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 three patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred 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
| International Patents: | 100 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 124 |
| Clinical Trials: | 39 |
| Patent Applications: | 3,503 |
| 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 |
|---|---|
| French Innovative Leukemia Organisation | Phase 2 |
| Acute Leukemia French Association | Phase 2 |
| Yale University | Phase 2 |
Pharmacology for ONUREG
| Drug Class | Nucleoside Metabolic Inhibitor |
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
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 three US patents and one FDA Regulatory Exclusivity.
Patents protecting ONUREG
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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
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 | ⤷ Sign Up | ||||
| Bristol | ONUREG | azacitidine | TABLET;ORAL | 214120-002 | Sep 1, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 | |
| 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 |
|---|---|---|---|
| Slovenia | 3692983 | ⤷ Sign Up | |
| China | 103479586 | Oral formulations of cytidine analogs and methods of use thereof | ⤷ Sign Up |
| Mexico | 2010012470 | FORMULACIONES ORALES DE ANALOGOS DE CITIDINA Y METODOS PARA USAR LOS MISMOS. (ORAL FORMULATIONS OF CYTIDINE ANALOGS AND METHODS OF USE THEREOF.) | ⤷ Sign Up |
| Costa Rica | 11789 | FORMULACIONES ORALES DE ANALOGOS CITIDINA Y METODOS PARA EL USO DE LOS MISMOS | ⤷ Sign Up |
| Poland | 2695609 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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.
ISSN: 2162-2639
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