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Last Updated: January 16, 2022

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ONUREG Drug Patent Profile


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When do Onureg patents expire, and when can generic versions of Onureg launch?

Onureg is a drug marketed by Celgene Corp and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has seventy-three patent family members in thirty-four countries.

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 ONUREG
International Patents:73
US Patents:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 25
Formulation / Manufacturing:see details
Drug Prices: Drug price information for ONUREG
What excipients (inactive ingredients) are in ONUREG?ONUREG excipients list
DailyMed Link:ONUREG at DailyMed
Drug patent expirations by year for ONUREG
Drug Prices for ONUREG

See drug prices for ONUREG

Recent Clinical Trials for ONUREG

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Brian JonasPhase 2
AbbViePhase 2
CelgenePhase 1

See all ONUREG clinical trials

Pharmacology for ONUREG
Paragraph IV (Patent) Challenges for ONUREG
Tradename Dosage Ingredient NDA Submissiondate
ONUREG TABLET;ORAL azacitidine 214120 2021-09-30

US Patents and Regulatory Information for ONUREG

ONUREG is protected by one US patents and two FDA Regulatory Exclusivities.

Patents protecting ONUREG

Oral formulations of cytidine analogs and methods of use thereof
Patent Number: ⤷  Sign up for a Free Trial
Patent Expiration: ⤷  Sign up for a Free Trial
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

FDA Regulatory Exclusivity protecting ONUREG

NEW PRODUCT
Exclusivity Expiration: ⤷  Sign up for a Free Trial

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
Exclusivity Expiration: ⤷  Sign up for a Free Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Celgene Corp ONUREG azacitidine TABLET;ORAL 214120-001 Sep 1, 2020 RX Yes No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial Y ⤷  Sign up for a Free Trial
Celgene Corp ONUREG azacitidine TABLET;ORAL 214120-002 Sep 1, 2020 RX Yes Yes ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial Y ⤷  Sign up for a Free Trial
Celgene Corp ONUREG azacitidine TABLET;ORAL 214120-001 Sep 1, 2020 RX Yes No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Mallinckrodt
Medtronic
Dow
Baxter
Moodys

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.