FDA Orange Book · active-ingredient family
Decitabine
Decitabine: 2 brands, 20 generics; first approved May 02, 2006; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 20 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
20
Listed patents
0
Presentations
22
Brand (NDA) products
Originator applications
- DECITABINERLDSUN PHARMNDA 2055822014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL POWDER INTRAVENOUS Discontinued — - DACOGENRLDOTSUKANDA 0217902006
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL INJECTABLE INTRAVENOUS Discontinued —
Generic (ANDA) products (20)
Abbreviated applications
- DECITABINERELIANCE LIFE SCIANDA 2178142025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL INJECTABLE INTRAVENOUS Rx AP - DECITABINEHETERO LABS LTD VIANDA 2153552024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL INJECTABLE INTRAVENOUS Rx AP - DECITABINEJIANGSU HANSOH PHARMANDA 2134722022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL INJECTABLE INTRAVENOUS Rx AP - DECITABINEZYDUS PHARMSANDA 2144862021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL INJECTABLE INTRAVENOUS Rx AP - DECITABINEEUGIA PHARMAANDA 2145692021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL INJECTABLE INTRAVENOUS Discontinued — - DECITABINEMEITHEALANDA 2129592021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL INJECTABLE INTRAVENOUS Rx AP - DECITABINEQILU PHARM HAINANANDA 2128262021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL INJECTABLE INTRAVENOUS Rx AP - DECITABINENIVAGEN PHARMS INCANDA 2121172020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL INJECTABLE INTRAVENOUS Rx AP - DECITABINEGLANDANDA 2055392020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL INJECTABLE INTRAVENOUS Rx AP - DECITABINEINGENUS PHARMS LLCANDA 2109842019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL INJECTABLE INTRAVENOUS Discontinued — - DECITABINEMSNANDA 2122652019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL INJECTABLE INTRAVENOUS Rx AP - DECITABINEWOCKHARDT BIO AGANDA 2090562019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL INJECTABLE INTRAVENOUS Rx AP - DECITABINELUPINANDA 2107562018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL INJECTABLE INTRAVENOUS Discontinued — - DECITABINESAGENT PHARMS INCANDA 2071002018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL INJECTABLE INTRAVENOUS Rx AP - DECITABINECIPLAANDA 2086012017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL INJECTABLE INTRAVENOUS Discontinued — - DECITABINECHEMI SPAANDA 2060332017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL INJECTABLE INTRAVENOUS Rx AP - DECITABINEPHARMASCIENCE INCANDA 2046072017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL INJECTABLE INTRAVENOUS Rx AP - DECITABINEACCORD HLTHCAREANDA 2034752017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL INJECTABLE INTRAVENOUS Rx AP - DECITABINESANDOZANDA 2029692014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL INJECTABLE INTRAVENOUS Rx AP - DECITABINERSDR REDDYSANDA 2031312013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL INJECTABLE INTRAVENOUS Rx AP
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
20 yr 7 mo ago
Most recent approval
8 mo ago
Approvals span 2006–2025 across 22 FDA applications.
Brand (NDA) 29%
Generic (ANDA) 2091%
Decitabine: 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.
