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 three 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 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:	3
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021560

Mechanism of Action	Protein Kinase Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors Cytochrome P450 2D6 Inhibitors mTOR Inhibitors
Physiological Effect	Decreased Immunologic Activity

Medical Subject Heading (MeSH) Categories for 021560

Antineoplastic Agents
Immunosuppressive Agents

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)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.25MG
Approval Date:	Apr 20, 2010	TE:	AB	RLD:	Yes
Patent:	➤ Sign Up	Patent Expiration:	Mar 9, 2020	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	➤ Sign Up	Patent Expiration:	Jan 29, 2018	Product Flag?		Substance Flag?		Delist Request?
Patent:	➤ Sign Up	Patent Expiration:	Jan 29, 2018	Product Flag?		Substance Flag?		Delist Request?

Expired US Patents for NDA 021560

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

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