➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

AstraZeneca
Boehringer Ingelheim
Colorcon
McKinsey
Baxter
Johnson and Johnson

Last Updated: June 24, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020083


Email this page to a colleague

« Back to Dashboard

NDA 020083 describes SPORANOX, which is a drug marketed by Janssen Pharms and is included in three NDAs. It is available from three suppliers. Additional details are available on the SPORANOX profile page.

The generic ingredient in SPORANOX is itraconazole. There are fifteen drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the itraconazole profile page.
Summary for 020083
Tradename:SPORANOX
Applicant:Janssen Pharms
Ingredient:itraconazole
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 020083
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SPORANOX itraconazole CAPSULE;ORAL 020083 NDA Patriot Pharmaceuticals 10147-1700 10147-1700-3 30 CAPSULE in 1 BOTTLE (10147-1700-3)
SPORANOX itraconazole CAPSULE;ORAL 020083 NDA Patriot Pharmaceuticals 10147-1700 10147-1700-7 7 POUCH in 1 DOSE PACK (10147-1700-7) > 1 BLISTER PACK in 1 POUCH > 4 CAPSULE in 1 BLISTER PACK
Paragraph IV (Patent) Challenges for 020083
Tradename Dosage Ingredient NDA Submissiondate
SPORANOX CAPSULE;ORAL itraconazole 020083

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Sep 11, 1992TE:ABRLD:Yes

Expired US Patents for NDA 020083

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms SPORANOX itraconazole CAPSULE;ORAL 020083-001 Sep 11, 1992   Try Before You Buy   Try Before You Buy
Janssen Pharms SPORANOX itraconazole CAPSULE;ORAL 020083-001 Sep 11, 1992   Try Before You Buy   Try Before You Buy
Janssen Pharms SPORANOX itraconazole CAPSULE;ORAL 020083-001 Sep 11, 1992   Try Before You Buy   Try Before You Buy
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Medtronic
Merck
McKinsey
AstraZeneca
Boehringer Ingelheim

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 verification 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.