Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 9, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021560

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NDA 021560 describes ZORTRESS, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the ZORTRESS profile page.

The generic ingredient in ZORTRESS is everolimus. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the everolimus profile page.
Summary for 021560
Tradename:ZORTRESS
Applicant:Novartis
Ingredient:everolimus
Patents:1
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 021560
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZORTRESS everolimus TABLET;ORAL 021560 NDA Novartis Pharmaceuticals Corporation 0078-0414 0078-0414-20 60 BLISTER PACK in 1 BOX (0078-0414-20) > 1 TABLET in 1 BLISTER PACK (0078-0414-61)
ZORTRESS everolimus TABLET;ORAL 021560 NDA Novartis Pharmaceuticals Corporation 0078-0415 0078-0415-20 60 BLISTER PACK in 1 BOX (0078-0415-20) > 1 TABLET in 1 BLISTER PACK (0078-0415-61)
Paragraph IV (Patent) Challenges for 021560
Tradename Dosage Ingredient NDA Submissiondate
ZORTRESS TABLET;ORAL everolimus 021560 2013-09-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.25MG
Approval Date:Apr 20, 2010TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Mar 9, 2020Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Apr 20, 2010TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Mar 9, 2020Product Flag?Substance Flag?Delist Request?Y

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.75MG
Approval Date:Apr 20, 2010TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Mar 9, 2020Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021560

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis ZORTRESS everolimus TABLET;ORAL 021560-002 Apr 20, 2010   Start Trial   Start Trial
Novartis ZORTRESS everolimus TABLET;ORAL 021560-003 Apr 20, 2010   Start Trial   Start Trial
Novartis ZORTRESS everolimus TABLET;ORAL 021560-001 Apr 20, 2010   Start Trial   Start Trial
Novartis ZORTRESS everolimus TABLET;ORAL 021560-002 Apr 20, 2010   Start Trial   Start Trial
Novartis ZORTRESS everolimus TABLET;ORAL 021560-003 Apr 20, 2010   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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