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Queensland Health
US Department of Justice
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Federal Trade Commission
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Mallinckrodt
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Express Scripts

Generated: November 14, 2018

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ZYCLARA Drug Profile

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Which patents cover Zyclara, and when can generic versions of Zyclara launch?

Zyclara is a drug marketed by Medicis and is included in one NDA. There are four patents protecting this drug and two Paragraph IV challenges.

The generic ingredient in ZYCLARA is imiquimod. There are fourteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the imiquimod profile page.

Drug patent expirations by year for ZYCLARA
Pharmacology for ZYCLARA
Synonyms for ZYCLARA
(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
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 (TN)

US Patents and Regulatory Information for ZYCLARA

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 022483-002 Jul 15, 2011 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Medicis ZYCLARA imiquimod CREAM;TOPICAL 022483-001 Mar 25, 2010 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Medicis ZYCLARA imiquimod CREAM;TOPICAL 022483-001 Mar 25, 2010 RX Yes Yes ➤ 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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Paragraph IV (Patent) Challenges for ZYCLARA
Drugname Dosage Strength RLD Date
➤ Subscribe Cream 3.75% ➤ Subscribe ➤ Sign Up
➤ Subscribe Cream 2.5% ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for ZYCLARA

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:

Queensland Health
US Department of Justice
Moodys
Federal Trade Commission
Harvard Business School
Daiichi Sankyo
Mallinckrodt
Deloitte
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.