

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB99/003 United Kingdom ➤ Sign Up PRODUCT NAME: IMIQUIMOD; REGISTERED: UK EU/1/98/080/001 19980918
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Covington
AstraZeneca
Cantor Fitzgerald
Moodys
Fish and Richardson
Fuji
Chinese Patent Office
Colorcon

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