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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 are four patents 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 nine 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 NDA: 021560

Tradename:
ZORTRESS
Applicant:
Novartis
Ingredient:
everolimus
Patents:4
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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.25MG
Approval Date:Apr 20, 2010TE:RLD:No
Patent:5,665,772*PEDPatent Expiration:Mar 9, 2020Product Flag?Substance Flag?Delist Request?Y
Patent:6,004,973*PEDPatent Expiration:Jan 12, 2017Product Flag?Substance Flag?Delist Request?Y
Patent:6,239,124*PEDPatent Expiration:Feb 11, 2018Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021560

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
ZORTRESS
everolimus
TABLET;ORAL021560-003Apr 20, 20106,440,990*PED► subscribe
Novartis
ZORTRESS
everolimus
TABLET;ORAL021560-001Apr 20, 20106,440,990*PED► subscribe
Novartis
ZORTRESS
everolimus
TABLET;ORAL021560-002Apr 20, 20106,440,990*PED► subscribe
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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.

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