FDA Orange Book · active-ingredient family
Clofarabine
Clofarabine is approved as 1 brand and 12 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CLOLAR · NDA 021673
1
Brand (NDA)
12
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CLOLARRLD | GENZYME | NDA 021673 | — | Dec 28, 2004 |
Generic (ANDA) products (12)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CLOFARABINE | SCINOPHARM TAIWAN | ANDA 216233 | AP | Jan 03, 2025 | |
| CLOFARABINE | EUGIA PHARMA | ANDA 212457 | — | Oct 03, 2022 | |
| CLOFARABINE | MEITHEAL | ANDA 213461 | AP | Oct 23, 2020 | |
| CLOFARABINE | ACCORD HLTHCARE | ANDA 212034 | AP | Feb 22, 2019 | |
| CLOFARABINE | HOSPIRA | ANDA 210283 | — | Dec 27, 2018 | |
| CLOFARABINE | GLAND | ANDA 207831 | AP | Oct 31, 2018 | |
| CLOFARABINE | INGENUS PHARMS LLC | ANDA 210270 | — | Sep 14, 2018 | |
| CLOFARABINE | MSN | ANDA 209775 | AP | Dec 06, 2017 | |
| CLOFARABINE | AMNEAL | ANDA 208857 | AP | Nov 06, 2017 | |
| CLOFARABINE | DR REDDYS | ANDA 205375 | AP | Nov 06, 2017 | |
| CLOFARABINE | PHARMOBEDIENT | ANDA 208860 | — | Nov 06, 2017 | |
| CLOFARABINE | ABON PHARMS LLC | ANDA 204029 | — | May 09, 2017 |
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.
Clofarabine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
