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Ciclopirox - Generic Drug Details

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

Ciclopirox is the generic ingredient in three branded drugs marketed by Cosette, 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. Seventeen suppliers are listed for this compound.

Summary for ciclopirox

US Patents:	0
Tradenames:	3
Applicants:	23
NDAs:	32
Drug Master File Entries:	10
Suppliers / Packagers:	17
Bulk Api Vendors:	83
Clinical Trials:	9
Patent Applications:	5,748
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for ciclopirox
Drug Sales Revenues:	Drug sales revenues for ciclopirox
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ciclopirox
DailyMed Link:	ciclopirox at DailyMed

See drug prices for ciclopirox

See drug sales revenues for ciclopirox

Recent Clinical Trials for ciclopirox

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

Sponsor	Phase
Galderma	Phase 4
Federal University of São Paulo	Phase 4
The Leukemia and Lymphoma Society	Phase 1

See all ciclopirox clinical trials

Pharmacology for ciclopirox

Mechanism of Action	Protein Synthesis Inhibitors
Physiological Effect	Decreased DNA Replication Decreased Protein Synthesis Decreased RNA Replication

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
Taro	CICLOPIROX	ciclopirox	SHAMPOO;TOPICAL	090269-001	Feb 23, 2011	AT	RX	No	No
Perrigo Israel	CICLOPIROX	ciclopirox	CREAM;TOPICAL	077364-001	Mar 3, 2006	AB	RX	No	No
Cnty Line Pharms	CICLOPIROX	ciclopirox	GEL;TOPICAL	020519-001	Jul 21, 1997	AB	RX	Yes	Yes
Teligent Pharma Inc	CICLOPIROX	ciclopirox	SHAMPOO;TOPICAL	209975-001	Apr 5, 2018	AT	RX	No	No
Paddock Llc	CICLOPIROX	ciclopirox	GEL;TOPICAL	078266-001	Jan 7, 2009	AB	RX	No	No
Actavis Mid Atlantic	CICLOPIROX	ciclopirox	SHAMPOO;TOPICAL	090490-001	Nov 24, 2009	AT	RX	No	No
Taro	CICLOPIROX	ciclopirox	CREAM;TOPICAL	076790-001	Apr 12, 2005	AB	RX	No	No

Expired US Patents for ciclopirox

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Bermuda	PENLAC	ciclopirox	SOLUTION;TOPICAL	021022-001	Dec 17, 1999
Medimetriks Pharms	LOPROX	ciclopirox	CREAM;TOPICAL	018748-001	Dec 30, 1982
Bausch	LOPROX	ciclopirox	SHAMPOO;TOPICAL	021159-001	Feb 28, 2003
Cnty Line Pharms	CICLOPIROX	ciclopirox	GEL;TOPICAL	020519-001	Jul 21, 1997
Bausch	LOPROX	ciclopirox	SHAMPOO;TOPICAL	021159-001	Feb 28, 2003
Medimetriks Pharms	LOPROX	ciclopirox	SUSPENSION;TOPICAL	019824-001	Dec 30, 1988
Cnty Line Pharms	CICLOPIROX	ciclopirox	GEL;TOPICAL	020519-001	Jul 21, 1997