FDA Orange Book · active-ingredient family
Decitabine
Decitabine is approved as 2 brand and 20 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DECITABINE · NDA 205582
2
Brand (NDA)
20
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, powder
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DECITABINERLD | SUN PHARM | NDA 205582 | — | Jan 28, 2014 | |
| DACOGENRLD | OTSUKA | NDA 021790 | — | May 02, 2006 |
Generic (ANDA) products (20)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DECITABINE | RELIANCE LIFE SCI | ANDA 217814 | AP | Dec 19, 2025 | |
| DECITABINE | HETERO LABS LTD VI | ANDA 215355 | AP | May 10, 2024 | |
| DECITABINE | JIANGSU HANSOH PHARM | ANDA 213472 | AP | Apr 15, 2022 | |
| DECITABINE | ZYDUS PHARMS | ANDA 214486 | AP | Nov 19, 2021 | |
| DECITABINE | EUGIA PHARMA | ANDA 214569 | — | Sep 20, 2021 | |
| DECITABINE | MEITHEAL | ANDA 212959 | AP | Jul 02, 2021 | |
| DECITABINE | QILU PHARM HAINAN | ANDA 212826 | AP | Apr 12, 2021 | |
| DECITABINE | NIVAGEN PHARMS INC | ANDA 212117 | AP | Dec 07, 2020 | |
| DECITABINE | GLAND | ANDA 205539 | AP | Nov 23, 2020 | |
| DECITABINE | NOVAST LABS | ANDA 210984 | — | Sep 16, 2019 | |
| DECITABINE | MSN | ANDA 212265 | AP | Aug 28, 2019 | |
| DECITABINE | WOCKHARDT BIO AG | ANDA 209056 | AP | Apr 09, 2019 | |
| DECITABINE | LUPIN | ANDA 210756 | — | Nov 09, 2018 | |
| DECITABINE | SAGENT PHARMS INC | ANDA 207100 | AP | Mar 16, 2018 | |
| DECITABINE | CIPLA | ANDA 208601 | — | Nov 16, 2017 | |
| DECITABINE | CHEMI SPA | ANDA 206033 | AP | Sep 22, 2017 | |
| DECITABINE | PHARMASCIENCE INC | ANDA 204607 | AP | May 31, 2017 | |
| DECITABINE | ACCORD HLTHCARE | ANDA 203475 | AP | Feb 27, 2017 | |
| DECITABINE | SANDOZ | ANDA 202969 | AP | Aug 28, 2014 | |
| DECITABINE | DR REDDYS | ANDA 203131 | AP | Jul 11, 2013 |
Listed patents
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.
Decitabine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
