Orange Book product · Brand (NDA)

ZOLINZA

VORINOSTAT

Brand (NDA)NDA 021991RX MSD SUB MERCK

Oct 06, 2006

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Oct 06, 2006
20 yr ago
Patent 8093295 expires
Listed drug product patent expiration.
May 16, 2026
1 mo ago
Today
Patent 7456219 expires
Listed drug substance patent expiration.
Mar 11, 2027
in 9 mo
Patent 8450372 expires
Listed method-of-use patent (U-892) expiration.
Mar 18, 2028
in 1 yr 9 mo

Active ingredient

VORINOSTAT

Strength

100MG

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 021991

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8093295	May 16, 2026	1 mo ago	Product
7456219	Mar 11, 2027	in 9 mo	Substance
8450372	Mar 18, 2028	in 1 yr 9 mo	U-892