FDA Orange Book · active-ingredient family
Azacitidine
Azacitidine: 3 brands, 15 generics; first approved May 19, 2004; generic available.
Generic available3 exclusivity periodsHas discontinued products
Generic status & protection
Generic available: 15 ANDA applications approved.
Earliest patent expiry Latest exclusivity ends
Brands (NDA)
3
Generics (ANDA)
15
Listed patents
3
Next patent expiry
May 14, 2029
in 2 yr 9 mo
Brand (NDA) products
Originator applications
- ONUREGRLDBRISTOLNDA 21412020202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Rx — 300MG TABLET ORAL Rx — - BRISTOL-MYERSNDA 0507942004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL POWDER INTRAVENOUS, SUBCUTANEOUS Rx AP - AZACITIDINEACTAVIS LLCNDA 2082162016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL POWDER INTRAVENOUS, SUBCUTANEOUS Rx AP
Generic (ANDA) products (15)
Abbreviated applications
- AZACITIDINERELIANCE LIFEANDA 2174532025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL POWDER INTRAVENOUS, SUBCUTANEOUS Rx AP - AZACITIDINEHETERO LABS LTD VIANDA 2157652024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL POWDER INTRAVENOUS, SUBCUTANEOUS Rx AP - AZACITIDINEMSN LABS PVT LTDANDA 2125802024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL POWDER INTRAVENOUS, SUBCUTANEOUS Rx AP - AZACITIDINEJIANGSU HANSOH PHARMANDA 2159052023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL POWDER INTRAVENOUS, SUBCUTANEOUS Rx AP - AZACITIDINEEUGIA PHARMAANDA 2150662022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL POWDER INTRAVENOUS, SUBCUTANEOUS Rx AP - AZACITIDINEAMNEALANDA 2115492022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL POWDER INTRAVENOUS, SUBCUTANEOUS Discontinued — - AZACITIDINEMEITHEALANDA 2121282020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL POWDER INTRAVENOUS, SUBCUTANEOUS Rx AP - AZACITIDINEEUROHLTH INTL SARLANDA 2093372020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL POWDER INTRAVENOUS, SUBCUTANEOUS Rx AP - AZACITIDINELUPINANDA 2107482019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL POWDER INTRAVENOUS, SUBCUTANEOUS Discontinued — - AZACITIDINEACCORD HLTHCAREANDA 2074752018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL POWDER INTRAVENOUS, SUBCUTANEOUS Rx AP - AZACITIDINECIPLAANDA 2095402018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL POWDER INTRAVENOUS, SUBCUTANEOUS Rx AP - AZACITIDINENATCO PHARMA LTDANDA 2072342017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL POWDER INTRAVENOUS, SUBCUTANEOUS Rx AP - AZACITIDINESHILPA MEDICAREANDA 2075182016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL POWDER INTRAVENOUS, SUBCUTANEOUS Rx AP - AZACITIDINEPHARMOBEDIENTANDA 2049492016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL POWDER INTRAVENOUS, SUBCUTANEOUS Discontinued — - AZACITIDINEDR REDDYSANDA 2015372013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL POWDER INTRAVENOUS, SUBCUTANEOUS Rx AP
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- ODE-399Orphan-drug exclusivity (7 years)
in 2 yr 10 mo
- ODE-320Orphan-drug exclusivity (7 years)
in 1 yr 1 mo
- ODE-320Orphan-drug exclusivity (7 years)
in 1 yr 1 mo
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 12053482 | in 2 yr 9 mo | U-2950 | |
| 11571436 | in 2 yr 9 mo | Product | |
| 8846628 | in 3 yr 10 mo | ProductU-2950 |
Approval history
FDA approval span
First approval
22 yr 7 mo ago
Most recent approval
1 yr 3 mo ago
Approvals span 2004–2025 across 18 FDA applications.
Brand (NDA) 317%
Generic (ANDA) 1583%
Azacitidine: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
