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Last Updated: October 19, 2019

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Imiquimod - Generic Drug Details

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

Imiquimod is the generic ingredient in three branded drugs marketed by Bausch, Acp Nimble, Anda Repository, Apotex Inc, Fougera Pharms, Glenmark Generics, Perrigo Israel, Strides Pharma, and Taro, and is included in ten NDAs. There are seven patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Imiquimod has fifty-four patent family members in twenty-nine countries.

There are fourteen drug master file entries for imiquimod. Six suppliers are listed for this compound.

Drug Prices for imiquimod

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Drug Sales Revenue Trends for imiquimod

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Recent Clinical Trials for imiquimod

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Assiut UniversityPhase 3
Merck Sharp & Dohme Corp.Phase 1
Washington University School of MedicinePhase 1

See all imiquimod clinical trials

Recent Litigation for imiquimod

Identify potential future generic entrants

District Court Litigation
Case NameDate
Graceway Pharmaceuticals, LLC2011-09-29
GRACEWAY PHARMACEUTICALS, LLC v. PERRIGO COMPANY2010-02-23

See all imiquimod litigation

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-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)-
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|||Beselna
AN-15735
ANW-41635
AOB6939
API0002986
BBL010772
BC205676
BCP05151
BDBM50240849
Beselna
BG0561
BIDD:GT0859
BRD-K26657438-001-01-2
BRD-K26657438-001-13-7
C-14410
CAS-99011-02-6
CC-23827
CCG-208015
CHEBI:36704
CHEMBL1282
CJ-16235
CS-2058
CTK8B3025
D02500
DB00724
DOUYETYNHWVLEO-UHFFFAOYSA-N
DSSTox_CID_21047
DSSTox_GSID_41047
DSSTox_RID_79617
DTXSID7041047
DZ-2636
EBD27815
FT-0080222
FT-0602727
GP9049
GTPL5003
HMS2090M14
HMS2232G07
HMS3373B13
HMS3715N19
HSDB 8129
HY-B0180
I06-0624
I0747
Imiquimod / 1-(2-METHYLPROPYL)-1H-IMIDAZO[4,5-C]Q
Imiquimod - Aldara
Imiquimod (JAN/USAN/INN)
Imiquimod [USAN:INN:BAN]
Imiquimod [USAN:INN]
Imiquimod acetate
Imiquimod, >=98% (HPLC), solid
Imiquimod, United States Pharmacopeia (USP) Reference Standard
Imiquimod,(S)
Imiquimodum
J10325
KB-52632
KS-000002KB
KS-5218
LS-178395
MCULE-9421195760
MFCD00866946
MFCD00866946 (97+%)
MLS000083577
MolPort-002-507-845
MTD-39
NCGC00070736-02
NCGC00070736-03
NCGC00070736-04
NSC-369100
NSC-759651
NSC369100
NSC759651
P1QW714R7M
Pharmakon1600-01502351
PubChem21071
R 837
R-837
S 26308
S-26308
s1211
S26308
SC-17224
SCHEMBL26136
SMR000048307
SR-01000611320
SR-01000611320-2
SR-01000611320-3
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
Anda Repository IMIQUIMOD imiquimod CREAM;TOPICAL 091044-001 Feb 28, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Taro IMIQUIMOD imiquimod CREAM;TOPICAL 200173-001 Apr 15, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Fougera Pharms IMIQUIMOD imiquimod CREAM;TOPICAL 078548-001 Feb 25, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
Bausch ZYCLARA imiquimod CREAM;TOPICAL 022483-001 Mar 25, 2010 RX Yes Yes   Start Trial   Start Trial   Start Trial
>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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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Medtronic
Moodys
Mallinckrodt
Colorcon
Johnson and Johnson

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