Time limited offer for new users ▶ Get up to 3 months free

Serving leading biopharmaceutical companies globally:

Dow
Moodys
Johnson and Johnson
Harvard Business School
Boehringer Ingelheim
Mallinckrodt

Last Updated: January 28, 2023

ONUREG Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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 is one patent protecting this drug and one Paragraph IV challenge.

This drug has eighty-seven patent family members in thirty-five countries.

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

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
Eastern Cooperative Oncology GroupPhase 2
Bristol-Myers SquibbPhase 1
Bristol-Myers SquibbPhase 2/Phase 3

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 one US patents and two FDA Regulatory Exclusivities.

Patents protecting ONUREG

Oral formulations of cytidine analogs and methods of use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing

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: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Bristol ONUREG azacitidine TABLET;ORAL 214120-002 Sep 1, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Bristol ONUREG azacitidine TABLET;ORAL 214120-001 Sep 1, 2020 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bristol ONUREG azacitidine TABLET;ORAL 214120-001 Sep 1, 2020 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bristol ONUREG azacitidine TABLET;ORAL 214120-002 Sep 1, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Bristol-Myers Squibb Pharma EEIG Onureg azacitidine EMEA/H/C/004761
Onureg is indicated as maintenance therapy in adult patients with acute myeloid leukaemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation (HSCT).
Authorised no no no 2021-06-17
>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
Portugal 2299984 See Plans and Pricing
Poland 2695609 See Plans and Pricing
Hungary E047707 See Plans and Pricing
Slovenia 2299984 See Plans and Pricing
Russian Federation 2765076 ПЕРОРАЛЬНЫЕ СОСТАВЫ, СОДЕРЖАЩИЕ АНАЛОГИ ЦИТИДИНА, И СПОСОБЫ ИХ ИСПОЛЬЗОВАНИЯ (ORAL COMPOUNDS CONTAINING CYTIDINE ANALOGUES AND METHODS FOR USE THEREOF) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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

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.