➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Merck
Moodys
Colorcon
Medtronic
Mallinckrodt
McKesson

Last Updated: September 27, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 214120


Email this page to a colleague

« Back to Dashboard

NDA 214120 describes ONUREG, which is a drug marketed by Celgene Corp and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the ONUREG profile page.

The generic ingredient in ONUREG is azacitidine. There are fifteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the azacitidine profile page.
Summary for 214120
Tradename:ONUREG
Applicant:Celgene Corp
Ingredient:azacitidine
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 214120
Medical Subject Heading (MeSH) Categories for 214120
Suppliers and Packaging for NDA: 214120
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ONUREG azacitidine TABLET;ORAL 214120 NDA Celgene Corporation 59572-730 59572-730-07 7 TABLET, FILM COATED in 1 BLISTER PACK (59572-730-07)
ONUREG azacitidine TABLET;ORAL 214120 NDA Celgene Corporation 59572-730 59572-730-14 14 TABLET, FILM COATED in 1 BOTTLE (59572-730-14)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Sep 1, 2020TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 1, 2027
Regulatory Exclusivity Use:INDICATED FOR CONTINUED TREATMENT OF ADULT PATIENTS WITH ACUTE MYELOID LEUKEMIA WHO ACHIEVED FIRST COMPLETE REMISSION (CR) OR COMPLETE REMISSION WITH INCOMPLETE BLOOD COUNT RECOVERY (CRI) FOLLOWING INTENSIVE INDUCTION CHEMOTHERAPY AND ARE NOT ABLE TO COMPLETE INTENSIVE CURATIVE THERAPY
Regulatory Exclusivity Expiration:Sep 1, 2023
Regulatory Exclusivity Use:NEW PRODUCT
Patent:⤷  Try it FreePatent Expiration:Jun 3, 2030Product Flag?YSubstance Flag?Delist Request?
Patented Use:CONTINUED TREATMENT OF ADULTS WITH ACUTE MYELOID LEUKEMIA WHO ACHIEVED FIRST COMPLETE REMISSION (CR) OR CR WITH INCOMPLETE BLOOD COUNT RECOVERY FOLLOWING INTENSIVE INDUCTION CHEMOTHERAPY AND ARE NOT ABLE TO COMPLETE INTENSIVE CURATIVE THERAPY

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Moodys
Johnson and Johnson
Harvard Business School
AstraZeneca
Dow
Medtronic

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.