FDA Orange Book · active-ingredient family
Ciclopirox
Ciclopirox is approved as 5 brand and 27 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:LOPROX · NDA 021159
5
Brand (NDA)
27
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · cream, gel, shampoo, solution, suspension
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LOPROXRLD | BAUSCH | NDA 021159 | — | Feb 28, 2003 | |
| PENLACRLD | VALEANT BERMUDA | NDA 021022 | — | Dec 17, 1999 | |
| CICLOPIROXRLD | ALVOGEN | NDA 020519 | — | Jul 21, 1997 | |
| LOPROXRLD | EUROFARMA | NDA 019824 | AB | Dec 30, 1988 | |
| LOPROXRLD | EUROFARMA | NDA 018748 | AB | Dec 30, 1982 |
Generic (ANDA) products (27)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CICLOPIROX | ENCUBE | ANDA 209975 | AT | Apr 05, 2018 | |
| CICLOPIROX | GLENMARK PHARMS | ANDA 091595 | AB | Feb 29, 2012 | |
| CICLOPIROX | SUN PHARMA CANADA | ANDA 090269 | AT | Feb 23, 2011 | |
| CICLOPIROX | COSETTE PHARMS NC | ANDA 078463 | AB | Dec 20, 2010 | |
| CICLOPIROX | FOUGERA PHARMS | ANDA 090146 | AT | May 25, 2010 | |
| CICLOPIROX | EPIC PHARMA LLC | ANDA 078975 | — | Feb 17, 2010 | |
| CICLOPIROX | PADAGIS US | ANDA 078594 | AT | Feb 16, 2010 | |
| CICLOPIROX | ACTAVIS MID ATLANTIC | ANDA 090490 | AT | Nov 24, 2009 | |
| CICLOPIROX | GLENMARK PHARMS | ANDA 090273 | AB | Nov 10, 2009 | |
| CICLOPIROX | PADAGIS US | ANDA 078266 | AB | Jan 07, 2009 | |
| CICLOPIROX | FOUGERA PHARMS | ANDA 077896 | AB | Jun 10, 2008 | |
| CICLOPIROX | ACELLA | ANDA 078172 | AT | Sep 18, 2007 | |
| CICLOPIROX | CHARTWELL RX | ANDA 078046 | AT | Sep 18, 2007 | |
| CICLOPIROX | COSETTE PHARMS NC | ANDA 078233 | — | Sep 18, 2007 | |
| CICLOPIROX | ENCUBE | ANDA 077687 | AT | Sep 18, 2007 | |
| CICLOPIROX | HIKMA | ANDA 078270 | — | Sep 18, 2007 | |
| CICLOPIROX | MYLAN PHARMS INC | ANDA 078567 | — | Sep 18, 2007 | |
| CICLOPIROX | PADAGIS US | ANDA 077623 | AT | Sep 18, 2007 | |
| CICLOPIROX | RISING | ANDA 078124 | AT | Sep 18, 2007 | |
| CICLOPIROX | TARO PHARM INDS | ANDA 078144 | — | Sep 18, 2007 | |
| CICLOPIROX | TEVA PHARMS | ANDA 078079 | — | Sep 18, 2007 | |
| CICLOPIROX | PADAGIS ISRAEL | ANDA 077676 | AB | Dec 15, 2006 | |
| CICLOPIROX | PADAGIS ISRAEL | ANDA 077364 | AB | Mar 03, 2006 | |
| CICLOPIROX | SUN PHARMA CANADA | ANDA 077092 | — | Aug 10, 2005 | |
| CICLOPIROX | SUN PHARMA CANADA | ANDA 076790 | AB | Apr 12, 2005 | |
| CICLOPIROX | FOUGERA PHARMS | ANDA 076435 | AB | Dec 29, 2004 | |
| CICLOPIROX | FOUGERA PHARMS | ANDA 076422 | AB | Aug 06, 2004 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Ciclopirox — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
