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 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.
DrugPatentWatch® Litigation and Generic Entry Outlook for Onureg
A generic version of ONUREG was approved as azacitidine by DR REDDYS on September 16th, 2013.
Summary for ONUREG
International Patents: | 87 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 116 |
Clinical Trials: | 34 |
Patent Applications: | 4,829 |
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 |


Recent Clinical Trials for ONUREG
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Eastern Cooperative Oncology Group | Phase 2 |
Bristol-Myers Squibb | Phase 1 |
Bristol-Myers Squibb | Phase 2/Phase 3 |
Pharmacology for ONUREG
Drug Class | Nucleoside Metabolic Inhibitor |
Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes 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 |