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Last Updated: June 20, 2024

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 Bristol and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-nine patent family members in thirty-five countries.

The generic ingredient in ONUREG is azacitidine. There are fifteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the azacitidine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Onureg

A generic version of ONUREG was approved as azacitidine by DR REDDYS on September 16th, 2013.

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Summary for ONUREG
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
City of Hope Medical CenterPhase 1
Northwestern UniversityPhase 1
Groupe Francophone des MyelodysplasiesPhase 1/Phase 2

See all ONUREG clinical trials

Pharmacology for ONUREG
Paragraph IV (Patent) Challenges for ONUREG
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ONUREG Tablets azacitidine 200 mg and 300 mg 214120 1 2021-09-30

US Patents and Regulatory Information for ONUREG

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

Patents protecting ONUREG


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Oral formulations of cytidine analogs and methods of use thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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

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

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

EU/EMA Drug Approvals for ONUREG

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Bristol-Myers Squibb Pharma EEIG Vidaza azacitidine EMEA/H/C/000978
Vidaza is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with: intermediate 2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS),chronic myelomonocytic leukaemia (CMML) with 10 29 % marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (AML) with 20 30 % blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) classification.Vidaza is indicated for the treatment of adult patients aged 65 years or older who are not eligible for HSCT with AML with >30% marrow blasts according to the WHO classification.
Authorised no no no 2008-12-17
Accord Healthcare S.L.U. Azacitidine Accord azacitidine EMEA/H/C/005147
Azacitidine Accord is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with:- intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS),- chronic myelomonocytic leukaemia (CMML) with 10-29 % marrow blasts without myeloproliferative disorder,- acute myeloid leukaemia (AML) with 20-30 % blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) classification,- AML with >30% marrow blasts according to the WHO classification.
Authorised yes no no 2020-02-13
Mylan Ireland Limited Azacitidine Mylan azacitidine EMEA/H/C/004984
Azacitidine Mylan is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with:intermediate 2 and high risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS),chronic myelomonocytic leukaemia (CMML) with 10 29% marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (AML) with 20 30% blasts and multi lineage dysplasia, according to World Health Organisation (WHO) classification,AML with > 30% marrow blasts according to the WHO classification.
Authorised yes no no 2020-03-27
betapharm Arzneimittel GmbH Azacitidine betapharm azacitidine EMEA/H/C/005075
Azacitidine betapharm is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with:intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS),chronic myelomonocytic leukaemia (CMML) with 10 % to 29 % marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (AML) with 20 % to 30 % blasts and multi-lineage dysplasia, according to World Health Organization (WHO) classification,AML with > 30 % marrow blasts according to the WHO classification.
Authorised yes no no 2020-03-24
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for ONUREG

See the table below for patents covering ONUREG around the world.

Country Patent Number Title Estimated Expiration
Australia 2015202884 ORAL FORMULATIONS OF CYTIDINE ANALOGS AND METHODS OF USE THEREOF ⤷  Sign Up
European Patent Office 3782612 FORMULATIONS ORALES D'ANALOGUES DE CYTIDINE ET LEURS PROCÉDÉS D'UTILISATION (ORAL FORMULATIONS OF CYTIDINE ANALOGS AND METHODS OF USE THEREOF) ⤷  Sign Up
Croatia P20231439 ⤷  Sign Up
Lithuania 2299984 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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