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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 Onureg, Azacitidine. 18 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 US8846628 Oral formulations of cytidine analogs and methods of use thereof Jun 03, 2030 Bristol
Onureg US11571436 Oral formulations of cytidine analogs and methods of use thereof May 14, 2029 Bristol
Onureg US12053482 Oral formulations of cytidine analogs and methods of use thereof May 14, 2029 Bristol



Azacitidine's Family Patents

Family Patents

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Azacitidine Generic API Manufacturers

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 Reliance Life Sciences Pvt Ltd and was approved on May 20, 2025.

Given below is the list of companies who have filed for Azacitidine generic, along with the locations of their manufacturing plants worldwide.


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. 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


Manufacturing Plant Locations
New

Amneal's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Amneal as present at those locations.

Country City Firm Name
United States
Glasgow Amneal Pharmaceuticals LLC
Piscataway Amneal Pharmaceuticals, LLC
Paterson Amneal Pharmaceuticals, Llc
East Hanover Amneal Pharmaceuticals LLC
Brookhaven Amneal Pharmaceuticals of New York, LLC
Hauppauge Amneal Pharmaceuticals of New York, LLC
Bridgewater Amneal Complex Products Research LLC
Branchburg Amneal Pharmaceuticals, LLC
India
Ahmedabad Amneal Pharmaceuticals Private Ltd.
Hyderabad Amneal Oncology Private Limited
Matoda Amneal Pharmaceuticals Private Ltd.
Tal Bavla, Ahmedabad Amneal Pharmaceuticals Pvt. Ltd.





3. 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


Manufacturing Plant Locations
New

Cipla's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Cipla as present at those locations.

Country City Firm Name
India
Kurkumbh Village, Dist. Pune Cipla, Ltd.
Raigad Cipla Limited
Vasco Da Gama Cipla Limited
Bengaluru Cipla Limited
Mumbai Cipla Limited
Bangalore Cipla Ltd.
Pithampur, District Dhar Cipla Limited





4. 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





5. 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


Manufacturing Plant Locations
New

Eugia Pharma's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Eugia Pharma as present at those locations.

Country City Firm Name
India
Riico Industrial Area EUGIA Pharma Specialities Limited
Medchal-Malkajgiri District EUGIA Pharma Specialities Limited
Pashamylaram Eugia Pharma Specialities Limited





6. 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





7. HETERO LABS LTD VI

Hetero Labs Ltd Unit Vi has filed for 1 generic for Azacitidine. Given below are the details of the strengths of this generic introduced by Hetero Labs Ltd Vi.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/VIAL

powder Prescription INTRAVENOUS, SUBCUTANEOUS AP Oct 15, 2024





8. 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


Manufacturing Plant Locations
New

Jiangsu Hansoh Pharm's manufacturing plants are situated in 1 country - China. Given below are the details of these plant locations as well as the firm names of Jiangsu Hansoh Pharm as present at those locations.

Country City Firm Name
China
Lianyungang Jiangsu Hansoh Pharmaceutical Group Co., Ltd.
Lianyungang Jiangsu Hansoh Pharmaceutical Group Co., Ltd





9. 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


Manufacturing Plant Locations
New

Lupin Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Lupin Ltd as present at those locations.

Country City Firm Name
India
Aurangabad Lupin Ltd.





10. 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





11. 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





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


Manufacturing Plant Locations
New

Natco Pharma Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Natco Pharma Ltd as present at those locations.

Country City Firm Name
India
Rangareddy District Natco Pharma Ltd. - Chemical Division
Hyderabad NATCO PHARMA LTD





13. NORVIUM BIOSCIENCE

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/VIAL

powder Discontinued INTRAVENOUS, SUBCUTANEOUS N/A Apr 28, 2016





14. RELIANCE LIFE

Reliance Life Sciences Pvt Ltd has filed for 1 generic for Azacitidine. Given below are the details of the strengths of this generic introduced by Reliance Life.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/VIAL

powder Prescription INTRAVENOUS, SUBCUTANEOUS AP May 20, 2025


Manufacturing Plant Locations
New

Reliance Life's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Reliance Life as present at those locations.

Country City Firm Name
India
Navi Mumbai Reliance Life Sciences Private Limited





15. 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


Manufacturing Plant Locations
New

Shilpa Medicare's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Shilpa Medicare as present at those locations.

Country City Firm Name
India
Polepally, Jadcherla Shilpa Medicare Limited
Hyderabad Shilpa Medicare Limited
Hyderbad Shilpa Medicare Limited
Bengaluru Shilpa Medicare Limited





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