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Last Updated: December 14, 2019

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Ciclopirox - Generic Drug Details

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What are the generic sources for ciclopirox and what is the scope of patent protection?

Ciclopirox is the generic ingredient in three branded drugs marketed by Acp Nimble, Fougera Pharms, Glenmark Pharms, Perrigo Israel, Taro, Medimetriks Pharms, Cnty Line Pharms, Glenmark Generics, Paddock Llc, Actavis Mid Atlantic, Perrigo Co, Teligent Pharma Inc, Bausch, Acella, Akorn, Anda Repository, Hi Tech Pharma, Mylan Pharms Inc, Novast Labs, Perrigo New York, Taro Pharm Inds, Teva Pharms, and Valeant Bermuda, and is included in thirty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for ciclopirox. Nineteen suppliers are listed for this compound.

Drug Prices for ciclopirox

See drug prices for ciclopirox

Drug Sales Revenue Trends for ciclopirox

See drug sales revenues for ciclopirox

Recent Clinical Trials for ciclopirox

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

SponsorPhase
GaldermaPhase 4
Federal University of São PauloPhase 4
The Leukemia and Lymphoma SocietyPhase 1

See all ciclopirox clinical trials

Recent Litigation for ciclopirox

Identify potential future generic entrants

District Court Litigation
Case NameDate
Medicis Pharmaceutical Corporation v. Watson Pharmaceuticals, Inc.2011-10-21
Medicis Pharmaceutical Corporation v. Nycomed U.S., Inc2011-07-19

See all ciclopirox litigation

Synonyms for ciclopirox
(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 (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
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
Paragraph IV (Patent) Challenges for CICLOPIROX
Tradename Dosage Ingredient NDA Submissiondate
CICLOPIROX GEL;TOPICAL ciclopirox 020519 2006-05-10

US Patents and Regulatory Information for ciclopirox

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fougera Pharms CICLOPIROX ciclopirox SHAMPOO;TOPICAL 090146-001 May 25, 2010 AT RX No No   Start Trial   Start Trial   Start Trial
Acella CICLOPIROX ciclopirox SOLUTION;TOPICAL 078172-001 Sep 18, 2007 AT RX No No   Start Trial   Start Trial   Start Trial
Acp Nimble CICLOPIROX ciclopirox SOLUTION;TOPICAL 078233-001 Sep 18, 2007 AT RX No No   Start Trial   Start Trial   Start Trial
Perrigo Co CICLOPIROX ciclopirox SHAMPOO;TOPICAL 078594-001 Feb 16, 2010 AT RX No No   Start Trial   Start Trial   Start Trial
Akorn CICLOPIROX ciclopirox SOLUTION;TOPICAL 078975-001 Feb 17, 2010 AT RX No No   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

Expired US Patents for ciclopirox

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Medimetriks Pharms LOPROX ciclopirox SUSPENSION;TOPICAL 019824-001 Dec 30, 1988   Start Trial   Start Trial
Medimetriks Pharms LOPROX ciclopirox CREAM;TOPICAL 018748-001 Dec 30, 1982   Start Trial   Start Trial
Valeant Bermuda PENLAC ciclopirox SOLUTION;TOPICAL 021022-001 Dec 17, 1999   Start Trial   Start Trial
Bausch LOPROX ciclopirox SHAMPOO;TOPICAL 021159-001 Feb 28, 2003   Start Trial   Start Trial
Bausch LOPROX ciclopirox SHAMPOO;TOPICAL 021159-001 Feb 28, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
AstraZeneca
Mallinckrodt
Colorcon
Moodys
Boehringer Ingelheim

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