Get our Free Patent Expiration, Litigation, and Drug Price Updates

Serving hundreds of leading biopharmaceutical companies globally:

Chubb
US Department of Justice
Argus Health
Moodys
Julphar
Boehringer Ingelheim

Generated: June 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205573

« Back to Dashboard

NDA 205573 describes ITRACONAZOLE, which is a drug marketed by Accord Hlthcare, Alembic Pharms Ltd, Alkem Labs Ltd, Amneal Pharms, Jubilant Generics, Mylan Pharms Inc, Par Pharm Inc, Sandoz, Torrent, and Zydus Pharms Usa Inc, and is included in eleven NDAs. It is available from fourteen suppliers. Additional details are available on the ITRACONAZOLE profile page.

The generic ingredient in ITRACONAZOLE is itraconazole. There are fifteen drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the itraconazole profile page.
Summary for 205573
Tradename:ITRACONAZOLE
Applicant:Amneal Pharms
Ingredient:itraconazole
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 205573
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ITRACONAZOLE itraconazole SOLUTION;ORAL 205573 ANDA Amneal Pharmaceuticals LLC 65162-087 65162-087-74 150 mL in 1 BOTTLE, GLASS (65162-087-74)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength10MG/ML
Approval Date:Oct 30, 2015TE:AARLD:No
Regulatory Exclusivity Expiration:Mar 17, 2019
Regulatory Exclusivity Use:PATENT CHALLENGE

Complete Access Available with Subscription

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

Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
US Department of Justice
Farmers Insurance
AstraZeneca
Boehringer Ingelheim
Moodys

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.