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Last Updated: December 11, 2019

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PENLAC Drug Profile

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Which patents cover Penlac, and what generic alternatives are available?

Penlac is a drug marketed by Valeant Bermuda and is included in one NDA.

The generic ingredient in PENLAC is ciclopirox. There are ten drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the ciclopirox profile page.

US ANDA Litigation and Generic Entry Outlook for Penlac

A generic version of PENLAC was launched as ciclopirox by CNTY LINE PHARMS on December 11th, 2019.

Drug patent expirations by year for PENLAC
Drug Prices for PENLAC

See drug prices for PENLAC

Recent Clinical Trials for PENLAC

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

SponsorPhase
9305-9954 Quebec IncPhase 2
Rady Children's Hospital, San DiegoPhase 4

See all PENLAC clinical trials

Synonyms for PENLAC
(6-Cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridone)
1-hydroxy-4-methyl-6-cyclohexyl-2-pyridone
19W019ZDRJ
2-aminoethanol;6-cyclohexyl-1-hydroxy-4-methyl-2-pyridinone
2-aminoethanol;6-cyclohexyl-1-hydroxy-4-methyl-2-pyridone
2-aminoethanol;6-cyclohexyl-1-hydroxy-4-methylpyridin-2-one
2-azanylethanol;6-cyclohexyl-4-methyl-1-oxidanyl-pyridin-2-one
2(1H)-Pyridinone, 6-cyclohexyl-1-hydroxy-4-methyl-
2(1H)-Pyridone, 6-cyclohexyl-1-hydroxy-4-methyl-
29342-05-0
342C050
6-Cyclohexenyl-1-hydroxy-4-methyl-2(1h)-pyridone
6-cyclohexyl-1-hydroxy-4-methyl-1,2-dihydropyridin-2-one
6-CYCLOHEXYL-1-HYDROXY-4-METHYL-1H-PYRIDIN-2-ONE
6-Cyclohexyl-1-hydroxy-4-methyl-2-(1H)-pyridone
6-cyclohexyl-1-hydroxy-4-methyl-2-pyridinone
6-cyclohexyl-1-hydroxy-4-methyl-2(1 H )-pyridinone
6-Cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridinone
6-Cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridinone #
6-Cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridone
6-cyclohexyl-1-hydroxy-4-methyl-pyridin-2-one
6-cyclohexyl-1-hydroxy-4-methylpyridin-2-one
6-cyclohexyl-1-hydroxy-4-methylpyridin-2(1H)-one
6-cyclohexyl-4-methyl-1-oxidanyl-pyridin-2-one
A819878
AB00053438_09
AB00053438_10
AB00053438_11
AB0011605
AB06517
AB2000628
AC-24195
AC1L1EDN
AJ-07970
AK544043
AKOS015895717
AN-773
Batrafen
Batrafen; Loprox;Mycoster;Stieprox;HOE 296b;Penlac
BC205517
BCP28530
BDBM66087
BG0571
BIDD:GT0080
BPBio1_000641
BRD-K13044802-213-04-1
BRD-K13044802-213-09-0
BSPBio_000581
BSPBio_002041
C-10474
C12H17NO2
CC-25776
CHEBI:453011
CHEMBL1413
CICLOPIROX
Ciclopirox (Penlac)
Ciclopirox (USP/INN)
Ciclopirox [USAN:BAN:INN]
Ciclopirox [USAN:USP:INN:BAN]
Ciclopirox gel
Ciclopirox Olamin
Ciclopirox-Olamin
Ciclopirox, >=98% (HPLC)
Ciclopirox, European Pharmacopoeia (EP) Reference Standard
Ciclopirox, United States Pharmacopeia (USP) Reference Standard
Ciclopiroxum
Ciclopiroxum [INN-Latin]
cid_38911
CNL8
CS-2561
CTK4G3143
cyclopirox
cyclopyroxolamine
D03488
Dafnegin-CSC
DB01188
DTXSID9048564
EINECS 249-577-2
FT-0602961
HMS3656I12
HOE 296b
HOE-296b
HY-B0450
I06-0862
KB-270156
KBio3_001261
KBioGR_000816
KS-00000L3N
KS-5085
KSC563C4H
Loprox
Loprox (TN)
Loprox cream
Loprox Gel
Loprox Shampoo
LS-174247
MLS002153867
MolPort-003-845-943
Mycoster
NCGC00017112-04
NCGC00017112-05
NCGC00017112-06
NCGC00017112-08
NCGC00017112-11
NCGC00178850-01
NCGC00178850-02
Penlac (TN)
Penlac nail lacquer
Prestwick0_000541
Prestwick1_000541
Prestwick2_000541
Prestwick3_000541
s2528
SBI-0206690.P002
SC-17361
SCHEMBL34424
SCKYRAXSEDYPSA-UHFFFAOYSA-N
SMR001233223
SPBio_000252
SPBio_002502
Spectrum2_000146
Spectrum3_000351
Spectrum4_000288
Spectrum5_000747
SR-05000001589-5
Stieprox
SW196923-5
Terit
TL8002303
UNII-19W019ZDRJ
W-106995
ZINC1145

US Patents and Regulatory Information for PENLAC

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Bermuda PENLAC ciclopirox SOLUTION;TOPICAL 021022-001 Dec 17, 1999 AT 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:

Mallinckrodt
Boehringer Ingelheim
Express Scripts
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Dow
Harvard Business School

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