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 Cosette, Fougera Pharms, Glenmark Pharms, Padagis Israel, Taro, Medimetriks Pharms, Alvogen, Glenmark Pharms Inc, Padagis Us, Actavis Mid Atlantic, Encube, Bausch, Acella, Chartwell Rx, Epic Pharma Llc, Hikma, Mylan Pharms Inc, Rising, 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. Sixteen suppliers are listed for this compound.

Summary for CICLOPIROX

US Patents:	0
Tradenames:	3
Applicants:	21
NDAs:	32
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	107
Clinical Trials:	13
Patent Applications:	6,712
Drug Prices:	Drug price trends for CICLOPIROX
Drug Sales Revenues:	Drug sales revenues for CICLOPIROX
What excipients (inactive ingredients) are in CICLOPIROX?	CICLOPIROX excipients list
DailyMed Link:	CICLOPIROX at DailyMed

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Drug Sales Revenue Trends for CICLOPIROX

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Recent Clinical Trials for CICLOPIROX

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

Sponsor	Phase
Universidad Complutense de Madrid	Phase 4
Atlas Molecular Pharma	Phase 1
BritaMed, Inc.	N/A

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

Anatomical Therapeutic Chemical (ATC) Classes for CICLOPIROX

D01AE	Other antifungals for topical use
D01A	ANTIFUNGALS FOR TOPICAL USE
D01	ANTIFUNGALS FOR DERMATOLOGICAL USE
D	Dermatologicals

G01AX	Other antiinfectives and antiseptics
G01A	ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01	GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for CICLOPIROX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CICLOPIROX	Gel	ciclopirox	0.77%	020519	1	2006-05-10

US Patents and Regulatory Information for CICLOPIROX

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Padagis Us	CICLOPIROX	ciclopirox	GEL;TOPICAL	078266-001	Jan 7, 2009	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glenmark Pharms Inc	CICLOPIROX	ciclopirox	GEL;TOPICAL	091595-001	Feb 29, 2012	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Medimetriks Pharms	LOPROX	ciclopirox	CREAM;TOPICAL	018748-001	Dec 30, 1982	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fougera Pharms	CICLOPIROX	ciclopirox	GEL;TOPICAL	077896-001	Jun 10, 2008	AB	RX	No	No	⤷ 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

Expired US Patents for CICLOPIROX

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Medimetriks Pharms	LOPROX	ciclopirox	CREAM;TOPICAL	018748-001	Dec 30, 1982	⤷ Sign Up	⤷ Sign Up
Bausch	LOPROX	ciclopirox	SHAMPOO;TOPICAL	021159-001	Feb 28, 2003	⤷ Sign Up	⤷ Sign Up
Bausch	LOPROX	ciclopirox	SHAMPOO;TOPICAL	021159-001	Feb 28, 2003	⤷ Sign Up	⤷ Sign Up
Medimetriks Pharms	LOPROX	ciclopirox	SUSPENSION;TOPICAL	019824-001	Dec 30, 1988	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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