AZACITIDINE Drug Patent Profile
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Which patents cover Azacitidine, and when can generic versions of Azacitidine launch?
Azacitidine is a drug marketed by Accord Hlthcare, Actavis Llc, Amneal, Cipla, Dr Reddys, Eugia Pharma, Eurohlth Intl Sarl, Jiangsu Hansoh Pharm, Lupin Ltd, Meitheal, Msn Labs Pvt Ltd, Mylan Institutional, Natco Pharma Ltd, and Shilpa Medicare. and is included in fourteen NDAs.
The generic ingredient in AZACITIDINE 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 Azacitidine
A generic version of AZACITIDINE was approved as azacitidine by DR REDDYS on September 16th, 2013.
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Summary for AZACITIDINE
| US Patents: | 0 |
| Applicants: | 14 |
| NDAs: | 14 |
| Finished Product Suppliers / Packagers: | 17 |
| Raw Ingredient (Bulk) Api Vendors: | 123 |
| Clinical Trials: | 603 |
| Patent Applications: | 906 |
| Drug Prices: | Drug price information for AZACITIDINE |
| What excipients (inactive ingredients) are in AZACITIDINE? | AZACITIDINE excipients list |
| DailyMed Link: | AZACITIDINE at DailyMed |
Recent Clinical Trials for AZACITIDINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Antonio M Jimenez Jimenez | Phase 1 |
| Syndax Pharmaceuticals | Phase 1 |
| Akeso | Phase 2 |
Pharmacology for AZACITIDINE
| Drug Class | Nucleoside Metabolic Inhibitor |
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for AZACITIDINE
Anatomical Therapeutic Chemical (ATC) Classes for AZACITIDINE
Paragraph IV (Patent) Challenges for AZACITIDINE
| 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 AZACITIDINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Accord Hlthcare | AZACITIDINE | azacitidine | POWDER;INTRAVENOUS, SUBCUTANEOUS | 207475-001 | Jul 2, 2018 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Eurohlth Intl Sarl | AZACITIDINE | azacitidine | POWDER;INTRAVENOUS, SUBCUTANEOUS | 209337-001 | Jun 8, 2020 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Cipla | AZACITIDINE | azacitidine | POWDER;INTRAVENOUS, SUBCUTANEOUS | 209540-001 | May 4, 2018 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan Institutional | AZACITIDINE | azacitidine | POWDER;INTRAVENOUS, SUBCUTANEOUS | 204949-001 | Apr 28, 2016 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Jiangsu Hansoh Pharm | AZACITIDINE | azacitidine | POWDER;INTRAVENOUS, SUBCUTANEOUS | 215905-001 | Jun 28, 2023 | AP | RX | No | 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 AZACITIDINE
| 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 |
