Last Updated: June 9, 2026

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 three 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:	3

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:	⤷ Start Trial	Patent Expiration:	Mar 11, 2027	Product Flag?		Substance Flag?	Y	Delist Request?
Patent:	⤷ Start Trial	Patent Expiration:	May 16, 2026	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Start Trial	Patent Expiration:	Mar 18, 2028	Product Flag?		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	⤷ Start Trial	⤷ Start Trial
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006	⤷ Start Trial	⤷ Start Trial
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006	⤷ Start Trial	⤷ Start Trial
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006	⤷ Start Trial	⤷ Start Trial
Msd Sub Merck	ZOLINZA	vorinostat	CAPSULE;ORAL	021991-001	Oct 6, 2006	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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