Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson
Express Scripts

Last Updated: January 19, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020519

Join the DrugPatentWatch Referral Program
Get access to a free drug patent landscape report or a free one-month subscription

« Back to Dashboard

NDA 020519 describes CICLOPIROX, which is a drug marketed by Acp Nimble, Fougera Pharms, Glenmark Pharms, Perrigo Israel, Taro, Cnty Line Pharms, Glenmark Generics, Paddock Llc, Actavis Mid Atlantic, Perrigo Co, Teligent Pharma Inc, Acella, Akorn, Anda Repository, Hi Tech Pharma, Mylan Pharms Inc, Novast Labs, Perrigo New York, Taro Pharm Inds, and Teva Pharms, and is included in twenty-eight NDAs. It is available from fourteen suppliers. Additional details are available on the CICLOPIROX profile page.

The generic ingredient in CICLOPIROX is ciclopirox. There are ten drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the ciclopirox profile page.
Summary for 020519
Applicant:Cnty Line Pharms
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 020519
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CICLOPIROX ciclopirox GEL;TOPICAL 020519 NDA Alvogen Inc. 47781-530 47781-530-73 1 TUBE in 1 CARTON (47781-530-73) > 30 g in 1 TUBE
CICLOPIROX ciclopirox GEL;TOPICAL 020519 NDA Alvogen Inc. 47781-530 47781-530-84 1 TUBE in 1 CARTON (47781-530-84) > 45 g in 1 TUBE
Paragraph IV (Patent) Challenges for 020519
Tradename Dosage Ingredient NDA Submissiondate
CICLOPIROX GEL;TOPICAL ciclopirox 020519 2006-05-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.77%
Approval Date:Jul 21, 1997TE:ABRLD:Yes

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.