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Last Updated: April 1, 2023

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 nine 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
Applicant:Msd Sub Merck
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 021991
Generic Entry Date for 021991*:
Constraining patent/regulatory exclusivity:

*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 ActionHistone 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:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Oct 6, 2006TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Feb 9, 2025Product Flag?Substance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Mar 11, 2027Product Flag?Substance Flag?YDelist Request?
Patent:⤷  Sign UpPatent Expiration:Mar 4, 2023Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021991

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Msd Sub Merck ZOLINZA vorinostat CAPSULE;ORAL 021991-001 Oct 6, 2006 ⤷  Sign Up ⤷  Sign Up
Msd Sub Merck ZOLINZA vorinostat CAPSULE;ORAL 021991-001 Oct 6, 2006 ⤷  Sign Up ⤷  Sign Up
Msd Sub Merck ZOLINZA vorinostat CAPSULE;ORAL 021991-001 Oct 6, 2006 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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 verification 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.