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Last Updated: September 21, 2021

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Azacitidine - Generic Drug Details

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What are the generic sources for azacitidine and what is the scope of patent protection?

Azacitidine is the generic ingredient in three branded drugs marketed by Accord Hlthcare, Actavis Llc, Cipla, Dr Reddys, Eurohlth Intl Sarl, Lupin Ltd, Meitheal, Mylan Institutional, Natco Pharma Ltd, Shilpa Medicare, Celgene, and Celgene Corp, and is included in twelve NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Azacitidine has seventy-one patent family members in thirty-four countries.

There are fifteen drug master file entries for azacitidine. Thirteen suppliers are listed for this compound.

Summary for azacitidine
Drug Prices for azacitidine

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Recent Clinical Trials for azacitidine

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Kahr MedicalPhase 1/Phase 2
Massachusetts General HospitalPhase 2
Polaris GroupPhase 1

See all azacitidine clinical trials

Pharmacology for azacitidine
Medical Subject Heading (MeSH) Categories for azacitidine

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
Celgene Corp ONUREG azacitidine TABLET;ORAL 214120-002 Sep 1, 2020 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Dr Reddys AZACITIDINE azacitidine POWDER;INTRAVENOUS, SUBCUTANEOUS 201537-001 Sep 16, 2013 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Celgene Corp ONUREG azacitidine TABLET;ORAL 214120-001 Sep 1, 2020 RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
Mallinckrodt
Medtronic
Express Scripts
Merck
Johnson and Johnson

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