Azacitidine Patent Expiration

Azacitidine is Used for continued treatment of adults with acute myeloid leukemia who achieved first complete remission following intensive chemotherapy. It was first introduced by Bristol-Myers Squibb Co in its drug Vidaza on May 19, 2004. Other drugs containing Azacitidine are Azacitidine, Onureg. 16 different companies have introduced drugs containing Azacitidine.


Azacitidine Patents

Given below is the list of patents protecting Azacitidine, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Onureg US11571436 Oral formulations of cytidine analogs and methods of use thereof May 14, 2029 Bristol
Onureg US8846628 Oral formulations of cytidine analogs and methods of use thereof Jun 03, 2030 Bristol


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Azacitidine Generics

Several generic applications have been filed for Azacitidine. The first generic version for Azacitidine was by Dr Reddys Laboratories Ltd and was approved on Sep 16, 2013. And the latest generic version is by Msn Laboratories Private Ltd and was approved on May 16, 2024.

Given below is the list of companies who have filed for Azacitidine generic.


1. ACCORD HLTHCARE

Accord Healthcare Inc has filed for 1 generic for Azacitidine. Given below are the details of the strengths of this generic introduced by Accord Hlthcare.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/VIAL powder Prescription INTRAVENOUS, SUBCUTANEOUS AP Jul 2, 2018


2. CIPLA

Cipla Ltd has filed for 1 generic for Azacitidine. Given below are the details of the strengths of this generic introduced by Cipla.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/VIAL powder Prescription INTRAVENOUS, SUBCUTANEOUS AP May 4, 2018


3. DR REDDYS

Dr Reddys Laboratories Ltd has filed for 1 generic for Azacitidine. Given below are the details of the strengths of this generic introduced by Dr Reddys.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/VIAL powder Prescription INTRAVENOUS, SUBCUTANEOUS AP Sep 16, 2013


4. AMNEAL

Amneal Eu Ltd has filed for 1 generic for Azacitidine. Given below are the details of the strengths of this generic introduced by Amneal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/VIAL powder Prescription INTRAVENOUS, SUBCUTANEOUS AP Feb 3, 2022


5. MSN LABS PVT LTD

Msn Laboratories Private Ltd has filed for 1 generic for Azacitidine. Given below are the details of the strengths of this generic introduced by Msn Labs Pvt Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/VIAL powder Prescription INTRAVENOUS, SUBCUTANEOUS AP May 16, 2024


6. LUPIN LTD

Lupin Ltd has filed for 1 generic for Azacitidine. Given below are the details of the strengths of this generic introduced by Lupin Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/VIAL powder Discontinued INTRAVENOUS, SUBCUTANEOUS N/A Feb 27, 2019


7. MYLAN INSTITUTIONAL

Mylan Institutional Llc has filed for 1 generic for Azacitidine. Given below are the details of the strengths of this generic introduced by Mylan Institutional.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/VIAL powder Discontinued INTRAVENOUS, SUBCUTANEOUS N/A Apr 28, 2016


8. SHILPA MEDICARE

Shilpa Medicare Ltd has filed for 1 generic for Azacitidine. Given below are the details of the strengths of this generic introduced by Shilpa Medicare.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/VIAL powder Prescription INTRAVENOUS, SUBCUTANEOUS AP Sep 29, 2016


9. MEITHEAL

Meitheal Pharmaceuticals Inc has filed for 1 generic for Azacitidine. Given below are the details of the strengths of this generic introduced by Meitheal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/VIAL powder Prescription INTRAVENOUS, SUBCUTANEOUS AP Nov 2, 2020


10. EUGIA PHARMA

Eugia Pharma Specialities Ltd has filed for 1 generic for Azacitidine. Given below are the details of the strengths of this generic introduced by Eugia Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/VIAL powder Prescription INTRAVENOUS, SUBCUTANEOUS AP Dec 30, 2022


11. EUROHLTH INTL SARL

Eurohealth International Sarl has filed for 1 generic for Azacitidine. Given below are the details of the strengths of this generic introduced by Eurohlth Intl Sarl.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/VIAL powder Prescription INTRAVENOUS, SUBCUTANEOUS AP Jun 8, 2020


12. NATCO PHARMA LTD

Natco Pharma Ltd has filed for 1 generic for Azacitidine. Given below are the details of the strengths of this generic introduced by Natco Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/VIAL powder Prescription INTRAVENOUS, SUBCUTANEOUS AP Jun 23, 2017


13. JIANGSU HANSOH PHARM

Jiangsu Hansoh Pharmaceutical Group Co Ltd has filed for 1 generic for Azacitidine. Given below are the details of the strengths of this generic introduced by Jiangsu Hansoh Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/VIAL powder Prescription INTRAVENOUS, SUBCUTANEOUS AP Jun 28, 2023