Details for New Drug Application (NDA): 021991

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NDA 021991 describes ZOLINZA, which is a drug marketed by Msd Sub Merck and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the ZOLINZA profile page.

The generic ingredient in ZOLINZA is vorinostat. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the vorinostat profile page.

Summary for 021991

Tradename:	ZOLINZA
Applicant:	Msd Sub Merck
Ingredient:	vorinostat
Patents:	5

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 021991

Generic Entry Date for 021991^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: 7,456,219 Dosage: CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 021991

Mechanism of Action	Histone Deacetylase Inhibitors

Suppliers and Packaging for NDA: 021991

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZOLINZA	vorinostat	CAPSULE;ORAL	021991	NDA	Merck Sharp & Dohme LLC	0006-0568	0006-0568-40	120 CAPSULE in 1 BOTTLE (0006-0568-40)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Oct 6, 2006	TE:		RLD:	Yes
Patent:	7,399,787	Patent Expiration:	Feb 9, 2025	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF CUTANEOUS MANIFESTATIONS IN PATIENTS WITH CUTANEOUS T-CELL LYMPHOMA (CTCL)
Patent:	7,456,219	Patent Expiration:	Mar 11, 2027	Product Flag?		Substance Flag?	Y	Delist Request?
Patent:	7,851,509	Patent Expiration:	Feb 21, 2024	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF CUTANEOUS MANIFESTATIONS IN PATIENTS WITH CUTANEOUS T-CELL LYMPHOMA (CTCL)

Expired US Patents for NDA 021991

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006	8,067,472	⤷ Subscribe
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006	6,087,367	⤷ Subscribe
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006	RE38506	⤷ Subscribe
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006	8,101,663	⤷ Subscribe
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006	7,851,509	⤷ Subscribe
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